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Safety Study of ProQuad® rHA in Infants (V221-037)

NCT00560755 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3388

Last updated 2017-10-17

Study results available
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Summary

Primary objective: To describe the safety profile of a second dose of ProQuad® manufactured with recombinant human albumin (rHA) when administered to children in their second year of life.

Secondary objectives: To describe the safety profile of a first dose of ProQuad® manufactured with rHA when administered to children in their second year of life.

Conditions

Interventions

BIOLOGICAL

ProQuad®

ProQuad® manufactured with recombinant human albumin (rHA) is an investigational combined attenuated live virus vaccine for vaccination against measles, mumps, rubella and varicella viruses.

Sponsors & Collaborators

Principal Investigators

  • Anne FIQUET, MD · MCM Vaccines B.V.

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2007-10-24
Primary Completion
2008-11-24
Completion
2008-11-24
FDA Drug
Yes

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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 NCT00560755 on ClinicalTrials.gov