- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00109278
A Measles, Mumps, and Rubella Investigational Vaccine Trial (V205C-010)(COMPLETED)
March 14, 2017 updated by: Merck Sharp & Dohme LLC
A Comparison of the Safety, Tolerability, and Immunogenicity of V205C Manufactured From the 2003 Measles Stock Seed With Recombinant Human Albumin (rHA) Versus Currently Licensed V205C Manufactured From the 1967 Measles Stock Seed With Human Serum Albumin (HSA) in Healthy Children 12 to 18 Months of Age
The purpose of this study is to test the safety of a measles, mumps, and rubella study vaccine made from a new measles stock seed (a component of the vaccine made in 2003) with rHA (recombinant human albumin).
Study Overview
Status
Completed
Conditions
Detailed Description
The duration of treatment is 6 weeks.
Study Type
Interventional
Enrollment (Actual)
1100
Phase
- Phase 2
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 to 18 months of age.
Exclusion Criteria:
- Previous receipt of measles, mumps, rubella and/or varicella vaccine.
- Prior infection or exposure to (within last 4 weeks) measles, mumps, rubella, varicella and/or zoster.
- Any medical condition that might interfere with the immune response to the given vaccines (including HIV infection and/or cancer) or has undergone immunosuppressive (weakens your body's ability to fight infection) therapy.
- History of seizures (convulsions)
- Allergies to any component of the vaccine, including sorbitol, gelatin, or neomycin.
- A recent (within the last 3 days) illness resulting in a fever (underarm temperature greater than 99.5° F [37.5° C]).
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
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Antibody response rate to measles at 6 weeks postvaccination
|
Secondary Outcome Measures
Outcome Measure |
---|
Geometric mean titers to measles by ELISA at 6 weeks 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
October 1, 2004
Primary Completion (ACTUAL)
May 1, 2005
Study Completion (ACTUAL)
May 1, 2005
Study Registration Dates
First Submitted
April 26, 2005
First Submitted That Met QC Criteria
April 25, 2005
First Posted (ESTIMATE)
April 26, 2005
Study Record Updates
Last Update Posted (ACTUAL)
March 15, 2017
Last Update Submitted That Met QC Criteria
March 14, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- V205C-010
- 2005_016
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.
Clinical Trials on Measles
-
Bandim Health ProjectHeidelberg University; Centre de Recherche en Sante de Nouna, Burkina Faso; Navrongo... and other collaboratorsUnknownMeasles VaccineBurkina Faso
-
Bandim Health ProjectUnknown
-
Postgraduate Institute of Medical Education and...Unknown
-
Bandim Health ProjectHeidelberg University; Centre de Recherche en Sante de Nouna, Burkina Faso; Navrongo... and other collaboratorsUnknown
-
Serum Institute of India Pvt. Ltd.Centers for Disease Control and Prevention; University of Colorado, BoulderCompletedProphylaxis for the Measles InfectionIndia
-
Bandim Health ProjectEnrolling by invitationMortality | Measles Vaccine | Hospital Admission | Non-specific (Heterologous) Effects of VaccinesGuinea-Bissau
-
GlaxoSmithKlineCompletedMeasles; Mumps; Rubella | Measles-Mumps-Rubella VaccineUnited States, Finland, Taiwan, Estonia, Puerto Rico
-
The Immunobiological Technology Institute (Bio-Manguinhos)...Not yet recruiting
Clinical Trials on Comparator: Measles, Mumps, and Rubella Virus Vaccine Live
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompletedMeasles | Rubella | Mumps | Varicella
-
Sichuan Center for Disease Control and PreventionChina National Biotec Group Company LimitedUnknown
-
Merck Sharp & Dohme LLCCompletedMeasles | Rubella | Mumps | Varicella
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompletedMeasles | Rubella | Mumps | Varicella
-
Merck Sharp & Dohme LLCCompletedMeasles | Rubella | Mumps | Varicella
-
Merck Sharp & Dohme LLCCompletedMeasles | Rubella | Mumps | Varicella
-
GlaxoSmithKlineCompletedMeasles | Rubella | Mumps | VaricellaBelgium, Germany, Netherlands
-
GlaxoSmithKlineCompletedMeasles | Rubella | Mumps | VaricellaGermany