Study to Evaluate Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 18-25 Years

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Infections, Meningococcal

Treatments

Biological: Meningococcal (vaccine)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00196950

102252 (Other Identifier)

102253 (Other Identifier)

102254 (Other Identifier)

134612/003

Details and patient eligibility

About

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 young adults aged 18-25 years.

Full 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 dose (GSK's MenACWY conjugate vaccine or Mencevax™ ACWY vaccine) and 3 years of follow-up. There are in total 7 visits to the doctor: before and 2, 7 and 30 days after vaccination (vaccination phase) as well as 12, 24 and 36 months after vaccination (follow-up phase). 7 blood samples are taken: one at each visit.

Enrollment

50 patients

Sex

All

Ages

18 to 25 years old

Volunteers

Accepts Healthy Volunteers

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