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

NCT06049940 | Completed Phase 3

• 1 other identifier: PRO-TT-3001
• Study Type: interventional
• Target: 1,260
• Locations: 1 country
• Sites: 1

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.

Conditions

Tetanus

Outcome Measures

Primary Outcomes (4)

• Incidence of adverse reactions

  Incidence of adverse reactions within 30 days after vaccination.

  within 30 days after vaccination

• Incidence of local or systemic adverse reactions

  Incidence of local or systemic adverse reactions within 7 days after vaccination.

  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

  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.

  From the beginning of vaccination to 6 months after vaccination

Secondary Outcomes (5)

• The seroprotective rate of anti-tetanus toxiod antibody

  30 days after vaccination

• Long-term seroprotective rate of anti-tetanus toxiod antibody

  30 days after vaccination

• Seroconversion rate of anti-tetanus toxiod antibody

  30 days after vaccination

• GMC of anti-tetanus toxiod antibody

  30 days after vaccination

• GMC increase folds (GMI) of anti-tetanus toxiod antibody

  30 days after vaccination

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Biological: Investigational tetanus vaccine, adsorbed

Control Group

ACTIVE COMPARATOR

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

Biological: Control tetanus vaccine, adsorbed

Interventions

Investigational tetanus vaccine, adsorbed BIOLOGICAL

The investigational vaccine was manufactured by Sinovac Life Sciences Co., Ltd. There is not less than 40IU tetanus toxoid in 0.5ml per dose.

Experimental Group

Control tetanus vaccine, adsorbed BIOLOGICAL

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy aldults aged 18-44 months;
• Proven legal identity;
• Subjects have the ability to understand and agree to sign the informed consent form.

You may not qualify if:

• 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 10 years, or has received a tetanus immunoglobulin or tetanus antitoxin within the previous 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;

Sponsors & Collaborators

• Sinovac Life Sciences Co., Ltd.: lead

Study Sites (1)

Liangyuan District Center for Disease Control and Prevention

Shangqiu, Henan, 450016, China

Location

MeSH Terms

Conditions

Tetanus

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Zhiqing Xie

  Henan Provincial Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 22, 2023
• Study Start: September 1, 2023
• Primary Completion: October 26, 2023
• Study Completion: March 22, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

CN (1)