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

Phase 3

Completed

• Conditions: Varicella
• Interventions: Biological: Varicella Virus Vaccine Live (2007 Process) (Oka/Merck); Biological: Measles, Mumps, and Rubella Virus Vaccine Live (MMR)

• Registration Number: NCT00822237
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

This treatment has been approved for sale to the public.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-09
• Study First Submitted QC: 2009-01-12
• Study First Posted: 2009-01-14
• Primary Completion: 2009-10
• Study Completion: 2009-12
• Results First Submitted: 2010-10-28
• Results First Submitted QC: 2011-04-19
• Results First Posted: 2011-04-21
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-14
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 598

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VARIVAX 2007 process + M-M-R II	Measles, Mumps, and Rubella Virus Vaccine Live (MMR)	-
VARIVAX 2007 process + M-M-R II	Varicella Virus Vaccine Live (2007 Process) (Oka/Merck)	-
VARIVAX 1999 process + M-M-R II	Measles, Mumps, and Rubella Virus Vaccine Live (MMR)	-

Primary Outcome Measures

Name	Time	Method
Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process).	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.