Protective Effect, Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Anhui Province
Varicella
About this trial
This is an interventional prevention trial for Varicella
Eligibility Criteria
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.
Sites / Locations
- Susong County Center for Disease Control and Prevention
- Laian Center for Disease Control and Prevention
- Funan County Center for Disease Control and Prevention
- Huoqiu County Center for Disease Control and Prevention
- Ningguo Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
No Intervention
Experimental
Experimental
Experimental Group in Protective effect study
Control Group in Protective effect study
Safety group
Etiological study group
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.
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.
30000 subjects from study 1 will be enrolled to conduct safety observation study,all adverse events of all subjects will be collected.
Herpes fluid collected from varicella cases in study 1 will be used to conduct etiological study on the pathogenic strains of varicella cases.