Comparison of GSK134612 in Subjects Previously Vaccinated Against Meningococcal Disease Versus No… (NCT00661557) | Clinical Trial Compass
CompletedPhase 2
Comparison of GSK134612 in Subjects Previously Vaccinated Against Meningococcal Disease Versus Non-vaccinated Subjects
Lebanon271 participantsStarted 2008-05-19
Plain-language summary
In this study, subjects who were vaccinated with a meningococcal polysaccharide vaccine in a previous study (whose objectives \& outcome measures are presented in a separate protocol posting with NCT number = 00227422) will be vaccinated with a new vaccine using conjugation technology.
These subjects will be compared to subjects vaccinated with the new vaccine, but who were not previously vaccinated with a meningococcal polysaccharide vaccine.
Who can participate
Age range4 Years – 34 Years
SexALL
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Inclusion Criteria:
* Only subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* For the MPS group, a male or female between, and including, 4.5 and 34 years of age at the time of the study vaccination, who has been vaccinated in GSK Biologicals' study 102394.
* For the noMPS group, a male or female between, and including, 4.5 and 34 years of age at the time of the study vaccination.
* Written informed consent obtained from the subject/ from the parent or guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Previously completed routine childhood vaccinations to the best of his/her knowledge.
* If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion Criteria:
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding administration of the study vaccine, or planned use during the complete study period (active phase and extended safety follow-up).
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs wit…