Phase I Clinical Trial of Adsorbed Tetanus Vaccine
ConditionTetanus
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAimei Vacin BioPharm (Zhejiang) Co., Ltd.
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Tetanus Vaccine, Adsorbed
Biological/VaccineThis 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
Biological/VaccineThis 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Investigational vaccine groupExperimental treatment 1 intervention
Group B: Control vaccine groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 vaccinationSecondary outcomes
1
Incidence of AEs and ARs.
The incidence of AEs and ARs within 30 days after vaccination.
Time frame
Within 30 days after vaccination2
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 vaccination3
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 vaccination4
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 vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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