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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
80
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.
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.
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, China
Incidence of adverse events (AEs) and adverse reactions (ARs).
The incidence of AEs and ARs within 7 days after vaccination.
Time frame: Within 7 days after vaccination
Incidence of AEs and ARs.
The incidence of AEs and ARs within 30 days after vaccination.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 30 after vaccination
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Geometric mean concentration (GMC) of anti-tetanus antibody.
The GMC of serum anti-tetanus antibody on Day 30 after vaccination in each group.
Time frame: 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.
Time frame: Day 30 after vaccination