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A Trial to Evaluate the Lot-to-lot Consistency of Live Attenuated Varicella Vaccine in Healthy People 1-12 Years of Age

Primary Purpose

Varicella

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Investigational live attenuated varicella vaccine (lot 1)
Investigational live attenuated varicella vaccine (lot 2)
Investigational live attenuated varicella vaccine (lot 3)
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 varicella vaccine, safety, immunogenicity, lot-to-lot consistency

Eligibility Criteria

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

Inclusion Criteria: Age 1 to 12 years on the day of enrollment ,male or female, and able to provide legal identity certificate. Subjects and/or guardians have the ability to understand the study requirements and process, agree to participate in the clinical trial and sign the informed consent form. Axillary temperature ≤ 37.0 ° C on the day of enrollment. Exclusion Criteria: Previous vaccination against varicella (eg, varicella vaccine, measles + varicella vaccine). History of varicella or herpes zoster infection, or exposure to varicella/herpes zoster within 30 days of enrollment or suspected varicella/herpes zoster; Current use of salicylates (including salicylic acid, aspirin, diflunisal, p-aminosalicylic acid (sodium), salsalsalate, benorilate, etc.), or planned long-term use during the study. Febrile illness (axillary temperature ≥ 38.5 ° C) or use of antipyretic, analgesic, and anti-allergic drugs (eg, acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) 3 days before vaccination. History of allergy to vaccine ingredients and excipients or severe drug allergy, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schonlein purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), severe urticaria. History of epilepsy, convulsions, or convulsions, or a family history of psychosis. Impaired immune function or has been 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. Patients suffering from serious congenital malformations, genetic diseases, serious cardiovascular diseases, serious liver/kidney diseases, diabetes with complications, malignant tumors, severe malnutrition. Immunosuppressant therapy such as chronic oral or injectable glucocorticoid therapy (≥ 14 days at doses ≥ 2 mg/kg/day or ≥ 20 mg/day prednisone or equivalent prednisone dose) within 3 months prior to administration of trial vaccine or planned 30 days following administration, but not limited by topical use (eg, ointment, eye drops, inhalers, or nasal sprays). Receiving blood/blood-related products or immunoglobulins 3 months before vaccination or planning to use such products 30 days after vaccination. Vaccination with a live attenuated vaccine within 30 days or any vaccine within 14 days prior to vaccination. Absence of spleen or splenectomy due to any condition such as splenectomy. Patients with a history of thrombocytopenia or other coagulation disorders, which may cause contraindications to subcutaneous injection. Infectious, suppurative and allergic skin diseases. Participating in other investigational or non-registered product (drug, vaccine or device, etc.) clinical trials, or planning to participate in other clinical trials before the end of this clinical trial. Subject has any other factor that, in the judgment of the investigator, would make the subject unsuitable for participation in the clinical trial.

Sites / Locations

  • Xinyi Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Experimental Group1

Experimental Group2

Experimental Group3

Arm Description

Single subcutaneous injection of the investigational vaccine (0.5ml)

Single subcutaneous injection of the investigational vaccine (0.5ml)

Single subcutaneous injection of the investigational vaccine (0.5ml)

Outcomes

Primary Outcome Measures

Geometric mean titers (GMT) of anti-VZV neutralizing antibodies
Geometric mean titers (GMT) of anti-VZV neutralizing antibodies 30 days after vaccination in the negative population before immunization

Secondary Outcome Measures

Positive conversion rate and geometric mean fold increase (GMFI) of anti-VZV neutralizing antibodies
Positive conversion rate and geometric mean fold increase (GMFI) of anti-VZV neutralizing antibodies 30 days after vaccination in the negative population before immunization
Positive conversion rate, GMT, and GMFI of anti-VZV neutralizing antibodies
Positive conversion rate, GMT, and GMFI of anti-VZV neutralizing antibodies 30 days after vaccination in the whole population
The incidences of adverse events (AEs)
AEs occurred witnin 30 days after vaccination will be collected
The incidences of serious adverse events (SAEs) and Adverse Event of Special Interest(AESI)
SAEs and AESI occurred witnin 6 months after vaccination will be collected

Full Information

First Posted
April 20, 2023
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
NCT05839301
Brief Title
A Trial to Evaluate the Lot-to-lot Consistency of Live Attenuated Varicella Vaccine in Healthy People 1-12 Years of Age
Official Title
A Single-center, Randomized, Double-blind Trial to Evaluate the Lot-to-lot Consistency of Live Attenuated Varicella Vaccine in Healthy People 1-12 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 27, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to evaluate the lot-to-lot consistency, immunogenicity, and safety of 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 lot-to-lot consistency, immunogenicity, and safety of live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy people 1 to 12 years of age.1200 healthy subjects aged 1-12 years were enrolled after their guardians passed the informed consent, inclusion and exclusion criteria screening in turn. Three batches were randomized in a 1:1: 1 ratio, with 400 subjects in each batch.All subjects received 1 dose of trial vaccine (Batch 1 or Batch 2 or Batch 3) and all were collected Blood samples were collected from subjects before vaccination, on Day 30 after vaccination for serum neutralizing antibody testing to evaluate immunogenicity, and Safety observations were performed until 6 months post-vaccination in all subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicella
Keywords
varicella vaccine, safety, immunogenicity, lot-to-lot consistency

