MedTrace Logo

Safety Study of a Refrigerator-stable Formulation of VARIVAX®

NCT00432731 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2017-03-14

No results posted yet for this study

Summary

Primary objective:

To describe the safety profile of a refrigerator-stable formulation of VARIVAX® as a first single dose injection in 12 to 15 month-old infants in the 42-day follow-up period post-vaccination.

Secondary objectives: NA

Conditions

Interventions

BIOLOGICAL

VARIVAX®

BIOLOGICAL

M-M-RTM II

Sponsors & Collaborators

Principal Investigators

  • Anne FIQUET, MD · SPMSD

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2005-09-30
Completion
2005-09-30

Countries

  • France
  • Italy

Study Locations

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 NCT00432731 on ClinicalTrials.gov