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BNT162b2

A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals

Ensayo de BioNTech SE en Infeccion por SARS-CoV-2 · COVID-19.

Más ensayos de: COVID-19.

Fase

Fase 2/3

Estado

Completado

Participantes

1.051

previstos

Centros

37

Fin del objetivo primario

mar 2025

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en ago 2023.

Qué mide

Porcentaje de participantes con reacciones locales dentro de los 7 dias posteriores a la vacunacion: SSA (Day 1 to Day 7 after vaccination) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of this clinical protocol is to learn about the safety, tolerability, and immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of SARS-CoV-2 in healthy people. Substudy A: * This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose, * in people who are 12 years of age and older, * who previously received at least 3 doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being an Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before the study vaccination (Visit 1). * The study is about 6 months long for each participant. * Participants will have at least 5 visits to the clinic. * At each clinic visit a blood sample will be taken. * At least 1 nasal swab will taken. Substudy B: * This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose, * in people who are 12 years of age and older, * who are COVID-19 vaccine-naïve * who have had any positive SARS-CoV-2 test result \>28 days before study vaccine administration. * The study is about 6 months long for each participant. * Participants will have at least 5 visits to the clinic. * At each clinic visit a blood sample will be taken. * At least 1 nasal swab will taken. Substudy C: * This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi JN.1) and BNT162b2 (Omi KP.2) given as a single 30 µg dose to: * Cohort 1: people who are 18 years of age and older, who will receive BNT162b2 (Omi JN.1), and, * Cohort 2: people who are 12 years of age and older, who will receive BNT162b2 (Omi JN.1), and, * Cohort 3: people who are 18 years of age and older who will receive BNT162b2 (Omi KP.2). * Participants may have never received a COVID-19 vaccine or, may have previously received COVID-19 vaccine(s), with the most recent dose received at least 150 days before the study vaccination (Visit 1). * The study is about 6 months long for each participant. * Participants will have at least 6 visits (Cohorts 1 and 3) or at least 5 visits (Cohort 2) to the clinic. * At each clinic visit a blood sample will be taken. * At least 1 nasal swab will taken.

Más ensayos de BNTX

Todos los de BNTX, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05997290), actualizada en abr 2026.