A Phase Ⅲ Clinical Study of SNA02-48 Injection
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
1 other identifier
interventional
600
1 country
30
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2026
Shorter than P25 for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2026
CompletedFirst Posted
Study publicly available on registry
June 8, 2026
CompletedStudy Start
First participant enrolled
June 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
June 8, 2026
June 1, 2026
9 months
June 2, 2026
June 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
The proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level.
Baseline up to 12 hours after receipt of study drug
Secondary Outcomes (6)
The incidence of tetanus
Up to 105 days after receipt of study drug
anti-tetanus neutralizing antibody titers
Up to 90 days after receipt of study drug
Incidence of adverse events
Up to 105 days after receipt of study drug
Incidence of severe adverse events (SAEs)
Up to 105 days after receipt of study drug
To evaluate the plasma concentration of SNA02-48
Up to 90 days after receipt of study drug
- +1 more secondary outcomes
Study Arms (2)
SNA02-48
EXPERIMENTALIf randomized to SNA02-48, participant will receive a single IM gluteal injection of SNA02-48
Human tetanus immunoglobulin (HTIG)
ACTIVE COMPARATORIf randomized to HTIG, participant will receive a single IM gluteal injection of HTIG
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Taihe County People's Hospital
Fuyang, Anhui, 236699, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100070, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510150, China
Guangzhou Eighth People's Hospital, Guangzhou Medical University
Guangzhou, Guangdong, 510440, China
The Fifth Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, 510900, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518025, China
Longhua District People's Hospital of Shenzhen
Shenzhen, Guangdong, 518100, China
Liuzhou Worker's Hospital
Liuzhou, Guangxi, 545000, China
Liuzhou People's Hospital
Liuzhou, Guangxi, 545200, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
Wuhan Union Hospital
Wuhan, Hubei, 430022, China
Affiliated Nanhua Hospital, University of South China
Hengyang, Hunan, 421010, China
Taizhou People's Hospital
Taizhou, Jiangsu, 225300, China
Affiliated Hospital of Yangzhou University
Yangzhou, Jiangsu, 225000, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212013, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330008, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337000, China
Weifang People's Hospital
Weifang, Shandong, 261000, China
Linfen Central Hospital
Linfen, Shanxi, 041000, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032, China
Yuncheng Central Hospital, Shanxi Province
Yuncheng, Shanxi, 044099, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Lishui Central Hospital
Lishui, Zhejiang, 323020, China
Ningbo Medical Center Li Huili Hospital
Ningbo, Zhejiang, 315000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2026
First Posted
June 8, 2026
Study Start
June 28, 2026
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
June 8, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share