A Study of An Approved Vaccine at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age (V205C-007)(COMPLETED)
Primary Purpose
Measles, Mumps, Rubella
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live
Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)
Sponsored by
About this trial
This is an interventional prevention trial for Measles
Eligibility Criteria
Inclusion Criteria: Healthy children 12 to 18 months of age Exclusion Criteria: History or prior exposure to measles, mumps, rubella or varicella History of anaphylactoid reactions or hypersensitivity to any component of the vaccine, including gelatin and neomycin
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control Group
Mumps Expiry Group 1
Mumps Expiry Group 2
Arm Description
M-M-R(TM) II at current release potency
M-M-R(TM) II at intermediate expiry potency
M-M-R(TM) II at expiry potency
Outcomes
Primary Outcome Measures
Neutralizing antibodies to mumps at 6 weeks postvaccination
Secondary Outcome Measures
Geometric mean titers to mumps by ELISA at 6 weeks and at 1 year postvaccination
Full Information
NCT ID
NCT00092391
First Posted
September 22, 2004
Last Updated
October 22, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00092391
Brief Title
A Study of An Approved Vaccine at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age (V205C-007)(COMPLETED)
Official Title
A Study of M-M-R(TM) II at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 1999 (undefined)
Primary Completion Date
July 2001 (Actual)
Study Completion Date
July 2001 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the mumps virus strength at the end of shelf-life (expiration date) of an approved vaccine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Measles, Mumps, Rubella, Varicella
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1997 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
M-M-R(TM) II at current release potency
Arm Title
Mumps Expiry Group 1
Arm Type
Experimental
Arm Description
M-M-R(TM) II at intermediate expiry potency
Arm Title
Mumps Expiry Group 2
Arm Type
Experimental
Arm Description
M-M-R(TM) II at expiry potency
Intervention Type
Biological
Intervention Name(s)
Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live
Intervention Description
0.5 mL subcutaneous injection of one of three sub-lots on Day 0
Intervention Type
Biological
Intervention Name(s)
Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)
Intervention Description
0.5 mL subcutaneous injection on Day 0
Primary Outcome Measure Information:
Title
Neutralizing antibodies to mumps at 6 weeks postvaccination
Time Frame
6 weeks postvaccination
Secondary Outcome Measure Information:
Title
Geometric mean titers to mumps by ELISA at 6 weeks and at 1 year postvaccination
Time Frame
6 weeks and 1 year postvaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy children 12 to 18 months of age
Exclusion Criteria:
History or prior exposure to measles, mumps, rubella or varicella
History of anaphylactoid reactions or hypersensitivity to any component of the vaccine, including gelatin and neomycin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study of An Approved Vaccine at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age (V205C-007)(COMPLETED)
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