The 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.
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Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSA
Timeframe: Day 1 to Day 7 after vaccination
Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSA
Timeframe: Day 1 to Day 7 after vaccination
Percentage of Participants With Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination: SSA
Timeframe: From vaccination on Day 1 up to 1 month after vaccination
Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSA
Timeframe: From vaccination on Day 1 up to 6 months after vaccination
Geometric Mean Titers (GMT) of SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
Timeframe: At 1 month after vaccination
GMT of SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
Timeframe: At 1 month after vaccination
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers From Before Study Vaccination to 1 Month After Vaccination: SSA and Historical Control of Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
Timeframe: From before vaccination on Day 1 up to 1 month after vaccination
GMFR of SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
Timeframe: From before vaccination on Day 1 up to 1 month after vaccination
Percentage of Participants With Seroresponse to SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
Timeframe: At 1 month after vaccination
Percentage of Participants With Seroresponse to SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
Timeframe: At 1 month after vaccination
Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSB
Timeframe: Day 1 to Day 7 after vaccination
Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSB
Timeframe: Day 1 to Day 7 after vaccination
Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSB
Timeframe: From vaccination on Day 1 up to 1 month after vaccination
Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSB
Timeframe: From vaccination on Day 1 up to 6 months after vaccination
Geometric Mean Ratio (GMR) of the SARS-CoV-2 XBB.1.5-Neutralizing Titers 1 Month After BNT162b2 (Omi XBB.1.5) COVID-19 Vaccine-Naive Participants in SSB Versus Vaccine-Experienced Participants in SSA
Timeframe: At 1 month after vaccination
Percentage of Participants and Difference in Percentage of Participants With Seroresponse to the XBB.1.5 Strain 1 Month After BNT162b2 (Omi XBB.1.5) COVID-19 Vaccine Naive Participants in SSB Versus Vaccine-Experienced Participants in SSA
Timeframe: At 1 month after vaccination
Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined
Timeframe: Day 1 to Day 7 after vaccination
Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined
Timeframe: Day 1 to Day 7 after vaccination
Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined
Timeframe: From vaccination on Day 1 up to 1 month after vaccination
Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined
Timeframe: From vaccination on Day 1 up to 6 months after vaccination
Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSC Cohort 3
Timeframe: Day 1 to Day 7 after vaccination
Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSC Cohort 3
Timeframe: Day 1 to Day 7 after vaccination
Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSC Cohort 3
Timeframe: From vaccination on Day 1 up to 1 month after vaccination
Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSC Cohort 3
Timeframe: From vaccination on Day 1 up to 6 months after vaccination
GMTs of SARS-CoV-2 Omi JN.1 and XBB.1.5 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA
Timeframe: At 1 month after vaccination
GMFR of SARS-CoV-2 Omi JN.1 and XBB.1.5 Variant-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA
Timeframe: From before Vaccination to 1 month after Vaccination
Percentage of Participants With Seroresponse to SARS-CoV-2 OMI JN.1 and XBB.1.5 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA
Timeframe: At 1 month after vaccination
GMTs of SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohort 3 and SSC Cohorts 1 + 2 Combined as Control
Timeframe: At 1 month after vaccination
GMFR of SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination in SSC Cohort 3 and Cohorts 1 + 2 Combined as Control
Timeframe: From before vaccination on Day 1 up to 1 month after vaccination
Percentage of Participants With Seroresponse to SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohort 3 and Cohorts 1 + 2 Combined as Control
Timeframe: At 1 month after vaccination