Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)
- Conditions
- Virus DiseasesBacterial Infections
- Interventions
- Biological: INFANRIX™ hexaBiological: V419Biological: RotaTeqBiological: Prevenar 13Biological: ProQuad™
- Registration Number
- NCT01341639
- Lead Sponsor
- MCM Vaccines B.V.
- Brief Summary
This study will determine whether participants who receive the vaccine V419 at 2, 3, 4, and 12 months of age have an acceptable immune response to the vaccine. The study will also determine whether the immune response to V419 is similar to that of participants who receive a licensed vaccine control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1250
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description INFANRIX™ hexa INFANRIX™ hexa INFANRIX™ hexa + RotaTeq + Prevenar 13 + ProQuad PR5I RotaTeq V419 + RotaTeq + Prevenar 13 + ProQuad PR5I ProQuad™ V419 + RotaTeq + Prevenar 13 + ProQuad PR5I V419 V419 + RotaTeq + Prevenar 13 + ProQuad INFANRIX™ hexa RotaTeq INFANRIX™ hexa + RotaTeq + Prevenar 13 + ProQuad INFANRIX™ hexa Prevenar 13 INFANRIX™ hexa + RotaTeq + Prevenar 13 + ProQuad PR5I Prevenar 13 V419 + RotaTeq + Prevenar 13 + ProQuad INFANRIX™ hexa ProQuad™ INFANRIX™ hexa + RotaTeq + Prevenar 13 + ProQuad
- Primary Outcome Measures
Name Time Method Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months One month after post-dose 3 of PRI5 (5 months old) Antibody titres were measured by RIA for PRP, MIT for diphtheria \& poliovirus, and ELISA for tetanus. Percentage of participants with an Ab titre ≥0.15 μg/mL for Hib) (PRP); ≥0.01 IU/mL; for diphtheria \& tetanus; ≥8 (1/dil) for inactivated poliovirus types 1, 2 \& 3 (IPV1, 2 \& 3) are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months One month after Toddler dose of PRI5 (13 months old) Antibody titres in the PR5I group were measured by RIA for PRP, MIT for diphtheria \& poliovirus, enhanced Chemiluminescence assay (ECi)) for Hepatitis B surface antigen (HBsAg) and ELISA for tetanus, Pertussis toxoid (PT), Filamentous haemagglutinin (FHA), Fimbriae types 2 \& 3 (FIM) \& Pertactin (PRN). Percentage of participants with an Ab titre ≥1.0 μg/mL for Hib (PRP); ≥0.1 IU/mL; for diphtheria \& tetanus; ≥10 mIU/mL HBsAg; ≥8 (1/dil) for IPV1, 2 \& 3, and seroresponse to PT, FHA, FIM and PRN are reported. 95% confidence interval (CI) were calculated based on the exact binomial method by Clopper and Pearson. The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the lower CI limits for PRP, PT, FHA, FIM, and PRN (75%); Diphtheria (80%); HBsAG, IPV 1, 2, 3 (90%).
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old One month after Toddler dose of PRI5 (13 months old) Antibody titres were measured by ECi for HBsAg and ELISA for PT, FHA, \& PRN. Percentage of participants with an Ab titre ≥10 mIU/mL HBsAg; ≥8 (1/dil) for IPV1, 2 \& 3, and seroresponse to PT, FHA, and PRN are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.
Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months One month after post-dose 3 of PRI5 (5 months old) Antibody titres in the PR5I group were measured by Radioimmunoassay (RIA) for Haemophilus influenzae type b (PRP), Micrometabolic inhibition test (MIT) for diphtheria \& poliovirus, and Enzyme-Linked Immunosorbent Assay (ELISA) for tetanus. Percentage of participants with an Ab titre ≥0.15 μg/mL for Haemophilus influenzae type b (Hib) (polyribosylribitol phosphate, PRP); ≥0.01 IU/mL; for diphtheria \& tetanus; ≥8 (1/dil) for inactivated poliovirus types 1, 2 \& 3 (IPV1, 2 \& 3) are reported. 95% confidence interval (CI) were calculated based on the exact binomial method by Clopper and Pearson. The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the predetermined lower CI limits for PRP, diphtheria (80%), tetanus (90%), and IPV1, 2 \& 3 (90%).
- Secondary Outcome Measures
Name Time Method Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination Day 1 to Day 15 after any vaccination Unsolicited ISRs with incidence ≥1% after any vaccination were reported daily on the VRC by the parent(s) or legal representative from (D1-D15). AEs at injection sites were always considered as vaccine-related ISRs
Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination Day 1 to Day 15 after any vaccination Global safety was assessed by measuring injection-site and systemic AEs reported daily on the Vaccination Report Card (VRC) by the parent(s) or legal representative from Day 1 to Day 15 (D1-D15) after each hexavalent vaccination. Solicited injection-site and systemic AEs were reported daily from Day 1 to Day 5 (D1-D5) after each hexavalent vaccination. AEs at injection sites were always considered as vaccine-related (Injection-Site Reactions (ISRs)). The investigator assessed whether systemic AEs were related (V-related) or not to the vaccine. All AEs (related and unrelated) are reported.
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old One month after Toddler dose of PRI5 (13 months old) Ab titres were measured by ELISA, excepting the Ab to varicella which was determined by glycoprotein ELISA. Percentage of participants with an Ab titre ≥255 mIU/mL for measles, ≥10 Ab units/mL for mumps, ≥10 IU/mL for rubella, and ≥5 gpELISA units/mL for varicella are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.
Percentage of Participants Reporting Solicited ISRs From Day 1 to Day 5 After Any Vaccination Day 1 to Day 5 after any vaccination Solicited ISRs were defined as injection-site erythema, injection-site pain, and injection-site swelling occurring from Day 1 (D1) to Day 5 (D5) after vaccination. AEs at injection sites were always considered as vaccine-related (Injection-Site Reactions (ISRs)).
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old One month after Toddler dose of PRI5 (13 months old) Ab titres were measured by ELISA, excepting the Ab to varicella which was determined by glycoprotein ELISA. Percentage of participants with an Ab titre ≥255 mIU/mL for measles, ≥10 Ab units/mL for mumps, ≥10 IU/mL for rubella, and ≥5 gpELISA units/mL for varicella are reported. 95% CI were calculated based on the exact binomial method by Clopper and Pearson. The immune response to ProQuad vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the predetermined lower CI limits: 90% for measles, mumps \& rubella, and 76% for varicella.
Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination Day 1 to Day 5 after any vaccination Solicited systemic AEs were defined as crying, decreased appetite, irritability, pyrexia (rectal temperature ≥38.0°C), somnolence, and vomiting occurring from D1 to D5 after vaccination. The investigator assessed whether these systemic AEs were related or not to the vaccines. All (related and unrelated) AEs are reported.