Last updated on July 2016

Study of Sanofi Pasteur's DTaP-IPV Hep B-PRP-T Combined Vaccine in Infants Who Previously Received Hepatitis B Vaccine


Brief description of study

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)

Clinical Study Identifier: NCT02821195

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Recruitment Status: Open


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