Tetanus
Conditions
Brief 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.
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.
Interventions
BIOLOGICALTetanus 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.
Sponsors
Aimei Vacin BioPharm (Zhejiang) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) and adverse reactions (ARs). | Within 7 days after vaccination | The incidence of AEs and ARs within 7 days after vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AEs and ARs. | Within 30 days after vaccination | The incidence of AEs and ARs within 30 days after vaccination. |
| Stratified incidence of AEs and ARs. | Within 30 days after vaccination | 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). |
| Incidence of abnormal and clinically significant laboratory parameters. | Day 3 after vaccination | 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. |
| The occurrence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs). | Within 6 months after vaccination | The occurrence of SAEs and AESIs 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). | Day 30 after vaccination | 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. |
| Geometric mean concentration (GMC) of anti-tetanus antibody. | Day 30 after vaccination | The GMC of serum anti-tetanus antibody on Day 30 after vaccination in each group. |
| Geometric mean increase (GMI) of anti-tetanus antibody. | Day 30 after vaccination | The GMI of serum anti-tetanus antibody on Day 30 after vaccination in each group. |
Countries
China
Outcome results
None listed