A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals
NCT ID: NCT05997290
Last Updated: 2025-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
1051 participants
INTERVENTIONAL
2023-08-10
2025-03-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study on the Safety and Immune Response of Investigational COVID-19 mRNA Vaccines in Healthy Adults
NCT05960097
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS-CoV-2 Variant (COVID-19 Omicron) mRNA Vaccine (Phase 1)
NCT05433194
A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants
NCT04713553
To Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of BNT162b2 Boosting Strategies Against COVID-19 in Participants ≥12 Years of Age.
NCT04955626
Safety and Immunogenicity of RNA-based Vaccines Against SARS-CoV-2 Variants in Healthy Participants
NCT05004181
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SSA: Group 1
Participants 12 years of age and older, COVID-19 vaccine-experienced will receive 30 µg of BNT162b2 (Omi XBB.1.5) at Visit 1.
BNT162b2 (Omi XBB.1.5)
BNT162b2 monovalent (Omicron XBB.1.5)
SSB: Group 2
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
BNT162b2 (Omi XBB.1.5)
BNT162b2 monovalent (Omicron XBB.1.5)
SSC: Group 3
Cohort 1 - Participants 18 years of age and older will receive 30 µg of BNT162b2 (Omi JN.1) at Visit 1.
BNT162b2 (Omi JN.1)
BNT162b2 monovalent (Omicron JN.1)
SSC: Group 4
Cohort 2 - Participants 12 years of age and older will receive 30 µg of BNT162b2 (Omi JN.1) at Visit 1.
BNT162b2 (Omi JN.1)
BNT162b2 monovalent (Omicron JN.1)
SSC - Group 5
Cohort 3 - Participants 18 years of age and older who will receive 30 µg of BNT162b2 (Omi KP.2) at Visit 1.
BNT162b2 (Omi KP.2)
BNT162b2 monovalent (Omicron KP.2)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BNT162b2 (Omi XBB.1.5)
BNT162b2 monovalent (Omicron XBB.1.5)
BNT162b2 (Omi JN.1)
BNT162b2 monovalent (Omicron JN.1)
BNT162b2 (Omi KP.2)
BNT162b2 monovalent (Omicron KP.2)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* 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.
12 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
BioNTech SE
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
North Alabama Research Center
Athens, Alabama, United States
Medical Affiliated Research Center
Huntsville, Alabama, United States
Alliance for Multispecialty Research, LLC
Mobile, Alabama, United States
Epic Medical Research - Surprise
Surprise, Arizona, United States
Alliance for Multispecialty Research, LLC
Tempe, Arizona, United States
West Coast Research
Dublin, California, United States
California Research Foundation
San Diego, California, United States
Bayview Research Group, LLC
Valley Village, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Clinical Research Consulting
Milford, Connecticut, United States
Indago Research & Health Center, Inc
Hialeah, Florida, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, United States
Care Research - West Flagler Street
Miami, Florida, United States
Acevedo Clinical Research Associates
Miami, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield, Missouri, United States
Bio-Kinetic Clinical Applications LLC DBA QPS_MO (Patient Screening Only)
Springfield, Missouri, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, United States
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, United States
Dayton Clinical Research
Dayton, Ohio, United States
Senders Pediatrics
South Euclid, Ohio, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, United States
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, United States
Zenos Clinical Research
Dallas, Texas, United States
Epic Medical Research - DeSoto
DeSoto, Texas, United States
DM Clinical Research - Bellaire
Houston, Texas, United States
SMS Clinical Research
Mesquite, Texas, United States
IMA Clinical Research San Antonio
San Antonio, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Alliance for Multispecialty Research, LLC
Layton, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States
Alliance for Multispecialty Research, LLC
Norfolk, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-000361-24
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCT05997290
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4591054
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.