Hepatitis B Clinical Trial
Official title:
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
Phase III, open, mono-center study in 177 infants who received a dose of Hep B vaccine at
birth or within 1 month after birth.
Infants will receive Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T combined vaccine (study vaccine)
at 2, 3, and 4 months of age.
All subjects will provide blood samples for immunogenicity assessment at baseline
(pre-vaccination) and at 30 days following the third vaccination. Regarding safety,
solicited reactions and unsolicited non-serious adverse events (AEs) will be collected up to
7 days and up to 30 days after each vaccination, respectively. Serious adverse events (SAEs)
will be collected throughout the study trial (from Visit 1 to Visit 4)
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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