Immunogenicity and Safety Study of PriorixTetra™ When Co-administered With Conjugated MenC Vaccin… (NCT01506193) | Clinical Trial Compass
CompletedPhase 3
Immunogenicity and Safety Study of PriorixTetra™ When Co-administered With Conjugated MenC Vaccine in Healthy Children
Italy716 participantsStarted 2012-02-06
Plain-language summary
The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' investigational measles, mumps, rubella and varicella (MMRV) vaccine (GSK208136, PriorixTetra™) when co-administered along with conjugated Meningococcal C (MenC) vaccine (Meningitec®, Nuron Biotechs' Vaccine) in healthy children.
Who can participate
Age range13 Months – 15 Months
SexALL
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Inclusion Criteria:
* Subjects who the investigator believes that parent(s)/Legally Acceptable Representatives (LAR) can and will comply with the requirements of the protocol.
* A male or female between, and including, 13 and 15 months of age at the time of the first vaccination.
* Written informed consent obtained from the parent(s)/ LAR of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
* Child in care.
* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period.
* Chronic administration 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 starting 30 days prior to the study vaccination/s and ending 42 days after the vaccination/s (at Visit 2), with the exception of inactivated influenza (flu) vaccine, which may be given at any time during the study, including the day of study vaccination/s.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Previous vaccination against measles, mumps, rubella, varicella/ herpes zoster and/or N. meningitidis serogroup C.
* History of measles, mum…
What they're measuring
1
Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus
Timeframe: At 42 days after vaccination
2
Number of Seroprotected Subjects for rSBA-MenC Antibodies