Varicella Clinical Trial
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
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.
Status | Completed |
Enrollment | 122 |
Est. completion date | December 2009 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 4 Years to 6 Years |
Eligibility |
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. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sanofi Pasteur, a Sanofi Company |
Argentina,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To provide information concerning the safety after administration of Varicella vaccine | one month after vaccination | Yes |
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