Phase I/III Clinical Trial of Adsorbed Tetanus Vaccine

Phase
Recruitment status
Participants
Lead sponsor
Beijing Minhai Biotechnology Co., Ltd
Start date
Number of sites

Summary
The study aimed to evaluate the safety and immunogenicity of an adsorbed tetanus vaccine in healthy individuals between 18 and 43 years of age.
Short title
Phase I/III Clinical Trial of Adsorbed Tetanus Vaccine
Official title
A Randomized, Blinded, Parallel-Controlled Phase I/III Clinical Trial to Evaluate the Safety and Immunogenicity of Adsorbed Tetanus Vaccine in Healthy Individuals Aged 18-43 Years

Control arm
Active comparator
Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Actual participants
Participants
Participant count basis
Protocol amendments
Number of sites

Registry sponsor category
Lead sponsor
Beijing Minhai Biotechnology Co., Ltd
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design

  1. Tetanus antibody seroconversion rate at 30 days post-immunization.

    Timeframe: From enrollment to completion of all follow-up visits, up to 180 days.

Sources for outcomes

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

  1. Healthy local residents aged 18-43 years;
  2. Obtain informed consent from volunteers and have them sign the informed consent form.
  3. Able to comply with the requirements of the clinical trial protocol;
  4. Axillary temperature ≤37.0°C.

  1. History of tetanus infection;
  2. Receipt of tetanus vaccine or a vaccine containing tetanus toxoid antigen within 10 years, or tetanus immunoglobulin within 6 months;
  3. Known allergy to vaccine components or history of severe post-vaccination allergy;
  4. History of epilepsy, seizures, convulsion or family history of psychiatric illness;
  5. Immunodeficiency, immunosuppressive / immunostimulatory therapy within 3 months (>14 days continuous oral/IV), or Immunocompromised individuals due to HIV;
  6. Asplenia or functional splenic deficiency due to any cause;
  7. Congenital anomalies, developmental disorders, or severe chronic diseases (e.g., Down syndrome, diabetes, sickle cell disease, neurological disorders, Guillain-Barré syndrome);
  8. Known or suspected co-existing conditions include: severe respiratory, cardiovascular, hepatorenal diseases, uncontrolled hypertension on medication, malignancy, acute infections, or active chronic diseases;
  9. Clinically diagnosed coagulation abnormalities (e.g., coagulation factor deficiencies, coagulopathies, platelet disorders) or Coagulation disorder;
  10. Blood product use within 3 months;
  11. Token another investigational drug study within 1 month;
  12. Live attenuated vaccine within 14 days;
  13. Subunit/inactivated vaccine within 7 days;

(13) Fever (≥38.0°C) or use of antipyretic/analgesic/anti-allergic drugs within 3 days; (14) Any other condition was deemed by the investigator to preclude trial participation.

Sources for eligibility

  • Guangdong Provincial Center for Diseases Control and PreventionGuangzhou, China
Sources for sites

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)