A Study of ProQuad™ in Healthy Children in Korea (V221-023)

NCT ID: NCT00839917

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-05-31

Brief Summary

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This study will compare ProQuad™ and concomitant administration of M-M-R™ II and Varivax™ with respect to immunogenicity, safety and tolerability. The primary hypothesis to be tested is that the antibody response rates to measles, mumps, rubella, and varicella 6 weeks after vaccination with ProQuad™ will be non-inferior to the antibody response rates after vaccination with concomitant M-M-R™ II and Varivax™.

Detailed Description

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Conditions

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Measles Mumps Rubella Varicella

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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ProQuad™

Group Type EXPERIMENTAL

Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™)

Intervention Type BIOLOGICAL

Single administration of 0.5 mL subcutaneous injection

M-M-R™ II and Varivax™

Group Type ACTIVE_COMPARATOR

M-M-R™ II and Varivax™

Intervention Type BIOLOGICAL

Single administration of 0.5 mL subcutaneous injection

Interventions

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Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™)

Single administration of 0.5 mL subcutaneous injection

Intervention Type BIOLOGICAL

M-M-R™ II and Varivax™

Single administration of 0.5 mL subcutaneous injection

Intervention Type BIOLOGICAL

Other Intervention Names

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V221

Eligibility Criteria

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Inclusion Criteria

* Subject is in good health
* Subject has a negative clinical history for measles, mumps, rubella, varicella and zoster

Exclusion Criteria

* Subject has previously received measles, mumps, rubella and/or varicella vaccine, either alone or in any combination
* Subject has any congenital or acquired immune deficiency, neoplastic disease or depressed immunity
* Subject has a history of seizure disorder
* Subject had exposure to measles, mumps, rubella, varicella and/or zoster in the last 4 weeks
* Subject has received an inactivated vaccine within the past 14 days
* Subject has received a live vaccine within the past 30 days
* Subject has received immune globulin within the past 5 months
* Subject has a recent history of fever (within the last 72 hours)
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_538

Identifier Type: -

Identifier Source: secondary_id

V221-023

Identifier Type: -

Identifier Source: org_study_id

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