Assess the Non-inferiority of GSK Biologicals' Mencevax™ ACWY (Manufactured by a New Process) vs Mencevax™ ACWY (the Already Existing Vaccine in the Market) When Given as a Single Dose to Subjects Aged 2-30 Yrs
Infections, Meningococcal
About this trial
This is an interventional treatment trial for Infections, Meningococcal focused on measuring Neisseria meningitidis serogroups A & C diseases, Hib diseases
Eligibility Criteria
Inclusion criteria: Healthy male or female between 2 and 30 years of age at the time of vaccination. If the subject is female, she must be of non-childbearing potential. If a subject is a female of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination. Exclusion criteria: Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of study vaccine, or planned use during the study period. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. Vaccination with a meningococcal vaccine within the last five years. Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 15 days before vaccine administration and ending 30 days after. History of or known exposure to meningococcal serogroup A, C, W135 or Y disease or contacts with subjects who had meningococcal disease. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Sites / Locations
- GSK Investigational Site