Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 immunogenicity and safety of a single dose of varicella vaccine in healthy children aged 1-6 years with different varicella immunization histories, to evaluate the antibody level of varicella-zoster virus in healthy people aged 0-59 years in Zhejiang Province.
This study is Phase â…£ clinical trial.The experimental vaccine manufactured by Sinovac(Dalian) Vaccine Technology Co., Ltd.This clinical trial consists of five parts,and A total of 37920 subjects will be enrolled.
Study 1,360 subjects including 120 subjects aged 1-3 years with no history of varicella vaccination ,240 subjects aged 4-6 years with a history of 1 dose of varicella vaccine will be enrolled to evaluate the immunogenicity and safety of varicella vaccine.All subjects will receive one dose of varicella vaccine.
Study 2,2530 subjects aged 0-59 years old will be enrolled and will be collected venous blood to detect varicella antibody and conduct investigation of varicella antibody level in healthy people.
Study 3,30000 subjects aged 1-12 years old will be enrolled to conduct safety observation study.All subjects will receive one dose of varicella vaccine and all adverse events of all subjects will be collected.
Study 4,5000 subjects aged 1-12 years old will be enrolled to conduct protective effect study of varicella vaccine after exposure.
Study 5,30 subjects aged 1-12 years old will be enrolled. Herpes fluid or pharyngeal swab samples of subjects will be collected to study the pathogenicity of varicella.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunogenicity and safety group | Experimental | 360 subjects including 120 subjects aged 1-3 years with no history of varicella vaccination,240 subjects aged 4-6 years with a history of 1 dose of varicella vaccine will be enrolled to evaluate the immunogenicity and safety of varicella vaccine.All subjects will receive one dose of varicella vaccine. |
|
| Antibody level investigation study group | Experimental | Immunization levels will be monitored among 2530 subjects aged 0-59 years old and will be collected venous blood to detect varicella antibody. |
|
| Safety group | Experimental | 30000 subjects aged 1-12 years old will be enrolled to conduct safety observation of mass vaccination of varicella vaccine.All subjects will receive one dose of varicella vaccine and all adverse events of all subjects will be collected. |
|
| Protective effect group | Experimental | 5000 subjects aged 1-12 years old will be enrolled to conduct protective effect study of varicella vaccine after exposure. |
|
| Etiology Group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live attenuated varicella vaccine | 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. And the immunization schedule is one dose of live attenuated varicella vaccine on day 0. |
| Measure | Description | Time Frame |
|---|---|---|
| GMT of varicella antibody in children aged 1-6 years | GMT of varicella antibody at 30 days after vaccination of varicella vaccine in children aged 1-6 years. | 30 days after vaccination |
| GMT of varicella antibody in healthy people aged 0-59 years | GMT of varicella antibody at 30 days after vaccination in different age groups of healthy people aged 0-59 years. | 30 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rates of varicella antibody in children aged 1-6 years | Seroconversion rates of varicella antibody at 30 days after vaccination of varicella vaccine in children aged 1-6 years. | 30 days after vaccination |
| GMI of varicella antibody in children aged 1-6 years |
Not provided
Unified Inclusion Criteria:
Special Inclusion Criteria for each study:
Inclusion criteria of the study population for immunogenicity and safety evaluation of varicella vaccine:
Inclusion criteria for investigation of varicella antibody level:
Inclusion criteria of the study population for safety evaluation of varicella vaccine mass vaccination:
Inclusion criteria of study population for protective effect of varicella vaccine after exposure:
Inclusion criteria of study population for etiological study on the pathogenic strains of varicella cases:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanqing He, Master | Contact | 13819483847 | hanqinghe@cdc.zj.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hanqing He | Zhejiang Provincial Center for Disease Prevention and Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laian Center for Disease Control and Prevention | Recruiting | Chuzhou | Anhui | 239299 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
30 varicella cases aged 1-12 years old from study 4 will be enrolled. Herpes fluid or pharyngeal swab samples of subjects will be collected to study the pathogenicity of varicella. |
|
|
GMI of varicella antibody at 30 days after vaccination of varicella vaccine in children aged 1-6 years. |
| 30 days after vaccination |
| Incidence of adverse reactions at 24 hours after vaccination | Incidence of adverse reactions at 24 hours after vaccination of varicella vaccine in children aged 1-6 years | 24 hours after vaccination |
| Incidence of adverse reactions at 3 days after vaccination | Incidence of adverse reactions at 3 days after vaccination of varicella vaccine in children aged 1-6 years | 3 days after vaccination |
| Incidence of adverse reactions at 14 days after vaccination | Incidence of adverse reactions at 14 days after vaccination of varicella vaccine in children aged 1-6 years. | 14 days after vaccination |
| Incidence of adverse reactions at 30 days after vaccination | Incidence of adverse reactions at 30 days after vaccination of varicella vaccine in children aged 1-6 years. | 30 days after vaccination |
| Incidence of adverse reactions at 14 days after mass vaccination | Incidence of adverse reactions at 14 days after mass vaccination of varicella vaccine in children aged 1-12 years | 14 days after mass vaccination |
| Incidence of adverse reactions at 30 days after mass vaccination | Incidence of adverse reactions at 30 days after mass vaccination of varicella vaccine in children aged 1-12 years | 30 days after mass vaccination |
| seropositive rates of varicella antibody | Seropositive rates of varicella antibody at 30 days after vaccination in all age groups of healthy people. | 30 days after vaccination |
| Liandu District Center for Disease Control and Prevention | Recruiting | Lishui | Zhejiang | 323050 | China |
|
| Jiangshan Center for Disease Control and Prevention | Recruiting | Quzhou | Zhejiang | 324199 | China |
|
| ID | Term |
|---|---|
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided