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Study to Test the Safety and Immunogenicity of VARIVAX (2007 Process) (Study V210-057) (Completed)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00822237
First received: January 9, 2009
Last updated: April 19, 2011
Last verified: April 2011
History of Changes
  Purpose

This study will test the safety, tolerability, and immunogenicity of VARIVAX manufactured with the 2007 commercial Varicella-Zoster Virus (VZV) bulk process when concomitantly administered with M-M-R II in healthy children.


Condition Intervention Phase
Varicella
 Biological: Varicella Virus Vaccine Live (2007 Process) (Oka/Merck)
Biological: Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck)
Biological: Measles, Mumps, and Rubella Virus Vaccine Live (MMR)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety, Tolerability, and Immunogenicity of VARIVAX (2007 Commercial VZV Bulk Process) Administered Concomitantly With M-M-R II in Healthy Children 12-to-23 Months of Age

Resource links provided by NLM:

MedlinePlus related topics: Chickenpox Shingles
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process). [ Time Frame: 6 weeks following first vaccination ] [ Designated as safety issue: No ]

    Percent of participants with varicella antibody titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) units/mL in participants with baseline varicella antibody titer < 1.25 gpELISA units/mL.

    Results for the VARIVAX (1999 Process) arm are not included in this table because the primary outcome measure is for the VARIVAX (2007 Process) arm only.



Enrollment: 598
Study Start Date: January 2009
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VARIVAX 2007 process + M-M-R II Biological: Varicella Virus Vaccine Live (2007 Process) (Oka/Merck)
VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart
Biological: Measles, Mumps, and Rubella Virus Vaccine Live (MMR)
M-M-R II in two 0.5 mL doses by injection ~6 weeks apart
Active Comparator: VARIVAX 1999 process + M-M-R II Biological: Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck)
VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart
Biological: Measles, Mumps, and Rubella Virus Vaccine Live (MMR)
M-M-R II in two 0.5 mL doses by injection ~6 weeks apart

Detailed Description:

This treatment has been approved for sale to the public.

  Eligibility

Ages Eligible for Study:   12 Months to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is in good health based on medical history
  • Subject has no history of measles, mumps, rubella, chickenpox, or shingles

Exclusion Criteria:

  • Subject has previously received measles, mumps, rubella, and/or varicella vaccine either alone or in combination
  • Subject has history of immune disorders
  • Subject has been exposed to chickenpox/shingles, measles, mumps, rubella or varicella within 4 weeks of study start
  • Subject has received an inactivated vaccine within 14 days of first dose of study vaccine
  • Subject has received a live vaccine within 30 days of first dose of study vaccine
  • Subject has received a blood transfusion or blood-derived products within 3 months of receiving study vaccine
  • Subject has had a fever within 72 hours of study start
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00822237

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00822237     History of Changes
Other Study ID Numbers: V210-057, 2009_510
Study First Received: January 9, 2009
Results First Received: October 28, 2010
Last Updated: April 19, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 19, 2013