Hepatitis B Clinical Trial
Official title:
Safety and Immunogenicity of Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) Compared to Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) and Hepatitis B Vaccine Given Concurrently In Adolescents 11-14 Years of Age
Primary objective:
- To determine the safety and immunogenicity of tetanus and diphtheria toxoids adsorbed
combined with component pertussis and inactivated poliomyelitis vaccine grown on vero
cells (TdcP-IPV) compared to tetanus and diphtheria toxoids adsorbed combined with
component pertussis and inactivated poliomyelitis vaccine grown on vero cells
(TdcP-IPV) and Hepatitis B vaccine administered concurrently in adolescents 11-14 years
of age.
Secondary objective:
- To determine whether concurrent administration of TdcP-IPV and Hepatitis B vaccines at
11-14 years of age results in detectable immunologic interactions between components of
the two vaccines.
Participants will be randomized into one of 2 groups to receive either a dose of the
TdcP-IPV on Day 0 (visit 1) and Hepatitis B vaccine on subsequent visits 2, 3 and 4 (Group
1); or no vaccination on Day 0, concomitant administration of TdcP-IPV and Hepatitis B
vaccine on Day 28 (Visit 2) and Hepatitis B vaccine on subsequent visits 3 and 4 (Group 2).
All participants will be followed up for immunogenicity and safety
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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