A Study on the Safety, Reactogenicity, and Immune Response to the GVGH iNTS-GMMA Vaccine Against Invasive Nontyphoidal Salmonella in Adults, Children, and Infants
Phase 2
Recruiting
- Conditions
- Salmonella Infections
- Interventions
- Biological: iNTS-GMMA Dose CBiological: MenACWYBiological: Measles and Rubella vaccineBiological: iNTS-GMMA Dose BBiological: Yellow Fever vaccineDrug: PlaceboBiological: iNTS-GMMA Dose ABiological: Pentavalent vaccineCombination Product: DTPa-HBV-IPV+HibBiological: Pneumococcal vaccineBiological: Inactivated polio vaccine
- Registration Number
- NCT06213506
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The purpose of this study is to evaluate the safety, reactogenicity, and immune response of the GlaxoSmithKline (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-generalized modules for membrane antigens (iNTS-GMMA) candidate vaccine against S. Typhimurium and S. Enteritidis with an age de-escalation and dose escalation approach in African population, starting with adults (18-50 years of age), then on children (24-59 months of age) and finally to infants (9 months and 6 weeks of age). Infants are the target for primary vaccination from 6 weeks of age.
- Detailed Description
The study will be conducted in two stages:
Stage 1: Age De-escalation from Adults to Children and Infants
* Adult participants will receive either iNTS-GMMA Dose C (high) or a control vaccine intramuscularly on Day 1 and Day 57.
* Child participants will receive either Dose B (medium) or Dose C (high) of the candidate vaccine or the control on Day 1 and Day 57.
* Infant participants (9 months of age) will receive either Dose A (low), Dose B (medium), or Dose C (high) of the candidate vaccine or the control on Day 1, Day 85, and Day 169.
* Infant participants (6 weeks of age) will receive either Dose A (low), Dose B (medium), or Dose C (high) of the candidate vaccine or the control on Day 1, Day 85 (Priming phase), and Day 232 (Booster phase).
Stage 2: Dose-finding in Infants of 6 weeks of age
-Infants (6 weeks of age) will receive one of the three dose levels (Dose A \[low\], Dose B \[medium\], or Dose C \[high\]) of the candidate vaccine or the control on Day 1, Day 85 (Priming phase), and Day 232 (Booster phase).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 516
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Children_Dose C Group iNTS-GMMA Dose C Children 24-59 months of age, part of the safety cohort, randomized to receive 2 doses of the iNTS-GMMA Dose C vaccine at Day 1 and Day 57. Infants_9M_Control A Group Yellow Fever vaccine Infants 9 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPaHBV-IPV+Hib vaccine at Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_9M_Control B Group DTPa-HBV-IPV+Hib Infants 9 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPaHBV-IPV+Hib vaccine at Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Adults_Dose C Group iNTS-GMMA Dose C Adults 18-50 years of age, part of the safety cohort, randomized to receive 2 doses of the iNTS-GMMA Dose C vaccine at Day 1 and Day 57. Adults_Control Group Placebo Adults 18-50 years of age, part of the safety cohort, randomized to receive 1 dose of the MenACWY vaccine at Day 1 and 1 dose of Placebo at Day 57. Children_Control C Group MenACWY Children 24-59 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 57. Infants_9M_Dose B Group Measles and Rubella vaccine Infants 9 months of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose B vaccine at Day 1, Day 85 and Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_9M_Dose C Group Measles and Rubella vaccine Infants 9 months of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose C vaccine at Day 1, Day 85 and Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Adults_Control Group MenACWY Adults 18-50 years of age, part of the safety cohort, randomized to receive 1 dose of the MenACWY vaccine at Day 1 and 1 dose of Placebo at Day 57. Children_Dose B Group iNTS-GMMA Dose B Children 24-59 months of age, part of the safety cohort, randomized to receive 2 doses of the iNTS-GMMA Dose B vaccine at Day 1 and Day 57. Infants_9M_Dose A Group Measles and Rubella vaccine Infants 9 months of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose A vaccine at Day 1, Day 85 and Day 169. These infants also receive an Expanded Program on Immunization (EPI) vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_9M_Dose A Group Yellow Fever vaccine Infants 9 months of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose A vaccine at Day 1, Day 85 and Day 169. These infants also receive an Expanded Program on Immunization (EPI) vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Children_Control B Group MenACWY Children 24-59 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 57. Infants_9M_Dose C Group Yellow Fever vaccine Infants 9 months of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose C vaccine at Day 1, Day 85 and Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_9M_Control C Group Yellow Fever vaccine Infants 9 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPaHBV-IPV+Hib vaccine at Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_9M_Dose A Group iNTS-GMMA Dose A Infants 9 months of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose A vaccine at Day 1, Day 85 and Day 169. These infants also receive an Expanded Program on Immunization (EPI) vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_9M_Dose B Group Yellow Fever vaccine Infants 9 months of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose B vaccine at Day 1, Day 85 and Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_9M_Control B Group Yellow Fever vaccine Infants 9 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPaHBV-IPV+Hib vaccine at Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Control C Group Yellow Fever vaccine Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the MenACWY vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). To allow completion of the vaccination schedule a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_9M_Dose C Group iNTS-GMMA Dose C Infants 9 months of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose C vaccine at Day 1, Day 85 and Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_9M_Control A Group Measles and Rubella vaccine Infants 9 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPaHBV-IPV+Hib vaccine at Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_9M_Control A Group MenACWY Infants 9 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPaHBV-IPV+Hib vaccine at Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_9M_Control A Group DTPa-HBV-IPV+Hib Infants 9 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPaHBV-IPV+Hib vaccine at Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_9M_Dose B Group iNTS-GMMA Dose B Infants 9 months of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose B vaccine at Day 1, Day 85 and Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_9M_Control B Group Measles and Rubella vaccine Infants 9 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPaHBV-IPV+Hib vaccine at Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_9M_Control B Group MenACWY Infants 9 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPaHBV-IPV+Hib vaccine at Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose A Group Measles and Rubella vaccine Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose A vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Control A Group Yellow Fever vaccine Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the MenACWY vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). To allow completion of the vaccination schedule a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose B Group Measles and Rubella vaccine Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose B vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_9M_Control C Group Measles and Rubella vaccine Infants 9 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPaHBV-IPV+Hib vaccine at Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_9M_Control C Group DTPa-HBV-IPV+Hib Infants 9 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPaHBV-IPV+Hib vaccine at Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose A Group Yellow Fever vaccine Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose A vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Control B Group Yellow Fever vaccine Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the MenACWY vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). To allow completion of the vaccination schedule a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_9M_Control C Group MenACWY Infants 9 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPaHBV-IPV+Hib vaccine at Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose A Group iNTS-GMMA Dose A Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose A vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Control A Group MenACWY Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the MenACWY vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). To allow completion of the vaccination schedule a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose C Group Measles and Rubella vaccine Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose C vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose C Group Yellow Fever vaccine Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose C vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Control A Group Measles and Rubella vaccine Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the MenACWY vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). To allow completion of the vaccination schedule a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose B Group iNTS-GMMA Dose B Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose B vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Control C Group Measles and Rubella vaccine Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the MenACWY vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). To allow completion of the vaccination schedule a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose B Group Yellow Fever vaccine Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose B vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Control B Group Measles and Rubella vaccine Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the MenACWY vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). To allow completion of the vaccination schedule a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose C Group iNTS-GMMA Dose C Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose C vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose A_2 Group Yellow Fever vaccine Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose A vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Control B Group MenACWY Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the MenACWY vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). To allow completion of the vaccination schedule a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose A_2 Group Pentavalent vaccine Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose A vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose A_2 Group Pneumococcal vaccine Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose A vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose B_2 Group Yellow Fever vaccine Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose B vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Control C Group MenACWY Infants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the MenACWY vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). To allow completion of the vaccination schedule a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose A_2 Group Inactivated polio vaccine Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose A vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose B_2 Group Measles and Rubella vaccine Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose B vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose A_2 Group Measles and Rubella vaccine Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose A vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose B_2 Group Pentavalent vaccine Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose B vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose C_2 Group Yellow Fever vaccine Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose C vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Control_2 Group Inactivated polio vaccine Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the MenACWY vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). To allow completion of the vaccination schedule a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last study intervention administration at Day 232, and the pentavalent vaccine (DTPw-HepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose A_2 Group iNTS-GMMA Dose A Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose A vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose B_2 Group Pneumococcal vaccine Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose B vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose B_2 Group Inactivated polio