A Phase 1/Phase 2 Study of Polyvalent Pneumococcal Conjugate Vaccine (pPCV) in Adults
Status:
Completed
Trial end date:
2021-07-12
Target enrollment:
Participant gender:
Summary
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 Pneumovax™23 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 Pneumovax™23.