Second Dose of Varicella Vaccine in Healthy Children
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age15-12
SponsorSinovac (Dalian) Vaccine Technology Co., Ltd.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy children aged 15 months to 12 years.
Have received one dose of varicella vaccine at 12 months of age in Turkey (verified by vaccination card or official electronic immunization record).
Written informed consent obtained from parent(s) or legally authorized representative(s); assent obtained from children as applicable according to local regulations.
Able to comply with study procedures, as assessed by the investigator.
Disqualifiers
History of varicella-zoster virus (VZV) infection (based on parental report or medical record).
Known exposure to VZV within 4 weeks prior to screening.
Receipt of more than one dose of varicella vaccine.
Interval between first dose of varicella vaccine and enrollment less than 3 months.
Trial design
Design model
Parallel
Treatments tested in this trial
PROVARIX
Biological/VaccineParticipants 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.
Treatment groups
300 Participants
are divided into 5 treatment groupsGroup A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention
Group C: Group 3Experimental treatment 1 intervention
Group D: Group 4Experimental treatment 1 intervention
Group E: Group 5Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Geometric Mean Concentration (GMC) of Varicella-Zoster Virus (VZV) Antibodies
Time frame
42 days after vaccination (Day 42)2
Geometric Mean Fold Rise (GMFR) of Varicella-Zoster Virus (VZV) Antibodies
Time frame
42 days after vaccination (Day 42)Secondary outcomes
1
Seropositive Rate of Varicella-Zoster Virus (VZV) Antibodies
Time frame
42 days after vaccination (Day 42)2
Seroresponse Rate of Varicella-Zoster Virus (VZV) Antibodies
Time frame
42 days after vaccination (Day 42)3
Incidence of Adverse Reactions Within 42 Days After Vaccination
Time frame
Day 0 to Day 42 after vaccination4
Incidence of Serious Adverse Events (SAEs)
Time frame
Day 0 to Day 180 after vaccinationSponsors and contacts
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Source ClinicalTrials.gov