Safety of a Second Dose of Biken's Varicella Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00830648
First received: January 27, 2009
Last updated: June 6, 2013
Last verified: June 2013
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

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 ]

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

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 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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00830648     History of Changes
Other Study ID Numbers: VBK12
Study First Received: January 27, 2009
Last Updated: June 6, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Sanofi:
varicella-zoster virus
varicella

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

ClinicalTrials.gov processed this record on April 21, 2014