Safety of a Second Dose of Biken's Varicella Vaccine

June 6, 2013 updated by: Sanofi Pasteur, a Sanofi Company

Safety of a Second Dose of Biken's Varicella Vaccine Administered at 4 to 6 Years of Age in Healthy Children in Argentina

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1406DGI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria :

  • Aged 4 to 6 years on the day of inclusion.
  • Informed consent form signed by the parent(s) or legal guardian and by an independent witness.
  • Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.
  • Written documentation of receipt of a first dose of Varicella Biken vaccine more than 3 months before inclusion.

Exclusion Criteria:

  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
  • Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances.
  • Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator.
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination;
  • Planned receipt of any vaccine in the 4 weeks following the trial vaccination.
  • Known Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or Hepatitis C seropositivity.
  • History of varicella infection (confirmed either clinically, serologically or microbiologically).
  • Previous vaccination against varicella disease with a vaccine different from Varicella Biken vaccine.
  • Febrile illness (temperature ≥ 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Biological: Live Attenuated Varicella Virus Vaccine
0.5 mL, Subcutaneous
Other Names:
  • Varicela Biken

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To provide information concerning the safety after administration of Varicella vaccine
Time Frame: one month after vaccination
one month after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

January 27, 2009

First Submitted That Met QC Criteria

January 27, 2009

First Posted (ESTIMATE)

January 28, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 10, 2013

Last Update Submitted That Met QC Criteria

June 6, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VBK12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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