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

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ClinicalTrials.gov Identifier: NCT00822237
Recruitment Status : Completed
First Posted : January 14, 2009
Results First Posted : April 21, 2011
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment 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

Detailed Description:
This treatment has been approved for sale to the public.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 598 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : January 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process). [ Time Frame: 6 weeks following first vaccination ]

    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.




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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:

  • 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

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): NCT00822237


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

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00822237     History of Changes
Other Study ID Numbers: V210-057
2009_510
First Posted: January 14, 2009    Key Record Dates
Results First Posted: April 21, 2011
Last Update Posted: April 12, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs