“A Phase 1/Phase 2 Study of Polyvalent Pneumococcal Conjugate Vaccine (pPCV) in Adults”
This Phase 1 and Phase 2 study will evaluate the safety, tolerability and immunogenicity of pPCV when administered to adults. Phase 1 has no formal hypothesis. The primary hypotheses for Phase 2 are: pPCV is noninferior to Pneumovaxa"c23 as measured by the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for the common serotypes at 30 days postvaccination and that the serotype-specific OPA GMTs for the unique serotypes in pPCV at 30 days postvaccination are statistically significantly greater following vaccination with pPCV than those following vaccination with Pneumovaxa"c23.
Drug - pPCV
Single 0.5 or 1.0 mL IM injection
Biological - Pneumovaxâ„¢23
Single 0.5 mL IM injection
A Phase 1/Phase 2, Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine in Adults.