Status:
COMPLETED
Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age
Lead Sponsor:
GlaxoSmithKline
Conditions:
Rubella
Mumps
Eligibility:
All Genders
12-15 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines (manufactured by GSK and Merck and Company ) in terms of the immune response elicited and safety with a six mo...
Eligibility Criteria
Inclusion
- Subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- Male or female between 12 and 15 months of age (e.g. from age 12 months until the day before age 16 months) at the time of vaccination.
- Written informed consent obtained from the parent/guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Have previously received three doses of 7-valent pneumococcal conjugate vaccine within the first year of life with the third dose administered at least 30 days prior to enrolment and vaccination with study vaccines.
Exclusion
- 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.
- 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 (pharmaceutical product or device).
- 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 from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine and Hib vaccine.
- Previous vaccination against measles, mumps, rubella and/or varicella.
- Previous vaccination against hepatitis A or receipt of a fourth dose of pneumococcal conjugate vaccine.
- History of measles, mumps, rubella, varicella/zoster and hepatitis A diseases.
- Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Hypersensitivity to latex
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures, including febrile seizures.
- Acute disease at the time of enrolment.
- Administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
Key Trial Info
Start Date :
June 3 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2012
Estimated Enrollment :
1259 Patients enrolled
Trial Details
Trial ID
NCT00861744
Start Date
June 3 2009
End Date
June 18 2012
Last Update
January 3 2020
Active Locations (48)
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1
GSK Investigational Site
Tuscaloosa, Alabama, United States, 35401
2
GSK Investigational Site
Conway, Arkansas, United States, 72034
3
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
4
GSK Investigational Site
Little Rock, Arkansas, United States, 72205