Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(COMPLETED)
NCT ID: NCT00985153
Last Updated: 2015-11-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3927 participants
INTERVENTIONAL
2000-03-31
2001-05-31
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
Study Groups
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1
ProQuad Lot 1
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
A Single 0.5 mL subcutaneous injection at Day 0
2
ProQuad Lot 2
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
A Single 0.5 mL subcutaneous injection at Day 0
3
ProQuad Lot 3
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
A Single 0.5 mL subcutaneous injection at Day 0
4
M-M-R II + Varivax
Comparator: Varivax
A Single 0.5 mL subcutaneous injection at Day 0
Comparator: M-M-R II
A Single 0.5 mL subcutaneous injection at Day 0
Interventions
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Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
A Single 0.5 mL subcutaneous injection at Day 0
Comparator: Varivax
A Single 0.5 mL subcutaneous injection at Day 0
Comparator: M-M-R II
A Single 0.5 mL subcutaneous injection at Day 0
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Negative clinical history of measles, mumps, rubella, varicella, and zoster
Exclusion Criteria
* Any immune impairment or deficiency
* Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
* Vaccination with an inactive vaccine with in the past 14 days
* Vaccination with a live vaccine within the past 30 days
12 Months
23 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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Lieberman JM, Williams WR, Miller JM, Black S, Shinefield H, Henderson F, Marchant CD, Werzberger A, Halperin S, Hartzel J, Klopfer S, Schodel F, Kuter BJ; Consistency Lot Study Group for ProQuad. The safety and immunogenicity of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children: a study of manufacturing consistency and persistence of antibody. Pediatr Infect Dis J. 2006 Jul;25(7):615-22. doi: 10.1097/01.inf.0000220209.35074.0b.
Other Identifiers
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2009_669
Identifier Type: -
Identifier Source: secondary_id
V221-012
Identifier Type: -
Identifier Source: org_study_id