SARS-CoV-2 InfectionPhase 2/3NCT05997290

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

A Phase 2/3 study testing BNT162b2 (Omi XBB.1.5), BNT162b2 (Omi JN.1) and BNT162b2 (Omi KP.2) in people with SARS-CoV-2 Infection and COVID-19, run by BioNTech SE at 37 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for: SARS-CoV-2 Infection, COVID-19
What is being tested?: BNT162b2 (Omi XBB.1.5), BNT162b2 (Omi JN.1) and BNT162b2 (Omi KP.2)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,051 participants
Where: 37 sitesUnited States
Study dates: 10 Aug 2023to 13 Mar 2025
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Received at least 3 prior doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being a US-authorized Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before Visit 1 (Day 1).
12 years of age and older
Healthy participants (stable pre-existing disease permitted).
Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations.
Capable of giving, or parent(s)/legal guardian capable of giving, signed informed consent.
COVID-19 vaccine-naïve.

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Any positive SARS-CoV-2 test result >28 days before study intervention administration.
12 years of age and older.
Healthy participants (stable pre-existing disease permitted).
Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations.
Capable of giving or parent(s)/legal guardian capable of giving, signed informed consent.
Cohort 1: 18 years of age and older
Cohort 2: 12 years of age and older
Cohort 3: 18 years of age and older
Healthy participants (stable pre-existing disease permitted).
Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations.
Capable of giving, or parent(s)/legal guardian capable of giving, signed informed consent.

Who cannot join

History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines.
Immunocompromised with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
Women who are pregnant or breastfeeding.
Any medical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
History of myocarditis or pericarditis.

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Receipt of systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study.
Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, used for the treatment or prevention of COVID-19 or those that are considered immunosuppressive, from 60 days before study vaccination or planned receipt throughout the study.
Participation in other studies involving receipt of other study intervention within 28 days before enrollment. Anticipated participation in other studies involving other study intervention from enrollment through the end of this study.
Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
SSB
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines.
Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
Women who are pregnant or breastfeeding.
Any medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
History of myocarditis or pericarditis.
Receipt of systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids*, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study.
Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies used for the treatment or prevention of COVID-19 or those that are considered immunosuppressive, from 60 days before study intervention administration or planned receipt throughout the study.
Participation in other studies involving receipt of other study intervention within 28 days before enrollment. Anticipated participation in other studies involving other study intervention from enrollment through the end of this study.
Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
SSC
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines.
Immunocompromised with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
Women who are pregnant or breastfeeding.
Any medical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
History of myocarditis or pericarditis.
Receipt of systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study.
Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, used for the treatment or prevention of COVID-19 or those that are considered immunosuppressive, from 60 days before study vaccination or planned receipt throughout the study.
Receipt of a COVID-19 vaccine less than 150 days before study intervention administration Visit 1 (Day 1).
Participation in other studies involving receipt of other study intervention within 28 days before enrollment. Anticipated participation in other studies involving other study intervention from enrollment through the end of this study.
Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Trial locations and contacts

37 sites in 1 country.

City, postcode or hospital

37 sites in 1 country

United States37 sites

North Alabama Research Center
Athens, Alabama, 35611
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, 40004
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, 43213
Zenos Clinical Research
Dallas, Texas, 75230
Dayton Clinical Research
Dayton, Ohio, 45409
Epic Medical Research - DeSoto
DeSoto, Texas, 75115
West Coast Research
Dublin, California, 94568
Indago Research & Health Center, Inc
Hialeah, Florida, 33012
East-West Medical Research Institute
Honolulu, Hawaii, 96814
DM Clinical Research - Bellaire
Houston, Texas, 77081
Medical Affiliated Research Center
Huntsville, Alabama, 35801
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, 32256
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37909
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37920
Alliance for Multispecialty Research, LLC
Layton, Utah, 84041
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, 38119
SMS Clinical Research
Mesquite, Texas, 75149
Care Research - West Flagler Street
Miami, Florida, 33130
Acevedo Clinical Research Associates
Miami, Florida, 33142
Clinical Research Consulting
Milford, Connecticut, 06460
Alliance for Multispecialty Research, LLC
Mobile, Alabama, 36608
Alliance for Multispecialty Research, LLC
Norfolk, Virginia, 23502
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121
IMA Clinical Research San Antonio
San Antonio, Texas, 78229
California Research Foundation
San Diego, California, 92123
Senders Pediatrics
South Euclid, Ohio, 44121
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield, Missouri, 65802
Bio-Kinetic Clinical Applications LLC DBA QPS_MO (Patient Screening Only)
Springfield, Missouri, 65807
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Epic Medical Research - Surprise
Surprise, Arizona, 85378
Alliance for Multispecialty Research, LLC
Tempe, Arizona, 85281
DM Clinical Research
Tomball, Texas, 77375
Bayview Research Group, LLC
Valley Village, California, 91607
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: A PHASE 2/3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b2 RNA-BASED VACCINE CANDIDATES FOR SARS-CoV-2 NEW VARIANTS IN HEALTHY INDIVIDUALS

