Status:
COMPLETED
Evaluate 4 Different Formulations of Meningococcal Serogroups A, C, W-135, Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 15-19 Yrs
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Meningococcal
Eligibility:
All Genders
15-19 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy subjects aged 1...
Detailed Description
3 formulations of GSK's MenACWY conjugate vaccine will be administered in a double-blind manner, while the 4th one will be single-blinded. Administration of the candidate vaccine or of the active cont...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy male or female between, and including, 15 and 19 years of age at the time of vaccination.
- Written informed consent obtained. Subject with previously completed routine childhood vaccinations to the best of his/her knowledge or his/her parents'/guardians' knowledge.
- Female subjects should be of non-childbearing potential, or abstinent, or using an adequate contraception.
- Exclusion criteria:
- Previous vaccination against OR history of OR exposure within previous 12 months to meningococcal serogroup A, C, W-135 or Y disease.
- Administration of a tetanus vaccine within 6 months before study vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of any neurologic disorders or seizures.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00196963
Start Date
March 1 2005
End Date
July 1 2005
Last Update
September 21 2016
Active Locations (1)
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1
GSK Investigational Site
Thuin, Belgium, 6530