Polyvalent Pneumococcal Conjugate Vaccine

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.

Pharmaceutical medication involved
Patients and healthy individuals accepted

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.