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.

Conditions: SARS-CoV-2 Infection, COVID-19
Being tested: BNT162b2 (Omi XBB.1.5), BNT162b2 (Omi JN.1), BNT162b2 (Omi KP.2)
Keywords: COVID-19, Coronavirus, Vaccine, SARS-CoV-2, RNA Vaccine, Vaccine-naïve
Medical subject headings: COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BNT162b2 (Omi XBB.1.5)Biological
BNT162b2 monovalent (Omicron XBB.1.5)
BNT162b2 (Omi JN.1)Biological
BNT162b2 monovalent (Omicron JN.1)
BNT162b2 (Omi KP.2)Biological
BNT162b2 monovalent (Omicron KP.2)

Study groups in NCT05997290
Study group	Role	What they receive
SSA: Group 1	Experimental	Participants 12 years of age and older, COVID-19 vaccine-experienced will receive 30 µg of BNT162b2 (Omi XBB.1.5) at Visit 1. Receives: Biological: BNT162b2 (Omi XBB.1.5)
SSB: Group 2	Experimental	Participants 12 years of age and older who were previously exposed to SARS-CoV-2 and are COVID-19 vaccine-naïve will receive 30 μg of BNT162b2 (Omi XBB.1.5) at Visit 1 Receives: Biological: BNT162b2 (Omi XBB.1.5)
SSC: Group 3	Experimental	Cohort 1 - Participants 18 years of age and older will receive 30 µg of BNT162b2 (Omi JN.1) at Visit 1. Receives: Biological: BNT162b2 (Omi JN.1)
SSC: Group 4	Experimental	Cohort 2 - Participants 12 years of age and older will receive 30 µg of BNT162b2 (Omi JN.1) at Visit 1. Receives: Biological: BNT162b2 (Omi JN.1)
SSC - Group 5	Experimental	Cohort 3 - Participants 18 years of age and older who will receive 30 µg of BNT162b2 (Omi KP.2) at Visit 1. Receives: Biological: BNT162b2 (Omi KP.2)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSA
Local reactions: pain at injection site, redness and swelling were recorded by participants in an electronic diary (e-diary) or as adverse events (AEs) in the case report form (CRF). Redness and swelling were recorded in measuring device units (mdu) (range: 1 to 21), 1 mdu =0.5 centimeter (cm) and were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] and necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalization for severe pain at injection site). Grade 4 local reactions were classified by investigator or medically qualified person.
Measured: Day 1 to Day 7 after vaccination
Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSA
Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature more than or equal to (>=38) degree Celsius (C) and categorized as >= 38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, chills, new or worsened muscle pain and joint pain were graded as: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24 hours (h), moderate: >2 times in 24h, severe: required intravenous (IV) hydration. Diarrhea was graded as: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 systemic events were classified by investigator or medically qualified person.
Measured: Day 1 to Day 7 after vaccination
Percentage of Participants With Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination: SSA
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. A serious AE (SAE) was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event. AEs included both SAEs and all non-SAEs. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Measured: 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
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event.
Measured: 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
GMTs and 2-sided 95 percentage (%) confidence interval (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ.
Measured: 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
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Measured: 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
GMFRs were defined as geometric mean ratios of the results after vaccination to the results before vaccination. GMFR and 2-sided 95% CI were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Measured: 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
GMFRs were defined as geometric mean ratios of the results after vaccination to the results before vaccination. GMFR and 2-sided 95% CI were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Measured: 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
Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4* LLOQ was considered a seroresponse.
Measured: 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
Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4* LLOQ was considered a seroresponse.
Measured: At 1 month after vaccination
Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSB
Local reactions: pain at injection site, redness and swelling were recorded by participants in an e-diary or as AEs in the CRF. Redness and swelling were recorded in mdu (range:1 to 21), 1 mdu= 0.5 cm and were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] and necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 local reactions were classified by investigator or medically qualified person.
Measured: Day 1 to Day 7 after vaccination
Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSB
Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature >=38 degree C and categorized as >= 38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, chills, new or worsened muscle pain and joint pain were graded as: mild (didn't interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24h, moderate: >2 times in 24h, severe: required IV hydration. Diarrhea were graded as: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 systemic events were classified by investigator or medically qualified person.
