Status:
COMPLETED
Study to Evaluate Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 18-25 Years
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Meningococcal
Eligibility:
All Genders
18-25 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety, reactogenicity, immunogenicity and persistence up to three years after administration of one dose of the MenACWY conjugate vaccine when given to yo...
Detailed Description
Administration of the candidate vaccine or of the active control (Mencevax™ ACWY) will be done in an open manner. The study consists of a vaccination phase during which subjects receive one vaccine do...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy male or female between, and including, 18 and 25 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.
- 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.
- History of chronic alcohol consumption and/or drug abuse
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2003
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00196950
Start Date
September 1 2003
End Date
October 1 2003
Last Update
September 7 2016
Active Locations (1)
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1
GSK Investigational Site
Gosselies, Belgium, 6041