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Not yet recruiting NCT07633119

A Phase Ⅲ Clinical Study of SNA02-48 Injection

Phase III Interventional Tetanus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SNA02-48, Human tetanus immunoglobulin (HTIG).
Who it may be relevant to
Registry conditions: Tetanus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug SNA02-48
    IM gluteal injection
  • Drug Human tetanus immunoglobulin (HTIG)
    IM gluteal injection

Primary outcome measures

  • 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 outcome measures (6)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

China · 30 centers
  • Taihe County People's Hospital — Fuyang
  • The Second Affiliated Hospital of Anhui Medical University — Hefei
  • Peking University First Hospital — Beijing
  • Peking University People's Hospital — Beijing
  • Beijing Tiantan Hospital Affiliated to Capital Medical University — Beijing
  • Peking Union Medical College Hospital — Beijing
  • The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
  • The Third Affiliated Hospital of Guangzhou Medical University — Guangzhou
  • … and 22 more centers

Identifiers

NCT: NCT07633119 · PRO-SNA02-48-3001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