vaccine Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose B vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose C_2 Group Measles and Rubella vaccine Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose C vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose C_2 Group Pentavalent vaccine Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose C vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Control_2 Group Pentavalent vaccine Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the MenACWY vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). To allow completion of the vaccination schedule a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last study intervention administration at Day 232, and the pentavalent vaccine (DTPw-HepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose C_2 Group iNTS-GMMA Dose C Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose C vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Control_2 Group MenACWY Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the MenACWY vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). To allow completion of the vaccination schedule a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last study intervention administration at Day 232, and the pentavalent vaccine (DTPw-HepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose B_2 Group iNTS-GMMA Dose B Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose B vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Control_2 Group Measles and Rubella vaccine Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the MenACWY vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). To allow completion of the vaccination schedule a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last study intervention administration at Day 232, and the pentavalent vaccine (DTPw-HepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose C_2 Group Pneumococcal vaccine Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose C vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Dose C_2 Group Inactivated polio vaccine Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose C vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Control_2 Group Yellow Fever vaccine Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the MenACWY vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). To allow completion of the vaccination schedule a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last study intervention administration at Day 232, and the pentavalent vaccine (DTPw-HepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial. Infants_6W_Control_2 Group Pneumococcal vaccine Infants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the MenACWY vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). To allow completion of the vaccination schedule a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last study intervention administration at Day 232, and the pentavalent vaccine (DTPw-HepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial.
- Primary Outcome Measures
Name Time Method Percentage of adult participants 18-50 years of age with unsolicited adverse events (AEs) During 28 days after the second study intervention administration occurring at Day 57 An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Percentage of child participants 24-59 months of age with unsolicited AEs During 28 days after the second study intervention administration occurring at Day 57 An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Percentage of child participants 24-59 months of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results At Day 64 (7 days after the second study intervention administration) Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in infants 6 weeks of age part of the dose-finding cohort At Day 85 (28 days after the second study intervention administration) Anti-Salmonella Typhimurium (S. Typhimurium) O antigen (Ag) total IgG and anti-Salmonella Enteritidis (S. Enteritidis) OAg total IgG GMCs are assessed.
Percentage of adult participants 18-50 years of age with deviations from reference ranges l or baseline values for hematological, renal and hepatic panel test results At Day 8 (7 days after the first study intervention administration) Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Percentage of child participants 24-59 months of age with solicited administration site events During 7 days after the second study intervention administration occurring at Day 57 The solicited administration site events are pain, redness and swelling.
Percentage of child participants 24-59 months of age with serious adverse events (SAEs) From first study intervention administration (Day 1) up to the end of study participation (Day 85) An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity or any other situation based on appropriate medical or scientific judgement.
Percentage of infant participants 9 months of age with solicited systemic events During 7 days after the third study intervention administration occurring at Day 169 The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting. Fever is defined as axillary temperature \>= 38.0 °C/100.4 degrees °F.
Percentage of adult participants 18-50 years of age with serious adverse events (SAEs) From first study intervention administration (Day 1) up to the end of study participation (Day 85) An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in abnormal pregnancy outcomes.
Percentage of adult participants 18-50 years of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results At Day 64 (7 days after the second study intervention administration) Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Percentage of child participants 24-59 months of age with solicited systemic events During 7 days after the second study intervention administration occurring at Day 57 The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness and vomiting. Fever is defined as axillary temperature \>= 38.0 °C/100.4 degrees °F.
Percentage of child participants 24-59 months of age with AEs leading to withdrawal from the study or discontinuation of study intervention From first study intervention administration (Day 1) up to the end of study participation (Day 85) An AE is any untoward medical occurrence (an unfavorable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. Any AEs that lead to discontinuation of study intervention and/or the study are considered under this outcome measure.
Percentage of infant participants 9 months of age with solicited administration site events During 7 days after the third study intervention administration occurring at Day 169 The solicited administration site events are pain, redness and swelling.
