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Safety and Immune Response Study of an Investigational Pneumococcal Vaccine.

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00327522
First received: May 17, 2006
Last updated: October 9, 2008
Last verified: October 2008
History of Changes

May 17, 2006
October 9, 2008
June 2006
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  • 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;
  • 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
Same as current
Complete list of historical versions of study NCT00327522 on ClinicalTrials.gov Archive Site
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Safety and Immune Response Study of an Investigational Pneumococcal Vaccine.
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.
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 .
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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Prophylactic Pneumococcal Diseases
Biological: pneumococcal vaccine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
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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.
Both
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00327522
106962
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Study Director, GSK
GlaxoSmithKline
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Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP