MedTrace Logo

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

NCT00985166 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 801

Last updated 2015-07-28

Study results available
· View outcomes & findings →

Summary

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.

Conditions

Interventions

BIOLOGICAL

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

A Single 0.5 mL subcutaneous injection at Day 1

BIOLOGICAL

Comparator: M-M-R II

A Single 0.5 mL subcutaneous injection at Day 1

BIOLOGICAL

Comparator: Varivax

A Single 0.5 mL subcutaneous injection at Day 1

BIOLOGICAL

Comparator: Placebo

A Single 0.5 mL subcutaneous placebo injection at Day 1

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-08-31
Primary Completion
2002-05-31
Completion
2003-05-31

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00985166 on ClinicalTrials.gov