- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00092391
A Study of An Approved Vaccine at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age (V205C-007)(COMPLETED)
October 22, 2015 updated by: Merck Sharp & Dohme LLC
A Study of M-M-R(TM) II at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age
The purpose of this study is to determine the mumps virus strength at the end of shelf-life (expiration date) of an approved vaccine.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
1997
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control Group
M-M-R(TM) II at current release potency
|
0.5 mL subcutaneous injection of one of three sub-lots on Day 0
0.5 mL subcutaneous injection on Day 0
|
Experimental: Mumps Expiry Group 1
M-M-R(TM) II at intermediate expiry potency
|
0.5 mL subcutaneous injection of one of three sub-lots on Day 0
0.5 mL subcutaneous injection on Day 0
|
Experimental: Mumps Expiry Group 2
M-M-R(TM) II at expiry potency
|
0.5 mL subcutaneous injection of one of three sub-lots on Day 0
0.5 mL subcutaneous injection on Day 0
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Neutralizing antibodies to mumps at 6 weeks postvaccination
Time Frame: 6 weeks postvaccination
|
6 weeks postvaccination
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Geometric mean titers to mumps by ELISA at 6 weeks and at 1 year postvaccination
Time Frame: 6 weeks and 1 year postvaccination
|
6 weeks and 1 year postvaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 1999
Primary Completion (Actual)
July 1, 2001
Study Completion (Actual)
July 1, 2001
Study Registration Dates
First Submitted
September 22, 2004
First Submitted That Met QC Criteria
September 24, 2004
First Posted (Estimate)
September 27, 2004
Study Record Updates
Last Update Posted (Estimate)
October 23, 2015
Last Update Submitted That Met QC Criteria
October 22, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Stomatognathic Diseases
- Mouth Diseases
- Paramyxoviridae Infections
- Mononegavirales Infections
- Salivary Gland Diseases
- Togaviridae Infections
- Rubivirus Infections
- Rubulavirus Infections
- Parotitis
- Parotid Diseases
- Rubella
- Mumps
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- V205C-007
- 2004_073
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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