Measured: Day 1 to Day 7 after vaccination
Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSB
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event. AEs included both SAEs and all non-SAEs. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Measured: 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
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event.
Measured: 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
GMTs / GMRs and 2-sided 95% CIs were calculated by exponentiating the least square (LS) means / difference of LS means and the corresponding CIs based on analysis of log-transformed assay results using a linear regression model with baseline assay results (log scale), age and vaccine group as covariates. Assay results below the LLOQ were set to 0.5*LLOQ. GMT was reported in descriptive section and GMR was reported in statistical analysis section
Measured: 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
Seroresponse was defined as achieving >=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4* LLOQ was considered a seroresponse. Percentage of participants with seroresponse were reported in descriptive section and difference in percentage of participants with seroresponse in SSB: All Age Groups (Vaccine Naive)- SSA: All Age Groups (Vaccine Experienced Control) were reported in statistical analysis section.
Measured: 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
Local reactions: pain at injection site, redness and swelling were recorded by participants in an e-diary or as AEs in the CRF. Redness and swelling were recorded in mdu (range:1 to 21), 1 mdu= 0.5 cm and were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] and necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 local reactions were classified by investigator or medically qualified person.
Measured: 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
Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature >=38 degree C and categorized as >= 38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, chills, new or worsened muscle pain and joint pain were graded as: mild (didn't interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24h, moderate: >2 times in 24h, severe: required IV hydration. Diarrhea were graded as: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 systemic events were classified by investigator or medically qualified person.
Measured: 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
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event. AEs included both SAEs and all non-SAEs. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Measured: 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
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event.
Measured: 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
Local reactions: pain at injection site, redness and swelling were recorded by participants in an e-diary or as AEs in the CRF. Redness and swelling were recorded in mdu (range:1 to 21), 1 mdu= 0.5 cm and were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] and necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 local reactions were classified by investigator or medically qualified person.
Measured: Day 1 to Day 7 after vaccination
Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSC Cohort 3
Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature >=38 deg C and categorized as >= 38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and joint pain: mild (didn't interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24h, moderate: >2 times in 24h, severe: required IV hydration. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 events were classified by investigator or medically qualified person.
Measured: Day 1 to Day 7 after vaccination
Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSC Cohort 3
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event. AEs included both SAEs and all non-SAEs. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Measured: 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
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event.
Measured: 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
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Measured: 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
GMFRs were defined as geometric mean ratios of the results after vaccination to the results before vaccination. GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.
Measured: 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
Seroresponse was defined as achieving a >=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, a postvaccination assay result >=4 *LLOQ is considered a seroresponse.
Measured: 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
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
Measured: 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
GMFRs were defined as geometric mean ratios of the results after vaccination to the results before vaccination. GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.
Measured: 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
Seroresponse was defined as achieving a >=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, a postvaccination assay result >=4 *LLOQ is considered a seroresponse.
Measured: At 1 month after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Aug 202313 Mar 2025

