ProQuad Dose Selection Study (V221-011)(COMPLETED)

NCT ID: NCT00986232

Last Updated: 2015-04-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1551 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-04-30

Study Completion Date

2000-09-30

Brief Summary

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A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II and PUVV (Process Upgrade Varicella Vaccine) vaccines.

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

DOUBLE

Participants Investigators

Study Groups

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1

ProQuad (low dose)

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90

2

ProQuad (middle dose)

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90

3

ProQuad (high dose)

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90

4

M-M-R II + PUVV

Group Type ACTIVE_COMPARATOR

Comparator: M-M-R II

Intervention Type BIOLOGICAL

A single 0.5 mL subcutaneous injection at Day 0

Comparator: PUVV

Intervention Type BIOLOGICAL

A single 0.5 mL subcutaneous injection at Day 0

Interventions

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

a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90

Intervention Type BIOLOGICAL

Comparator: M-M-R II

A single 0.5 mL subcutaneous injection at Day 0

Intervention Type BIOLOGICAL

Comparator: PUVV

A single 0.5 mL subcutaneous injection at Day 0

Intervention Type BIOLOGICAL

Other Intervention Names

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ProQuad

Eligibility Criteria

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Inclusion Criteria

* In good health
* Negative clinical history of measles, mumps, rubella, varicella, and zoster

Exclusion Criteria

* Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination
* Any immune impairment or deficiency
* Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
* Vaccination with an inactive vaccine with in the past 14 days
* Vaccination with a live vaccine within the past 30 days
* Immune globulin or any blood product administered in the past 3 months
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

References

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Shinefield H, Black S, Williams WR, Marchant C, Reisinger K, Stewart T, Meissner HC, Guerrero J, Klopfer SO, Xu J, Schodel F, Kuter BJ; Dose Selection Study Group for Proquad. Dose-response study of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Pediatr Infect Dis J. 2005 Aug;24(8):670-5. doi: 10.1097/01.inf.0000172901.29621.e9.

Reference Type RESULT
PMID: 16094218 (View on PubMed)

Other Identifiers

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2009_667

Identifier Type: -

Identifier Source: secondary_id

V221-011

Identifier Type: -

Identifier Source: org_study_id

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