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An Immunity Persistence Study of Live Attenuated Varicella Vaccine

Primary Purpose

Varicella

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Investigational Live Attenuated Varicella Vaccine
Placebo (Freeze Dired Dilution)
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 - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects in PPS immunogenicity subgroup of phase Ⅲ clinical trial of protective effect of varicella vaccine;
  • The subject and/or guardian can understand and voluntarily sign the informed consent form;
  • Proven legal identity.

Exclusion Criteria:

  • History of chickenpox or shingles;
  • History of varicella vaccination since phase Ⅲ clinical trial;
  • Autoimmune disease or immunodeficiency / immunosuppression;
  • History of immunosuppressive therapy since phase Ⅲ clinical trial;
  • According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Sites / Locations

  • Xiangcheng County Center for Disease Control and Prevention
  • Biyang County Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Group

Control Group

Arm Description

349 subjects who enrolled in the experimental group of clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 will be collected venous blood 3.0~3.5ml at 5 and 8 years after primary immunization.

354 subjects who enrolled in the control group of clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 will be collected venous blood 3.0~3.5ml at 5 and 8 years after primary immunization.

Outcomes

Primary Outcome Measures

Immunogenicity index-seropositive rates of varicella antibody
The seropositive rates of varicella antibody in 5 years after primary immunization with varicella vaccine
Immunogenicity index-GMT of varicella antibody
GMT of varicella antibody in 5 years after primary immunization with varicella vaccine
Immunogenicity index-the seropositive rates of varicella antibody
The seropositive rates of varicella antibody in 8 years after primary immunization with varicella vaccine
Immunogenicity index-the GMT of varicella antibody
GMT of varicella antibody in 8 years after primary immunization with varicella

Secondary Outcome Measures

Full Information

First Posted
October 14, 2021
Last Updated
October 14, 2021
Sponsor
Sinovac (Dalian) Vaccine Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05095701
Brief Title
An Immunity Persistence Study of Live Attenuated Varicella Vaccine
Official Title
An Open Clinical Trial to Evaluate the Immunity Persistence of Live Attenuated Varicella Vaccine at 5 and 8 Years After Primary Immunization With Live Attenuated Varicella Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
July 1, 2022 (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 an open phase Ⅳ clinical trial of live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the immunity persistence of live attenuated varicella vaccine at 5 and 8 years after primary immunization with live attenuated varicella vaccine.
Detailed Description
This study is an open phase Ⅳ clinical trial in subjects who enrolled in the clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 .The experimental vaccine and placebo (Freeze Dired Dilution) were manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.A total of 703 subjects will be enrolled including 349 subjects in experimental group and 354 subjects in control group .And 3.0-3.5ml of venous blood was collected from all subjects at 5 and 8 years after primary immunization, and the serum was separated for varicella antibody detection. The window period of blood collection was six months.

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
703 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
349 subjects who enrolled in the experimental group of clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 will be collected venous blood 3.0~3.5ml at 5 and 8 years after primary immunization.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
354 subjects who enrolled in the control group of clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 will be collected venous blood 3.0~3.5ml at 5 and 8 years after primary immunization.
Intervention Type
Biological
Intervention Name(s)
Investigational 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.
Intervention Type
Biological
Intervention Name(s)
Placebo (Freeze Dired Dilution)
Intervention Description
The placebo (freeze dired dilution) was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. and contained no active ingredient.It was 0·5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride and phosphate.
Primary Outcome Measure Information:
Title
Immunogenicity index-seropositive rates of varicella antibody
Description
The seropositive rates of varicella antibody in 5 years after primary immunization with varicella vaccine
Time Frame
5 years after primary immunization
Title
Immunogenicity index-GMT of varicella antibody
Description
GMT of varicella antibody in 5 years after primary immunization with varicella vaccine
Time Frame
5 years after primary immunization
Title
Immunogenicity index-the seropositive rates of varicella antibody
Description
The seropositive rates of varicella antibody in 8 years after primary immunization with varicella vaccine
Time Frame
8 years after primary immunization
Title
Immunogenicity index-the GMT of varicella antibody
Description
GMT of varicella antibody in 8 years after primary immunization with varicella
Time Frame
8 years after primary immunization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects in PPS immunogenicity subgroup of phase Ⅲ clinical trial of protective effect of varicella vaccine; The subject and/or guardian can understand and voluntarily sign the informed consent form; Proven legal identity. Exclusion Criteria: History of chickenpox or shingles; History of varicella vaccination since phase Ⅲ clinical trial; Autoimmune disease or immunodeficiency / immunosuppression; History of immunosuppressive therapy since phase Ⅲ clinical trial; 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
Lili Huang, Bachelor
Phone
13643826177
Email
13643826177@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lili Huang, Bachelor
Organizational Affiliation
Henan Provincial Center for Disease Prevention and Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiangcheng County Center for Disease Control and Prevention
City
Xuchang
State/Province
Henan
ZIP/Postal Code
461700
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongqiang Yan
Phone
13849897071
Email
xcxfyz@163.com
Facility Name
Biyang County Center for Disease Control and Prevention
City
Zhumadian
State/Province
Henan
ZIP/Postal Code
463700
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongmei Liu
Phone
86-13783315561
Email
939145972@qq.com

12. IPD Sharing Statement

Learn more about this trial

An Immunity Persistence Study of Live Attenuated Varicella Vaccine

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