First posted18 Aug 2023
Study start10 Aug 2023
Primary completion13 Mar 2025
Study completion13 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
More trials run by BioNTech SEThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Model description: Phase 2/3, controlled study
Masking: None (open label)
Enrolment: 1,051 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05997290
Sponsor's protocol ID: C4591054
Other IDs: 2024-000361-24, NCT05997290
Status last verified: Apr 2026
First submitted: 10 Aug 2023
Last updated: 28 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Diya O, Gayed J, Lowry FS, Ma H, Bangad V, Mensa F, Zou J, Xie X, Hu Y, Cutler M, Belanger T, Cooper D, Xu X, Mogg R, Tureci O, Sahin U, Swanson KA, Modjarrad K, Anderson AS, Gurtman A, Kitchin N. Safety and Immunogenicity of Monovalent Omicron KP.2-Adapted BNT162b2 COVID-19 Vaccine in Adults: Single-Arm Substudy from a Phase 2/3 Trial. Infect Dis Ther. 2025 Aug;14(8):1973-1987. doi: 10.1007/s40121-025-01185-4. Epub 2025 Jul 1.
PubMed 40591130
Diya O, Gayed J, Lowry FS, Ma H, Bangad V, Mensa F, Zou J, Xie X, Hu Y, Cutler M, Belanger T, Cooper D, Xu X, Koury K, Tureci O, Sahin U, Swanson KA, Modjarrad K, Anderson AS, Gurtman A, Kitchin N. A phase 2/3 trial to investigate the safety and immunogenicity of monovalent Omicron JN.1-adapted BNT162b2 COVID-19 vaccine in adults >/=18 years old. Vaccine. 2025 Apr 11;52:126869. doi: 10.1016/j.vaccine.2025.126869. Epub 2025 Feb 24.
PubMed 39999538
Gayed J, Bangad V, Xu X, Mensa F, Cutler M, Tureci O, Sahin U, Modjarrad K, Swanson KA, Anderson AS, Gurtman A, Kitchin N; C4591054 Study Group. Immunogenicity of the Monovalent Omicron XBB.1.5-Adapted BNT162b2 COVID-19 Vaccine against XBB.1.5, BA.2.86, and JN.1 Sublineages: A Phase 2/3 Trial. Vaccines (Basel). 2024 Jul 2;12(7):734. doi: 10.3390/vaccines12070734.
PubMed 39066372
Gayed J, Diya O, Lowry FS, Xu X, Bangad V, Mensa F, Zou J, Xie X, Hu Y, Lu C, Cutler M, Belanger T, Cooper D, Koury K, Anderson AS, Tureci O, Sahin U, Swanson KA, Modjarrad K, Gurtman A, Kitchin N; C4591054 Study Group. Safety and Immunogenicity of the Monovalent Omicron XBB.1.5-Adapted BNT162b2 COVID-19 Vaccine in Individuals >/=12 Years Old: A Phase 2/3 Trial. Vaccines (Basel). 2024 Jan 24;12(2):118. doi: 10.3390/vaccines12020118.
PubMed 38400102

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Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 2/3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b2 RNA-BASED VACCINE CANDIDATES FOR SARS-CoV-2 NEW VARIANTS IN HEALTHY INDIVIDUALS
ClinicalTrials.gov ID: NCT05997290
Acronym / sponsor ID: C4591054
Conditions: SARS-CoV-2 Infection, COVID-19
Keywords: COVID-19, Coronavirus, Vaccine, SARS-CoV-2, RNA Vaccine, Vaccine-naïve
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,051 participants (actual)
Lead sponsor: BioNTech SEIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: 10 Aug 2023 (actual)
Primary completion: 13 Mar 2025 (actual)
Study completion: 13 Mar 2025 (actual)
First posted: 18 Aug 2023 (actual)
Results: Posted 28 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 5
Model description: Phase 2/3, controlled study

Arm	Type	Receives
SSA: Group 1	Experimental	Biological: BNT162b2 (Omi XBB.1.5)Participants 12 years of age and older, COVID-19 vaccine-experienced will receive 30 µg of BNT162b2 (Omi XBB.1.5) at Visit 1.
SSB: Group 2	Experimental	Biological: BNT162b2 (Omi XBB.1.5)Participants 12 years of age and older who were previously exposed to SARS-CoV-2 and are COVID-19 vaccine-naïve will receive 30 μg of BNT162b2 (Omi XBB.1.5) at Visit 1
SSC: Group 3	Experimental	Biological: BNT162b2 (Omi JN.1)Cohort 1 - Participants 18 years of age and older will receive 30 µg of BNT162b2 (Omi JN.1) at Visit 1.
SSC: Group 4	Experimental	Biological: BNT162b2 (Omi JN.1)Cohort 2 - Participants 12 years of age and older will receive 30 µg of BNT162b2 (Omi JN.1) at Visit 1.
SSC - Group 5	Experimental	Biological: BNT162b2 (Omi KP.2)Cohort 3 - Participants 18 years of age and older who will receive 30 µg of BNT162b2 (Omi KP.2) at Visit 1.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (17 listed)

Received at least 3 prior doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being a US-authorized Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before Visit 1 (Day 1).
12 years of age and older
Healthy participants (stable pre-existing disease permitted).
Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations.
Capable of giving, or parent(s)/legal guardian capable of giving, signed informed consent.