Percentage of infant participants 6 weeks of age with solicited systemic events During 7 days after the second study intervention administration occurring at Day 57 in the Priming phase The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting. Fever is defined as axillary temperature \>= 38.0 °C/100.4 degrees °F.
Percentage of adult participants 18-50 years of age with solicited administration site events During 7 days after the second study intervention administration occurring at Day 57 The solicited administration site events are pain, redness and swelling.
Percentage of adult participants 18-50 years of age with adverse events (AEs) leading to withdrawal from the study or discontinuation of study intervention From first study intervention administration (Day 1) up to the end of study participation (Day 85) An AE is any untoward medical occurrence (an unfavorable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. Any AEs that lead to discontinuation of study intervention and/or the study are considered under this outcome measure.
Percentage of infant participants 9 months of age with unsolicited adverse events (AEs) During 28 days after the third study intervention administration occurring at Day 169 An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Percentage of infant participants 9 months of age with serious adverse events (SAEs) From first study intervention administration (Day 1) up to the end of study participation (Day 337) An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity or any other situation based on appropriate medical or scientific judgement.
Percentage of infant participants 6 weeks of age with adverse events (AEs) leading to MR-VAC administration withdrawal from the study or discontinuation of study intervention From first study intervention administration (Day 1) up to 28 days after second study intervention (Day 85) An AE is any untoward medical occurrence (an unfavorable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. Any AEs that lead to discontinuation of study intervention and/or the study are considered under this outcome measure.
Percentage of adult participants 18-50 years of age with solicited systemic events During 7 days after the second study intervention administration occurring at Day 57 The solicited systemic events are fever, headache, myalgia, arthralgia and fatigue. Fever is defined as axillary temperature \>= 38.0 °C/100.4 degrees °F.
Percentage of infant participants 9 months of age with adverse events (AEs) leading to withdrawal from the study or discontinuation of study intervention From first study intervention administration (Day 1) up to the end of study participation (Day 337) An AE is any untoward medical occurrence (an unfavorable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. Any AEs that lead to discontinuation of study intervention and/or the study are considered under this outcome measure.
Percentage of infant participants 9 months of age with deviations from reference range or baseline values for hematological, renal and hepatic panel test results At Day 176 (7 days after the third study intervention administration) Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Percentage of infant participants 6 weeks of age with solicited administration site events During 7 days after the second study intervention administration occurring at Day 57 in the Priming phase The solicited administration site events are pain, redness and swelling.
Percentage of infant participants 6 weeks of age with deviations from reference ranges or baseline values for hematological, renal, and hepatic panel test results at Day 64 At Day 64 (7 days after the second study intervention administration) in the Priming phase Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Percentage of infant participants 6 weeks of age with unsolicited adverse events (AEs) During 28 days after the second study intervention administration occurring at Day 57 in the Priming phase An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Percentage of infant participants 6 weeks of age with deviations from reference ranges or baseline values for hematological, renal, and hepatic panel test results At Day 8 (7 days after the first study intervention administration) in the Priming phase Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Percentage of infant participants 6 weeks of age with SAEs From first study intervention administration (Day 1) up to 28 days after second study intervention (Day 85) An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity or any other situation based on appropriate medical or scientific judgement.
- Secondary Outcome Measures
Name Time Method Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in infants 6 weeks of age dose finding cohort At Day 260 (28 days after the booster study intervention administration) Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG GMCs are assessed.
Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in infant participants 6 weeks of age At Days 1, 57 and 232 (before each study intervention administration) at Days 29, 85 and 260 (28 days after each study intervention administration) and at Day 239 (7 days after the third study intervention administration) Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG GMCs are assessed.
Percentage of infant participants 6 weeks of age with solicited systemic events During 7 days after the third study intervention administration occurring at Day 232 in the Booster phase The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting. Fever is defined as axillary temperature \>= 38.0 °C/100.4 degrees °F
Percentage of infant participants 6 weeks of age with deviations from reference ranges or baseline values for hematological, renal, and hepatic panel test results At Day 239 (7 days after the study intervention administration) in the Booster phase Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Percentage of infant participants 6 weeks of age with solicited administration site events During 7 days after the third study intervention administration occurring at Day 232 in the Booster phase The solicited administration site events are pain, redness and swelling.
