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Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants

Pneumonia Clinical Trial

Official title:
Safety and Immunogenicity of Pneumococcal Protein Vaccine (PPrV) in Healthy Adults, Toddlers and Infants in Bangladesh

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

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