Status:
COMPLETED
Immunogenicity and Safety Study of PriorixTetra™ When Co-administered With Conjugated MenC Vaccine in Healthy Children
Lead Sponsor:
GlaxoSmithKline
Conditions:
Rubella
Varicella
Eligibility:
All Genders
13-15 years
Phase:
PHASE3
Brief 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-adminis...
Eligibility Criteria
Inclusion
- 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
- 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, mumps, rubella, varicella and/or N. meningitidis serogroup C diseases.
- Known exposure to measles, mumps, rubella and or varicella starting 30 days prior to enrolment.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- Acute disease and/or fever at the time of enrollment.
- Documented human immunodeficiency virus (HIV) positive subject.
- Any contraindications as stated in the Summary of Product Characteristics.
- Administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period.
Key Trial Info
Start Date :
February 6 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2014
Estimated Enrollment :
716 Patients enrolled
Trial Details
Trial ID
NCT01506193
Start Date
February 6 2012
End Date
March 31 2014
Last Update
August 17 2018
Active Locations (13)
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1
GSK Investigational Site
Rome, Lazio, Italy, 00165
2
GSK Investigational Site
Chiavari, Liguria, Italy, 16043
3
GSK Investigational Site
Genoa, Liguria, Italy, 16132
4
GSK Investigational Site
Milan, Lombardy, Italy, 20122