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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00822237
First received: January 9, 2009
Last updated: October 1, 2014
Last verified: October 2014
  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:


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

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
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: NCT00822237

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: 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: October 1, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 20, 2014