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Clinical Trial Summary

This study is designed to explore the safety and tolerability of an investigational pneumococcal vaccine through a step-down enrollment.

Primary Objective:

- To evaluate the safety and tolerability of an investigational pneumococcal vaccine.

Secondary Objective:

- To evaluate the immunogenicity of an investigational pneumococcal vaccine.


Clinical Trial Description

All adult participants will receive a single injection of study vaccine or placebo. After satisfactory safety evaluation, toddler participants will receive a single injection of study vaccine or placebo. After satisfactory safety evaluation, infant participants will receive 3 injections of study vaccine or placebo in dose-ascending order (low, medium, and high dose), with a safety evaluation after each dose level before the study proceeds to the next higher dose. All participants will undergo immunogenicity testing and monitoring for safety. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01446926
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1
Start date September 2011
Completion date June 2013

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