Infections, Meningococcal
Conditions
Keywords
Neisseria meningitidis serogroups A & C diseases, Hib diseases
Brief summary
The purpose of this study is to evaluate that the vaccine produced with the new process and administered as a single dose is at least as good as the existing Mencevax™ ACWY vaccine in terms of immunogenicity, safety and reactogenicity, in healthy subjects aged 2-30 years.
Detailed description
Randomized study with four groups to receive one of the following vaccination regimens: - One of the 3 lots of GSK Biologicals' Mencevax™ ACWY vaccine manufactured by the new process (3 different groups) - GSK Biologicals' already existing Mencevax™ ACWY
Interventions
BIOLOGICALMencevax ACWY
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
2 Years to 30 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 month after vaccination, measurement of serum bactericidal titers against meningococcal serogroups A, C, W135 and Y (SBA-MenA; SBA-MenC; SBA-MenW135 and SBA-MenY) | — |
Secondary
| Measure | Time frame |
|---|---|
| Immuno : the same immuno evaluation performed 1 month after vaccination will also be performed before vaccination; also vaccine response at Post-dose 1. | — |
| Safety : Solicited symptoms during day 0-3, unsol. symptoms during day 0-30 & SAEs during entire study. | — |
Countries
Lebanon
Outcome results
None listed