Safety of a Second Dose of Biken's Varicella Vaccine

Phase 4

Completed

• Conditions: Varicella
• Interventions: Biological: Live Attenuated Varicella Virus Vaccine

• Registration Number: NCT00830648
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-27
• Study First Submitted QC: 2009-01-27
• Study First Posted: 2009-01-28
• Primary Completion: 2009-10
• Study Completion: 2009-12
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-06
• Last Update Posted: 2013-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Live Attenuated Varicella Virus Vaccine	-

Primary Outcome Measures

Name	Time	Method
To provide information concerning the safety after administration of Varicella vaccine	one month after vaccination