Protective Effect, Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Anhui Province

Phase 4

• Conditions: Varicella
• Interventions: Biological: Live attenuated varicella vaccine

• Registration Number: NCT05470855
• Lead Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.

Brief Summary

This is Phase 4 clinical trial of live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the protective effect of varicella vaccine in children aged 1-12 years and the correlation between varicella antibody and protective effect,to evaluate the immunogenicity and safety of varicella vaccine in children aged 1-12 years.

Detailed Description

This study is Phase Ⅳ clinical trial.The experimental vaccine manufactured by Sinovac(Dalian) Vaccine Technology Co., Ltd.This clinical trial consists of four parts,and A total of 45400 subjects will be enrolled.

Study 1,45000 subjects including 15000 subjects aged 1-3 years with no history of varicella vaccination ,15000 subjects aged 4-6 years with a history of 1 dose of varicella vaccine,15000 subjects aged 7-12 years with a history of 1 dose of varicella vaccine will be enrolled to evaluate protective effect of varicella vaccine. There will be 7500 subjects in the experimental group and 7500 in the control group in each age group.And subjects who voluntarily receive varicella vaccine will be included in the experimental group and other subjects will be included in the control group.All subjects in the experimental group will receive one dose of varicella vaccine.

Study 2,400 healthy children including 100 subjects aged 1-3 years with no history of varicella ,150 subjects aged 4-6 years(50 children with no history of varicella vaccination and 100 children with a history of one dose of varicella vaccine),150 subjects aged 7-12 years (50 children with no history of varicella vaccination and 100 children with a history of one dose of varicella vaccine),each subject will receive one or two doses (0,3 months) of varicella vaccine.

Study 3,30000 subjects from study 1 will be enrolled to conduct safety observation study,all adverse events of all subjects will be collected.

Study 4,Herpes fluid collected from study 1 varicella cases will be used to conduct etiological study on the pathogenic strains of varicella cases.

Study Timeline

• Status Verified: 2022-07
• Study Start: 2022-07-06
• Study First Submitted: 2022-07-12
• Study First Submitted QC: 2022-07-20
• Study First Posted: 2022-07-22
• Primary Completion: 2022-11-30
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-12
• Study Completion: 2023-02-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45400

Inclusion Criteria

Not provided

Exclusion Criteria

• Received two doses of varicella vaccine from other manufacturers(applied to study 1 exclusion criteria);
• Received two doses of varicella vaccine;
• History of severe allergic reactions to vaccines (e.g.acute anaphylaxis, angioneurotic edema, dyspnea, etc.);
• Any confirmed or suspected immunodeficiency disease, including human immunodeficiency virus (HIV) infection;
• Axillary temperature >37.0°C;
• Receipt of other investigational drugs in the past 30 days;
• Receipt of attenuated live vaccines in the past 28 days;
• Receipt of inactivated or subunit vaccines in the past 7 days;
• According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group in Protective effect study	Live attenuated varicella vaccine	22500 subjects including 7500 subjects aged 1-3 years with no history of varicella vaccination,7500 subjects aged 4-6 years with a history of 1 dose of varicella vaccine,7500 subjects aged 7-12 years with a history of 1 dose of varicella vaccine will receive one dose of varicella vaccine.
Etiological study group	Live attenuated varicella vaccine	Herpes fluid collected from varicella cases in study 1 will be used to conduct etiological study on the pathogenic strains of varicella cases.
Safety group	Live attenuated varicella vaccine	30000 subjects from study 1 will be enrolled to conduct safety observation study,all adverse events of all subjects will be collected.

Primary Outcome Measures

Name	Time	Method
The incidence density	42 days after vaccination	The incidence density will be calculated by the number of confirmed cases of varicella at 42 days after vaccination.
The protection rate	42 days after vaccination	The protection rate will be calculated by the number of confirmed cases of varicella at 42 days after vaccination.

Secondary Outcome Measures

Name	Time	Method
The incidence of adverse events, serious adverse events and adverse reactions	12 months after varicella vaccination	The incidence of adverse events, serious adverse events and adverse reactions in 12 months after varicella vaccination.
GMI of varicella antibody	42 days after varicella vaccination	GMI of varicella antibody at 42 days after varicella vaccination.
Positive rates of varicella antibody	42 days after varicella vaccination	Positive rate of varicella antibody at 42 days after varicella vaccination.
Immunogenicity index-GMT of varicella antibody	4 months after varicella vaccination	GMT of varicella antibody at 4 months after varicella vaccination.
Immunogenicity index- positive rates	4 months after varicella vaccination	Positive rates of varicella antibody at 4 months after varicella vaccination.
Incidence of adverse events, serious adverse events and adverse reactions	42 days after varicella vaccination.	The incidence of adverse events, serious adverse events and adverse reactions at 42 days after varicella vaccination.
Safety index-Incidence of adverse events, serious adverse events and adverse reactions	3 months after varicella vaccination	The incidence of adverse events, serious adverse events and adverse reactions in 3 months after varicella vaccination.
Safety index-incidence of adverse events, serious adverse events and adverse reactions	6 months after varicella vaccination	The incidence of adverse events, serious adverse events and adverse reactions in 6 months after varicella vaccination.
Safety index- incidence of adverse events, serious adverse events and adverse reactions	9 months after varicella vaccination	The incidence of adverse events, serious adverse events and adverse reactions in 9 months after varicella vaccination.
GMT of varicella antibody	42 days after varicella vaccination	GMT of varicella antibody at 42 days after varicella vaccination.
Immunogenicity index-GMI of varicella antibody	4 months after varicella vaccination	GMI of varicella antibody at 4 months after varicella vaccination.

Trial Locations

Locations (5)

Susong County Center for Disease Control and Prevention; 🇨🇳 Anqing, Anhui, China

Laian Center for Disease Control and Prevention; 🇨🇳 Chuzhou, Anhui, China

Funan County Center for Disease Control and Prevention; 🇨🇳 Fuyang, Anhui, China

Huoqiu County Center for Disease Control and Prevention; 🇨🇳 Liu'an, Anhui, China

Ningguo Center for Disease Control and Prevention; 🇨🇳 Xuancheng, Anhui, China