TetanusPhase 3NCT07633119
A Phase Ⅲ Clinical Study of SNA02-48 Injection
A Phase 3 study testing SNA02-48 and Human tetanus immunoglobulin (HTIG) in people with Tetanus, run by Sinovac Life Sciences Co., Ltd. at 30 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tetanus
- What is being tested?
- SNA02-48 and Human tetanus immunoglobulin (HTIG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 30 sitesChina
- Study dates
- 28 Jun 2026to 31 May 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
China30 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100070
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Taihe County People's Hospital
Fuyang, Anhui, 236699
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510150
Guangzhou Eighth People's Hospital, Guangzhou Medical University
Guangzhou, Guangdong, 510440
The Fifth Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, 510900
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
Affiliated Nanhua Hospital, University of South China
Hengyang, Hunan, 421010
Linfen Central Hospital
Linfen, Shanxi, 041000
Lishui Central Hospital
Lishui, Zhejiang, 323020
Liuzhou Worker's Hospital
Liuzhou, Guangxi, 545000
Liuzhou People's Hospital
Liuzhou, Guangxi, 545200
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330008
Ningbo Medical Center Li Huili Hospital
Ningbo, Zhejiang, 315000
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337000
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518025
Longhua District People's Hospital of Shenzhen
Shenzhen, Guangdong, 518100
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032
Taizhou People's Hospital
Taizhou, Jiangsu, 225300
Weifang People's Hospital
Weifang, Shandong, 261000
Wuhan Union Hospital
Wuhan, Hubei, 430022
Affiliated Hospital of Yangzhou University
Yangzhou, Jiangsu, 225000
Yuncheng Central Hospital, Shanxi Province
Yuncheng, Shanxi, 044099
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212013
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000
About this study
Official title: A Multicenter, Randomized, Double-Blind, Active-Controlled Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of SNA02-48 Injection in Populations With High-Risk Tetanus Exposure
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.
- Conditions
- Tetanus
- Being tested
- SNA02-48, Human tetanus immunoglobulin (HTIG)
- Medical subject headings
- Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNA02-48Drug
IM gluteal injection
Human tetanus immunoglobulin (HTIG)Drug
IM gluteal injection
| Study group | Role | What they receive |
|---|---|---|
| SNA02-48 | Experimental | If randomized to SNA02-48, participant will receive a single IM gluteal injection of SNA02-48 Receives: Drug: SNA02-48 |
| Human tetanus immunoglobulin (HTIG) | Active comparator | If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG Receives: Drug: Human tetanus immunoglobulin (HTIG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level.
Measured: Baseline up to 12 hours after receipt of study drug
Secondary outcomes (6)
The incidence of tetanus
Measured: Up to 105 days after receipt of study drug
anti-tetanus neutralizing antibody titers
Measured: Up to 90 days after receipt of study drug
Incidence of adverse events
Measured: Up to 105 days after receipt of study drug
Incidence of severe adverse events (SAEs)
Measured: Up to 105 days after receipt of study drug
To evaluate the plasma concentration of SNA02-48
Measured: Up to 90 days after receipt of study drug
Incidence of anti-drug antibody (ADA) and neutralizing antibody (Nab)
Measured: Up to 90 days after receipt of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start28 Jun 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633119
- Sponsor's protocol ID
- PRO-SNA02-48-3001
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No