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BNT162b2s01

A Trial Investigating the Safety and Effects of One or Two Additional Doses of Comirnaty or One Dose of BNT162b2s01 in BNT162-01 or BNT162-04 Trial Subjects

Ensayo de BioNTech SE en COVID-19.

Más ensayos de: COVID-19.

Fase

Fase 2

Estado

Completado

Participantes

137

previstos

Centros

4

Fin del objetivo primario

abr 2022

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jul 2021.

Qué mide

The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs) (Up to 26 weeks after the first IMP injection) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroTrial to evaluate the safety and immunogenicity of one or two boosting doses of Comirnaty or one dose of BNT162b2s01 (Variant of concern \[VOC\] strain B.1.351) in BNT162-01 trial participants, or two boosting doses of Comirnaty in BNT162-04 trial participants. Trial participants from BNT162-01 who received two injections of 30 μg Comirnaty were randomized 2:1 to one booster injection (BNT162b2s01: Comirnaty). Trial participants in either the trial BNT162-01 or BNT162-04 who did not receive the full two vaccinations of 30 μg Comirnaty were offered two injections of 30 μg Comirnaty as per the conditional marketing authorization. All potential rollover volunteers must enroll in this trial within less than 18 months of their last injection of a BNT162 candidate vaccine in the parent BNT162-01 or BNT162-04 trials.

Más ensayos de BNTX

Todos los de BNTX, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04949490), actualizada en may 2024.