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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 (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00822237
First received: January 9, 2009
Last updated: March 14, 2017
Last verified: March 2017
January 9, 2009
March 14, 2017
January 2009
October 2009   (Final data collection date for primary outcome measure)
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.

Varicella antibody levels post dose 1 of VARIVAX 2007 process [ Time Frame: 6 weeks following first vaccination ]
Complete list of historical versions of study NCT00822237 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Study to Test the Safety and Immunogenicity of VARIVAX (2007 Process) (Study V210-057) (Completed)
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
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.
This treatment has been approved for sale to the public.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Varicella
  • Biological: Varicella Virus Vaccine Live (2007 Process) (Oka/Merck)
    VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart
  • 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
  • Experimental: VARIVAX 2007 process + M-M-R II
    Interventions:
    • Biological: Varicella Virus Vaccine Live (2007 Process) (Oka/Merck)
    • Biological: Measles, Mumps, and Rubella Virus Vaccine Live (MMR)
  • Active Comparator: VARIVAX 1999 process + M-M-R II
    Interventions:
    • Biological: Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck)
    • Biological: Measles, Mumps, and Rubella Virus Vaccine Live (MMR)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
598
December 2009
October 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Months to 23 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00822237
V210-057
2009_510
No
Not Provided
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

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP