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BNT162b3
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
Ensayo de BioNTech SE en Covid-19 · Protection Against COVID-19 (del registro, en inglés).
Más ensayos de: COVID-19.
- Fase
- Fase 1/2
- Estado
- Completado
- Participantes
- 96
- Centros
- 2
- Fin del objetivo primario
- mar 2021
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en sep 2020.
Qué mide
Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose (From Day 1 to Day 8 for Prime Immunization and from Day 22 to Day 29 for Boost Immunization) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroOriginally, the study was planned to include two parts, i.e., Part A and Part B, however Part B was skipped due to changes in the overall clinical development plan. The conducted Part A was a dose-finding part to investigate the optimal dose, allowing dose adjustments upwards and downwards in younger participants. Doses tested in older participants were chosen based on acceptability of dosing in younger participants.
Más ensayos de BNTX
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| BNT164a1 | Fase 1/2 | En marcha, sin reclutar | mar 2026 (real) |
| BNT162b2 Vaccine | Fase 3 | En marcha, sin reclutar | jul 2026 (prevista, ya pasada: sin actualizar en el registro) |
| BNT314 | Fase 1 | En marcha, sin reclutar | ago 2026 (real) |
| BNT163 | Fase 1 | En marcha, sin reclutar | oct 2026 (prevista) |
| RO7198457 intravenous | Fase 2 | En marcha, sin reclutar | nov 2026 (prevista) |
| BNT351 | Fase 1 | Reclutando pacientes | nov 2026 (prevista) |
Todos los de BNTX, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04537949), actualizada en mar 2023.