A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)

Merck Sharp & Dohme LLC801 enrolled

Overview

The study was conducted to determine if ProQuad may be used in place of the second dose of M-M-R II routinely given to children 4 to 6 years old who were previously immunized with M-M-R II and Varivax.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

801

Conditions

Measles Mumps Rubella Varicella

Interventions

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

A Single 0.5 mL subcutaneous injection at Day 1

Comparator: M-M-R IIBIOLOGICAL

A Single 0.5 mL subcutaneous injection at Day 1

Comparator: VarivaxBIOLOGICAL

A Single 0.5 mL subcutaneous injection at Day 1

Eligibility

Sex: ALLMin age: 4 YearsMax age: 6 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * In good health * Received primary dose of M-M-R II at less than or equal to 12 months of age * Received primary dose of Varivax at less than or equal to 12 months of age * Negative history of varicella, zoster, measles, mumps, and rubella Exclusion Criteria: * history of receiving more than once dose of M-M-R II or Varivax * 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 * Receipt of immune globulin, or blood product in the past 5 months

Outcomes

Primary Outcomes

Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer

Postvaccination observed Geometric Mean Titer of antibody to Varicella

Time frame: 6 weeks Postvaccination

Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer

Postvaccination observed Geometric Mean Titer of antibody to Measles

Time frame: 6 weeks Postvaccination

Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer

Postvaccination observed Geometric Mean Titer of antibody to Mumps

Time frame: 6 weeks Postvaccination

Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer

Postvaccination observed Geometric Mean Titer of antibody to Rubella

Time frame: 6 weeks Postvaccination

Data from ClinicalTrials.gov

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