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

CompletadoFase 4ClinicalTrials.gov

ID: NCT00830648Tipo: INTERVENTIONALInicio: 1 de ene de 2009Fin estimado: 1 de dic de 2009

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 4 YearsEdad máxima: 6 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

Planned receipt of any vaccine in the 4 weeks following the trial vaccination.
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;
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.

Intervenciones

biological

Live Attenuated Varicella Virus Vaccine

0.5 mL, Subcutaneous

Ubicaciones

Buenos Aires, Argentina

Patrocinadores

PrincipalSanofi Pasteur, a Sanofi Company

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