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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
300
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.
Akdeniz University Health, Research and Application Center (Hospital), Department of Child Health and Diseases, Department of Social Pediatrics
Akdeniz, Turkey (Türkiye)
RECRUITINGAnkara Bilkent City Hospital, Pediatrics and Pediatric Infectious Diseases Clinic
Ankara, Turkey (Türkiye)
NOT_YET_RECRUITINGHacettepe University Hospitals, Department of Pediatrics, Department of Social Pediatrics
Ankara, Turkey (Türkiye)
RECRUITINGREPUBLIC of TURKEY MINISTRY of HEALTH ANKARA BILKENT CITY HOSPITAL
Ankara, Turkey (Türkiye)
NOT_YET_RECRUITINGEge University Hospital (Application and Research Center) Department of Child Health and Diseases
Ege, Turkey (Türkiye)
NOT_YET_RECRUITINGGeometric Mean Concentration (GMC) of Varicella-Zoster Virus (VZV) Antibodies
Time frame: 42 days after vaccination (Day 42)
Geometric Mean Fold Rise (GMFR) of Varicella-Zoster Virus (VZV) Antibodies
Time frame: 42 days after vaccination (Day 42)
Seropositive Rate of Varicella-Zoster Virus (VZV) Antibodies
Time frame: 42 days after vaccination (Day 42)
Seroresponse Rate of Varicella-Zoster Virus (VZV) Antibodies
Time frame: 42 days after vaccination (Day 42)
Incidence of Adverse Reactions Within 42 Days After Vaccination
Time frame: Day 0 to Day 42 after vaccination
Incidence of Serious Adverse Events (SAEs)
Time frame: Day 0 to Day 180 after vaccination
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