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...
The investigational tetanus vaccine, adsorbed is used for the prevention of tetanus, a serious bacterial infection. It is being developed by Sinovac Biotech, Ltd (SVA) and is currently in Phase 3 clinical development. The vaccine is designed to be administered to adults aged 18 to 44 years.
The investigational tetanus vaccine, adsorbed is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company traded under the ticker SVA. The company is conducting clinical trials to evaluate the safety and immunogenicity of this vaccine in the target population.
The investigational tetanus vaccine, adsorbed is in Phase 3 clinical development. It is not yet approved and remains investigational. A Phase 3 clinical trial has been completed to assess its safety and immunogenicity in adults aged 18 to 44 years.
The investigational tetanus vaccine, adsorbed has one completed Phase 3 clinical trial, NCT06049940, titled 'Safety and Immunogenicity of Tetanus Vaccine, Adsorbed in 18~44 Years Old Population.' This randomized, double-blind, active-controlled trial enrolled 1,260 healthy volunteers in China.
The investigational tetanus vaccine, adsorbed is not FDA approved. It is still in clinical development, with a completed Phase 3 trial. The vaccine is being evaluated for safety and immunogenicity, but regulatory approval status has not been established.
The investigational tetanus vaccine, adsorbed is a vaccine designed to prevent tetanus, a disease caused by the bacterium Clostridium tetani. It works by stimulating the immune system to produce antibodies against the tetanus toxin, providing protection against infection.