NCT00327665

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 335 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Infections, Streptococcal

Interventions

Type	Name	Description
BIOLOGICAL	11-valent pneumococcal vaccine GSK513026	Two-dose intramuscular injection. Each group receiving one of the 3 formulations
BIOLOGICAL	Pneumo 23™	Single-dose intramuscular injection.
BIOLOGICAL	Placebo	1 intramuscular injection.
BIOLOGICAL	10-valent pneumococcal vaccine GSK513026	Two-dose intramuscular injection

Timeline

• Start date: 2006-05-01
• Primary completion: 2007-01-01
• Completion: 2007-01-08
• First posted: 2006-05-18
• Last updated: 2017-05-08

Locations

3 sites across 3 countries: Belgium, Finland, Sweden