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

Varicella Clinical Trial

Official title:

A Clinical Trial to Evaluate Protective Effect, Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Children Aged 1-12 Years

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05470855
• Other study ID #: PRO-VAR-MA4003-AH
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 6, 2022
• Est. completion date: February 10, 2023

Study information

• Verified date: July 2022
• Source: Sinovac (Dalian) Vaccine Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45400
• Est. completion date: February 10, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

Study 1: Inclusion criteria for a protective effect study of varicella vaccine:

• 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);

Study 2: Inclusion criteria for immunogenicity and safety evaluation of varicella vaccine:

• 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.

Study 3: Inclusion criteria for safety evaluation of mass vaccination of varicella vaccine :

• 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;

Study 4: Inclusion criteria for etiological study on the pathogenic strains of varicella cases:

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

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.

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Varicella

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac (Dalian) Vaccine Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence density	The incidence density will be calculated by the number of confirmed cases of varicella at 42 days after vaccination.	42 days after vaccination
Primary	The protection rate	The protection rate will be calculated by the number of confirmed cases of varicella at 42 days after vaccination.	42 days after vaccination
Secondary	GMT of varicella antibody	GMT of varicella antibody at 42 days after varicella vaccination.	42 days after varicella vaccination
Secondary	GMI of varicella antibody	GMI of varicella antibody at 42 days after varicella vaccination.	42 days after varicella vaccination
Secondary	Positive rates of varicella antibody	Positive rate of varicella antibody at 42 days after varicella vaccination.	42 days after varicella vaccination
Secondary	Immunogenicity index-GMT of varicella antibody	GMT of varicella antibody at 4 months after varicella vaccination.	4 months after varicella vaccination
Secondary	Immunogenicity index-GMI of varicella antibody	GMI of varicella antibody at 4 months after varicella vaccination.	4 months after varicella vaccination
Secondary	Immunogenicity index- positive rates	Positive rates of varicella antibody at 4 months after varicella vaccination.	4 months after varicella vaccination
Secondary	The incidence of adverse events, serious adverse events and adverse reactions	The incidence of adverse events, serious adverse events and adverse reactions at 14 days after varicella vaccination.	14 days after varicella vaccination
Secondary	Incidence of adverse events, serious adverse events and adverse reactions	The incidence of adverse events, serious adverse events and adverse reactions at 42 days after varicella vaccination.	42 days after varicella vaccination.
Secondary	Safety index-Incidence of adverse events, serious adverse events and adverse reactions	The incidence of adverse events, serious adverse events and adverse reactions in 3 months after varicella vaccination.	3 months after varicella vaccination
Secondary	Safety index-incidence of adverse events, serious adverse events and adverse reactions	The incidence of adverse events, serious adverse events and adverse reactions in 6 months after varicella vaccination.	6 months after varicella vaccination
Secondary	Safety index- incidence of adverse events, serious adverse events and adverse reactions	The incidence of adverse events, serious adverse events and adverse reactions in 9 months after varicella vaccination.	9 months after varicella vaccination
Secondary	The incidence of adverse events, serious adverse events and adverse reactions	The incidence of adverse events, serious adverse events and adverse reactions in 12 months after varicella vaccination.	12 months after varicella vaccination