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

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ClinicalTrials.gov Identifier: NCT00307008
Recruitment Status : Completed
First Posted : March 27, 2006
Last Update Posted : April 15, 2013
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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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.

Condition or disease Intervention/treatment Phase
Streptococcus Pneumoniae Vaccines Biological: Pneumovax 23™ Phase 2

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1198 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : October 2003
Actual Primary Completion Date : February 2005
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A Biological: Pneumovax 23™
Single dose intramuscular injection


Outcome Measures
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Primary Outcome Measures :
  1. Response rate to 11 vaccine serotypes [ Time Frame: One month post vaccination ]

Secondary Outcome Measures :
  1. Anti-polysaccharide total IgG ELISA for 11 vaccine pneumococcal serotypes [ Time Frame: At all time points ]
  2. Opsonophagocytic activity against 11 vaccine pneumococcal serotypes in a subset of subjects [ Time Frame: At Day 0 and Day 30. ]
  3. 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 ]
  4. Persistence of the immune response in a subset of subjects. [ Time Frame: Until Month 36. ]
  5. Opsonophagocytic activity response in a subset of subjects. [ Time Frame: At Day 30 ]
  6. Occurrence of serious adverse events (SAE). [ Time Frame: Up to 1 month after vaccination. ]
  7. Occurrence of study related SAEs. [ Time Frame: Throughout the study period. ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00307008


Locations
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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
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00307008    
Other Study ID Numbers: 513026/004
100421
100436
First Posted: March 27, 2006    Key Record Dates
Last Update Posted: April 15, 2013
Last Verified: September 2011
Keywords provided by GlaxoSmithKline:
Prophylaxis Invasive pneumococcal diseases and pneumonia
Additional relevant MeSH terms:
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Pneumonia
Pneumonia, Pneumococcal
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Pneumococcal Infections
Streptococcal Infections
 Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Pneumonia, Bacterial
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs