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Safety of a Second Dose of Biken's Varicella Vaccine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00830648
First Posted: January 28, 2009
Last Update Posted: June 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
  Purpose

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.


Condition Intervention Phase
Varicella Biological: Live Attenuated Varicella Virus Vaccine Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety of a Second Dose of Biken's Varicella Vaccine Administered at 4 to 6 Years of Age in Healthy Children in Argentina

Resource links provided by NLM:


Further study details as provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

Primary Outcome Measures:
  • To provide information concerning the safety after administration of Varicella vaccine [ Time Frame: one month after vaccination ]

Enrollment: 122
Study Start Date: January 2009
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Live Attenuated Varicella Virus Vaccine
0.5 mL, Subcutaneous
Other Name: Varicela Biken

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830648


Locations
Argentina
Buenos Aires, Argentina, C1406DGI
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00830648     History of Changes
Other Study ID Numbers: VBK12
First Submitted: January 27, 2009
First Posted: January 28, 2009
Last Update Posted: June 10, 2013
Last Verified: June 2013

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
varicella-zoster virus
varicella

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs