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
Qualifiers
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
Treatments tested in this trial
- Tetanus Vaccine, Adsorbed
- Tetanus Vaccine, Adsorbed
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov