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NCT Number: NCT07633119

A Phase Ⅲ Clinical Study of SNA02-48 Injection

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.

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Key information

Conditions

Tetanus Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Taihe County People's Hospital, Fuyang, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

SNA02-48

Drug

IM gluteal injection

Human tetanus immunoglobulin (HTIG)

Drug

IM gluteal injection

Primary outcomes

  1. 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

Secondary outcomes

  1. The incidence of tetanus

    Time frame: Up to 105 days after receipt of study drug

  2. anti-tetanus neutralizing antibody titers

    Time frame: Up to 90 days after receipt of study drug

  3. Incidence of adverse events

    Time frame: Up to 105 days after receipt of study drug

  4. Incidence of severe adverse events (SAEs)

    Time frame: Up to 105 days after receipt of study drug

  5. To evaluate the plasma concentration of SNA02-48

    Time frame: Up to 90 days after receipt of study drug

  6. Incidence of anti-drug antibody (ADA) and neutralizing antibody (Nab)

    Time frame: Up to 90 days after receipt of study drug

Study contacts

Contact information is provided by the study sponsor or research team.

Chuanlin Wang, MD

CONTACT

[email protected]

+86 13911883012

Sponsors and collaborators

Lead sponsor

Sinovac Life Sciences Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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