Safety of a Second Dose of Biken's Varicella Vaccine
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|ClinicalTrials.gov Identifier: NCT00830648|
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : June 10, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Varicella||Biological: Live Attenuated Varicella Virus Vaccine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||December 2009|
Biological: Live Attenuated Varicella Virus Vaccine
0.5 mL, Subcutaneous
Other Name: Varicela Biken
- To provide information concerning the safety after administration of Varicella vaccine [ Time Frame: one month after vaccination ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830648
|Buenos Aires, Argentina, C1406DGI|
|Study Director:||Medical Director||Sanofi Pasteur Inc.|