Study of Two Investigational Pneumococcal Vaccines in Healthy Adults

Phase 1 Completed 131 enrolled Sanofi

RandomizedParallel-groupQuadruple-blindPrevention

Summary

This study is designed to evaluate the safety, tolerability, and immunogenicity of two investigational pneumococcal vaccines at three dose levels in healthy adults. Primary Objective: \- To evaluate the safety and tolerability of two investigational pneumococcal vaccines. Observational Objective: \- To evaluate the immunogenicity of the investigational pneumococcal vaccines.

Timeline

Start: 2010-02
Primary completion: 2010-09
Completion: 2010-09

Publications

Bologa M, Kamtchoua T, Hopfer R, Sheng X, Hicks B, Bixler G, Hou V, Pehlic V, Yuan T, Gurunathan S. Safety and immunogenicity of pneumococcal protein vaccine candidates: monovalent choline-binding protein A (PcpA) vaccine and bivalent PcpA-pneumococcal histidine triad protein D vaccine. Vaccine. 2012 Dec 14;30(52):7461-8. doi: 10.1016/j.vaccine.2012.10.076. Epub 2012 Nov 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pneumococcal Vaccine Formulation 1	Unknown	0.5 ml	Intramuscular
Subject	Pneumococcal Vaccine Formulation 2	Unknown	0.5 ml	Intramuscular
Subject	Pneumococcal Vaccine Formulation 3	Unknown	0.5 ml	Intramuscular
Subject	Pneumococcal Vaccine Formulation 4	Unknown	0.5 ml	Intramuscular
Subject	Pneumococcal Vaccine Formulation 5	Unknown	0.5 ml	Intramuscular

Study of Two Investigational Pneumococcal Vaccines in Healthy Adults

Summary

Timeline

Publications

Drugs

Indications