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Safety of a Second Dose of Biken's Varicella Vaccine
This study is currently recruiting participants.
Verified by Sanofi-Aventis, January 2009
First Received: January 27, 2009   No Changes Posted
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00830648
  Purpose

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

All subjects will receive a second dose of Varicella vaccine (Varicela 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 IV

MedlinePlus related topics: Chickenpox Shingles
Drug Information available for: Chickenpox Vaccine
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Further study details as provided by Sanofi-Aventis:

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

Estimated Enrollment: 150
Study Start Date: January 2009
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Biological: Live Attenuated Varicella Virus Vaccine
0.5 mL, Subcutaneous

  Eligibility

Ages Eligible for Study:   4 Years to 6 Years
Genders Eligible for Study:   Both
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 Varicela 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), HBs 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 Varicela 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830648

Contacts
Contact: Public Registry Sanofi pasteur RegistryContacUs@sanofipasteur.com

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

Additional Information:
No publications provided

Responsible Party: Sanofi Pasteur SA ( Medical Director )
Study ID Numbers: VBK12
Study First Received: January 27, 2009
Last Updated: January 27, 2009
ClinicalTrials.gov Identifier: NCT00830648     History of Changes
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Sanofi-Aventis:
varicella-zoster virus
varicella

Study placed in the following topic categories:
Virus Diseases
Herpes Zoster
Chickenpox
DNA Virus Infections
Healthy
Varicella Zoster
Herpesviridae Infections

Additional relevant MeSH terms:
Virus Diseases
Herpes Zoster
Chickenpox
DNA Virus Infections
Herpesviridae Infections

ClinicalTrials.gov processed this record on May 06, 2009