Status:
COMPLETED
Safety and Immune Response Study of an Investigational Pneumococcal Vaccine.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Prophylactic Pneumococcal Diseases
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
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 .
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 do...
Eligibility Criteria
Inclusion
- healthy male or female between 18 and 40 years of age
- 23-valent pneumococcal polysaccharide vaccine naive adults.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00327522
Start Date
June 1 2006
Last Update
October 13 2008
Active Locations (1)
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1
GSK Investigational Site
Ghent, Belgium, 9000