Safety and Immune Response Study of an Investigational Pneumococcal Vaccine.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00327522
Recruitment Status : Completed
First Posted : May 18, 2006
Last Update Posted : October 13, 2008
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Brief Summary:
The purpose of this study is to evaluate the safety and immunogenicity of two doses of GSK Biologicals' 11 PCV vaccine when given to healthy subjects aged 18 to 40 years .

Condition or disease Intervention/treatment Phase
Prophylactic Pneumococcal Diseases Biological: pneumococcal vaccine Phase 2

Detailed Description:
The study is open and subjects will receive two vaccine doses of GSK Biologicals' 11 PCV vaccine. Five blood samples will be taken: prior to and one month after each vaccine dose, and 2 weeks after dose 2.

Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open, Phase I/II Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' 11PCV Vaccine Given as a 2-Dose Vaccination in Adults Aged 18-40 Years Old.
Study Start Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Occurrence of solicited local & general symptoms (Day 0-7) and unsolicited symptoms (Day 0-30) after vaccination. Occurrence of serious adverse events during the entire study;
  2. Frequencies of IgG PS-specific plasma cells (by B-cell ELISPOT) for 11 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F) prior to & 1 month post dose 1, 2 weeks & 1 month post dose 2

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy male or female between 18 and 40 years of age
  • 23-valent pneumococcal polysaccharide vaccine naive adults.

Exclusion Criteria:

  • Previous vaccination against Streptococcus pneumoniae.
  • History of pneumonia within 3 years prior to the first vaccination
  • Any confirmed or suspected immunosuppressive or immunodeficient condition
  • All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
  • Subjects with documented anaemia or iron-deficiency (Hemoglobin level more than 10% below lower limit of normal)
  • History of administration of an experimental/licensed vaccine containing similar adjuvants.
  • History of chronic alcohol consumption and/or drug abuse.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.

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 identifier (NCT number): NCT00327522

GSK Investigational Site
Gent, Belgium, 9000
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: Study Director, GSK Identifier: NCT00327522     History of Changes
Obsolete Identifiers: NCT00309153
Other Study ID Numbers: 106962
First Posted: May 18, 2006    Key Record Dates
Last Update Posted: October 13, 2008
Last Verified: October 2008

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs