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View Clinical Trial (Medical Research Study)
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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 - NCT00861744-27609 (Clinical Trial 278258)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy278258.aspx
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| City: |
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Raleigh |
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State:
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NC |
| Zip Code: |
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27609 |
| Conditions: |
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Diseases Caused by Measles, Mumps, Rubella and Varicella Viruses |
| Purpose: |
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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
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| Study summary: |
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| Criteria: |
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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.
- 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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| Study is available at: |
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GSK Investigational Site
Raleigh, NC 27609
United States
Primary Contact:
US GSK Clinical Trials Call Center
Phone: 877-379-3718 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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