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ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00975507
First Posted: September 11, 2009
Last Update Posted: October 6, 2015
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
This study will compare Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant administration of Varivax and M-M-R II vaccines in healthy children.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Pilot Study to Compare the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine and the Concomitant Administration of the Currently Licensed VARIVAX™ and M-M-R II™ in Healthy Children

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline [ Time Frame: 6 weeks Postvaccination ]
    Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of <0.6 gpELISA units/mL) to Varicella at Baseline


Secondary Outcome Measures:
  • Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL [ Time Frame: 6 weeks Postvaccination ]
    Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <207.8 mIU/mL) to Measles at Baseline

  • Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline [ Time Frame: 6 weeks Postvaccination ]
    Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline

  • Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL [ Time Frame: 6 weeks Postvaccination ]
    Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <2.0 Ab Units/mL) to Mumps at Baseline

  • Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL [ Time Frame: 6 weeks Postvaccination ]
    Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline


Enrollment: 480
Study Start Date: March 1998
Study Completion Date: June 1999
Primary Completion Date: January 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ProQuad™ (V221) + Placebo Followed by ProQuad™
Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
a single 0.5 mL subcutaneous injection of V221 at Day 0 and Day 90
Other Name: ProQuad™
Biological: Comparator: Placebo
a single 0.5 mL subcutaneous placebo injection at Day 0
Active Comparator: 2
M-M-R™ II + VARIVAX™
Biological: Comparator: Varivax
a single 0.5 mL subcutaneous injection of Varivax at Day 0
Biological: Comparator: M-M-R II
a single 0.5 mL subcutaneous injection of M-M-R II at Day 0

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • In good health
  • Negative clinical history of varicella, shingles, measles, mumps, and rubella

Exclusion Criteria:

  • Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination
  • 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
  • Immune globulin or any blood product administered in the past 3 months
  Contacts and Locations
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): NCT00975507


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

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00975507     History of Changes
Other Study ID Numbers: V221-009
2009_660
First Submitted: September 10, 2009
First Posted: September 11, 2009
Results First Submitted: September 23, 2009
Results First Posted: February 10, 2010
Last Update Posted: October 6, 2015
Last Verified: October 2015

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