A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)

July 16, 2015 updated by: Merck Sharp & Dohme LLC

Administration of Frozen Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine to Healthy Children at 4 to 6 Years of Age

The study was conducted to determine if ProQuad may be used in place of the second dose of M-M-R II routinely given to children 4 to 6 years old who were previously immunized with M-M-R II and Varivax.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

801

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

6 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • In good health
  • Received primary dose of M-M-R II at less than or equal to 12 months of age
  • Received primary dose of Varivax at less than or equal to 12 months of age
  • Negative history of varicella, zoster, measles, mumps, and rubella

Exclusion Criteria:

  • history of receiving more than once dose of M-M-R II or Varivax
  • Any immune impairment or deficiency
  • Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
  • Vaccination with an inactive vaccine with in the past 14 days
  • Vaccination with a live vaccine within the past 30 days
  • Receipt of immune globulin, or blood product in the past 5 months

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
ProQuad + Placebo
Biological: ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live)
A Single 0.5 mL subcutaneous injection at Day 1
Other Names:
  • ProQuad
Biological: Comparator: Placebo
A Single 0.5 mL subcutaneous placebo injection at Day 1
Active Comparator: 2
M-M-R II + Placebo
Biological: Comparator: Placebo
A Single 0.5 mL subcutaneous placebo injection at Day 1
Biological: Comparator: M-M-R II
A Single 0.5 mL subcutaneous injection at Day 1
Active Comparator: 3
M-M-R II + Varivax
Biological: Comparator: M-M-R II
A Single 0.5 mL subcutaneous injection at Day 1
Biological: Comparator: Varivax
A Single 0.5 mL subcutaneous injection at Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Time Frame: 6 weeks Postvaccination
Postvaccination observed Geometric Mean Titer of antibody to Varicella
6 weeks Postvaccination
Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Time Frame: 6 weeks Postvaccination
Postvaccination observed Geometric Mean Titer of antibody to Measles
6 weeks Postvaccination
Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Time Frame: 6 weeks Postvaccination
Postvaccination observed Geometric Mean Titer of antibody to Mumps
6 weeks Postvaccination
Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Time Frame: 6 weeks Postvaccination
Postvaccination observed Geometric Mean Titer of antibody to Rubella
6 weeks Postvaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

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.

General Publications

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

August 1, 2000

Primary Completion (Actual)

May 1, 2002

Study Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

September 24, 2009

First Submitted That Met QC Criteria

September 25, 2009

First Posted (Estimate)

September 28, 2009

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 16, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V221-014
  • 2009_668

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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