Study to Evaluate the Response Rate to the Licensed Pneumovax 23™ in Elderly Population.

Phase 2

Completed

• Conditions: Streptococcus Pneumoniae Vaccines
• Interventions: Biological: Pneumovax 23™

• Registration Number: NCT00307008
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Streptococcus pneumoniae are bacteria which normally live in the upper respiratory tract of humans. However, these bacteria can also cause severe infectious diseases such as pneumonia, septicemia and meningitis. Elderly subjects are especially vulnerable to these infections, and the diseases can result in death. The currently available licensed Streptococcus pneumoniae vaccine is recommended for prevention of pneumococcal diseases in individuals over the age of 65. However, the antibody level elicited by this vaccine, is not always satisfactory in elderly people. To overcome the problem, GlaxoSmithKline Biologicals is currently developing candidate vaccines that are hoped to work better than the currently available vaccines. As a first step in this development, the present study is being conducted in order to evaluate the immune response to the currently marketed vaccine.

Detailed Description

Since influenza vaccination is recommended in the age range of the study population, Fluarix™ (GlaxoSmithKline Biologicals) vaccine will be offered free of charge for the study period (3 consecutive years), to be used by Investigators according to national vaccination schedule/practice.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-10
• Primary Completion: 2005-02
• Study Completion: 2005-02
• Study First Submitted: 2006-03-24
• Study First Submitted QC: 2006-03-24
• Study First Posted: 2006-03-27
• Status Verified: 2011-09
• Last Update Submitted: 2013-04-11
• Last Update Posted: 2013-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1198

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A	Pneumovax 23™	-

Primary Outcome Measures

Name	Time	Method
Response rate to 11 vaccine serotypes	One month post vaccination

Secondary Outcome Measures

Name	Time	Method
Anti-polysaccharide total IgG ELISA for 11 vaccine pneumococcal serotypes	At all time points
Opsonophagocytic activity against 11 vaccine pneumococcal serotypes in a subset of subjects	At Day 0 and Day 30.
The rank of subjects from "poorest responder" to "best responder" based on the number of serotypes each subject responds to	One month post vaccination
Persistence of the immune response in a subset of subjects.	Until Month 36.
Opsonophagocytic activity response in a subset of subjects.	At Day 30
Occurrence of serious adverse events (SAE).	Up to 1 month after vaccination.
Occurrence of study related SAEs.	Throughout the study period.

Trial Locations

Locations (1)

GSK Investigational Site; 🇸🇪 Västerås, Sweden