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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Varicella

Treatments

Biological: Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck)

Biological: Varicella Virus Vaccine Live (2007 Process) (Oka/Merck)

Biological: Measles, Mumps, and Rubella Virus Vaccine Live (MMR)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00822237

V210-057

2009_510

Details and patient eligibility

About

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.

Full description

This treatment has been approved for sale to the public.

Enrollment

598 patients

Sex

All

Ages

12 to 23 months old

Volunteers

Accepts Healthy Volunteers

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