Key exclusion criteria (33 listed)

History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines.
Immunocompromised with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
Women who are pregnant or breastfeeding.
Any medical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BNT162b2 (Omi XBB.1.5)BNT162b2 monovalent (Omicron XBB.1.5)	Biological	SSA: Group 1, SSB: Group 2
BNT162b2 (Omi JN.1)BNT162b2 monovalent (Omicron JN.1)	Biological	SSC: Group 3, SSC: Group 4
BNT162b2 (Omi KP.2)BNT162b2 monovalent (Omicron KP.2)	Biological	SSC - Group 5

Primary outcome

Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSA
Time frame: Day 1 to Day 7 after vaccination
Local reactions: pain at injection site, redness and swelling were recorded by participants in an electronic diary (e-diary) or as adverse events (AEs) in the case report form (CRF). Redness and swelling were recorded in measuring device units (mdu) (range: 1 to 21), 1 mdu =0.5 centimeter (cm) and were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] and necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalization for severe pain at injection site). Grade 4 local reactions were classified by investigator or medically qualified person.
Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSA
Time frame: Day 1 to Day 7 after vaccination
Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature more than or equal to (>=38) degree Celsius (C) and categorized as >= 38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, chills, new or worsened muscle pain and joint pain were graded as: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24 hours (h), moderate: >2 times in 24h, severe: required intravenous (IV) hydration. Diarrhea was graded as: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 systemic events were classified by investigator or medically qualified person.
Percentage of Participants With Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination: SSA
Time frame: From vaccination on Day 1 up to 1 month after vaccination
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. A serious AE (SAE) was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event. AEs included both SAEs and all non-SAEs. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSA
Time frame: From vaccination on Day 1 up to 6 months after vaccination
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event.
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
Time frame: At 1 month after vaccination
GMTs and 2-sided 95 percentage (%) confidence interval (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ.
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
Time frame: At 1 month after vaccination
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
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
Time frame: From before vaccination on Day 1 up to 1 month after vaccination
GMFRs were defined as geometric mean ratios of the results after vaccination to the results before vaccination. GMFR and 2-sided 95% CI were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
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
Time frame: From before vaccination on Day 1 up to 1 month after vaccination
GMFRs were defined as geometric mean ratios of the results after vaccination to the results before vaccination. GMFR and 2-sided 95% CI were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
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
Time frame: At 1 month after vaccination
Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4* LLOQ was considered a seroresponse.
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
Time frame: At 1 month after vaccination
Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4* LLOQ was considered a seroresponse.
Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSB
Time frame: Day 1 to Day 7 after vaccination
Local reactions: pain at injection site, redness and swelling were recorded by participants in an e-diary or as AEs in the CRF. Redness and swelling were recorded in mdu (range:1 to 21), 1 mdu= 0.5 cm and were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] and necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 local reactions were classified by investigator or medically qualified person.
Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSB
Time frame: Day 1 to Day 7 after vaccination
Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature >=38 degree C and categorized as >= 38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, chills, new or worsened muscle pain and joint pain were graded as: mild (didn't interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24h, moderate: >2 times in 24h, severe: required IV hydration. Diarrhea were graded as: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 systemic events were classified by investigator or medically qualified person.
Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSB
Time frame: From vaccination on Day 1 up to 1 month after vaccination
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event. AEs included both SAEs and all non-SAEs. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSB
Time frame: From vaccination on Day 1 up to 6 months after vaccination
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event.
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
Time frame: At 1 month after vaccination
