Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tdap · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| group I | EXPERIMENTAL | Tdap |
| group 2 | ACTIVE_COMPARATOR | Td |
| Name | Type | Description |
|---|---|---|
| Tdap | BIOLOGICAL | 0.5 mL IM once at visit #2 |
| Td | BIOLOGICAL | 0.5 mL IM once at visit #2 |
Inclusion Criteria: * Pregnant women 18 years of age and over. * Women who, at ≥30-\<32 weeks gestation, are at low risk for complications as determined by the obstetrical algorithm for identification of eligible subjects and the obstetrical risk assessment form. * Signed, informed consent. Exclus...
Tdap is an investigational vaccine being studied for use in pregnant women to prevent pertussis, also known as whooping cough. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The vaccine is being evaluated for its safety and effectiveness in this population.
Tdap is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the vaccine's use in pregnant women for the prevention of pertussis.
Tdap is currently in Phase 2 clinical development. It is an investigational vaccine and has not yet received regulatory approval. The Phase 2 trial, which has been completed, was designed to assess the vaccine's safety and immunogenicity in pregnant women.
Tdap has been studied in one clinical trial with the identifier NCT00553228, titled 'Pertussis Maternal Immunization Study.' This Phase 2 trial was completed and enrolled 320 healthy female participants aged 18 years and older in Canada. The study was randomized, double-blind, and active-controlled.
Tdap is a vaccine being studied for the prevention of pertussis, commonly known as whooping cough. It is specifically being evaluated for maternal immunization, meaning it is given to pregnant women to potentially protect their infants from the disease. The vaccine is still investigational and not yet approved.