A Phase 3 interventional study of SNA02-48 and Human tetanus immunoglobulin (HTIG) in Tetanus, sponsored by Sinovac Life Sciences Co., Ltd.. Not yet recruiting at 30 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Sinovac Life Sciences Co., Ltd. (part of Sinovac Biotech Co., Ltd) · Phase 3, Interventional, and Prevention
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.
318 studies on the registry are indexed under Tetanus; 29 are open to participants now.
This study's planned enrollment of 600 is above the median of 418 across 280 interventional studies indexed under Tetanus.
Browse Tetanus studies →Sinovac Life Sciences Co., Ltd. is the lead sponsor of 26 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
If randomized to SNA02-48, participant will receive a single IM gluteal injection of SNA02-48
Drug: SNA02-48
If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG
Drug: Human tetanus immunoglobulin (HTIG)
IM gluteal injection
IM gluteal injection
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
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Mar 2027, 9 months later.
Of 54 industry-sponsored phase 3 interventional studies under Tetanus, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 21. This study's planned 9 months is below that.
Counting every sponsor, half of 55 studies reached it within 12 months; a quarter within 6 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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