Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00830648 |
The objective of the present study is to assess and document the safety of a second dose of Varicela Biken vaccine administered at 4 to 6 years of age in healthy children having previously received a first dose of Varicela Biken vaccine.
All subjects will receive a second dose of Varicella vaccine (Varicela 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.
Condition | Intervention | Phase |
---|---|---|
Varicella |
Biological: Live Attenuated Varicella Virus Vaccine |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
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 |
Estimated Enrollment: | 150 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Biological: Live Attenuated Varicella Virus Vaccine
0.5 mL, Subcutaneous
|
Ages Eligible for Study: | 4 Years to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria:
Contact: Public Registry Sanofi pasteur | RegistryContacUs@sanofipasteur.com |
Argentina | |
Recruiting | |
Buenos Aires, Argentina, C1406DGI |
Study Director: | Medical Director | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi Pasteur SA ( Medical Director ) |
Study ID Numbers: | VBK12 |
Study First Received: | January 27, 2009 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00830648 History of Changes |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
varicella-zoster virus varicella |
Virus Diseases Herpes Zoster Chickenpox DNA Virus Infections |
Healthy Varicella Zoster Herpesviridae Infections |
Virus Diseases Herpes Zoster Chickenpox DNA Virus Infections Herpesviridae Infections |