Safety of a Second Dose of Biken's Varicella Vaccine

Varicella Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00830648
• Other study ID #: VBK12
• Status: Completed
• Phase: Phase 4
• First received: January 27, 2009
• Last updated: June 6, 2013
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: June 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 6 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Varicella

Intervention

Biological:
• Live Attenuated Varicella Virus Vaccine
0.5 mL, Subcutaneous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide information concerning the safety after administration of Varicella vaccine		one month after vaccination	Yes

External Links

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