Status:

COMPLETED

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

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Varicella

Eligibility:

All Genders

12-23 years

Phase:

PHASE3

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 ...

Detailed Description

This treatment has been approved for sale to the public.

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

January 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2009

Estimated Enrollment :

598 Patients enrolled

Trial Details

Trial ID

NCT00822237

Start Date

January 1 2009

End Date

December 1 2009

Last Update

April 12 2017

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