Phase I/III Clinical Trial of Adsorbed Tetanus Vaccine

NCT07740733 | Completed Phase 3

• 1 other identifier: 2023LP00599
• Study Type: interventional
• Target: 1,240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tetanus; Tetanus Vaccine

Outcome Measures

Primary Outcomes (1)

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

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

Study Arms (2)

study group

EXPERIMENTAL

620 participant

Biological: Tetanus Toxoid (Adsorbed)

control group

ACTIVE COMPARATOR

620

Biological: Tetanus Toxoid (Adsorbed)

Interventions

Tetanus Toxoid (Adsorbed) BIOLOGICAL

The study group's vaccines had been produced by Beijing Minhai Biotechnology Co., Ltd. Liquid formulation. 0.5 mL/vial.

study group

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Minhai Biotechnology Co., Ltd: lead

Study Sites (1)

Guangdong Provincial Center for Diseases Control and Prevention

Guangzhou, Guangdong, 510440, China

Location

MeSH Terms

Conditions

Tetanus

Interventions

Tetanus Toxoid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures

Study Design

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

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 3, 2026
• Study Start: February 29, 2024
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2024
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

CN (1)