Influenza Clinical Trial
Official title:
Immunogenicity Study of the Antibody Persistence and Booster Effect of DTaP-Hep B-PRP-T Combined Vaccine at 12 to 18 Months of Age Following a Primary Series at 6, 10 and 14 Weeks of Age in Healthy Filipino Infants Having Received Hepatitis B Vaccine at Birth
DTaP-HB-PRP~T combined vaccine is being developed in order to comply with expanding programs
for immunization in infancy, while offering the benefit of a reduced number of injections,
and potentially of an increased acceptance.
Primary Objectives:
- To describe the antibody persistence at 12 to 18 months following a three-dose primary
series vaccination of either DTaP-HB-PRP~T or Tritanrix-Hep B/Hib™ given at 6, 10 and
14 weeks of age, and one dose of Hepatitis B (Hep B) vaccine given at birth.
- To describe the effect of a booster dose of DTaP-HB-PRP~T on immunogenicity at 12 to 18
months following a three-dose primary series vaccination of either DTaP-HB-PRP~T or
Tritanrix HepB/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hep B vaccine
given at birth.
Secondary Objective:
- To describe the safety profile of the booster dose of the DTaP-HB-PRP~T vaccine when
administered concomitantly with Oral Polio Vaccine (OPV).
This study will assess the immunogenicity and reactogenicity of the investigational DTaP-HB-PRP~T combined vaccine when given as a booster dose, concomitantly with OPV, in Filipino children previously primed at 6, 10, and 14 weeks with the investigational DTaP-HB-PRP~T combined vaccine or Tritanrix-Hep B/Hib™ vaccine and having received a first dose of Hep B vaccine (Recomvax B™) at birth in a previous study, AL201 (NCT00348881). ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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