Full Text View
Tabular View
No Study Results Posted
Related Studies
Study to Evaluate the Response Rate to the Licensed Pneumovax 23™ in Elderly Population.
This study has been completed.
First Received: March 24, 2006   Last Updated: October 9, 2008   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00307008
  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
Pneumococcal Disease
Pneumonia
Biological: Pneumovax 23™
Phase II

Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
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:


Further study details as provided by GlaxoSmithKline:

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

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

Enrollment: 1198
Study Start Date: October 2003
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A: Experimental 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
Finland
GSK Investigational Site
Nokia, Finland, 37100
Sweden
GSK Investigational Site
ESKILSTUNA, Sweden, SE-631 88
GSK Investigational Site
JÖNKÖPING, Sweden, SE-551 85
GSK Investigational Site
STOCKHOLM, Sweden, SE-141 86
GSK Investigational Site
VÄSTERÅS, Sweden, SE 721 89
GSK Investigational Site
SKÖVDE, Sweden, SE-541 85
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 513026/004, 100421, 100436
Study First Received: March 24, 2006
Last Updated: October 9, 2008
ClinicalTrials.gov Identifier: NCT00307008     History of Changes
Health Authority: Sweden: Swedish National Council on Medical Ethics

Keywords provided by GlaxoSmithKline:
Prophylaxis Invasive pneumococcal diseases and pneumonia

Study placed in the following topic categories:
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Pneumonia

Additional relevant MeSH terms:
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Pneumonia

ClinicalTrials.gov processed this record on September 11, 2009