Safety of a Second Dose of Biken's Varicella Vaccine

Sanofi

Status and phase

Completed

Phase 4

Conditions

Varicella

Treatments

Biological: Live Attenuated Varicella Virus Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00830648

VBK12

Details and patient eligibility

About

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.

Enrollment

122 patients

Sex

All

Ages

4 to 6 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.