Safety of a Second Dose of Biken's Varicella Vaccine

Study Overview
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Brief Summary
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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.

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

Conditions
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Varicella

Intervention / Treatment
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* Biological: Live Attenuated Varicella Virus Vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: Live Attenuated Varicella Virus Vaccine<br>* 0.5 mL, Subcutaneous<br>* Other names: Varicela Biken;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide information concerning the safety after administration of Varicella vaccine |  | one month after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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varicella-zoster virus, varicella