TetanusPhase 1NCT07598890
Phase I Clinical Trial of Adsorbed Tetanus Vaccine
A Phase 1 study testing Tetanus Vaccine, Adsorbed in people with Tetanus, run by Aimei Vacin BioPharm (Zhejiang) Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tetanus
- What is being tested?
- Tetanus Vaccine, Adsorbed
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2026to 31 Dec 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants aged ≥ 18 years.
- Able to provide valid personal identification.
- 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.
- Able to comply with the trial protocol, attend scheduled examinations, and cooperate with follow-up visits.
Who cannot join
- 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.)
- History of confirmed tetanus infection.
- 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.
- Axillary temperature > 37.0 ℃ on the day of vaccination before inoculation*.
- 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.
- Presence of any acute disease or acute exacerbation of chronic disease within 3 days before vaccination.
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- 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.
- 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).
- 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.
- History of confirmed thrombocytopenia or other coagulation disorders that may constitute a contraindication to intramuscular injection.
- 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.
- Asplenia or functional asplenia, and asplenia or splenectomy caused by any conditions.
- 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.
- History of neurological diseases such as epilepsy, Parkinson's disease, Guillain-Barré syndrome, convulsions (excluding simple febrile seizures), or progressive neurological disorders.
- Previous or current history of psychiatric/psychological disorders including dementia, schizophrenia, depression, autism, delusional disorder, abulia, bipolar disorder, etc.
- Currently participating in or planning to participate in other clinical trials during this trial period.
- 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.
- Any other condition that may interfere with the trial evaluation as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei
About this study
Official title: A Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Adsorbed Tetanus Vaccine in Participants Aged ≥18 Years
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.
Read the detailed description
This trial will adopt a randomized, double-blind, parallel-controlled design. A total of 80 participants aged ≥18 years will be enrolled, with 40 participants in the 18-59 years group and 40 participants in the ≥60 years group. Participants in each age group will be randomized at a 1:1 ratio into the investigational vaccine group and the control vaccine group to receive one dose of investigational vaccine or control vaccine. Participants aged 18-59 years will be enrolled first and will receive a 7-day safety observation after vaccination. If the trial suspension criteria are not met, enrollment of participants aged ≥60 years will be initiated subsequently.
All participants will be observed for adverse events (AEs) within 30 days after vaccination, and for serious adverse events (SAEs), adverse events of special interest (AESIs), and pregnancy events within 6 months after vaccination. In addition, all participants will undergo complete blood count, blood biochemistry and routine urinalysis tests before vaccination and on Day 3 after vaccination.
All participants will have peripheral venous blood samples collected before vaccination and on Day 30 after vaccination to determine serum tetanus antibody levels.
- Conditions
- Tetanus
- Being tested
- Tetanus Vaccine, Adsorbed
- Medical subject headings
- Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanus Vaccine, AdsorbedBiological
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, AdsorbedBiological
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 group | Role | What they receive |
|---|---|---|
| Investigational vaccine group | Experimental | Participants will receive one dose of the investigational vaccine. Receives: Biological: Tetanus Vaccine, Adsorbed |
| Control vaccine group | Active comparator | Participants will receive one dose of the control vaccine. Receives: Biological: Tetanus Vaccine, Adsorbed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) and adverse reactions (ARs).
The incidence of AEs and ARs within 7 days after vaccination.
Measured: Within 7 days after vaccination
Secondary outcomes (7)
Incidence of AEs and ARs.
The incidence of AEs and ARs within 30 days after vaccination.
Measured: Within 30 days after vaccination
Stratified incidence of AEs and ARs.
The incidence of AEs and ARs within 30 days after vaccination, stratified by injection site vs. non-injection site, severity, system organ class (SOC), and preferred term (PT).
Measured: Within 30 days after vaccination
Incidence of abnormal and clinically significant laboratory parameters.
The incidence of abnormal and clinically significant changes in laboratory parameters (including complete blood count, blood biochemistry, and routine urinalysis) on Day 3 after vaccination.
Measured: Day 3 after vaccination
The occurrence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs).
The occurrence of SAEs and AESIs within 6 months after vaccination.
Measured: Within 6 months after vaccination
Rates of anti-tetanus antibody responses (seroconversion rate (SCR), seroprotection rate, and percentage of participants with anti-tetanus antibody ≥1.0 IU/mL).
The SCR, seroprotection rate, and percentage of participants with anti-tetanus antibody ≥1.0 IU/mL of serum tetanus antibody on Day 30 after vaccination in each group.
Measured: Day 30 after vaccination
Geometric mean concentration (GMC) of anti-tetanus antibody.
The GMC of serum anti-tetanus antibody on Day 30 after vaccination in each group.
Measured: Day 30 after vaccination
Geometric mean increase (GMI) of anti-tetanus antibody.
The GMI of serum anti-tetanus antibody on Day 30 after vaccination in each group.
Measured: Day 30 after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start21 May 2026
- Primary completion20 Jun 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aimei Vacin BioPharm (Zhejiang) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598890
- Sponsor's protocol ID
- AIM-1804-I-01
- Status last verified
- Sep 2026
- First submitted
- 11 May 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No