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

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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.

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.

Condition or disease Intervention/treatment Phase
Measles Mumps Rubella Varicella Biological: ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live) Biological: Comparator: M-M-R II Biological: Comparator: Varivax Biological: Comparator: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 801 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Administration of Frozen Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine to Healthy Children at 4 to 6 Years of Age
Study Start Date : August 2000
Actual Primary Completion Date : May 2002
Actual Study Completion Date : May 2003

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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 Name: 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: M-M-R II
A Single 0.5 mL subcutaneous injection at Day 1

Biological: Comparator: Placebo
A Single 0.5 mL subcutaneous placebo 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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00985166


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Additional Information:
Publications of Results:
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00985166     History of Changes
Other Study ID Numbers: V221-014
2009_668
First Posted: September 28, 2009    Key Record Dates
Results First Posted: January 29, 2010
Last Update Posted: July 28, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
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Measles
Chickenpox
Herpes Zoster
Rubella
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Rubivirus Infections
Togaviridae Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs