Varicella
Conditions
Keywords
varicella-zoster virus, varicella
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 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.
Interventions
BIOLOGICALLive Attenuated Varicella Virus Vaccine
0.5 mL, Subcutaneous
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To provide information concerning the safety after administration of Varicella vaccine | one month after vaccination |
Countries
Argentina
Outcome results
None listed