ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Rubella; Varicella; Mumps; Measles

Treatments: Biological: Comparator: Placebo; Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live; Biological: Comparator: M-M-R II; Biological: Comparator: Varivax

Study type: Interventional

Funder types: Industry

Identifiers

NCT00975507

V221-009

2009_660

Details and patient eligibility

About

This study will compare Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant administration of Varivax and M-M-R II vaccines in healthy children.

Enrollment: 480 patients

Sex: All

Ages: 12 to 23 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• In good health
• Negative clinical history of varicella, shingles, measles, mumps, and rubella

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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480 participants in 2 patient groups

1

Experimental group

Description:

ProQuad™ (V221) + Placebo Followed by ProQuad™

Treatment:

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

Biological: Comparator: Placebo

2

Active Comparator group

Description:

M-M-R™ II + VARIVAX™

Treatment:

Biological: Comparator: M-M-R II

Biological: Comparator: Varivax