common.study.topics.clinical

Polyvalent Pneumococcal Conjugate Vaccine

common.study.values.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.

common.study.values.location

participant.ui.study.affiliations-map.online-study.header-virtual

participant.ui.study.affiliations-map.online-study.text

participant.ui.study.affiliations-map.legend.locations participant.ui.study.affiliations-map.legend.selected

common.study.values.methods

Pharmaceutical medication involved common.study.methods.has-drugs-yes
Patients and healthy individuals accepted common.study.methods.is-healthy-no

Drug - pPCV

Single 0.5 or 1.0 mL IM injection

Biological - Pneumovaxâ„¢23

Single 0.5 mL IM injection

participant.views.study.view.additional

participant.views.study.view.scientific-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.

common.study.values.clinical-trial-id

NCT04168190

participant.views.study.view.id

erkA6a