Clinical Trial

Polyvalent Pneumococcal Conjugate Vaccine

Study Description

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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted 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

Additional Information

Official Study Title

A Phase 1/Phase 2, Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine in Adults.

Clinical Trial ID

NCT04168190

ParticipAid ID

erkA6a