The purpose of this study is to describe the immunogenicity and safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T fully liquid combined hexavalent vaccine (Hexaxim®) administered at 2, 3, and 4 months of age and at 16 to 17 months of age in infants and toddlers who received a dose of Hep B vaccine at birth or within 1 week after birth. Primary Objective: * To describe the safety profile after each and all doses of Sanofi-Pasteur's DTaP-IPV-Hep B-PRP-T combined vaccine in Vietnamese infants and toddlers. Secondary Objective: * To demonstrate the non-inferiority of the immune response to all antigens induced by the study vaccine in Vietnamese infants one month after the third dose in a 3-dose primary series with the immune response to all antigens induced by the same study vaccine outside Vietnam. * To evaluate the immunogenicity of the study vaccine one month after the 3-dose primary series. * To describe the persistence of all antibodies before receipt of the booster vaccination. * To evaluate the immunogenicity of the study vaccine one month after the booster.
Participants will receive a total of 5 doses of Hep B: One dose of Hep B monovalent vaccine given at birth or within 1 week after birth followed by 3 doses of the Sanofi Pasteur's hexavalent vaccine given as primary series at 2, 3, and 4 months of age and then a booster dose at 16 to 17 months of age, to comply with Vietnamese vaccination recommendations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
354
DTaP-IPV-Hep B-PRP-T combined vaccine, 0.5 mL, Intramuscular
Preventive Medicine Centre of Thai Binh Province
Thái Bình, Vietnam
Number of Participants Reporting Solicited Injection Site Reactions or Solicited Systemic Reactions
Solicited injection site reactions: tenderness, erythema, and swelling (and extensive limb swelling for booster dose). Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite loss, and irritability
Time frame: Within 7 days after vaccination
Number of Subjects With Seroprotection/Seroconversion/Vaccine Response After Infant Series in Cohort 1
Seroconversion:4-fold increase in anti-Pertussis(PT)\& anti-Filamentous hemagglutinin(FHA) antibody(Ab) concentrations from pre-vaccination to one month after first dose.Vaccine response:anti-PT/anti-FHA Ab concentrations in Enzyme Linked Immunosorbent Assay(ELISA) units(EU)/mL\>=4\*Lower Limit of Quantitation(LLOQ) if pre-vaccination concentration \<4\*LLOQ/\>=pre-vaccination concentration if prevaccination concentrations\>=4\*LLOQ. Seroprotection:anti-Diphtheria \&anti-Tetanus\>=0.01 International Units(IU)/mL\&\>=0.1 IU/mL;anti-PT \&anti-FHA\>=2 EU/mL \&\>=8 EU/mL;anti-Polyribosyl Ribitol Phosphate(PRP)\>=0.15 microgram per milliliter(mcg/mL) \&\>=1.0mcg/mL;anti-Polio types 1,2,\&3\>=8(1/dilution),anti-Hepatitis B\>=10 mili-international units per mililiter(mIU/mL)\&\>=100 mIU/mL
Time frame: Day 90 (1 month after third dose)
Number of Subjects With Seroprotection/Seroconversion/Vaccine and Booster Response Before and After Booster Vaccination in Cohort 1
Seroconversion:4-fold increase in anti-PT \& anti-FHA Ab concentrations from pre-booster vaccination to 1 month after booster dose.Vaccine response post-booster vaccination:post-booster Ab concentrations\>=4\*LLOQ if pre-dose 1 Ab concentrations\<4\*LLOQ/post-booster Ab concentrations\>=predose 1 Ab concentrations if pre-dose 1\>=4\*LLOQ. Booster response:\>=4 fold Ab concentrations increase from pre-dose 4 to one-month post-dose 4 if one-month post-dose 3\<4\*LLOQ/\>=2 fold Ab concentrations increase from pre-dose 4 to one-month post-dose 4 if pre-dose 4\>=4\*LLOQ.Seroprotection:anti-Diphtheria \& anti-Tetanus\>=0.01 IU/mL \&\>=0.1 IU/mL \&\>=1.0 IU/mL;anti-PRP \>=0.15 mcg/mL \&\>=1.0 mcg/mL;anti-Polio types 1, 2, \& 3\>=8 (1/dilution),anti-Hepatitis B\>=10 mIU/mL \&\>=100 mIU/mL
Time frame: Day 425 (pre-booster) and Day 455 (1 month after booster dose)
Geometric Mean Titers or Geometric Mean Concentrations of DTaP-IPV-HB-PRP~T Antibodies Before and After Infant Series in Cohort
Geometric mean of concentrations of antibodies against PT, FHA, diphtheria, tetanus, PRP, poliovirus 1, 2 and 3, and Hep B
Time frame: Day 90 (1 month after third dose)
Geometric Mean Titers or Geometric Mean Concentrations of DTaP-IPV-HB-PRP~T Antibodies Before and After Booster Vaccination in Cohort 1
Geometric mean of concentrations of antibodies against PT, FHA, diphtheria, tetanus, PRP, poliovirus 1, 2 and 3, and Hep B
Time frame: Day 425 (pre-booster) and Day 455 (1 month after booster dose)
Percentage of Subjects With Seroprotection/Seroconversion Rates after Infant Series in Cohort 1 and Group 3 of A3L15 (NCT01105559)
Seroconversion defined as 4-fold increase in anti-PT \& anti-FHA Ab concentrations from pre-vaccination to one month after first dose. Seroprotection defined as following: anti-Diphtheria \& anti-Tetanus \>=0.01 IU/mL; anti-PT \& anti-FHA \>=4EU/mL; anti-PRP \>=0.15 mcg/mL; anti-Polio types 1, 2, \& 3 \>=8 (1/dilution), anti-Hepatitis B \>=10 mIU/mL. Results observed in Group 3 of Study A3L15 (NCT00362336), a study conducted in South Africa where participants had been given DTaP-IPV-HB-PRP\~T at 6, 10, and 14 weeks of age following Hep B vaccination at birth, were used as the non-inferiority reference value
Time frame: Day 90 (1 month after third dose)
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