Hepatitis B Clinical Trial
Official title:
Immunogenicity Study of the Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months of Age Following a Primary Series of DTaP-IPV-HB-PRP~T Combined Vaccine or of PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age in Healthy Argentinean Infants
This study will assess both the antibody persistence of the investigational vaccine and the
immune response and safety of a booster dose of PENTAXIM™ vaccine in 18 months-old toddlers
who participated in an earlier study in order to determine if they are still protected
before they receive a booster dose of D, T, IPV, pertussis or Hib vaccines and also to
assess the quality of the induced immune memory in response to a booster dose of the same
vaccine as in the primary series.
Primary Objective:
To describe the antibody persistence at 18 months of age and the booster effect of a dose of
PENTAXIM™ on immunogenicity.
Secondary objective:
To describe the safety profile of the booster dose PENTAXIM™ in each vaccine group defined
by the vaccines received during the primary series.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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