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Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(COMPLETED)

NCT00985153 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3927

Last updated 2015-11-23

Study results available
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Summary

This study will compare three consistency lots of ProQuad to each other as well as to M-M-R II and Varivax, administered concomitantly at different injection sites, with respect to immunogenicity, safety, and tolerability.

Conditions

Interventions

BIOLOGICAL

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

A Single 0.5 mL subcutaneous injection at Day 0

BIOLOGICAL

Comparator: Varivax

A Single 0.5 mL subcutaneous injection at Day 0

BIOLOGICAL

Comparator: M-M-R II

A Single 0.5 mL subcutaneous injection at Day 0

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-03-31
Primary Completion
2001-05-31
Completion
2001-05-31

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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 NCT00985153 on ClinicalTrials.gov