A Phase Ⅲ Clinical Study of SNA02-48 Injection
ConditionTetanus
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSinovac Life Sciences Co., Ltd.
About this trial
The primary objective of this clinical trial is to compare the efficacy and safety of SNA02-48 injection with Human Tetanus Immunoglobulin (HTIG) for tetanus prophylaxis.
Eligibility criteria
Qualifiers
Males or females aged 18 years and above;
Participants who can understand and voluntarily sign the informed consent form;
Participants with high-risk tetanus exposure;
Participants of childbearing potential and their sexual partners voluntarily adopt effective contraceptive measures from the time the participant signs the informed consent form until 6 months after administration, with no plans for sperm or egg donation.
Disqualifiers
Suspected or confirmed tetanus ;
A history of previous tetanus infection;
A known history of 3 or more doses of tetanus toxoid or vaccines containing tetanus toxoid, or fewer than 3 previous doses but with the last dose of tetanus toxoid or vaccines containing tetanus toxoid administered within 6 months prior to the administration of the investigational product;
Known hypersensitivity to the investigational product (including excipients, HTIG, and other therapeutic monoclonal antibodies), or suffering from severe allergic diseases that, in the investigator's judgment, may impair the participant's safety; Other protocol defined Inclusion/Exclusion criteria may apply.
Trial design
Treatments tested in this trial
- SNA02-48
- Human tetanus immunoglobulin (HTIG)
Treatment groups
600 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov