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

Overview

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.

Full Title of Study: “Administration of Frozen Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine to Healthy Children at 4 to 6 Years of Age”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2002

Interventions

  • Biological: ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live)
    • A Single 0.5 mL subcutaneous injection at Day 1
  • 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
  • Biological: Comparator: Placebo
    • A Single 0.5 mL subcutaneous placebo injection at Day 1

Arms, Groups and Cohorts

  • Experimental: 1
    • ProQuad + Placebo
  • Active Comparator: 2
    • M-M-R II + Placebo
  • Active Comparator: 3
    • M-M-R II + Varivax

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 4 Years

Maximum Age: 6 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme Corp.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Merck Sharp & Dohme Corp.

Citations Reporting on Results

Reisinger KS, Brown ML, Xu J, Sullivan BJ, Marshall GS, Nauert B, Matson DO, Silas PE, Schödel F, Gress JO, Kuter BJ; Protocol 014 Study Group for ProQuad. A combination measles, mumps, rubella, and varicella vaccine (ProQuad) given to 4- to 6-year-old healthy children vaccinated previously with M-M-RII and Varivax. Pediatrics. 2006 Feb;117(2):265-72. Erratum in: Pediatrics. 2006 Jun;117(6):2338.

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