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

Last updated: July 10, 2024
Sponsor: Sinovac Life Sciences Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Hypoparathyroidism

Treatment

Control tetanus vaccine, adsorbed

Investigational tetanus vaccine, adsorbed

Clinical Study ID

NCT06049940
PRO-TT-3001
  • Ages 18-44
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Armpit temperature of persons with fever on the day of experimental vaccineadministration>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 hasreceived a tetanus immunoglobulin or tetanus antitoxin within the previous 6 months;

  • Women who are lactating, pregnant (with a positive urine pregnancy test) or planningto become pregnant within the last 3 months;

  • History of asthma, allergy to vaccines or vaccine components, and severe adversereactions to vaccines, such as urticaria, dyspnea, angioedema, or abdominal pain;

  • Congenital malformations or developmental disorders, genetic defects, severemalnutrition, 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, aspleniaor 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 kidneydiseases,malignant tumors, etc;

  • Currently suffering from or have suffered from encephalopathy (such as congenitalbrain hypoplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebralinfarction, brain infection, chemical poisoning, etc.); A history of convulsions,epilepsy, psychosis or a family history of psychosis, and other serious neurologicaldisorders;

  • Diagnosed abnormal blood coagulation function (e.g. coagulation factor deficiency,coagulation disorders, abnormal platelets) or obvious bruising or coagulationdisorders;

  • Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excludingallergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitissuperficial 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 arenot suitable for participating in the clinical trial.

Study Design

Total Participants: 1260
Treatment Group(s): 2
Primary Treatment: Control tetanus vaccine, adsorbed
Phase: 3
Study Start date:
September 01, 2023
Estimated Completion Date:
March 22, 2024

Study 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.

Connect with a study center

  • Liangyuan District Center for Disease Control and Prevention

    Shangqiu, Henan 450016
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.