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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00985166
Recruitment Status : Completed
First Posted : September 28, 2009
Results First Posted : January 29, 2010
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE September 24, 2009
First Posted Date  ICMJE September 28, 2009
Results First Submitted Date  ICMJE December 23, 2009
Results First Posted Date  ICMJE January 29, 2010
Last Update Posted Date July 28, 2015
Study Start Date  ICMJE August 2000
Actual Primary Completion Date May 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2009)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: September 25, 2009)
  • Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer [ Time Frame: 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 ]
  • Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer [ Time Frame: 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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)
Official Title  ICMJE Administration of Frozen Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine to Healthy Children at 4 to 6 Years of Age
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Measles
  • Mumps
  • Rubella
  • Varicella
Intervention  ICMJE
  • Biological: ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live)
    A Single 0.5 mL subcutaneous injection at Day 1
    Other Name: ProQuad
  • 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
Study Arms  ICMJE
  • Experimental: 1
    ProQuad + Placebo
    Interventions:
    • Biological: ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live)
    • Biological: Comparator: Placebo
  • Active Comparator: 2
    M-M-R II + Placebo
    Interventions:
    • Biological: Comparator: M-M-R II
    • Biological: Comparator: Placebo
  • Active Comparator: 3
    M-M-R II + Varivax
    Interventions:
    • Biological: Comparator: M-M-R II
    • Biological: Comparator: Varivax
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 23, 2009)
801
Original Actual Enrollment  ICMJE
 (submitted: September 25, 2009)
802
Actual Study Completion Date  ICMJE May 2003
Actual Primary Completion Date May 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00985166
Other Study ID Numbers  ICMJE V221-014
2009_668
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP