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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
SNA02-48
DrugIM gluteal injection
Human tetanus immunoglobulin (HTIG)
DrugIM gluteal injection
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: SNA02-48Experimental treatment 1 intervention
Group B: Human tetanus immunoglobulin (HTIG)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
The proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level.
Time frame
Baseline up to 12 hours after receipt of study drugSecondary outcomes
1
The incidence of tetanus
Time frame
Up to 105 days after receipt of study drug2
anti-tetanus neutralizing antibody titers
Time frame
Up to 90 days after receipt of study drug3
Incidence of adverse events
Time frame
Up to 105 days after receipt of study drug4
Incidence of severe adverse events (SAEs)
Time frame
Up to 105 days after receipt of study drugSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: