A Phase Ⅲ Clinical Study of SNA02-48 Injection

Starting soon · Phase 3

Conditions studied: Tetanus

In brief

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.

Key facts

Study ID

NCT07633119

Run by

Sinovac Life Sciences Co., Ltd.

People needed

600

Starts

2026-06-28

Expected to finish

2027-05-31

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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;
• 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.

Where it is running

• Linfen Central Hospital — Linfen, Shanxi, China
• Shanxi Bethune Hospital — Taiyuan, Shanxi, China
• Yuncheng Central Hospital, Shanxi Province — Yuncheng, Shanxi, China
• West China Hospital, Sichuan University — Chengdu, Sichuan, China
• Lishui Central Hospital — Lishui, Zhejiang, China
• Ningbo Medical Center Li Huili Hospital — Ningbo, Zhejiang, China
• Taihe County People's Hospital — Fuyang, Anhui, China
• The Second Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China
• Peking University First Hospital — Beijing, Beijing Municipality, China
• Peking University People's Hospital — Beijing, Beijing Municipality, China
• Beijing Tiantan Hospital Affiliated to Capital Medical University — Beijing, Beijing Municipality, China
• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China
• The Third Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China
• Guangzhou Eighth People's Hospital, Guangzhou Medical University — Guangzhou, Guangdong, China
• The Fifth Affiliated Hospital of Southern Medical University — Guangzhou, Guangdong, China
• Shenzhen Second People's Hospital — Shenzhen, Guangdong, China
• Longhua District People's Hospital of Shenzhen — Shenzhen, Guangdong, China
• Liuzhou Worker's Hospital — Liuzhou, Guangxi, China
• Liuzhou People's Hospital — Liuzhou, Guangxi, China
• Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China
• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China
• Wuhan Union Hospital — Wuhan, Hubei, China
• Affiliated Nanhua Hospital, University of South China — Hengyang, Hunan, China
• Taizhou People's Hospital — Taizhou, Jiangsu, China

Full record on ClinicalTrials.gov

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