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Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age - NCT00861744-97030(Clinical Trial 278263)



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City:  Gresham
State:  
OR
Zip Code: 97030
Conditions: Diseases Caused by Measles, Mumps, Rubella and Varicella Viruses
Purpose: 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 month follow-up after first vaccination. Additionally, antibody persistence will be assessed one and two years after administration of MMR vaccine. The Protocol Posting has been updated following Protocol amendment 1 and 2, Oct 2009.
Study summary:
Criteria: Inclusion Criteria: - 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 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. - 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.
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Data Source: ClinicalTrials.gov
Date Processed: June 11, 2010
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