A Phase Ⅲ Clinical Study of SNA02-48 Injection

ConditionTetanus
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSinovac Life Sciences Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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 design

Treatments tested in this trial

  • SNA02-48
  • Human tetanus immunoglobulin (HTIG)

Treatment groups

600 Participants
are divided into 2 treatment groups

Locations

30
Taihe County People's Hospital236699, FuyangAnhui, China
The Second Affiliated Hospital of Anhui Medical University230601, HefeiAnhui, China
Beijing Tiantan Hospital Affiliated to Capital Medical University100070, BeijingBeijing Municipality, China
Peking Union Medical College Hospital100730, BeijingBeijing Municipality, China

Sponsors and collaborators

Sinovac Life Sciences Co., Ltd.

Lead sponsor