Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Investigational tetanus vaccine, adsorbed · 1 trial · 1 indication
Incidence of adverse reactions within 30 days after vaccination.
Incidence of local or systemic adverse reactions within 7 days after vaccination.
Incidence of grade 3 and above adverse reactions within 30 days after vaccination
Incidence of SAE related to vaccination from the beginning of vaccination to 6 months after vaccination.
| Arm | Type | Description |
|---|---|---|
| Experimental Group | EXPERIMENTAL | 630 Participants (including 30 subjects in phaseⅠ, 600 subjects in phase Ⅲ ) will receive one dose of experimental vaccine or control vaccine. |
| Control Group | ACTIVE_COMPARATOR | 630 Participants (including 30 subjects in phaseⅠ, 600 subjects in phase Ⅲ ) will receive one dose of experimental vaccine or control vaccine. |
| Name | Type | Description |
|---|---|---|
| Investigational tetanus vaccine, adsorbed | BIOLOGICAL | The investigational vaccine was manufactured by Sinovac Life Sciences Co., Ltd. There is not less than 40IU tetanus toxoid in 0.5ml per dose. |
| Control tetanus vaccine, adsorbed | BIOLOGICAL | The control tetanus vaccine, adsorbed was manufactured by Chengdu Olymvax Biopharmaceuticals Inc.There is not less than 40IU tetanus toxoid in 0.5ml per dose. |
Inclusion Criteria: * Healthy aldults aged 18-44 months; * Proven legal identity; * Subjects have the ability to understand and agree to sign the informed consent form. Exclusion Criteria: * Armpit temperature of persons with fever on the day of experimental vaccine administration\>37.0 ℃; * Prev...
It is a Phase 3 vaccine candidate developed by Sinovac Biotech, Ltd for the prevention of tetanus. It is an adsorbed tetanus vaccine, meaning the vaccine antigen is combined with an adjuvant to enhance the immune response. It is being studied in healthy adults aged 18 to 44 years.
It is intended for immunization against tetanus, an infectious disease caused by Clostridium tetani. The vaccine is designed to induce protective immunity in healthy adults. Its clinical program has focused on adults aged 18 to 44 years in China.
Sinovac Biotech, Ltd develops the investigational tetanus vaccine, adsorbed. Sinovac is a China-based vaccine company whose shares trade under the ticker SVA. The company is the sponsor of the Phase 3 trial evaluating this candidate.
It is in Phase 3 clinical development. The candidate is investigational and has not been approved. Its single Phase 3 trial, NCT06049940, has been completed, and no trials are currently active.
One trial has evaluated the investigational tetanus vaccine, adsorbed: NCT06049940, titled Safety and Immunogenicity of Tetanus Vaccine, Adsorbed in 18~44 Years Old Population. The Phase 3 trial enrolled 1,260 healthy volunteers in China, was randomized, double-blind, and actively controlled, and is now completed.