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Trial record 8 of 21 for:    varivax | Chicken Pox | merck | Phase 3
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ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00975507
Recruitment Status : Completed
First Posted : September 11, 2009
Results First Posted : February 10, 2010
Last Update Posted : October 6, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
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 or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 480 participants
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
Study Start Date : March 1998
Actual Primary Completion Date : January 1999
Actual Study Completion Date : June 1999

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Shingles

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. 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

  4. 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


Eligibility Criteria
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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
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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 LLC
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme LLC
More Information
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Publications:

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT00975507    
Other Study ID Numbers: V221-009
2009_660
First Posted: September 11, 2009    Key Record Dates
Results First Posted: February 10, 2010
Last Update Posted: October 6, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Chickenpox
Varicella Zoster Virus Infection
Measles
Herpes Zoster
Rubella
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
 RNA Virus Infections
Virus Diseases
Infections
Herpesviridae Infections
DNA Virus Infections
Rubivirus Infections
Togaviridae Infections