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

Primary Purpose

Varicella

Status
Active
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

1 Year - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

No Intervention

Experimental

Experimental

Arm Label

Experimental Group in Protective effect study

Control Group in Protective effect study

Safety group

Etiological study group

Arm Description

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.

Outcomes

Primary Outcome Measures

The incidence density
The incidence density will be calculated by the number of confirmed cases of varicella at 42 days after vaccination.
The protection rate
The protection rate will be calculated by the number of confirmed cases of varicella at 42 days after vaccination.

Secondary Outcome Measures

GMT of varicella antibody
GMT of varicella antibody at 42 days after varicella vaccination.
GMI of varicella antibody
GMI of varicella antibody at 42 days after varicella vaccination.
Positive rates of varicella antibody
Positive rate of varicella antibody at 42 days after varicella vaccination.
Immunogenicity index-GMT of varicella antibody
GMT of varicella antibody at 4 months after varicella vaccination.
Immunogenicity index-GMI of varicella antibody
GMI of varicella antibody at 4 months after varicella vaccination.
Immunogenicity index- positive rates
Positive rates of varicella antibody at 4 months after varicella vaccination.
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.
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.
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.
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.
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.
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.

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
NCT05470855
Brief Title
Protective Effect, Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Anhui Province
Official Title
A Clinical Trial to Evaluate Protective Effect, Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Children Aged 1-12 Years
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 6, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
February 10, 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 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.

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
45400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group in Protective effect study
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group in Protective effect study
Arm Type
No Intervention
Arm Description
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.
Arm Title
Safety group
Arm Type
Experimental
Arm Description
30000 subjects from study 1 will be enrolled to conduct safety observation study,all adverse events of all subjects will be collected.
Arm Title
Etiological study group
Arm Type
Experimental
Arm Description
Herpes fluid collected from varicella cases in study 1 will be used to conduct etiological study on the pathogenic strains of varicella cases.
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.
Primary Outcome Measure Information:
Title
The incidence density
Description
The incidence density will be calculated by the number of confirmed cases of varicella at 42 days after vaccination.
Time Frame
42 days after vaccination
Title
The protection rate
Description
The protection rate will be calculated by the number of confirmed cases of varicella at 42 days after vaccination.
Time Frame
42 days after vaccination
Secondary Outcome Measure Information:
Title
GMT of varicella antibody
Description
GMT of varicella antibody at 42 days after varicella vaccination.
Time Frame
42 days after varicella vaccination
Title
GMI of varicella antibody
Description
GMI of varicella antibody at 42 days after varicella vaccination.
Time Frame
42 days after varicella vaccination
Title
Positive rates of varicella antibody
Description
Positive rate of varicella antibody at 42 days after varicella vaccination.
Time Frame
42 days after varicella vaccination
Title
Immunogenicity index-GMT of varicella antibody
Description
GMT of varicella antibody at 4 months after varicella vaccination.
Time Frame
4 months after varicella vaccination
Title
Immunogenicity index-GMI of varicella antibody
Description
GMI of varicella antibody at 4 months after varicella vaccination.
Time Frame
4 months after varicella vaccination
Title
Immunogenicity index- positive rates
Description
Positive rates of varicella antibody at 4 months after varicella vaccination.
Time Frame
4 months after varicella vaccination
Title
The incidence of adverse events, serious adverse events and adverse reactions
Description
The incidence of adverse events, serious adverse events and adverse reactions at 14 days after varicella vaccination.
Time Frame
14 days after varicella vaccination
Title
Incidence of adverse events, serious adverse events and adverse reactions
Description
The incidence of adverse events, serious adverse events and adverse reactions at 42 days after varicella vaccination.
Time Frame
42 days after varicella vaccination.
Title
Safety index-Incidence of adverse events, serious adverse events and adverse reactions
Description
The incidence of adverse events, serious adverse events and adverse reactions in 3 months after varicella vaccination.
Time Frame
3 months after varicella vaccination
Title
Safety index-incidence of adverse events, serious adverse events and adverse reactions
Description
The incidence of adverse events, serious adverse events and adverse reactions in 6 months after varicella vaccination.
Time Frame
6 months after varicella vaccination
Title
Safety index- incidence of adverse events, serious adverse events and adverse reactions
Description
The incidence of adverse events, serious adverse events and adverse reactions in 9 months after varicella vaccination.
Time Frame
9 months after varicella vaccination
Title
The incidence of adverse events, serious adverse events and adverse reactions
Description
The incidence of adverse events, serious adverse events and adverse reactions in 12 months after varicella vaccination.
Time Frame
12 months after varicella vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jihai Tang, Master
Organizational Affiliation
Anhui Provincial Center for Disease Prevention and Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Susong County Center for Disease Control and Prevention
City
Anqing
State/Province
Anhui
ZIP/Postal Code
246525
Country
China
Facility Name
Laian Center for Disease Control and Prevention
City
Chuzhou
State/Province
Anhui
ZIP/Postal Code
239299
Country
China
Facility Name
Funan County Center for Disease Control and Prevention
City
Fuyang
State/Province
Anhui
ZIP/Postal Code
236399
Country
China
Facility Name
Huoqiu County Center for Disease Control and Prevention
City
Liu'an
State/Province
Anhui
ZIP/Postal Code
237483
Country
China
Facility Name
Ningguo Center for Disease Control and Prevention
City
Xuancheng
State/Province
Anhui
ZIP/Postal Code
242399
Country
China

12. IPD Sharing Statement

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

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