Tetanus Clinical Trial
Official title:
Immunogenicity Assessment of Pentacel™ (Hybrid CP20/20/5/3DT-mIPV//PRP-T) When Given at Different Times From or Concurrently With a Pneumococcal Conjugate Vaccine
This study is designed to evaluate in a controlled manner the effect of Prevnar® on the
immune responses of Pentacel™
Primary Objective - Stage I:
To compare the immune responses elicited by an infant series of Pentacel™ when given at
different times from or concurrently with a Pneumococcal conjugate vaccine (Prevnar®).
Primary Objective - Stage II:
To compare the immune responses elicited by a 4th dose of Pentacel™ when given at different
times from or concurrently with Prevnar®.
This is a 2-staged study. Stage I of this study is designed to compare the immune responses
elicited by an infant series (3 doses) of Pentacel™ when given at different times from or
concurrently with Prevnar®.
Stage II is designed to describe the immune responses elicited by a 4th dose of Pentacel™
(all antigens) when given at different times from or concurrently with Prevnar®.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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