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RECRUITING
NCT07475000
PHASE3

Second Dose of Varicella Vaccine in Healthy Children

Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.

View on ClinicalTrials.gov

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

BIOLOGICAL

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)