Safety, Tolerability, and Immunogenicity of an Investigational Vaccine With Recombinant Human Albumin (rHA) in Children 12 to 18 Months of Age (V205C-009)(COMPLETED)
NCT ID: NCT00092404
Last Updated: 2017-03-15
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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COMPLETED
PHASE2
1210 participants
INTERVENTIONAL
2001-12-31
2005-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
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measles, mumps, and rubella virus vaccine live
Comparator: Measles, Mumps, and Rubella Virus Vaccine Live
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of allergic reactions to any component of the vaccines as evaluated by the study doctor
12 Months
18 Months
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Wiedmann RT, Reisinger KS, Hartzel J, Malacaman E, Senders SD, Giacoletti KE, Shaw E, Kuter BJ, Schodel F, Musey LK. M-M-R((R))II manufactured using recombinant human albumin (rHA) and M-M-R((R))II manufactured using human serum albumin (HSA) exhibit similar safety and immunogenicity profiles when administered as a 2-dose regimen to healthy children. Vaccine. 2015 Apr 27;33(18):2132-40. doi: 10.1016/j.vaccine.2015.03.017. Epub 2015 Mar 18.
Study Documents
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Document Type: CSR Synopsis
View DocumentOther Identifiers
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2004_074
Identifier Type: -
Identifier Source: secondary_id
V205C-009
Identifier Type: -
Identifier Source: org_study_id
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