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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07633119
- Acronym / sponsor ID
- PRO-SNA02-48-3001
- Conditions
- Tetanus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SNA02-48 | Experimental | Drug: SNA02-48If randomized to SNA02-48, participant will receive a single IM gluteal injection of SNA02-48 |
| Human tetanus immunoglobulin (HTIG) | Active comparator | Drug: Human tetanus immunoglobulin (HTIG)If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNA02-48IM gluteal injection | Drug | SNA02-48 |
| Human tetanus immunoglobulin (HTIG)IM gluteal injection | Drug | Human tetanus immunoglobulin (HTIG) |
Primary outcome
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 drug
6 secondary outcomes
The incidence of tetanus
Time frame: Up to 105 days after receipt of study drug
anti-tetanus neutralizing antibody titers
Time frame: Up to 90 days after receipt of study drug
Incidence of adverse events
Time frame: Up to 105 days after receipt of study drug
Incidence of severe adverse events (SAEs)
Time frame: Up to 105 days after receipt of study drug
To evaluate the plasma concentration of SNA02-48
Time frame: Up to 90 days after receipt of study drug
Incidence of anti-drug antibody (ADA) and neutralizing antibody (Nab)
Time frame: Up to 90 days after receipt of study drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chuanlin Wang, MD (+86 13911883012, wangchuanlinvip@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.