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Clinical Trials in China / NCT07598890
Active, not recruiting Phase 1

Phase I Clinical Trial of Adsorbed Tetanus Vaccine

NCT07598890 · tracked via the Priya Life Science China tracker
Sponsor
Aimei Vacin BioPharm (Zhejiang) Co., Ltd.
Phase
Phase 1
Started
2026-05-21
Last updated
2026-08-14

Condition(s) studied

Tetanus

Investigational drug(s) / intervention(s)

Tetanus Vaccine, AdsorbedTetanus Vaccine, Adsorbed

Tetanus Vaccine, Adsorbed: This investigational vaccine is manufactured by AIM Persistence Biopharmaceutical Co., Ltd. Participants will receive one dose of adsorbed tetanus vaccine via intramuscular injection into the deltoid muscle of the upper arm.

Tetanus Vaccine, Adsorbed: This control vaccine is manufactured by Chengdu Olymvax Biopharmaceuticals Inc. Participants will receive one dose of adsorbed tetanus vaccine via intramuscular injection into the deltoid muscle of the upper arm.

Study summary

This is a randomized, double-blind, parallel-controlled Phase I clinical trial of Adsorbed Tetanus Vaccine. Participants aged ≥18 years will receive one dose of the vaccine to evaluate its safety and immunogenicity.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
Accepted
Inclusion Criteria: 1. Participants aged ≥ 18 years. 2. Able to provide valid personal identification. 3. Able to provide their own informed consent, voluntarily participate in the trial, and sign the informed consent form; able to use a thermometer and ruler, and complete diary/contact cards as required. 4. Able to comply with the trial protocol, attend scheduled examinations, and cooperate with follow-up visits. Exclusion Criteria: The following criteria will be assessed during screening/enrollment. Participants meeting any of the following conditions will be excluded from the trial. (Participants meeting only the exclusion criteria marked with an asterisk (\*) may be rescheduled for screening.) 1. History of confirmed tetanus infection. 2. Receipt of tetanus vaccine or vaccines containing tetanus toxoid component (such as DTaP, DT, or vaccines using tetanus toxoid as carrier) within 10 years; or administration of tetanus immunoglobulin (human or animal origin) within 6 months. 3. Axillary temperature \> 37.0 ℃ on the day of vaccination before inoculation\*. 4. Abnormal laboratory findings in complete blood count, blood biochemistry and routine urinalysis during the screening period, which are judged to be clinically significant by the investigator. 5. Presence of any acute disease or acute exacerbation of chronic disease within 3 days before vaccination. 6. Receipt of the following medications or vaccines before vaccination\*: * Have used antipyretic, analgesic or anti-allergic drugs within 3 days before vaccination; * Have received inactivated vaccines, subunit vaccines or other non-live vaccines within 7 days (inclusive); * Have received live attenuated vaccines within 14 days (inclusive); * Have used blood products including gamma globulin or immunoglobulin therapy within 3 months; * Have used long-term (continuous use ≥ 14 days) immunosuppressants or other immunomodulatory drugs (e.g., corticosteroids such as prednisone or similar drugs) within 6 months; however, topical medications (e.g., ointments, eye drops, inhalants or nasal sprays) are permitted, provided the dose should not exceed the recommended dose in the product labeling. 7. Positive urine pregnancy test, inability to rule out pregnancy before vaccination, or breastfeeding status; For women of childbearing potential who are pre-menopausal: last menstrual period more than 1 month ago, or plan to become pregnant within 6 months after enrollment (applicable only to female participants of childbearing potential). 8. History of severe allergic diseases or severe adverse reactions to vaccines (such as anaphylactic shock, allergic laryngeal edema, allergic purpura, local allergic necrosis reaction (Arthus reaction), severe urticaria, angioneurotic edema, etc.), or allergy to any component of the investigational vaccine. 9. History of confirmed thrombocytopenia or other coagulation disorders that may constitute a contraindication to intramuscular injection. 10. History of congenital or acquired immunodeficiency or autoimmune diseases, such as autoimmune diseases (e.g., systemic lupus erythematosus), immunodeficiency (e.g., acquired immunodeficiency syndrome), lymphoma, leukemia, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other immune-related diseases or immunocompromised conditions that may interfere with trial evaluation as judged by the investigator. 11. Asplenia or functional asplenia, and asplenia or splenectomy caused by any conditions. 12. Presence of congenital malformations affecting organ function, developmental disorders, Down syndrome, sickle cell anemia, or any severe or potentially severe diseases that may interfere with trial completion; including but not limited to respiratory diseases such as asthma, uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg), pulmonary diseases, cardiovascular and cerebrovascular diseases, hepatic and renal diseases, malignant tumors, type I diabetes, uncontrolled type Ⅱ diabetes, infectious or allergic skin diseases. 13. History of neurological diseases such as epilepsy, Parkinson's disease, Guillain-Barré syndrome, convulsions (excluding simple febrile seizures), or progressive neurological disorders. 14. Previous or current history of psychiatric/psychological disorders including dementia, schizophrenia, depression, autism, delusional disorder, abulia, bipolar disorder, etc. 15. Currently participating in or planning to participate in other clinical trials during this trial period. 16. Plan to permanently move from the local area before the end of the trial, or plan to leave the local area for a long period that will affect scheduled trial visits. 17. Any other condition that may interfere with the trial evaluation as judged by the investigator.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hubei Provincial Center for Disease Control and Prevention Wuhan Hubei

More Aimei Vacin BioPharm (Zhejiang) Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07598890 on ClinicalTrials.gov ↗ ← All trials in China