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A Phase III Clinical Trial to Evaluate the Efficacy and Safety of the Live Attenuated Varicella Vaccine

Primary Purpose

Varicella

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Investigational live attenuated varicella vaccine
Placebo of live attenuated varicella vaccine
Sponsored by
China National Biotec Group Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Varicella focused on measuring vaccine efficacy, varicella vaccine, safety, immunogenicity

Eligibility Criteria

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

Inclusion Criteria: Healthy volunteer between 13 - 59 years old for Stage 1, 1-12 years old for Stage 2, and be able to provide legal identification ; Subject and/or guardian has the ability to understand study requirements and processes, consent to participate in clinical trials, and sign informed consent forms; Consent to use effective contraception during study participation, no pregnancy and no family planning (for women of childbearing potential or their spouses); Axillary temperature ≤ 37.0 °C on the day of enrollment; Exclusion Criteria: Has received any varicella vaccine before ( Not applicable to Stage 1); Has history of varicella or herpes zoster infection, or contact with varicella/shingles patients or suspected varicella/shingles patients within 30 days before enrollment ( Not applicable to Stage 1); Currently using salicylates (including salicylic acid, aspirin, diflunisalin, p-aminosalicylate (sodium), dicalicylate, benoxate, etc.), or plan to use it for a long time during the study; Have had febrile illness (axillary temperature ≥ 38.5 °C) or used antipyretic, analgesic, anti-allergic drugs (such as acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) 3 days before vaccination; Have a history of allergy to vaccine components and excipients or severe drug allergy, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schönlein purpura, thrombocytopenic purpura, local allergic necrosis (Arthus) reaction, severe urticaria, etc; Have a history of epilepsy, convulsions or convulsions, and have a family history of severe neurological disease or psychosis Immunocompromised or diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune diseases; With severe congenital malformations, hereditary diseases, serious cardiovascular diseases, serious liver/kidney diseases, complicated diabetes, malignant tumors, and severe malnutrition Immunosuppressant therapy, such as long-term oral or injectable glucocorticoid therapy (≥ 14 days, dose ≥2 mg/kg/day or ≥20 mg/day or equivalent to prednisone), within 3 months prior to enrollment or planned within 30 days of vaccination, but topical medications (e.g., ointments, eye drops, inhalers, or nasal sprays) are not restricted Have received blood/blood-related products or immunoglobulins 3 months prior to vaccination, or plan to use such products 30 days after vaccination; Have received a live attenuated vaccine within 30 days prior to the trial vaccine, or any vaccine within 14 days prior to vaccination; Asplenectomy or splenectomy due to any condition (e.g. splenectomy); Those with a history of thrombocytopenia or other coagulation disorders, which may cause contraindications to subcutaneous injection; Suffering from various infectious, purulent or allergic skin diseases; Are participating in other investigational or unregistered clinical trials of products (drugs, vaccines or devices, etc.), or have plans to participate in other clinical trials before the end of this clinical trial; Has any other factors that are not suitable for participation in the clinical trial in the judgment of the investigator

Sites / Locations

  • Sinan County Center for Disease Control and Prevention
  • Songtao Miao Autonomous County Center for Disease Control and Prevention
  • Yuping Dong Autonomous County Center for Disease Control and Prevention
  • Qi County Center for Disease Control and Prevention
  • Wuzhi County Center for Disease Control and Prevention
  • Wuyang County Center for Disease Control and Prevention
  • Pei County Center for Disease Control and Prevention
  • Huaiyin District Center for Disease Control and Prevention
  • Mianyang Anzhou District Center for Disease Control and Prevention
  • Southern County Center for Disease Control and Prevention
  • Neijiang City Center for Disease Control and Prevention
  • Lancang Lahu Autonomous County Center for Disease Control and Prevention
  • Yanshan County Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Group

Placebo Group

Arm Description

Single subcutaneous injection of the investigational vaccine (0.5 ml)

Single subcutaneous injection of the investigational placebo (0.5 ml)

Outcomes

Primary Outcome Measures

The incidences of varicella in each group
The first 24 cases of varicella occurred 30 days after injection will be collected
The efficacy of the live attenuated varicella vaccine
The vaccine efficacy will be calculated based on the reported cases occurred 30 days after vaccination

Secondary Outcome Measures

The vaccine efficacy against laboratory-confirmed cases of moderate and severe varicella
The vaccine efficacy will be calculated based on the reported cases occurred 30 days after vaccination
The vaccine efficacy against clinical-confirmed cases
calculated based on the reported cases occurred 30 days after vaccination
The incidences of adverse events (AEs)
AEs occurred within 30 days after injection will be collected
The incidences of serious adverse events (SAEs)
SAEs occurred within 6 months after vaccination will be collected
The geometric mean titer (GMT) in the immunogenicity subgroup
Geometric mean titer (GMT) will be measured before and 30 days after vaccination
The seroconversion rate of the immunogenicity subgroup
The seroconversion rate will be calculated before and 30 days after vaccination
The geometric mean fold increase (GMI) of the immunogenicity subgroup
Geometric mean fold increase (GMI) of the immunogenicity group will be calculated based on the geometric mean titer
The immune persistence of the immunogenicity subgroup
Geometric mean titer (GMT) will be measured

Full Information

First Posted
December 20, 2022
Last Updated
June 15, 2023
Sponsor
China National Biotec Group Company Limited
Collaborators
Beijing Institute of Biological Products Co Ltd., Jiangsu Province Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT05669625
Brief Title
A Phase III Clinical Trial to Evaluate the Efficacy and Safety of the Live Attenuated Varicella Vaccine
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Live Attenuated Varicella Vaccine in Healthy People
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 26, 2022 (Actual)
Primary Completion Date
April 14, 2024 (Anticipated)
Study Completion Date
September 14, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Biotec Group Company Limited
Collaborators
Beijing Institute of Biological Products Co Ltd., Jiangsu Province Center for Disease Control and Prevention

