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Safety of a Second Dose of Biken's Varicella Vaccine

NCT00830648 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2013-06-10

No results posted yet for this study

Summary

The objective of the present study is to assess and document the safety of a second dose of Varicella Biken vaccine administered at 4 to 6 years of age in healthy children having previously received a first dose of Varicella Biken vaccine.

All subjects will receive a second dose of Varicella vaccine (Varicella Biken) at 4 to 6 years of age.

The expected total duration of follow-up (first visit to last visit) for each subject will be one month.

Conditions

  • Varicella

Interventions

BIOLOGICAL

Live Attenuated Varicella Virus Vaccine

0.5 mL, Subcutaneous

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-10-31
Completion
2009-12-31

Countries

  • Argentina

Study Locations

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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 NCT00830648 on ClinicalTrials.gov