NCT00307008

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

An Open, Phase II Study to Evaluate the Response Rate to the Licensed Single-Dose Polysaccharide Pneumococcal Vaccine Pneumovax 23™ (MSD Aventis Pasteur) in Elderly Population.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,198 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Streptococcus Pneumoniae Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	Pneumovax 23™	Single dose intramuscular injection

Timeline

• Start date: 2003-10-01
• Primary completion: 2005-02-01
• Completion: 2005-02-01
• First posted: 2006-03-27
• Last updated: 2013-04-15

Locations

5 sites across 1 country: Sweden