Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tetanus and Diphtheria Vaccine · 1 trial · 1 indication
A "positive response" is defined as a 4-fold increase if the pre-vaccination titer was less than or equal to 2.7IU/mL or a 2-fold increase if the pre-vaccination titer was greater than 2.7IU/mL
| Arm | Type | Description |
|---|---|---|
| Sanofi Pasteur (Tenivac) | EXPERIMENTAL | Tetanus and Diphtheria (Td) Vaccine, Manufacturer: Sanofi Pasteur (Tenivac), Dose: 0.5 mL, Route: Intramuscular (IM) in the deltoid muscle, Frequency: Every 90 days, Duration: 5 doses, 1 year. |
| MassBiologics | EXPERIMENTAL | Tetanus and Diphtheria (Td) Vaccine, Manufacturer: MassBiologics, Dose: 0.5 mL, Route: Intramuscular (IM) in the deltoid muscle, Frequency: Every 90 days, Duration: 5 doses, 1 year. |
| Name | Type | Description |
|---|---|---|
| Tetanus and Diphtheria (Td) Vaccine | BIOLOGICAL | - |
Inclusion Criteria: 1. Male or female ≥18\* years of age at Visit 1. 2. Subject has met all suitability criteria that would allow donation as a Normal Source Plasma donor 3. Subject has not been immunized for tetanus within the prior three (3) months 4. Subject is not participating in any other imm...
Tetanus and Diphtheria Vaccine is used to immunize healthy adults against tetanus and diphtheria. It is being studied in a Phase 1 clinical trial for donor hyperimmunization, a process where vaccinated individuals donate plasma containing high levels of antibodies for use in producing immune globulin therapies.
Tetanus and Diphtheria Vaccine is being developed by Grifols, S.A., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GRFS. The company is conducting clinical research on this vaccine to support its donor hyperimmunization program.
Tetanus and Diphtheria Vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 1 trial has been completed, with results expected to inform further development of the vaccine for donor immunization purposes.
Tetanus and Diphtheria Vaccine has one completed clinical trial, identified as NCT02673255. This Phase 1 study, titled 'Safety and Efficacy of Two Tetanus-Diphtheria Vaccines for a Donor Hyper Immunization Program,' enrolled 300 healthy adults in the United States and was a randomized, controlled trial.
Tetanus and Diphtheria Vaccine works by stimulating the immune system to produce antibodies against tetanus and diphtheria toxins. This immune response is intended to protect vaccinated individuals from these diseases and, in the context of the clinical trial, to generate high-titer plasma for donor hyperimmunization programs.
Tetanus and Diphtheria Vaccine is being evaluated in a clinical trial comparing two tetanus-diphtheria vaccines for use in a donor hyperimmunization program. The trial is designed to assess the safety and efficacy of these vaccines in healthy adult donors, but specific alternative names for this vaccine are not disclosed in the available information.