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SNA02-48 vs HTIG for Tetanus Prophylaxis
NCT07633119Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Jun 2026
- Primary completion
- Mar 2027
- Countries
- 1
- Sponsor
- Sinovac Life Sciences
- Drugs
- SNA02-48
- Conditions
- Tetanus
01
Overview
Phase 3, randomised, double-blind trial of SNA02-48 in Tetanus (2 arms), sponsored by Sinovac Life Sciences. Primary endpoint: Proportion of participants with an increase of anti-tetanus neutralizing antibody titers over protective level at 12 hours. Planned start Jun 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
SNA02-48
Single IM gluteal injection of SNA02-48
Human tetanus immunoglobulin (HTIG)
Single IM gluteal injection of HTIG
03
Who it enrols
Adults with high-risk tetanus exposure, excluding those with suspected/confirmed tetanus, history of tetanus infection, or recent/complete tetanus vaccination.
04
Endpoints
Primary
Proportion of participants with an increase of anti-tetanus neutralizing antibody titers over protective level
Secondary
Incidence of tetanus
Anti-tetanus neutralizing antibody titers
Incidence of adverse events
Incidence of severe adverse events (SAEs)
Plasma concentration of SNA02-48
Incidence of anti-drug antibody (ADA) and neutralizing antibody (Nab)
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