Calendario›BNTX›BNT162b2
BNT162b2
Safety and Immunogenicity of RNA-based Vaccines Against SARS-CoV-2 Variants in Healthy Participants
Ensayo de BioNTech SE en SARS-CoV-2 Infection · COVID-19 · SARS-CoV-2 Acute Respiratory Disease · SARS (Disease) (del registro, en inglés).
Más ensayos de: COVID-19.
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 1.380
- Centros
- 35
- Fin del objetivo primario
- ago 2023
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en ago 2021.
Qué mide
All Parts - Percentage of Participants Reporting Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) (from Day 1 to Day 7 after each IMP dose) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis trial consisted of three parts, Part A, Part B, and Part C, and evaluated the safety and immunogenicity of a third (booster) injection of the multivalent vaccine BNT162b2 (B.1.1.7 + B.1.617.2), and the safety and immunogenicity of a third booster injection of the monovalent vaccine BNT162b2 (B.1.617.2) or BNT162b2 (B.1.1.7), in participants who had received two doses of the parent vaccine BNT162b2 at 30 µg, at least 6 months after the second dose of BNT162b2. It also evaluated the safety and immunogenicity of a three-dose regimen of BNT162b2 (B.1.1.7 + B.1.617.2) in participants who had not received prior Coronavirus Disease 2019 (COVID-19) vaccination. In addition, the safety and immunogenicity of BNT162b2 (B.1.1.529.1) or BNT162b2 given as a third or fourth vaccine dose to RNA COVID-19 vaccine-experienced participants with history of SARS-CoV-2 Omicron variant infection was evaluated and contrasted with the natural immune response reached after infection with the SARS-CoV-2 Omicron variant in RNA COVID-19 vaccine-experienced 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 (NCT05004181), actualizada en nov 2024.