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group1
Arm Type
Experimental
Arm Description
Single subcutaneous injection of the investigational vaccine (0.5ml)
Arm Title
Experimental Group2
Arm Type
Experimental
Arm Description
Single subcutaneous injection of the investigational vaccine (0.5ml)
Arm Title
Experimental Group3
Arm Type
Experimental
Arm Description
Single subcutaneous injection of the investigational vaccine (0.5ml)
Intervention Type
Biological
Intervention Name(s)
Investigational live attenuated varicella vaccine (lot 1)
Intervention Description
0.5ml/vial
Intervention Type
Biological
Intervention Name(s)
Investigational live attenuated varicella vaccine (lot 2)
Intervention Description
0.5ml/vial
Intervention Type
Biological
Intervention Name(s)
Investigational live attenuated varicella vaccine (lot 3)
Intervention Description
0.5ml/vial
Primary Outcome Measure Information:
Title
Geometric mean titers (GMT) of anti-VZV neutralizing antibodies
Description
Geometric mean titers (GMT) of anti-VZV neutralizing antibodies 30 days after vaccination in the negative population before immunization
Time Frame
30 days after vaccination
Secondary Outcome Measure Information:
Title
Positive conversion rate and geometric mean fold increase (GMFI) of anti-VZV neutralizing antibodies
Description
Positive conversion rate and geometric mean fold increase (GMFI) of anti-VZV neutralizing antibodies 30 days after vaccination in the negative population before immunization
Time Frame
30 days after vaccination
Title
Positive conversion rate, GMT, and GMFI of anti-VZV neutralizing antibodies
Description
Positive conversion rate, GMT, and GMFI of anti-VZV neutralizing antibodies 30 days after vaccination in the whole population
Time Frame
30 days after vaccination
Title
The incidences of adverse events (AEs)
Description
AEs occurred witnin 30 days after vaccination will be collected
Time Frame
30 days after vaccination
Title
The incidences of serious adverse events (SAEs) and Adverse Event of Special Interest(AESI)
Description
SAEs and AESI occurred witnin 6 months after vaccination will be collected
Time Frame
6 months after vaccination

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: Age 1 to 12 years on the day of enrollment ,male or female, and able to provide legal identity certificate. Subjects and/or guardians have the ability to understand the study requirements and process, agree to participate in the clinical trial and sign the informed consent form. Axillary temperature ≤ 37.0 ° C on the day of enrollment. Exclusion Criteria: Previous vaccination against varicella (eg, varicella vaccine, measles + varicella vaccine). History of varicella or herpes zoster infection, or exposure to varicella/herpes zoster within 30 days of enrollment or suspected varicella/herpes zoster; Current use of salicylates (including salicylic acid, aspirin, diflunisal, p-aminosalicylic acid (sodium), salsalsalate, benorilate, etc.), or planned long-term use during the study. Febrile illness (axillary temperature ≥ 38.5 ° C) or use of antipyretic, analgesic, and anti-allergic drugs (eg, acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) 3 days before vaccination. History of allergy to vaccine ingredients and excipients or severe drug allergy, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schonlein purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), severe urticaria. History of epilepsy, convulsions, or convulsions, or a family history of psychosis. Impaired immune function or has been 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. Patients suffering from serious congenital malformations, genetic diseases, serious cardiovascular diseases, serious liver/kidney diseases, diabetes with complications, malignant tumors, severe malnutrition. Immunosuppressant therapy such as chronic oral or injectable glucocorticoid therapy (≥ 14 days at doses ≥ 2 mg/kg/day or ≥ 20 mg/day prednisone or equivalent prednisone dose) within 3 months prior to administration of trial vaccine or planned 30 days following administration, but not limited by topical use (eg, ointment, eye drops, inhalers, or nasal sprays). Receiving blood/blood-related products or immunoglobulins 3 months before vaccination or planning to use such products 30 days after vaccination. Vaccination with a live attenuated vaccine within 30 days or any vaccine within 14 days prior to vaccination. Absence of spleen or splenectomy due to any condition such as splenectomy. Patients with a history of thrombocytopenia or other coagulation disorders, which may cause contraindications to subcutaneous injection. Infectious, suppurative and allergic skin diseases. Participating in other investigational or non-registered product (drug, vaccine or device, etc.) clinical trials, or planning to participate in other clinical trials before the end of this clinical trial. Subject has any other factor that, in the judgment of the investigator, would make the subject unsuitable for participation in the clinical trial.
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
Xinyi Center for Disease Control and Prevention
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221600
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Trial to Evaluate the Lot-to-lot Consistency of Live Attenuated Varicella Vaccine in Healthy People 1-12 Years of Age

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