Safety and Immunogenicity of Catch-up Vaccination Regimens of V114 (V114-024)
- Conditions
- Pneumococcal Infections
- Interventions
- Biological: V114Biological: Prevnar 13®
- Registration Number
- NCT03885934
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is 1) to evaluate the safety and tolerability of V114 with respect to the proportion of participants with adverse events (AEs) and 2) to evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days following the last dose for each vaccination group. There is no formal hypothesis testing in this study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 606
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description V114, Schedule C: Participants 2-17 years V114 Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced. V114, Schedule B: Participants 12-23 months V114 Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1. Prevnar 13®, Schedule B: Participants 12-23 months Prevnar 13® Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1. Prevnar 13®, Schedule A: Participants 7-11 months Prevnar 13® Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age. Prevnar 13®, Schedule C: Participants 2-17 years Prevnar 13® Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced. V114, Schedule A: Participants 7-11 months V114 Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \[PCV\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
- Primary Outcome Measures
Name Time Method Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months 30 days post last vaccination The geometric mean concentration (GMC) of immunoglobulin G (IgG) serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-pneumococcal polysaccharides (PnPs) serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% confidence intervals (CIs) were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
GMC of Serotype-specific IgG - Schedule B: 12-23 Months 30 days post last vaccination The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
GMC of Serotype-specific IgG - Schedule C: 2-17 Years 30 days post vaccination The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Percentage of Participants With Solicited Injection-site Adverse Events - Schedule A: 7-11 Months Up to 14 days post any vaccination An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized.
Percentage of Participants With Solicited Injection-site AEs - Schedule B: 12-23 Months Up to 14 days post any vaccination An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized.
Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years Up to 14 days post vaccination An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to \<3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. For participants ≥3 years of age at enrollment, solicited systemic AEs include muscle pain/ myalgia, joint pain/arthralgia, headache, tiredness/fatigue, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized.
Percentage of Participants With Solicited Systemic AEs - Schedule A: 7-11 Months Up to 14 days post any vaccination An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to \<3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized.
Percentage of Participants With at Least 1 Vaccine-related SAE - Schedule B: 12-23 Months Up to ~6 months post final vaccination A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.
Percentage of Participants With Solicited Systemic AEs - Schedule B: 12-23 Months Up to 14 days post any vaccination An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to \<3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized.
Percentage of Participants With at Least 1 Vaccine-related Serious Adverse Event - Schedule A: 7-11 Months Up to ~6 months post final vaccination A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.
Percentage of Participants With Solicited Injection-site AEs - Schedule C: 2-17 Years Up to 14 days post vaccination An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized.
Percentage of Participants With at Least 1 Vaccine-related SAE - Schedule C: 2-17 Years Up to ~6 months post vaccination A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months 30 days post final vaccination Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL assay. The percentage that achieved the IgG threshold value of ≥0.35 μg/mL was summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months 30 days post final vaccination Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL assay. The percentage that achieved the IgG threshold value of ≥0.35 μg/mL was summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan. The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years 30 days post vaccination Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL assay. The percentage that achieved the IgG threshold value of ≥0.35 μg/mL was summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.
Trial Locations
- Locations (26)
Uniwersytecki Szpital Kliniczny ( Site 0207)
🇵🇱Wroclaw, Poland
Research Institute of Children Infections ( Site 0301)
🇷🇺Saint Petersburg, Russian Federation
Children s City Polyclinic No. 45 of the Nevsky District ( Site 0312)
🇷🇺St.Petersburg, Russian Federation
Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)
🇫🇮Tampere, Finland
Tampereen yliopisto Porin rokotetutkimusklinikka ( Site 0008)
🇫🇮Pori, Finland
Seinajoki Vaccine Research Center ( Site 0010)
🇫🇮Seinajoki, Finland
Sabah Womens & Childrens Hospital ( Site 0902)
🇲🇾Kota Kinabalu, Malaysia
Przychodnia Vitamed Gaaj i Cichomski Spolka Jawna ( Site 0212)
🇵🇱Bydgoszcz, Poland
Tampereen yliopisto Etelä-Helsingin rokotetutkimusklinikka ( Site 0005)
🇫🇮Helsinki, Finland
Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)
🇫🇮Turku, Finland
MAI Childrens City Clinical Hospital 11 ( Site 0305)
🇷🇺Ekaterinburg, Russian Federation
Siriraj Hospital ( Site 0600)
🇹🇭Bangkok, Thailand
Central Clinical Hospital of Russian Academy Science ( Site 0317)
🇷🇺Moscow, Russian Federation
Tampereen yliopisto Ita-Helsingin rokotetutkimusklinikka ( Site 0006)
🇫🇮Helsinki, Finland
Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)
🇫🇮Espoo, Finland
Srinagarind Hospital ( Site 0602)
🇹🇭Khonkaen, Thailand
Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0009)
🇫🇮Kokkola, Finland
Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)
🇫🇮Jarvenpaa, Finland
University Malaya Medical Centre ( Site 0901)
🇲🇾Kuala Lumpur, Malaysia
SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 0209)
🇵🇱Lomianki, Poland
NZ Lecznictwa Ambulatoryjnego - Michalkowice - Jarosz i Partnerzy ( Site 0211)
🇵🇱Siemianowice Slaskie, Poland
Vaccine Trial Center Faculty of Tropical Medicine ( Site 0603)
🇹🇭Bangkok, Thailand
Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)
🇫🇮Oulu, Finland
Spec Zesp Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu ( Site 0213)
🇵🇱Poznan, Poland
Chulalongkorn University ( Site 0601)
🇹🇭Bangkok, Thailand
Centrum Medyczne Pratia Bydgoszcz ( Site 0210)
🇵🇱Bydgoszcz, Poland