Number of infant participants 6 weeks of age with unsolicited AEs During 28 days after the third study intervention administration occurring at Day 232 in the Booster phase An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Percentage of infant participants 6 weeks of age with adverse events (AEs) leading to withdrawal from the study or discontinuation of study intervention From 28 days after the second study intervention administration (Day 85) up to end of study participation (Day 400) An AE is any untoward medical occurrence (an unfavorable /unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. Any AEs that lead to discontinuation of study intervention and/or the study are considered under this outcome measure.
Anti-Hib polyribosylribitol phosphate (PRP) geometric mean concentrations (GMCs), in a subset of infant participants 6 weeks of age (dose-finding cohort) At Day 1 (before the first study intervention administration) and at Day 85 (28 days after the third pentavalent vaccine administration) Percentage of infant participants 6 weeks of age with SAEs From 28 days after the second study intervention administration (Day 85) up to end of study participation (Day 400) An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity or any other situation based on appropriate medical or scientific judgement.
Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in child participants 24-59 months of age At Days 1 and 57 (before each study intervention administration) and at Days 29 and 85 (28 days after each study intervention administration) Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG GMCs are assessed.
Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in infant participants 9 months of age At Days 1, 85 and 169 (before each study intervention administration) and at Days 29, 113 and 197 (28 days after each study intervention administration) Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG GMCs are assessed.
Percentage of infant participants 6 weeks of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration At Days 29, 85 and 260 (28 days after each study intervention administration) and at Day 239 (7 days after the third study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration) Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG antibody concentrations are assessed.
Percentage of a subset of infant participants 6 weeks of age (dose finding cohort) achieving an anti-rubella IgG antibody concentration of ≥ 4 international units per milliliter (IU/mL) and ≥ 10 IU/mL At Day 232 (before MR-VAC administration) and at Day 260 (28 days after MR-VAC administration) Percentage of a subset of infant participants 6 weeks of age (dose finding cohort) achieving an anti-Hepatitis B IgG antibody concentration of ≥ 10 mIU/mL At Day 1 (before the first study intervention administration) and at Day 85 (28 days after third pentavalent vaccine administration) Percentage of adult participants 18-50 years of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration At Days 29 and 85 (28 days after each study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration) Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgGantibody concentrations are assessed.
Percentage of child participants 24-59 months of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration At Days 29 and 85 (28 days after each study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration) Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG antibody concentrations are assessed.
Percentage of infant participants 9 months of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration At Days 29, 113 and 197 (28 days after each study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration) Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG antibody concentrations are assessed.
Percentage of a subset of infant participants 6 weeks of age (dose-finding cohort) achieving an anti-measles IgG antibody concentration of equal to or above (≥) 150 milli international units per milliliter (mIU/mL) and ≥ 200 mIU/mL At Day 232 (before MR-VAC administration) and at Day 260 (28 days after MR-VAC administration) Percentage of a subset of infant participants 6 weeks of age (dose-finding cohort) achieving an anti-Hib polyribosylribitol phosphate (PRP) IgG antibody concentration of ≥ 0.15 microgram per milliliter (µg/mL) At Day 1 (before the first study intervention administration) and at Day 85 (28 days after third pentavalent vaccine administration) Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in adult participants 18-50 years of age At Days 1 and 57 (before each study intervention administration) and at Days 29 and 85 (28 days after each study intervention administration) Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG GMCs are assessed.
Anti-Hepatitis B surface (HBs) antigen (Ag) geometric mean concentrations (GMCs), in a subset of infant participants 6 weeks of age (dose-finding cohort) At Day 1 (before the first study intervention administration) and at Day 85 (28 days after the third pentavalent vaccine administration) Anti-measles immunoglobulin G (IgG) antibody geometric mean concentrations (GMCs), in a subset of infant participants 6 weeks of age (dose-finding cohort) At Day 232 (before MR-VAC administration) and at Day 260 (28 days after MR-VAC administration) Anti-rubella immunoglobulin G (IgG) antibody geometric mean concentrations (GMCs), in a subset of infant participants 6 weeks of age (dose-finding cohort) At Day 232 (before MR-VAC administration) and at Day 260 (28 days after MR-VAC administration)
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇭Kumasi, Ghana