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Immunogenicity, Safety and Protective Effect of Live Attenuated Varicella Vaccine and Study on Antibody Level and Etiology of Varicella Zoster Virus

Primary Purpose

Varicella

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Live attenuated varicella vaccine
Sponsored by
Sinovac (Dalian) Vaccine Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Varicella

Eligibility Criteria

undefined - 59 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Unified Inclusion Criteria:

  • Participants aged 1-12 years ;
  • The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 8-12 years, both subjects and guardians need to sign the informed consent form) and be able to follow all research procedures;
  • Proven legal identity.

Special Inclusion Criteria for each study:

Inclusion criteria of the study population for immunogenicity and safety evaluation of varicella vaccine:

  • Be able to participate in the whole process of vaccination and blood collection;
  • Healthy children aged 1-3 years with no history of varicella vaccination;
  • Healthy children aged 4-6 years with a history of 1 dose of varicella vaccine.

Inclusion criteria for investigation of varicella antibody level:

  • Healthy people aged 0-59 years and participate voluntarily for the study;
  • Have no serious chronic disease or acute disease;

Inclusion criteria of the study population for safety evaluation of varicella vaccine mass vaccination:

  • Participants aged 1-3 years with no history of varicella vaccination;
  • Participants aged 4-12 years with no history of varicella vaccination or with a history of 1 dose of varicella vaccine.

Inclusion criteria of study population for protective effect of varicella vaccine after exposure:

  • Children aged 1-12 years exposed to varicella outbreaks;
  • History with no varicella or shingles;

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

  • Clinical cases of varicella consent for herpes zoster or pharyngeal swab collection.

Exclusion Criteria:

  • History of 2 doses of varicella vaccination;
  • Previous history of varicella or herpes zoster (not applicable to investigation of varicella antibody level);
  • History of severe allergic reactions to vaccines (e.g.acute anaphylaxis, angioneurotic edema, dyspnea, etc.);
  • Suffering from acute disease or acute episode of chronic disease;
  • 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

  • Laian Center for Disease Control and PreventionRecruiting
  • Liandu District Center for Disease Control and PreventionRecruiting
  • Jiangshan Center for Disease Control and PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Immunogenicity and safety group

Antibody level investigation study group

Safety group

Protective effect group

Etiology Group

Arm Description

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.

Immunization levels will be monitored among 2530 subjects aged 0-59 years old and will be collected venous blood to detect varicella antibody.

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.

5000 subjects aged 1-12 years old will be enrolled to conduct protective effect study of varicella vaccine after exposure.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
GMI of varicella antibody in children aged 1-6 years
GMI of varicella antibody at 30 days after vaccination of varicella vaccine in children aged 1-6 years.
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
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
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.
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.
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
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
seropositive rates of varicella antibody
Seropositive rates of varicella antibody at 30 days after vaccination in all age groups of healthy people.

Full Information

First Posted
July 12, 2022
Last Updated
January 11, 2023
Sponsor
Sinovac (Dalian) Vaccine Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05460429
Brief Title
Immunogenicity, Safety and Protective Effect of Live Attenuated Varicella Vaccine and Study on Antibody Level and Etiology of Varicella Zoster Virus
Official Title
An Open Clinical Trial to Evaluate Immunogenicity,Safety and Protective Effect of Live Attenuated Varicella Vaccine and a Clinical Trial on Antibody Level and Etiology of Varicella Zoster Virus in Zhejiang Province
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2022 (Actual)
Primary Completion Date
March 15, 2023 (Anticipated)
Study Completion Date
May 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac (Dalian) Vaccine Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicella

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37920 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immunogenicity and safety group
Arm Type
Experimental
Arm Description
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.
Arm Title
Antibody level investigation study group
Arm Type
Experimental
Arm Description
Immunization levels will be monitored among 2530 subjects aged 0-59 years old and will be collected venous blood to detect varicella antibody.
Arm Title
Safety group
Arm Type
Experimental
Arm Description
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.
Arm Title
Protective effect group
Arm Type
Experimental
Arm Description
5000 subjects aged 1-12 years old will be enrolled to conduct protective effect study of varicella vaccine after exposure.
Arm Title
Etiology Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Live attenuated varicella vaccine
Intervention Description
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.
Primary Outcome Measure Information:
Title
GMT of varicella antibody in children aged 1-6 years
Description
GMT of varicella antibody at 30 days after vaccination of varicella vaccine in children aged 1-6 years.
Time Frame
30 days after vaccination
Title
GMT of varicella antibody in healthy people aged 0-59 years
Description
GMT of varicella antibody at 30 days after vaccination in different age groups of healthy people aged 0-59 years.
Time Frame
30 days after vaccination
Secondary Outcome Measure Information:
Title
Seroconversion rates of varicella antibody in children aged 1-6 years
Description
Seroconversion rates of varicella antibody at 30 days after vaccination of varicella vaccine in children aged 1-6 years.
Time Frame
30 days after vaccination
Title
GMI of varicella antibody in children aged 1-6 years
Description
GMI of varicella antibody at 30 days after vaccination of varicella vaccine in children aged 1-6 years.
Time Frame
30 days after vaccination
Title
Incidence of adverse reactions at 24 hours after vaccination
Description
Incidence of adverse reactions at 24 hours after vaccination of varicella vaccine in children aged 1-6 years
Time Frame
24 hours after vaccination
Title
Incidence of adverse reactions at 3 days after vaccination
Description
Incidence of adverse reactions at 3 days after vaccination of varicella vaccine in children aged 1-6 years
Time Frame
3 days after vaccination
Title
Incidence of adverse reactions at 14 days after vaccination
Description
Incidence of adverse reactions at 14 days after vaccination of varicella vaccine in children aged 1-6 years.
Time Frame
14 days after vaccination
Title
Incidence of adverse reactions at 30 days after vaccination
Description
Incidence of adverse reactions at 30 days after vaccination of varicella vaccine in children aged 1-6 years.
Time Frame
30 days after vaccination
Title
Incidence of adverse reactions at 14 days after mass vaccination
Description
Incidence of adverse reactions at 14 days after mass vaccination of varicella vaccine in children aged 1-12 years
Time Frame
14 days after mass vaccination
Title
Incidence of adverse reactions at 30 days after mass vaccination
Description
Incidence of adverse reactions at 30 days after mass vaccination of varicella vaccine in children aged 1-12 years
Time Frame
30 days after mass vaccination
Title
seropositive rates of varicella antibody
Description
Seropositive rates of varicella antibody at 30 days after vaccination in all age groups of healthy people.
Time Frame
30 days after vaccination

10. Eligibility

Sex
All
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Unified Inclusion Criteria: Participants aged 1-12 years ; The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 8-12 years, both subjects and guardians need to sign the informed consent form) and be able to follow all research procedures; Proven legal identity. Special Inclusion Criteria for each study: Inclusion criteria of the study population for immunogenicity and safety evaluation of varicella vaccine: Be able to participate in the whole process of vaccination and blood collection; Healthy children aged 1-3 years with no history of varicella vaccination; Healthy children aged 4-6 years with a history of 1 dose of varicella vaccine. Inclusion criteria for investigation of varicella antibody level: Healthy people aged 0-59 years and participate voluntarily for the study; Have no serious chronic disease or acute disease; Inclusion criteria of the study population for safety evaluation of varicella vaccine mass vaccination: Participants aged 1-3 years with no history of varicella vaccination; Participants aged 4-12 years with no history of varicella vaccination or with a history of 1 dose of varicella vaccine. Inclusion criteria of study population for protective effect of varicella vaccine after exposure: Children aged 1-12 years exposed to varicella outbreaks; History with no varicella or shingles; Inclusion criteria of study population for etiological study on the pathogenic strains of varicella cases: Clinical cases of varicella consent for herpes zoster or pharyngeal swab collection. Exclusion Criteria: History of 2 doses of varicella vaccination; Previous history of varicella or herpes zoster (not applicable to investigation of varicella antibody level); History of severe allergic reactions to vaccines (e.g.acute anaphylaxis, angioneurotic edema, dyspnea, etc.); Suffering from acute disease or acute episode of chronic disease; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanqing He, Master
Phone
13819483847
Email
hanqinghe@cdc.zj.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanqing He
Organizational Affiliation
Zhejiang Provincial Center for Disease Prevention and Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laian Center for Disease Control and Prevention
City
Chuzhou
State/Province
Anhui
ZIP/Postal Code
239299
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiyan Wu, Bachelor
Phone
18805505218
Email
2544285048@qq.com
Facility Name
Liandu District Center for Disease Control and Prevention
City
Lishui
State/Province
Zhejiang
ZIP/Postal Code
323050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juqing Xu, Bachelor
Phone
0578-2025951
Email
1026123729@qq.com
Facility Name
Jiangshan Center for Disease Control and Prevention
City
Quzhou
State/Province
Zhejiang
ZIP/Postal Code
324199
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huishu Mao, Bachelor
Phone
13857027530
Email
1690894042@qq.com

12. IPD Sharing Statement

Learn more about this trial

Immunogenicity, Safety and Protective Effect of Live Attenuated Varicella Vaccine and Study on Antibody Level and Etiology of Varicella Zoster Virus

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