search
Back to results

Safety and Immunogenicity of Tetanus Vaccine, Adsorbed in 18~44 Years Old Population

Primary Purpose

Tetanus

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Investigational tetanus vaccine, adsorbed
Control tetanus vaccine, adsorbed
Sponsored by
Sinovac Life Sciences Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tetanus

Eligibility Criteria

18 Years - 44 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy aldults aged 18-44 months; Proven legal identity; Subjects have the ability to understand and agree to sign the informed consent form. Exclusion Criteria: Armpit temperature of persons with fever on the day of experimental vaccine administration>37.0 ℃; Previous history of tetanus infection; Has received tetanus vaccines or vaccines containing tetanus toxoid antigen (DTP, DTP, meningococcal conjugate vaccine, etc.) within the last 5 years, or has received a tetanus immunoglobulin or tetanus antitoxin within the last 6 months; Women who are lactating, pregnant (with a positive urine pregnancy test) or planning to become pregnant within the last 3 months; History of asthma, allergy to vaccines or vaccine components, and severe adverse reactions to vaccines, such as urticaria, dyspnea, angioedema, or abdominal pain; Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; Have congenital or acquired immunodeficiency such as HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA); Thyroid disease or history of thyroidectomy, asplenia,functional asplenia, asplenia or splenectomy resulting from any condition; Severe chronic diseases,such as severe cardiovascular diseases, hypertension(Systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc; Currently suffering from or have suffered from encephalopathy (such as congenital brain hypoplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection, chemical poisoning, etc.); A history of convulsions, epilepsy, psychosis or a family history of psychosis, and other serious neurological disorders; Diagnosed abnormal blood coagulation function (e.g. coagulation factor deficiency, coagulation disorders, abnormal platelets) or obvious bruising or coagulation disorders; Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months; A long history of alcohol or drug abuse; Receipt of blood products within in the past 3 months; Receipt of attenuated live vaccines in the past 14 days; Receipt of inactivated or subunit vaccines in the past 7 days; Acute onset of various acute diseases or chronic diseases in the last 7 days; Participating in clinical studies of other vaccines or drugs; According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Sites / Locations

  • Liangyuan District Center for Disease Control and PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

630 Participants (including 30 subjects in phaseⅠ, 600 subjects in phase Ⅲ ) will receive one dose of experimental vaccine or control vaccine.

630 Participants (including 30 subjects in phaseⅠ, 600 subjects in phase Ⅲ ) will receive one dose of experimental vaccine or control vaccine.

Outcomes

Primary Outcome Measures

Incidence of adverse reactions
Incidence of adverse reactions within 30 days after vaccination.
Incidence of local or systemic adverse reactions
Incidence of local or systemic adverse reactions within 7 days after vaccination.
Incidence of grade 3 and above adverse reactions
Incidence of grade 3 and above adverse reactions within 30 days after vaccination
Incidence of SAE related to vaccination
Incidence of SAE related to vaccination from the beginning of vaccination to 6 months after vaccination.

Secondary Outcome Measures

The seroprotective rate of anti-tetanus toxiod antibody
The seroprotective rate of anti-tetanus toxiod antibody 30 days after vaccination.
Long-term seroprotective rate of anti-tetanus toxiod antibody
Long-term seroprotective rate of anti-tetanus toxiod antibody 30 days after vaccination.
Seroconversion rate of anti-tetanus toxiod antibody
Seroconversion rate of anti-tetanus toxiod antibody 30 days after vaccination.
GMC of anti-tetanus toxiod antibody
GMC of anti-tetanus toxiod antibody 30 days after vaccination.
GMC increase folds (GMI) of anti-tetanus toxiod antibody
GMC increase folds (GMI) of anti-tetanus toxiod antibody 30 days after vaccination.

