Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06049940 | Safety and Immunogenicity of Tetanus Vaccine, Adsorbed in 18~44 Years Old Population | PHASE3 | COMPLETED | 1,260 | — | — | Sep 1, 2023 | Mar 22, 2024 | Jul 12, 2024 | 1 | China |
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...