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Second Dose of Varicella Vaccine in Healthy Children
Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
Summary
This study aim to assess the immunogenicity and safety of interchangeable administration of the second dose of varicella vaccine. A total of 300 healthy participants aged 15 months - 12 years will be enrolled. Written informed consent form will be obtained from participants' parents or legally acceptable representatives (and assents will be obtained from participants aged above 9 years old and written consent forms will be prepared and consent will be obtained in writing if possible from the participants aged 3-8 years old.) before enrollment. Participants will be assigned to 5 groups according to the brand of first dose varicella vaccine they received at the age of 12 months. All participants will receive the second dose of varicella vaccine manufactured by Sinovac. The duration of individual participation from enrollment to the last onsite visit will be a maximum of 42 days. The end of study is considered the completion of the last visit for the last participant in this study. Blood samples (2.5 - 3.0ml per time) for immunogenicity assessment will be collected. The blood samples will be collected before vaccination and 42 days after vaccination.
Official title: Immunogenicity and Safety of the Second Dose of Varicella Vaccine in Healthy Children: An Open-label Study
Key Details
Gender
All
Age Range
15 Months - 12 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-01-28
Completion Date
2026-11-15
Last Updated
2026-03-16
Healthy Volunteers
Yes
Interventions
PROVARIX
Participants will receive one dose (0.5 mL) of PROVARIX (VarV), a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd., administered as the second dose of varicella vaccination.
Locations (5)
Akdeniz University Health, Research and Application Center (Hospital), Department of Child Health and Diseases, Department of Social Pediatrics
Akdeniz, Turkey (Türkiye)
Ankara Bilkent City Hospital, Pediatrics and Pediatric Infectious Diseases Clinic
Ankara, Turkey (Türkiye)
Hacettepe University Hospitals, Department of Pediatrics, Department of Social Pediatrics
Ankara, Turkey (Türkiye)
REPUBLIC of TURKEY MINISTRY of HEALTH ANKARA BILKENT CITY HOSPITAL
Ankara, Turkey (Türkiye)
Ege University Hospital (Application and Research Center) Department of Child Health and Diseases
Ege, Turkey (Türkiye)