Status:
COMPLETED
Safety of a Second Dose of Biken's Varicella Vaccine
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Varicella
Eligibility:
All Genders
4-6 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00830648
Start Date
January 1 2009
End Date
December 1 2009
Last Update
June 10 2013
Active Locations (1)
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1
Buenos Aires, Argentina, C1406DGI