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
The goal of this clinical trial is to evaluate the efficacy, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy children.
Detailed Description
This trial is aim to evaluate the efficacy, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy children aged 1-12 years old. This study will be conducted in two stage. the stage 1 adopts an open design, and 20 subjects aged 18~59 and 13~17 years old (18~59 years old→ 13~17 years old, sequentially enrolled) are enrolled, and 1 dose of the trial vaccine is administered to explore safety. The stage 2 adopts a randomized, blinded, placebo-controlled design, 12400 healthy participants aged 1-12 years old will be randomly assigned into experimental group or control group with 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
vaccine efficacy, varicella vaccine, safety, immunogenicity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12440 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Single subcutaneous injection of the investigational vaccine (0.5 ml)
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Single subcutaneous injection of the investigational placebo (0.5 ml)
Intervention Type
Biological
Intervention Name(s)
Investigational live attenuated varicella vaccine
Intervention Description
0.5 ml/vial
Intervention Type
Biological
Intervention Name(s)
Placebo of live attenuated varicella vaccine
Intervention Description
0.5 ml/vial
Primary Outcome Measure Information:
Title
The incidences of varicella in each group
Description
The first 24 cases of varicella occurred 30 days after injection will be collected
Time Frame
number of cases reported 30 days after vaccination
Title
The efficacy of the live attenuated varicella vaccine
Description
The vaccine efficacy will be calculated based on the reported cases occurred 30 days after vaccination
Time Frame
number of cases reported 30 days after vaccination
Secondary Outcome Measure Information:
Title
The vaccine efficacy against laboratory-confirmed cases of moderate and severe varicella
Description
The vaccine efficacy will be calculated based on the reported cases occurred 30 days after vaccination
Time Frame
number of cases reported 30 days after vaccination
Title
The vaccine efficacy against clinical-confirmed cases
Description
calculated based on the reported cases occurred 30 days after vaccination
Time Frame
number of cases reported 30 days after vaccination
Title
The incidences of adverse events (AEs)
Description
AEs occurred within 30 days after injection will be collected
Time Frame
within 30 days after vaccination
Title
The incidences of serious adverse events (SAEs)
Description
SAEs occurred within 6 months after vaccination will be collected
Time Frame
at least 6 months after vaccination
Title
The geometric mean titer (GMT) in the immunogenicity subgroup
Description
Geometric mean titer (GMT) will be measured before and 30 days after vaccination
Time Frame
30 days after vaccination
Title
The seroconversion rate of the immunogenicity subgroup
Description
The seroconversion rate will be calculated before and 30 days after vaccination
Time Frame
30 days after vaccination
Title
The geometric mean fold increase (GMI) of the immunogenicity subgroup
Description
Geometric mean fold increase (GMI) of the immunogenicity group will be calculated based on the geometric mean titer
Time Frame
30 days after vaccination
Title
The immune persistence of the immunogenicity subgroup
Description
Geometric mean titer (GMT) will be measured
Time Frame
1 year, 2 years, and 3 years after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteer between 13 - 59 years old for Stage 1, 1-12 years old for Stage 2, and be able to provide legal identification ; Subject and/or guardian has the ability to understand study requirements and processes, consent to participate in clinical trials, and sign informed consent forms; Consent to use effective contraception during study participation, no pregnancy and no family planning (for women of childbearing potential or their spouses); Axillary temperature ≤ 37.0 °C on the day of enrollment; Exclusion Criteria: Has received any varicella vaccine before ( Not applicable to Stage 1); Has history of varicella or herpes zoster infection, or contact with varicella/shingles patients or suspected varicella/shingles patients within 30 days before enrollment ( Not applicable to Stage 1); Currently using salicylates (including salicylic acid, aspirin, diflunisalin, p-aminosalicylate (sodium), dicalicylate, benoxate, etc.), or plan to use it for a long time during the study; Have had febrile illness (axillary temperature ≥ 38.5 °C) or used antipyretic, analgesic, anti-allergic drugs (such as acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) 3 days before vaccination; Have a history of allergy to vaccine components and excipients or severe drug allergy, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schönlein purpura, thrombocytopenic purpura, local allergic necrosis (Arthus) reaction, severe urticaria, etc; Have a history of epilepsy, convulsions or convulsions, and have a family history of severe neurological disease or psychosis Immunocompromised or diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune diseases; With severe congenital malformations, hereditary diseases, serious cardiovascular diseases, serious liver/kidney diseases, complicated diabetes, malignant tumors, and severe malnutrition Immunosuppressant therapy, such as long-term oral or injectable glucocorticoid therapy (≥ 14 days, dose ≥2 mg/kg/day or ≥20 mg/day or equivalent to prednisone), within 3 months prior to enrollment or planned within 30 days of vaccination, but topical medications (e.g., ointments, eye drops, inhalers, or nasal sprays) are not restricted Have received blood/blood-related products or immunoglobulins 3 months prior to vaccination, or plan to use such products 30 days after vaccination; Have received a live attenuated vaccine within 30 days prior to the trial vaccine, or any vaccine within 14 days prior to vaccination; Asplenectomy or splenectomy due to any condition (e.g. splenectomy); Those with a history of thrombocytopenia or other coagulation disorders, which may cause contraindications to subcutaneous injection; Suffering from various infectious, purulent or allergic skin diseases; Are participating in other investigational or unregistered clinical trials of products (drugs, vaccines or devices, etc.), or have plans to participate in other clinical trials before the end of this clinical trial; Has any other factors that are not suitable for participation in the clinical trial in the judgment of the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongxing Pan
Organizational Affiliation
Jiangsu Province Centers for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sinan County Center for Disease Control and Prevention
City
Tongren
State/Province
Guizhou
Country
China
Facility Name
Songtao Miao Autonomous County Center for Disease Control and Prevention
City
Tongren
State/Province
Guizhou
Country
China
Facility Name
Yuping Dong Autonomous County Center for Disease Control and Prevention
City
Tongren
State/Province
Guizhou
Country
China
Facility Name
Qi County Center for Disease Control and Prevention
City
Hebi
State/Province
Henan
Country
China
Facility Name
Wuzhi County Center for Disease Control and Prevention
City
Jiaozuo
State/Province
Henan
Country
China
Facility Name
Wuyang County Center for Disease Control and Prevention
City
Luohe
State/Province
Henan
Country
China
Facility Name
Pei County Center for Disease Control and Prevention
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221600
Country
China
Facility Name
Huaiyin District Center for Disease Control and Prevention
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
223300
Country
China
Facility Name
Mianyang Anzhou District Center for Disease Control and Prevention
City
Mianyang
State/Province
Sichuan
Country
China
Facility Name
Southern County Center for Disease Control and Prevention
City
Nanchong
State/Province
Sichuan
Country
China
Facility Name
Neijiang City Center for Disease Control and Prevention
City
Neijiang
State/Province
Sichuan
Country
China
Facility Name
Lancang Lahu Autonomous County Center for Disease Control and Prevention
City
Pu'er
State/Province
Yunnan
Country
China
Facility Name
Yanshan County Center for Disease Control and Prevention
City
Wenshan
State/Province
Yunnan
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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A Phase III Clinical Trial to Evaluate the Efficacy and Safety of the Live Attenuated Varicella Vaccine

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