GMTs / GMRs and 2-sided 95% CIs were calculated by exponentiating the least square (LS) means / difference of LS means and the corresponding CIs based on analysis of log-transformed assay results using a linear regression model with baseline assay results (log scale), age and vaccine group as covariates. Assay results below the LLOQ were set to 0.5*LLOQ. GMT was reported in descriptive section and GMR was reported in statistical analysis section
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
Time frame: At 1 month after vaccination
Seroresponse was defined as achieving >=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4* LLOQ was considered a seroresponse. Percentage of participants with seroresponse were reported in descriptive section and difference in percentage of participants with seroresponse in SSB: All Age Groups (Vaccine Naive)- SSA: All Age Groups (Vaccine Experienced Control) were reported in statistical analysis section.
Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined
Time frame: Day 1 to Day 7 after vaccination
Local reactions: pain at injection site, redness and swelling were recorded by participants in an e-diary or as AEs in the CRF. Redness and swelling were recorded in mdu (range:1 to 21), 1 mdu= 0.5 cm and were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] and necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 local reactions were classified by investigator or medically qualified person.
Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined
Time frame: Day 1 to Day 7 after vaccination
Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature >=38 degree C and categorized as >= 38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, chills, new or worsened muscle pain and joint pain were graded as: mild (didn't interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24h, moderate: >2 times in 24h, severe: required IV hydration. Diarrhea were graded as: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 systemic events were classified by investigator or medically qualified person.
Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined
Time frame: From vaccination on Day 1 up to 1 month after vaccination
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event. AEs included both SAEs and all non-SAEs. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined
Time frame: From vaccination on Day 1 up to 6 months after vaccination
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event.
Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSC Cohort 3
Time frame: Day 1 to Day 7 after vaccination
Local reactions: pain at injection site, redness and swelling were recorded by participants in an e-diary or as AEs in the CRF. Redness and swelling were recorded in mdu (range:1 to 21), 1 mdu= 0.5 cm and were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] and necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 local reactions were classified by investigator or medically qualified person.
Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSC Cohort 3
Time frame: Day 1 to Day 7 after vaccination
Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature >=38 deg C and categorized as >= 38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and joint pain: mild (didn't interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24h, moderate: >2 times in 24h, severe: required IV hydration. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 events were classified by investigator or medically qualified person.
Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSC Cohort 3
Time frame: From vaccination on Day 1 up to 1 month after vaccination
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event. AEs included both SAEs and all non-SAEs. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSC Cohort 3
Time frame: From vaccination on Day 1 up to 6 months after vaccination
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event.
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
Time frame: At 1 month after vaccination
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
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
Time frame: From before Vaccination to 1 month after Vaccination
GMFRs were defined as geometric mean ratios of the results after vaccination to the results before vaccination. GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.
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
Time frame: At 1 month after vaccination
Seroresponse was defined as achieving a >=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, a postvaccination assay result >=4 *LLOQ is considered a seroresponse.
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
Time frame: At 1 month after vaccination
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
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
Time frame: From before vaccination on Day 1 up to 1 month after vaccination
GMFRs were defined as geometric mean ratios of the results after vaccination to the results before vaccination. GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.
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
Time frame: At 1 month after vaccination
Seroresponse was defined as achieving a >=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, a postvaccination assay result >=4 *LLOQ is considered a seroresponse.

