Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1551 participants
INTERVENTIONAL
1999-04-30
2000-09-30
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
Study Groups
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1
ProQuad (low dose)
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90
2
ProQuad (middle dose)
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90
3
ProQuad (high dose)
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90
4
M-M-R II + PUVV
Comparator: M-M-R II
A single 0.5 mL subcutaneous injection at Day 0
Comparator: PUVV
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 of ProQuad (low, middle, or high dose) at Day 0 and Day 90
Comparator: M-M-R II
A single 0.5 mL subcutaneous injection at Day 0
Comparator: PUVV
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
* Immune globulin or any blood product administered in the past 3 months
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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Shinefield H, Black S, Williams WR, Marchant C, Reisinger K, Stewart T, Meissner HC, Guerrero J, Klopfer SO, Xu J, Schodel F, Kuter BJ; Dose Selection Study Group for Proquad. Dose-response study of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Pediatr Infect Dis J. 2005 Aug;24(8):670-5. doi: 10.1097/01.inf.0000172901.29621.e9.
Other Identifiers
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2009_667
Identifier Type: -
Identifier Source: secondary_id
V221-011
Identifier Type: -
Identifier Source: org_study_id
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