Study to Evaluate Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 18-25 Years
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Condition or disease
Biological: Meningococcal (vaccine)
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.
Assess the Safety, Reactogenicity, Immunogenicity & Long-term Persistence of One Intramuscular Dose of GSK Biologicals' MenACWY Conjugate Vaccine vs One Subcutaneous Dose of Mencevax™ ACWY in Healthy Adults Aged 18-25 Yrs
Study Start Date
Primary Completion Date
Study Completion Date
Resource links provided by the National Library of Medicine
The occurrence of any grade 3 solicited symptoms within 8 days (day 0-7) following vaccination.
Secondary Outcome Measures
Sol (d 0-7, local&general), unsol (d 0-30) symptoms. SAEs. Routine blood & urine examination before, 2&7 d post vacc. % SBA-MenA C W Y responders 1m post vacc. Antibodies to MenA C W Y before, 1, 12, 24&36m post vacc & tetanus before, 1m post vacc
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 25 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 134612/003 are summarised with studies 102252, 102253, and 102254 on the GSK Clinical Study Register.