- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00092430
Study to Evaluate Frozen Versus Refrigerated MMRV (Combined Measles, Mumps, Rubella, and Varicella) Investigational Vaccine (V221-016)
November 13, 2019 updated by: Merck Sharp & Dohme LLC
A Comparison of the Safety, Tolerability, and Immunogenicity of a Refrigerator-Stable Measles, Mumps, Rubella, and Varicella Combination Vaccine V221 (Refrigerated) Versus V221 (Frozen) in Healthy Children
The purpose of this study is to demonstrate that an investigational refrigerated vaccine with measles, mumps, rubella, and varicella is well tolerated and has similar immune response when compared to a frozen vaccine with measles, mumps, rubella, and varicella.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment
1200
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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy children 12-23 months of age
Exclusion Criteria:
- Previously had measles, mumps, rubella, or varicella
- Compromised immune system
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: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Percent of patients demonstrating adequate antibody titers 6 weeks following administration
|
Secondary Outcome Measures
Outcome Measure |
---|
Geometric mean titers (GMT) 6 weeks post vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
September 26, 2002
Primary Completion (Actual)
June 9, 2003
Study Completion (Actual)
June 9, 2003
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 (Actual)
November 15, 2019
Last Update Submitted That Met QC Criteria
November 13, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Stomatognathic Diseases
- Mouth Diseases
- DNA Virus Infections
- Morbillivirus Infections
- Paramyxoviridae Infections
- Mononegavirales Infections
- Herpesviridae Infections
- Varicella Zoster Virus Infection
- Salivary Gland Diseases
- Togaviridae Infections
- Rubivirus Infections
- Rubulavirus Infections
- Parotitis
- Parotid Diseases
- Measles
- Herpes Zoster
- Chickenpox
- Rubella
- Mumps
Other Study ID Numbers
- V221-016
- 2004_076
Plan for Individual participant data (IPD)
Study Data/Documents
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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