MMR and MMRV Vaccines: Effect of Age at First Dose on Safety and Immunogenicity of the Measles Component.
NCT ID: NCT02712203
Last Updated: 2016-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
5808 participants
OBSERVATIONAL
2004-07-31
2016-12-31
Brief Summary
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In addition, this study will evaluate if the effect of the age at first dose is modified by the type of vaccine administered.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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12 months
MMR vaccine / MMRV vaccine : administration of the first dose at 12 months of age
MMR vaccine / MMRV vaccine
Subcutaneous injection, two doses
13 months
MMR vaccine / MMRV vaccine : administration of the first dose at 13 months of age
MMR vaccine / MMRV vaccine
Subcutaneous injection, two doses
14 months
MMR vaccine / MMRV vaccine : administration of the first dose at 14 months of age
MMR vaccine / MMRV vaccine
Subcutaneous injection, two doses
15 months or more
MMR vaccine / MMRV vaccine : administration of the first dose at 12 months of age or older
MMR vaccine / MMRV vaccine
Subcutaneous injection, two doses
Interventions
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MMR vaccine / MMRV vaccine
Subcutaneous injection, two doses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent obtained from the parent/guardian of the subject.
Exclusion Criteria
* Any confirmed or suspected immunosuppressive or immunodeficient condition, included the chronic administration (defined as more than 14 days) of immune-suppressants or other immune-modifying drugs within six months prior to the firs vaccine dose.
* History of any neurologic disorders or seizures.
* History of allergic diseases or reactions likely to be exacerbated by any component of the vaccines.
* Planned administration of a vaccine not foreseen by the study protocol from 30 days prior to each vaccination until 42-56 days after each vaccination
11 Months
22 Months
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
CHU de Quebec-Universite Laval
OTHER
Responsible Party
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Gaston De Serres
MD, PhD
Principal Investigators
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Gaston De Serres, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHU de Quebec-Universite Laval
References
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Czajka H, Schuster V, Zepp F, Esposito S, Douha M, Willems P. A combined measles, mumps, rubella and varicella vaccine (Priorix-Tetra): immunogenicity and safety profile. Vaccine. 2009 Nov 5;27(47):6504-11. doi: 10.1016/j.vaccine.2009.07.076. Epub 2009 Aug 7.
Schuster V, Otto W, Maurer L, Tcherepnine P, Pfletschinger U, Kindler K, Soemantri P, Walther U, Macholdt U, Douha M, Pierson P, Willems P. Immunogenicity and safety assessments after one and two doses of a refrigerator-stable tetravalent measles-mumps-rubella-varicella vaccine in healthy children during the second year of life. Pediatr Infect Dis J. 2008 Aug;27(8):724-30. doi: 10.1097/INF.0b013e318170bb22.
Knuf M, Habermehl P, Zepp F, Mannhardt W, Kuttnig M, Muttonen P, Prieler A, Maurer H, Bisanz H, Tornieporth N, Descamps D, Willems P. Immunogenicity and safety of two doses of tetravalent measles-mumps-rubella-varicella vaccine in healthy children. Pediatr Infect Dis J. 2006 Jan;25(1):12-8. doi: 10.1097/01.inf.0000195626.35239.58.
Other Identifiers
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200783
Identifier Type: -
Identifier Source: org_study_id
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