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

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.

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

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.

Clinical Trials on Measles

Clinical Trials on Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live

3
Subscribe