NCT02428491

Immunogenicity and Safety of Sanofi Pasteur's Combined Vaccine Given as a Three-Dose Primary Series at 2, 3,4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or Within 1 Week After Birth

Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T Combined Vaccine Given as a Three-Dose Primary Series at 2, 3, and 4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or Within 1 Week After Birth

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 354 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 61 Days – 91 Days
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Poliomyelitis
• Hepatitis B
• Haemophilus Influenzae Type b

Interventions

Type	Name	Description
BIOLOGICAL	Hexaxim®	DTaP-IPV-Hep B-PRP-T combined vaccine, 0.5 mL, Intramuscular

Timeline

• Start date: 2015-04-20
• Primary completion: 2017-01-11
• Completion: 2017-01-11
• First posted: 2015-04-28
• Last updated: 2022-04-05

Locations

1 site across 1 country: Vietnam