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

NCT ID: NCT00822237

Last Updated: 2017-04-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

598 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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This treatment has been approved for sale to the public.

Conditions

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Varicella

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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VARIVAX 2007 process + M-M-R II

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

VARIVAX (2007 process) in two 0.5 mL doses by injection \~6 weeks apart

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

Intervention Type BIOLOGICAL

M-M-R II in two 0.5 mL doses by injection \~6 weeks apart

VARIVAX 1999 process + M-M-R II

Group Type ACTIVE_COMPARATOR

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

Intervention Type BIOLOGICAL

VARIVAX (1999 process) in two 0.5 mL doses by injection \~6 weeks apart

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

Intervention Type BIOLOGICAL

M-M-R II in two 0.5 mL doses by injection \~6 weeks apart

Interventions

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

VARIVAX (2007 process) in two 0.5 mL doses by injection \~6 weeks apart

Intervention Type BIOLOGICAL

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

VARIVAX (1999 process) in two 0.5 mL doses by injection \~6 weeks apart

Intervention Type BIOLOGICAL

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

M-M-R II in two 0.5 mL doses by injection \~6 weeks apart

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Months

Maximum Eligible Age

23 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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2009_510

Identifier Type: -

Identifier Source: secondary_id

V210-057

Identifier Type: -

Identifier Source: org_study_id

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