Safety of a Second Dose of Biken's Varicella Vaccine

NCT ID: NCT00830648

Last Updated: 2013-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-12-31

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.

Conditions

Varicella

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Live Attenuated Varicella Virus Vaccine

Intervention Type: BIOLOGICAL

0.5 mL, Subcutaneous

Interventions

Live Attenuated Varicella Virus Vaccine

0.5 mL, Subcutaneous

Intervention Type: BIOLOGICAL

Other Intervention Names

Varicela Biken

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

Buenos Aires, , Argentina

Countries

Argentina

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

VBK12

Identifier Type: -

Identifier Source: org_study_id