Results and safety

Results posted to the registry on 28 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SSA - Group 1: 12-17 Years	30	29
SSA - Group 2: 18-55 Years	177	172
SSA - Group 3: >55 Years	210	203
SSB - Group 1: 12-17 Years	9	9
SSB - Group 2: 18-55 Years	253	225
SSB - Group 3: >55 Years	49	44
SSC - Cohort 2: 12-17 Years	18	18
SSC - Cohort 1 and Cohort 2 Combined: 18-55 Years	95	87
SSC - Cohort 1 and Cohort 2 Combined: >55 Years	106	100
SSC - Cohort 3: 18-55 Years	51	48
SSC - Cohort 3: >55 Years	51	49

Primary outcome: Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSA

Time frame: Day 1 to Day 7 after vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	SSA - Group 1: 12-17 Years n = 30	SSA - Group 2: 18-55 Years n = 174	SSA - Group 3: >55 Years n = 206	SSA - All Age Groups n = 410
Redness: Any	10.0 (2.1 to 26.5)	4.0 (1.6 to 8.1)	5.8 (3.0 to 10.0)	5.4 (3.4 to 8.0)
Redness: Mild	6.7 (0.8 to 22.1)	3.4 (1.3 to 7.4)	3.9 (1.7 to 7.5)	3.9 (2.2 to 6.3)
Redness: Moderate	3.3 (0.1 to 17.2)	0.6 (0.0 to 3.2)	1.9 (0.5 to 4.9)	1.5 (0.5 to 3.2)
Redness: Severe	0 (0.0 to 11.6)	0 (0.0 to 2.1)	0 (0.0 to 1.8)	0 (0.0 to 0.9)
Redness: Grade 4	0 (0.0 to 11.6)	0 (0.0 to 2.1)	0 (0.0 to 1.8)	0 (0.0 to 0.9)
Swelling: Any	16.7 (5.6 to 34.7)	7.5 (4.0 to 12.4)	5.8 (3.0 to 10.0)	7.3 (5.0 to 10.3)
Swelling: Mild	13.3 (3.8 to 30.7)	5.7 (2.8 to 10.3)	3.9 (1.7 to 7.5)	5.4 (3.4 to 8.0)
Swelling: Moderate	3.3 (0.1 to 17.2)	1.7 (0.4 to 5.0)	1.9 (0.5 to 4.9)	2.0 (0.8 to 3.8)

Population analysed: Safety population included all participants who received the study intervention. Here, "Overall Number of Participants Analyzed" signifies number of participants reporting at least 1 response in the e-diary.

Primary outcome: Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSA

Time frame: Day 1 to Day 7 after vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	SSA - Group 1: 12-17 Years n = 30	SSA - Group 2: 18-55 Years n = 174	SSA - Group 3: >55 Years n = 206	SSA - All Age Groups n = 410
Fever: Any	16.7 (5.6 to 34.7)	4.0 (1.6 to 8.1)	3.9 (1.7 to 7.5)	4.9 (3.0 to 7.4)
Fever: >=38.0 degree C to 38.4 degree C	10.0 (2.1 to 26.5)	3.4 (1.3 to 7.4)	2.4 (0.8 to 5.6)	3.4 (1.9 to 5.7)
Fever: >38.4 degree C to 38.9 degree C	3.3 (0.1 to 17.2)	0.6 (0.0 to 3.2)	1.0 (0.1 to 3.5)	1.0 (0.3 to 2.5)
Fever: >38.9 degree C to 40.0 degree C	3.3 (0.1 to 17.2)	0 (0.0 to 2.1)	0.5 (0.0 to 2.7)	0.5 (0.1 to 1.8)
Fever: >40.0 degree C	0 (0.0 to 11.6)	0 (0.0 to 2.1)	0 (0.0 to 1.8)	0 (0.0 to 0.9)
Fatigue: Any	56.7 (37.4 to 74.5)	56.9 (49.2 to 64.4)	35.4 (28.9 to 42.4)	46.1 (41.2 to 51.1)
Fatigue: Mild	30.0 (14.7 to 49.4)	31.6 (24.8 to 39.1)	18.4 (13.4 to 24.4)	24.9 (20.8 to 29.4)
Fatigue: Moderate	26.7 (12.3 to 45.9)	24.1 (18.0 to 31.2)	17.0 (12.1 to 22.8)	20.7 (16.9 to 25.0)

Primary outcome: Percentage of Participants With Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination: SSA

Time frame: From vaccination on Day 1 up to 1 month after vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	SSA - Group 1: 12-17 Years n = 30	SSA - Group 2: 18-55 Years n = 174	SSA - Group 3: >55 Years n = 208	SSA - All Age Groups n = 412
Value	16.7 (5.6 to 34.7)	7.5 (4.0 to 12.4)	8.2 (4.8 to 12.8)	8.5 (6.0 to 11.6)

Population analysed: Safety population included all participants who received the study intervention.

Primary outcome: Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSA

Time frame: From vaccination on Day 1 up to 6 months after vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	SSA - Group 1: 12-17 Years n = 30	SSA - Group 2: 18-55 Years n = 174	SSA - Group 3: >55 Years n = 208	SSA - All Age Groups n = 412
Value	3.3 (0.1 to 17.2)	0 (0.0 to 2.1)	1.9 (0.5 to 4.9)	1.2 (0.4 to 2.8)

Population analysed: Safety population included all participants who received the study intervention.

