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Study to Evaluate the Safety and Immunogenicity of an Investigational Pneumococcal Vaccine in the Elderly Population

Infections, Streptococcal Clinical Trial

Official title:
A Phase I/II, Randomized, Observer Blinded Study to Evaluate and Compare the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline Biologicals' Investigational Pneumococcal Vaccine Formulations Versus a Licensed Non-GlaxoSmithKline Biologicals' Vaccine and GlaxoSmithKline Biologicals' Aluminum-based 10-valent Pneumococcal Conjugate Vaccine, in Healthy Elderly Subjects

Clinical Trial Summary

As the licensed pneumococcal vaccine is not always satisfactory in elderly, new investigational pneumococcal vaccines are evaluated in the healthy elderly population. Note: The study consists of the primary phase (106068): vaccination and follow-up and the extension (106072) of the primary phase: 1 year follow-up.

This protocol posting details the procedures of both the primary & extension phase.

Clinical Trial Description

No new subjects will be enrolled in the Extension Phase of the study. All outcome measures at Month 12 will only be evaluated in the subjects in the Belgian site.

Upon request, volunteers will receive flu vaccination free of charge. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00327665
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 1
Start date May 1, 2006
Completion date January 8, 2007
View Details
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