Safety of a Second Dose of Biken's Varicella Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00830648
First received: January 27, 2009
Last updated: June 6, 2013
Last verified: June 2013

January 27, 2009
June 6, 2013
January 2009
October 2009   (final data collection date for primary outcome measure)
To provide information concerning the safety after administration of Varicella vaccine [ Time Frame: one month after vaccination ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00830648 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety of a Second Dose of Biken's Varicella Vaccine
Safety of a Second Dose of Biken's Varicella Vaccine Administered at 4 to 6 Years of Age in Healthy Children in Argentina

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Varicella
Biological: Live Attenuated Varicella Virus Vaccine
0.5 mL, Subcutaneous
Other Name: Varicela Biken
Experimental: 1
Intervention: Biological: Live Attenuated Varicella Virus Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
December 2009
October 2009   (final data collection date for primary outcome measure)

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.
Both
4 Years to 6 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT00830648
VBK12
No
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc.
Sanofi
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP