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A Blind, Randomized and Controlled Study of Live Attenuated Varicella Vaccines

Primary Purpose

Varicella

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Investigational live attenuated varicella vaccine
diluent of lyophilized 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 focused on measuring live attenuated varicella vaccine, protective effect, safety, immunogenicity, child

Eligibility Criteria

1 Year - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteer between 1 - 12 years old;
  • Proven legal identity;
  • Guardian(s) of the volunteer and/or volunteers themselves should be capable of understanding the written consent form, and such form should be signed before the volunteer being included into this study;

Exclusion Criteria:

  • Prior vaccination with varicella vaccine or with history of varicella zoster virus (VZV) infection;
  • Axillaty temperature > 37.0 °C;
  • History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
  • History of epilepsy, seizures or convulsions, or a family history of mental illness, autoimmune disease or immunodeficiency;
  • Severe malnutrition, congenital malformation, developmental disorders, or serious chronic diseases;
  • Acute disease or acute stage of chronic disease within 7 days prior to study entry;
  • Receipt of any of the following products:

    1. Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
    2. Any live attenuated vaccine within 1 month prior to study entry;
    3. Any blood product, immunosuppressant, hormone, or other investigational medicine(s) within 30 days prior to study entry;
  • Any significant abnormity of heart, lung, skin, or pharynx;
  • Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;

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

Sham Comparator

Arm Label

Experimental Group

Control Group

Arm Description

Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0; Intervention: investigational live attenuated varicella vaccine;

Single intramuscular injection of the diluent of lyophilized vaccine (0.5 ml) on Day 0; Intervention: diluent of lyophilized vaccine;

Outcomes

Primary Outcome Measures

The incidences of varicella of each group
The first 30 cases of varicella occurred 30 days after injection will be collected.
The protection rate of the vaccine
The protection rate will be calculated based on the reported cases occurred 30 days after injection.

Secondary Outcome Measures

The incidences of adverse events (AEs) of each group
AEs occurred within 30 days after injection will be collected.
The incidences of serious adverse events (SAEs) of each group
SAEs occurred within 6 months after injection will be collected.
The seroconversion rate of the immunogenicity group
Seroconversion rate of the immonogenicity group 30 days after injection will be collected.
The geometric mean titer (GMT) of the immunogenicity group
Geometric mean titer (GMT) of the immonogenicity group will be collected before and 30 days after injection.
The geometric mean fold increase (GMI) of the immunogenicity group
Geometric mean fold increse (GMI) of the immonogenicity group will be calculated based on the geometric mean titer.

Full Information

First Posted
November 28, 2016
Last Updated
October 24, 2017
Sponsor
Sinovac (Dalian) Vaccine Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02981836
Brief Title
A Blind, Randomized and Controlled Study of Live Attenuated Varicella Vaccines
Official Title
A Blind, Randomized and Controlled Clinical Trial to Evaluate the Protective Effect, Safety and Immunogenicity of Live Attenuated Varicella Vaccines for Healthy Children
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine in healthy children.
Detailed Description
This study is a randomized, blind, controlled phase III clinical trial. The purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The control is diluent of lyophilized vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. All participants are healthy, and will be randomly assigned into experimental group or control group in the ratio 1:1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicella
Keywords
live attenuated varicella vaccine, protective effect, safety, immunogenicity, child

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5997 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0; Intervention: investigational live attenuated varicella vaccine;
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Single intramuscular injection of the diluent of lyophilized vaccine (0.5 ml) on Day 0; Intervention: diluent of lyophilized vaccine;
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.
Intervention Type
Biological
Intervention Name(s)
diluent of lyophilized vaccine
Intervention Description
The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
Primary Outcome Measure Information:
Title
The incidences of varicella of each group
Description
The first 30 cases of varicella occurred 30 days after injection will be collected.
Time Frame
≥30 cases reported 30 days after injection
Title
The protection rate of the vaccine
Description
The protection rate will be calculated based on the reported cases occurred 30 days after injection.
Time Frame
≥30 cases reported after 30 days of the injection
Secondary Outcome Measure Information:
Title
The incidences of adverse events (AEs) of each group
Description
AEs occurred within 30 days after injection will be collected.
Time Frame
30 days
Title
The incidences of serious adverse events (SAEs) of each group
Description
SAEs occurred within 6 months after injection will be collected.
Time Frame
6 months
Title
The seroconversion rate of the immunogenicity group
Description
Seroconversion rate of the immonogenicity group 30 days after injection will be collected.
Time Frame
30 days after injection
Title
The geometric mean titer (GMT) of the immunogenicity group
Description
Geometric mean titer (GMT) of the immonogenicity group will be collected before and 30 days after injection.
Time Frame
30 days
Title
The geometric mean fold increase (GMI) of the immunogenicity group
Description
Geometric mean fold increse (GMI) of the immonogenicity group will be calculated based on the geometric mean titer.
Time Frame
30 days after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteer between 1 - 12 years old; Proven legal identity; Guardian(s) of the volunteer and/or volunteers themselves should be capable of understanding the written consent form, and such form should be signed before the volunteer being included into this study; Exclusion Criteria: Prior vaccination with varicella vaccine or with history of varicella zoster virus (VZV) infection; Axillaty temperature > 37.0 °C; History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc; History of epilepsy, seizures or convulsions, or a family history of mental illness, autoimmune disease or immunodeficiency; Severe malnutrition, congenital malformation, developmental disorders, or serious chronic diseases; Acute disease or acute stage of chronic disease within 7 days prior to study entry; Receipt of any of the following products: Any subunit vaccine or inactivated vaccine within 7 days prior to study entry; Any live attenuated vaccine within 1 month prior to study entry; Any blood product, immunosuppressant, hormone, or other investigational medicine(s) within 30 days prior to study entry; Any significant abnormity of heart, lung, skin, or pharynx; Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shengli Xia
Organizational Affiliation
Henan Provincial Center for Disease Control and Prevention
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 Name
Biyang County Center for Disease Control and Prevention
City
Zhumadian
State/Province
Henan
ZIP/Postal Code
463700
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35632416
Citation
Zhang Y, Wang L, Wang Y, Zhang W, Jia N, Xie Z, Huang L, You W, Lu W, Li E, Gao F, Hu Y, Meng F, Xia S. Immunogenicity and Safety of a Booster Dose of Live Attenuated Varicella Vaccine, and Immune Persistence of a Primary Dose for Children Aged 2 to 6 Years. Vaccines (Basel). 2022 Apr 22;10(5):660. doi: 10.3390/vaccines10050660.
Results Reference
derived
PubMed Identifier
30616012
Citation
Hao B, Chen Z, Zeng G, Huang L, Luan C, Xie Z, Chen J, Bao M, Tian X, Xu B, Wang Y, Wu J, Xia S, Yuan L, Huang J. Efficacy, safety and immunogenicity of live attenuated varicella vaccine in healthy children in China: double-blind, randomized, placebo-controlled clinical trial. Clin Microbiol Infect. 2019 Aug;25(8):1026-1031. doi: 10.1016/j.cmi.2018.12.033. Epub 2019 Jan 4.
Results Reference
derived

Learn more about this trial

A Blind, Randomized and Controlled Study of Live Attenuated Varicella Vaccines

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