Clinical trial NCT00830648: Safety of a Second Dose of Biken's Varicella Vaccine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Varicella
Keywords: varicella-zoster virus
varicella
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-01-28
Enrollment: 122
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To provide information concerning the safety after administration of Varicella vaccine
timeFrame: one month after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: