An Open-labelled Clinical Trial of Live Attenuated Varicella Vaccines to Evaluate the Immunity Persistence After Primary Immunization and Safety and Immunogenicity After the Booster Immunization
Primary Purpose
Varicella
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Investigational live attenuated varicella vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Varicella
Eligibility Criteria
Inclusion Criteria:
- Received one dose live attenuated varicella vaccine in the phase Ⅲ lot-consistency clinical trial;
- Guardian(s) of the volunteer should be capable of understanding the written - consent form, and such form should be signed before the children being included into this study.
Exclusion Criteria:
- Received one dose live attenuated varicella vaccine at the end of the phase Ⅲ lot-consistency 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
- Xiangfu County Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Booster immunization 1 year after primary immunization
Booster immunization 2 year after primary immunization
Booster immunization 3 year after primary immunization
Arm Description
Subjects C0001-C0400 except C0243 received 1 dose of booster immunization 1 year after primary immunization.
Subjects C0401-C0800 except C0556 received 1 dose of booster immunization 2 years after primary immunization.
Subjects C0801-C1197 received 1 dose of booster immunization 3 years after primary immunization.
Outcomes
Primary Outcome Measures
Immunogenicity index-seroconversion rate of antibody
seroconversion rates of antibody 1 year after primary immunization
Immunogenicity index-seroconversion rate of antibody
seroconversion rates of antibody 2 years after primary immunization
Immunogenicity index-seroconversion rate of antibody
seroconversion rates of antibody 3 years after primary immunization
Immunogenicity index-Seroconversion rate of antibody
Seroconversion rate of the neutralizing antibody 30 days after booster immunization
Immunogenicity index-seropositivity rate of antibody
Seropositivity rate of antibody 30 days after booster immunization
Secondary Outcome Measures
Immunogenicity index-Seropositivity rate of antibody
Seropositivity rate of antibody before booster immunization
Immunogenicity index-GMT of the antibody
GMT of the antibody before booster immunization
Immunogenicity index- GMT of the antibody
GMT of the antibody 30 days after booster immunization
Immunogenicity index- GMI of the antibody
GMI of the antibody 30 days after booster immunization
Safety index-Incidence of solicited local or systemic AE
Incidence of solicited local or systemic AE within 14 days after vaccination
Safety index-Incidence of local or systemic AE
Incidence of local or systemic AE within 30 days after vaccination
Safety index-Incidence of SAE
Incidence of SAE within 30 days after vaccination
Full Information
NCT ID
NCT05150392
First Posted
November 22, 2021
Last Updated
December 8, 2021
Sponsor
Sinovac (Dalian) Vaccine Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05150392
Brief Title
An Open-labelled Clinical Trial of Live Attenuated Varicella Vaccines to Evaluate the Immunity Persistence After Primary Immunization and Safety and Immunogenicity After the Booster Immunization
Official Title
An Open-labelled Clinical Trial,to Evaluate the Immunity Persistence of the Single-dose Primary Immunization of Live Attenuated Varicella Vaccine on Different Time Points,and the Safety and Immunogenicity After the Booster Immunization
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 11, 2018 (Actual)
Primary Completion Date
August 11, 2018 (Actual)
Study Completion Date
August 14, 2020 (Actual)
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 an open-labelled 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 the single-dose primary immunization of live attenuated varicella vaccine on different time points ,and the safety and immunogenicity after the booster immunization
Detailed Description
This study is an open-labelled phase Ⅲ clinical trial.The experimental vaccine manufactured by Sinovac(Dalian) Vaccine Technology Co., Ltd.A total of 1195 subjects who received vaccine in the phase Ⅲ lot-consistency clinical trial were be enrolled .All subjects except C0243 and C0556 were divided into 3 groups according to the order of study number.Subjects in 3 groups received a booster immunization of live attenuated varicella vaccines 1 year,2 years and 3 years after primary immunization,respectively.About 3.0ml of venous blood was collected from each enrolled subject at pre-booster immunization,30 days after booster immunization and the serum was separated for neutralizing antibody detection.The antibody levels were used to evaluate the immunity persistence and immunogenicity after booster immunization of live attenuated varicella vaccines .
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 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1193 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Booster immunization 1 year after primary immunization
Arm Type
Experimental
Arm Description
Subjects C0001-C0400 except C0243 received 1 dose of booster immunization 1 year after primary immunization.
Arm Title
Booster immunization 2 year after primary immunization
Arm Type
Experimental
Arm Description
Subjects C0401-C0800 except C0556 received 1 dose of booster immunization 2 years after primary immunization.
Arm Title
Booster immunization 3 year after primary immunization
Arm Type
Experimental
Arm Description
Subjects C0801-C1197 received 1 dose of booster immunization 3 years after primary immunization.
Intervention Type
Biological
Intervention Name(s)
Investigational live attenuated varicella vaccine
Intervention Description
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.And the live varicella-zoster virus in 0·5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection
Primary Outcome Measure Information:
Title
Immunogenicity index-seroconversion rate of antibody
Description
seroconversion rates of antibody 1 year after primary immunization
Time Frame
1 year after primary immunization
Title
Immunogenicity index-seroconversion rate of antibody
Description
seroconversion rates of antibody 2 years after primary immunization
Time Frame
2 years after primary immunization
Title
Immunogenicity index-seroconversion rate of antibody
Description
seroconversion rates of antibody 3 years after primary immunization
Time Frame
3 years after primary immunization
Title
Immunogenicity index-Seroconversion rate of antibody
Description
Seroconversion rate of the neutralizing antibody 30 days after booster immunization
Time Frame
30 days after booster immunization
Title
Immunogenicity index-seropositivity rate of antibody
Description
Seropositivity rate of antibody 30 days after booster immunization
Time Frame
30 days after booster immunization
Secondary Outcome Measure Information:
Title
Immunogenicity index-Seropositivity rate of antibody
Description
Seropositivity rate of antibody before booster immunization
Time Frame
Before the booster dose immunization
Title
Immunogenicity index-GMT of the antibody
Description
GMT of the antibody before booster immunization
Time Frame
Before the booster dose immunization
Title
Immunogenicity index- GMT of the antibody
Description
GMT of the antibody 30 days after booster immunization
Time Frame
30 days after booster immunization
Title
Immunogenicity index- GMI of the antibody
Description
GMI of the antibody 30 days after booster immunization
Time Frame
30 days after booster immunization
Title
Safety index-Incidence of solicited local or systemic AE
Description
Incidence of solicited local or systemic AE within 14 days after vaccination
Time Frame
within 14 days after vaccination
Title
Safety index-Incidence of local or systemic AE
Description
Incidence of local or systemic AE within 30 days after vaccination
Time Frame
within 30 days after vaccination
Title
Safety index-Incidence of SAE
Description
Incidence of SAE within 30 days after vaccination
Time Frame
within 30 days after vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Received one dose live attenuated varicella vaccine in the phase Ⅲ lot-consistency clinical trial;
Guardian(s) of the volunteer should be capable of understanding the written - consent form, and such form should be signed before the children being included into this study.
Exclusion Criteria:
Received one dose live attenuated varicella vaccine at the end of the phase Ⅲ lot-consistency clinical trial;
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
Shengli Xia, Master
Organizational Affiliation
Henan Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiangfu County Center for Disease Control and Prevention
City
Kaifeng
State/Province
Henan
ZIP/Postal Code
461700
Country
China
12. IPD Sharing Statement
Learn more about this trial
An Open-labelled Clinical Trial of Live Attenuated Varicella Vaccines to Evaluate the Immunity Persistence After Primary Immunization and Safety and Immunogenicity After the Booster Immunization
We'll reach out to this number within 24 hrs