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Also known as Td vaccine
Td · 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...
Td is a diphtheria and tetanus vaccine studied for use in pregnant women. A Phase 2 trial called the Pertussis Maternal Immunization Study evaluated it in this population in Canada. The study enrolled 320 female participants aged 18 years and older who were healthy volunteers.
Sanofi develops the Td vaccine, which is also known as the Diphtheria and Tetanus Combined Vaccine for Adults and Adolescents, Adsorbed. Sanofi trades under the ticker SNY. The company sponsored the maternal immunization research conducted for this vaccine candidate.
The Td vaccine is in Phase 2 development for pregnant women. One Phase 2 trial has been completed, and no trials are currently active. The vaccine is investigational in this setting and is not described as approved for this indication.
The Pertussis Maternal Immunization Study, registered as NCT00553228, was a Phase 2 trial of the Td vaccine in pregnant women. It was completed, enrolled 320 participants, and took place in Canada. The trial was randomized, double blind, and active controlled.
NCT00553228 was a randomized, double blind, active controlled Phase 2 study of the Td vaccine. It enrolled 320 healthy female volunteers aged 18 years and older in Canada. The trial focused on pregnant women and has been completed.