Study to Evaluate the Response Rate to the Licensed Pneumovax 23™ in Elderly Population. - Full Text View

Purpose

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.

Condition	Intervention	Phase
Streptococcus Pneumoniae Vaccines	Biological: Pneumovax 23™	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	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.

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Response rate to 11 vaccine serotypes [ Time Frame: One month post vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Anti-polysaccharide total IgG ELISA for 11 vaccine pneumococcal serotypes [ Time Frame: At all time points ] [ Designated as safety issue: No ]
Opsonophagocytic activity against 11 vaccine pneumococcal serotypes in a subset of subjects [ Time Frame: At Day 0 and Day 30. ] [ Designated as safety issue: No ]
The rank of subjects from "poorest responder" to "best responder" based on the number of serotypes each subject responds to [ Time Frame: One month post vaccination ] [ Designated as safety issue: No ]
Persistence of the immune response in a subset of subjects. [ Time Frame: Until Month 36. ] [ Designated as safety issue: No ]
Opsonophagocytic activity response in a subset of subjects. [ Time Frame: At Day 30 ] [ Designated as safety issue: No ]
Occurrence of serious adverse events (SAE). [ Time Frame: Up to 1 month after vaccination. ] [ Designated as safety issue: Yes ]
Occurrence of study related SAEs. [ Time Frame: Throughout the study period. ] [ Designated as safety issue: Yes ]

Enrollment:	1198
Study Start Date:	October 2003
Study Completion Date:	February 2005
Primary Completion Date:	February 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A	Biological: Pneumovax 23™ Single dose intramuscular injection

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

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria

Subjects who the investigator believes will comply with the requirements of the protocol.
A male or female >= 65 years at the time of the first vaccination.
Written informed consent obtained from the subject.

Exclusion criteria

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study.
Previous vaccination against Streptococcus pneumoniae.
History of administration of an experimental vaccine containing MPL or QS21.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Planned administration of a vaccine not foreseen by the study protocol within 2 weeks before and after first dose of vaccines, excluding influenza vaccine which can be administered at any time, including co-administration with Pneumovax23™.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Current serious neurologic or mental disorders.
Inflammatory processes such as known chronic active infections (e.g.Hep B, C).
All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
Acute disease at the time of enrolment.
Chronic disease that might preclude participation to the whole study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307008

Locations

Sweden
GSK Investigational Site
Eskilstuna, Sweden, SE-631 88
GSK Investigational Site
Jönköping, Sweden, SE-551 85
GSK Investigational Site
Skövde, Sweden, SE-541 85
GSK Investigational Site
Uppsala, Sweden, SE-751 85
GSK Investigational Site
Västerås, Sweden, SE 721 89

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00307008 History of Changes
Other Study ID Numbers:	513026/004, 100421, 100436
Study First Received:	March 24, 2006
Last Updated:	April 11, 2013
Health Authority:	Sweden: Swedish National Council on Medical Ethics

Keywords provided by GlaxoSmithKline:

Prophylaxis Invasive pneumococcal diseases and pneumonia

Additional relevant MeSH terms:

Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on June 17, 2013