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

Merck Sharp & Dohme LLC480 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

480

Conditions

Measles Mumps Rubella Varicella

Interventions

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

a single 0.5 mL subcutaneous injection of V221 at Day 0 and Day 90

Comparator: PlaceboBIOLOGICAL

a single 0.5 mL subcutaneous placebo injection at Day 0

Comparator: VarivaxBIOLOGICAL

a single 0.5 mL subcutaneous injection of Varivax at Day 0

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 23 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline

Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of \<0.6 gpELISA units/mL) to Varicella at Baseline