A Study of An Approved Vaccine at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age (V205C-007)(COMPLETED)
NCT ID: NCT00092391
Last Updated: 2015-10-23
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
PHASE3
1997 participants
INTERVENTIONAL
1999-02-28
2001-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
DOUBLE
Study Groups
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Control Group
M-M-R(TM) II at current release potency
Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live
0.5 mL subcutaneous injection of one of three sub-lots on Day 0
Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)
0.5 mL subcutaneous injection on Day 0
Mumps Expiry Group 1
M-M-R(TM) II at intermediate expiry potency
Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live
0.5 mL subcutaneous injection of one of three sub-lots on Day 0
Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)
0.5 mL subcutaneous injection on Day 0
Mumps Expiry Group 2
M-M-R(TM) II at expiry potency
Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live
0.5 mL subcutaneous injection of one of three sub-lots on Day 0
Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)
0.5 mL subcutaneous injection on Day 0
Interventions
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Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live
0.5 mL subcutaneous injection of one of three sub-lots on Day 0
Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)
0.5 mL subcutaneous injection on Day 0
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of anaphylactoid reactions or hypersensitivity to any component of the vaccine, including gelatin and neomycin
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
Other Identifiers
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2004_073
Identifier Type: -
Identifier Source: secondary_id
V205C-007
Identifier Type: -
Identifier Source: org_study_id
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