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ProQuad® Intramuscular vs Subcutaneous

NCT00402831 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 405

Last updated 2018-08-13

Study results available
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Summary

Primary objective:

To demonstrate that two doses of ProQuad® administered by IM route are as immunogenic as two doses of ProQuad® administered by SC route to healthy children 12 to 18 months of age in terms of antibody response rates to measles, mumps, rubella and to varicella at 42 days following the second dose of ProQuad®

Secondary objectives:

* To describe the antibody response rates to measles, mumps, rubella and varicella measured 30 days following the first dose of ProQuad® administered by IM or SC route,
* To describe the antibody titres to measles, mumps, rubella and varicella at 30 days following the first dose and at 42 days following the second dose of ProQuad® both administered by IM or SC route,
* To describe the safety profile of two doses of ProQuad® both administered by IM or SC route.

Conditions

Interventions

BIOLOGICAL

ProQuad®

Each dose (0.5 mL) contains live attenuated versions of measles virus Enders' Edmonston strain, mumps virus Jeryl Lynn™ (Level B) strain, rubella virus Wistar RA 27/3 strain, and varicella virus Oka/Merck strain.

Sponsors & Collaborators

Principal Investigators

  • Anne FIQUET, MD · SPMSD

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-10-06
Primary Completion
2007-05-11
Completion
2007-05-11
FDA Drug
Yes

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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 NCT00402831 on ClinicalTrials.gov