Safety of a Second Dose of Biken's Varicella Vaccine

NCT00830648 | Completed Phase 4

• 1 other identifier: VBK12
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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

Keywords

varicella-zoster virus; varicella

Outcome Measures

Primary Outcomes (1)

• To provide information concerning the safety after administration of Varicella vaccine

  one month after vaccination

Study Arms (1)

1

EXPERIMENTAL

Biological: Live Attenuated Varicella Virus Vaccine

Interventions

Live Attenuated Varicella Virus Vaccine BIOLOGICAL

0.5 mL, Subcutaneous

Also known as: Varicela Biken

1

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Unknown Facility

Buenos Aires, C1406DGI, Argentina

Location

Related Links

• Related Info

MeSH Terms

Conditions

Chickenpox

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 28, 2009
• Study Start: January 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 10, 2013

Record last verified: 2013-06

Locations

AR (1)