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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00985166
First received: September 24, 2009
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer [ Time Frame: 6 weeks Postvaccination ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Postvaccination observed Geometric Mean Titer of antibody to Rubella


Enrollment: 801
Study Start Date: August 2000
Study Completion Date: May 2003
Primary Completion Date: May 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   4 Years to 6 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985166

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

Additional Information:
No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00985166     History of Changes
Other Study ID Numbers: V221-014, 2009_668
Study First Received: September 24, 2009
Results First Received: December 23, 2009
Last Updated: April 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Measles
Mumps
Rubella
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Rubulavirus Infections
Parotitis
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on July 24, 2014