Adverse events

Time frame: Local reactions and systemic events by systematic assessment: Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs and all-cause mortality = from Day 1 of vaccination up to 6 months after vaccination and Non-SAEs = from Day 1 of vaccination up to 1 month after vaccination. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SSA - Group 1: 12-17 Years	1 of 30 (3.3%)	27 of 30 (90%)	0 of 30
SSA - Group 2: 18-55 Years	0 of 174 (0%)	154 of 174 (88.5%)	0 of 174
SSA - Group 3: >55 Years	4 of 208 (1.9%)	134 of 208 (64.4%)	1 of 208
SSB - Group 1: 12-17 Years	0 of 9 (0%)	4 of 9 (44.4%)	0 of 9
SSB - Group 2: 18-55 Years	2 of 253 (0.8%)	166 of 253 (65.6%)	0 of 253
SSB - Group 3: >55 Years	1 of 49 (2%)	25 of 49 (51%)	0 of 49
SSC - Cohort 2: 12-17 Years	0 of 18 (0%)	16 of 18 (88.9%)	0 of 18
SSC - Cohort 1 and Cohort 2 Combined: 18-55 Years	1 of 92 (1.1%)	77 of 92 (83.7%)	0 of 92
SSC - Cohort 1 and Cohort 2 Combined: >55 Years	3 of 106 (2.8%)	66 of 106 (62.3%)	1 of 106
SSC - Cohort 3: 18-55 Years	0 of 51 (0%)	43 of 51 (84.3%)	0 of 51
SSC - Cohort 3: >55 Years	1 of 51 (2%)	35 of 51 (68.6%)	0 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40591130Diya O, Gayed J, Lowry FS, Ma H, Bangad V, Mensa F, Zou J, Xie X, Hu Y, Cutler M, Belanger T, Cooper D, Xu X, Mogg R, Tureci O, Sahin U, Swanson KA, Modjarrad K, Anderson AS, Gurtman A, Kitchin N. Safety and Immunogenicity of Monovalent Omicron KP.2-Adapted BNT162b2 COVID-19 Vaccine in Adults: Single-Arm Substudy from a Phase 2/3 Trial. Infect Dis Ther. 2025 Aug;14(8):1973-1987. doi: 10.1007/s40121-025-01185-4. Epub 2025 Jul 1.
Derived from this study: PubMed 39999538Diya O, Gayed J, Lowry FS, Ma H, Bangad V, Mensa F, Zou J, Xie X, Hu Y, Cutler M, Belanger T, Cooper D, Xu X, Koury K, Tureci O, Sahin U, Swanson KA, Modjarrad K, Anderson AS, Gurtman A, Kitchin N. A phase 2/3 trial to investigate the safety and immunogenicity of monovalent Omicron JN.1-adapted BNT162b2 COVID-19 vaccine in adults >/=18 years old. Vaccine. 2025 Apr 11;52:126869. doi: 10.1016/j.vaccine.2025.126869. Epub 2025 Feb 24.
Derived from this study: PubMed 39066372Gayed J, Bangad V, Xu X, Mensa F, Cutler M, Tureci O, Sahin U, Modjarrad K, Swanson KA, Anderson AS, Gurtman A, Kitchin N; C4591054 Study Group. Immunogenicity of the Monovalent Omicron XBB.1.5-Adapted BNT162b2 COVID-19 Vaccine against XBB.1.5, BA.2.86, and JN.1 Sublineages: A Phase 2/3 Trial. Vaccines (Basel). 2024 Jul 2;12(7):734. doi: 10.3390/vaccines12070734.
Derived from this study: PubMed 38400102Gayed J, Diya O, Lowry FS, Xu X, Bangad V, Mensa F, Zou J, Xie X, Hu Y, Lu C, Cutler M, Belanger T, Cooper D, Koury K, Anderson AS, Tureci O, Sahin U, Swanson KA, Modjarrad K, Gurtman A, Kitchin N; C4591054 Study Group. Safety and Immunogenicity of the Monovalent Omicron XBB.1.5-Adapted BNT162b2 COVID-19 Vaccine in Individuals >/=12 Years Old: A Phase 2/3 Trial. Vaccines (Basel). 2024 Jan 24;12(2):118. doi: 10.3390/vaccines12020118.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

37 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing BNT162b2 (Omi XBB.1.5), BNT162b2 (Omi JN.1) and BNT162b2 (Omi KP.2) in people with SARS-CoV-2 Infection and COVID-19, run by BioNTech SE at 37 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSA (time frame: Day 1 to Day 7 after vaccination). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05997290, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.