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

NCT06049940
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Phase
Phase 3
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Recruitment status
Completed
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Participants
1,260
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Lead sponsor
Sinovac Life Sciences Co., Ltd.
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Start date
2023-09-01
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Number of sites
1
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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.
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Short title
Safety and Immunogenicity of Tetanus Vaccine, Adsorbed in 18~44 Years Old Population
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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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2024-03-22
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First posted
2023-09-22
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Registry last updated
2024-07-12
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Primary completion date
2023-10-26
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Start date
2023-09-01
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Actual participants
1,260
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Participants
1,260
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Participant count basis
Actual
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Protocol amendments
2
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Randomisation ratio
1:1
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Sinovac Life Sciences Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06049940
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ClinicalTrials.gov ID
NCT06049940
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Incidence of adverse reactions

    Timeframe: within 30 days after vaccination

    Incidence of adverse reactions within 30 days after vaccination.

  2. Incidence of local or systemic adverse reactions

    Timeframe: Within 7 days after vaccination

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

  3. Incidence of grade 3 and above adverse reactions

    Timeframe: Within 30 days after vaccination

    Incidence of grade 3 and above adverse reactions within 30 days after vaccination

  4. Incidence of SAE related to vaccination

    Timeframe: From the beginning of vaccination to 6 months after vaccination

    Incidence of SAE related to vaccination from the beginning of vaccination to 6 months after vaccination.

  1. The seroprotective rate of anti-tetanus toxiod antibody

    Timeframe: 30 days after vaccination

    The seroprotective rate of anti-tetanus toxiod antibody 30 days after vaccination.

  2. Long-term seroprotective rate of anti-tetanus toxiod antibody

    Timeframe: 30 days after vaccination

    Long-term seroprotective rate of anti-tetanus toxiod antibody 30 days after vaccination.

  3. Seroconversion rate of anti-tetanus toxiod antibody

    Timeframe: 30 days after vaccination

    Seroconversion rate of anti-tetanus toxiod antibody 30 days after vaccination.

  4. GMC of anti-tetanus toxiod antibody

    Timeframe: 30 days after vaccination

    GMC of anti-tetanus toxiod antibody 30 days after vaccination.

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

    Timeframe: 30 days after vaccination

    GMC increase folds (GMI) of anti-tetanus toxiod antibody 30 days after vaccination.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
44 Years
Healthy volunteers
Yes

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

  • 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;
  • 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.
Sources for eligibility
clinicaltrials.gov

  • Liangyuan District Center for Disease Control and PreventionShangqiu, China
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)