Full Information

First Posted
September 15, 2023
Last Updated
October 16, 2023
Sponsor
Sinovac Life Sciences Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT06049940
Brief Title
Safety and Immunogenicity of Tetanus Vaccine, Adsorbed in 18~44 Years Old Population
Official Title
Randomized, Double-blind, Controlled Phase Ⅰ and Phase Ⅲ Clinical Trial to Evaluate the Safety and Immunogenicity of Tetanus Vaccine, Adsorbed in 18~44 Years Old Population
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Life Sciences 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 a randomized, double-blind, positive controlled design clinical trial of tetanus vaccine, adsorbed manufactured by Sinovac Life Sciences Co., Ltd.The purpose of this study is to evaluate the safety and immunogenicity of tetanus vaccine, adsorbed in 18~44 years old population.
Detailed Description
This is a randomized, double-blind, positive controlled design clinical trial of tetanus vaccine, adsorbed.The purpose of this study is to evaluate the safety and immunogenicity of tetanus vaccine, adsorbed in 18~44 years old population.The study will conduct in two phases.A total of 1260 subjects including 60 subjects in phase Ⅰ and 1200 subjects in phase III will be enrolled.All of subjects in phase Ⅰ and phase III will be randomly assigned 2 groups in a 1:1 ratio to receive one dose of experimental vaccine or control vaccine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetanus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
630 Participants (including 30 subjects in phaseⅠ, 600 subjects in phase Ⅲ ) will receive one dose of experimental vaccine or control vaccine.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
630 Participants (including 30 subjects in phaseⅠ, 600 subjects in phase Ⅲ ) will receive one dose of experimental vaccine or control vaccine.
Intervention Type
Biological
Intervention Name(s)
Investigational tetanus vaccine, adsorbed
Intervention Description
The investigational vaccine was manufactured by Sinovac Life Sciences Co., Ltd. There is not less than 40IU tetanus toxoid in 0.5ml per dose.
Intervention Type
Biological
Intervention Name(s)
Control tetanus vaccine, adsorbed
Intervention Description
The control tetanus vaccine, adsorbed was manufactured by Chengdu Olymvax Biopharmaceuticals Inc.There is not less than 40IU tetanus toxoid in 0.5ml per dose.
Primary Outcome Measure Information:
Title
Incidence of adverse reactions
Description
Incidence of adverse reactions within 30 days after vaccination.
Time Frame
within 30 days after vaccination
Title
Incidence of local or systemic adverse reactions
Description
Incidence of local or systemic adverse reactions within 7 days after vaccination.
Time Frame
Within 7 days after vaccination
Title
Incidence of grade 3 and above adverse reactions
Description
Incidence of grade 3 and above adverse reactions within 30 days after vaccination
Time Frame
Within 30 days after vaccination
Title
Incidence of SAE related to vaccination
Description
Incidence of SAE related to vaccination from the beginning of vaccination to 6 months after vaccination.
Time Frame
From the beginning of vaccination to 6 months after vaccination
Secondary Outcome Measure Information:
Title
The seroprotective rate of anti-tetanus toxiod antibody
Description
The seroprotective rate of anti-tetanus toxiod antibody 30 days after vaccination.
Time Frame
30 days after vaccination
Title
Long-term seroprotective rate of anti-tetanus toxiod antibody
Description
Long-term seroprotective rate of anti-tetanus toxiod antibody 30 days after vaccination.
Time Frame
30 days after vaccination
Title
Seroconversion rate of anti-tetanus toxiod antibody
Description
Seroconversion rate of anti-tetanus toxiod antibody 30 days after vaccination.
Time Frame
30 days after vaccination
Title
GMC of anti-tetanus toxiod antibody
Description
GMC of anti-tetanus toxiod antibody 30 days after vaccination.
Time Frame
30 days after vaccination
Title
GMC increase folds (GMI) of anti-tetanus toxiod antibody
Description
GMC increase folds (GMI) of anti-tetanus toxiod antibody 30 days after vaccination.
Time Frame
30 days after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy aldults aged 18-44 months; Proven legal identity; Subjects have the ability to understand and agree to sign the informed consent form. Exclusion Criteria: Armpit temperature of persons with fever on the day of experimental vaccine administration>37.0 ℃; Previous history of tetanus infection; Has received tetanus vaccines or vaccines containing tetanus toxoid antigen (DTP, DTP, meningococcal conjugate vaccine, etc.) within the last 5 years, or has received a tetanus immunoglobulin or tetanus antitoxin within the last 6 months; Women who are lactating, pregnant (with a positive urine pregnancy test) or planning to become pregnant within the last 3 months; History of asthma, allergy to vaccines or vaccine components, and severe adverse reactions to vaccines, such as urticaria, dyspnea, angioedema, or abdominal pain; Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; Have congenital or acquired immunodeficiency such as HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA); Thyroid disease or history of thyroidectomy, asplenia,functional asplenia, asplenia or splenectomy resulting from any condition; Severe chronic diseases,such as severe cardiovascular diseases, hypertension(Systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc; Currently suffering from or have suffered from encephalopathy (such as congenital brain hypoplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection, chemical poisoning, etc.); A history of convulsions, epilepsy, psychosis or a family history of psychosis, and other serious neurological disorders; Diagnosed abnormal blood coagulation function (e.g. coagulation factor deficiency, coagulation disorders, abnormal platelets) or obvious bruising or coagulation disorders; Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months; A long history of alcohol or drug abuse; Receipt of blood products within in the past 3 months; Receipt of attenuated live vaccines in the past 14 days; Receipt of inactivated or subunit vaccines in the past 7 days; Acute onset of various acute diseases or chronic diseases in the last 7 days; Participating in clinical studies of other vaccines or drugs; 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
Zhiqiang Xie
Phone
13526534586
Email
xiezqshang@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiqing Xie
Organizational Affiliation
Henan Provincial Center for Disease Prevention and Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liangyuan District Center for Disease Control and Prevention
City
Shangqiu
State/Province
Henan
ZIP/Postal Code
450016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang Liu
Phone
13569386065
Email
44477039@qq.com

12. IPD Sharing Statement

Learn more about this trial

Safety and Immunogenicity of Tetanus Vaccine, Adsorbed in 18~44 Years Old Population

We'll reach out to this number within 24 hrs