Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects (NCT00514904) | Clinical Trial Compass
CompletedPhase 3
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects
India, Lebanon1,504 participantsStarted 2007-09-18
Plain-language summary
The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Who can participate
Age range2 Years – 10 Years
SexALL
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Inclusion Criteria:
* Subjects who the investigator believes that their parents or guardians can and will comply with the requirements of the protocol.
* A male or female between, and including, 2 and 10 years of age at the time of vaccination.
* Written informed consent obtained from the parent or guardian of the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Previously completed routine childhood vaccinations to the best of his/her parents'/guardians' knowledge.
Exclusion Criteria:
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose 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 first vaccine dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine.
* Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above).
* Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups A, C, W-135 and/or Y.
* Previous vaccination with tetanus toxoid within the last month.
* History of meningococcal disease.
* Any co…
What they're measuring
1
Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135
Timeframe: One month after vaccination (Post-vaccination, study Month 1)
2
Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited)
Timeframe: During the 4-day (Days 0-3) post-vaccination period