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

NCT ID: NCT05470855

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 45400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-06
• Study Completion Date: 2023-02-10

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.

Conditions

Varicella

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental Group in Protective effect study

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.

Group Type: EXPERIMENTAL

Live attenuated varicella vaccine

Intervention Type: BIOLOGICAL

The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. Live attenuated varicella-virus in 0.5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride, sodium dihydrogen phosphate, potassium dihydrogen phosphate per injection.The routine of administration is intramuscular injection into deltoid region of the lateral upper arm.

Control Group in Protective effect study

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Safety group

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

Group Type: EXPERIMENTAL

Live attenuated varicella vaccine

Intervention Type: BIOLOGICAL

The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. Live attenuated varicella-virus in 0.5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride, sodium dihydrogen phosphate, potassium dihydrogen phosphate per injection.The routine of administration is intramuscular injection into deltoid region of the lateral upper arm.

Etiological study group

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

Group Type: EXPERIMENTAL

Live attenuated varicella vaccine

Intervention Type: BIOLOGICAL

The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. Live attenuated varicella-virus in 0.5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride, sodium dihydrogen phosphate, potassium dihydrogen phosphate per injection.The routine of administration is intramuscular injection into deltoid region of the lateral upper arm.

Interventions

Live attenuated varicella vaccine

The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. Live attenuated varicella-virus in 0.5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride, sodium dihydrogen phosphate, potassium dihydrogen phosphate per injection.The routine of administration is intramuscular injection into deltoid region of the lateral upper arm.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Healthy children aged 1-12 years without a history of varicella;
• The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 8 years and above, both subjects and guardians need to sign the informed consent form);

• Healthy children aged 1-12 years without a history of varicella;
• The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 8 years and above, both subjects and guardians need to sign the informed consent form);
• The subjects and their guardians voluntarily participate in the study and are able to follow all study procedures;
• Proven legal identity.

• Healthy children aged 1-12 years without a history of varicella;
• The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 8 years and above, both subjects and guardians need to sign the informed consent form);
• The subjects and their guardians voluntarily participate in the study and are able to follow all study procedures;
• Proven legal identity;
• Subjects'guardians can fill in adverse events using mobile apps;

• Varicella cases among study 1 enrolled subjects who signed informed consent for biological samples collection.

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sinovac (Dalian) Vaccine Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jihai Tang, Master

Role: PRINCIPAL_INVESTIGATOR

Anhui Provincial Center for Disease Prevention and Control

Locations

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

Countries

China

Other Identifiers

PRO-VAR-MA4003-AH

Identifier Type: -

Identifier Source: org_study_id