The purpose of this clinical protocol is to learn about the safety, tolerability, andimmunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants ofSARS-CoV-2 in healthy people.Substudy A: - This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose, - in people who are 12 years of age and older, - who previously received at least 3 doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being an Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before the study vaccination (Visit 1). - The study is about 6 months long for each participant. - Participants will have at least 5 visits to the clinic. - At each clinic visit a blood sample will be taken. - At least 1 nasal swab will taken.Substudy B: - This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose, - in people who are 12 years of age and older, - who are COVID-19 vaccine-naïve - who have had any positive SARS-CoV-2 test result >28 days before study vaccine administration. - The study is about 6 months long for each participant. - Participants will have at least 5 visits to the clinic. - At each clinic visit a blood sample will be taken. - At least 1 nasal swab will taken.Substudy C: - This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi JN.1) and BNT162b2 (Omi KP.2) given as a single 30 µg dose to: - Cohort 1: people who are 18 years of age and older, who will receive BNT162b2 (Omi JN.1), and, - Cohort 2: people who are 12 years of age and older, who will receive BNT162b2 (Omi JN.1), and, - Cohort 3: people who are 18 years of age and older who will receive BNT162b2 (Omi KP.2). - Participants may have never received a COVID-19 vaccine or, may have previously received COVID-19 vaccine(s), with the most recent dose received at least 150 days before the study vaccination (Visit 1). - The study is about 6 months long for each participant. - Participants will have at least 6 visits (Cohorts 1 and 3) or at least 5 visits (Cohort 2) to the clinic. - At each clinic visit a blood sample will be taken. - At least 1 nasal swab will taken.
Not Provided
Biological: BNT162b2 (Omi XBB.1.5)
BNT162b2 monovalent (Omicron XBB.1.5)
Biological: BNT162b2 (Omi JN.1)
BNT162b2 monovalent (Omicron JN.1)
Biological: BNT162b2 (Omi KP.2)
BNT162b2 monovalent (Omicron KP.2)
SSA
Inclusion Criteria:
- 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.
Exclusion Criteria
- 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.
- 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
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Inclusion Criteria:
- 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
- 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.
North Alabama Research Center
Athens 4830668, Alabama 4829764, United States
Medical Affiliated Research Center
Huntsville 4068590, Alabama 4829764, United States
Alliance for Multispecialty Research, LLC
Mobile 4076598, Alabama 4829764, United States
Epic Medical Research - Surprise
Surprise 5316428, Arizona 5551752, United States
Alliance for Multispecialty Research, LLC
Tempe 5317058, Arizona 5551752, United States
West Coast Research
Dublin 5344157, California 5332921, United States
California Research Foundation
San Diego 5391811, California 5332921, United States
Bayview Research Group, LLC
Valley Village 7284982, California 5332921, United States
Diablo Clinical Research, Inc.
Walnut Creek 5406990, California 5332921, United States
Clinical Research Consulting
Milford 4838652, Connecticut 4831725, United States
Indago Research & Health Center, Inc
Hialeah 4158476, Florida 4155751, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville 4160021, Florida 4155751, United States
Care Research - West Flagler Street
Miami 4164138, Florida 4155751, United States
Acevedo Clinical Research Associates
Miami 4164138, Florida 4155751, United States
Clinical Neuroscience Solutions, Inc.
Orlando 4167147, Florida 4155751, United States
Clinical Research Atlanta
Stockbridge 4224681, Georgia 4197000, United States
East-West Medical Research Institute
Honolulu 5856195, Hawaii 5855797, United States
Kentucky Pediatric/ Adult Research
Bardstown 4283133, Kentucky 6254925, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield 4409896, Missouri 4398678, United States
Bio-Kinetic Clinical Applications LLC DBA QPS_MO (Patient Screening Only)
Springfield 4409896, Missouri 4398678, United States
M3 Wake Research, Inc.
Raleigh 4487042, North Carolina 4482348, United States
Centricity Research Columbus Ohio Multispecialty
Columbus 4509177, Ohio 5165418, United States
Dayton Clinical Research
Dayton 4509884, Ohio 5165418, United States
Senders Pediatrics
South Euclid 5172485, Ohio 5165418, United States
Alliance for Multispecialty Research, LLC
Knoxville 4634946, Tennessee 4662168, United States
Alliance for Multispecialty Research, LLC
Knoxville 4634946, Tennessee 4662168, United States
Clinical Neuroscience Solutions Inc.
Memphis 4641239, Tennessee 4662168, United States
Zenos Clinical Research
Dallas 4684888, Texas 4736286, United States
Epic Medical Research - DeSoto
DeSoto 4685524, Texas 4736286, United States
DM Clinical Research - Bellaire
Houston 4699066, Texas 4736286, United States
SMS Clinical Research
Mesquite 4710826, Texas 4736286, United States
IMA Clinical Research San Antonio
San Antonio 4726206, Texas 4736286, United States
DM Clinical Research
Tomball 4737094, Texas 4736286, United States
Alliance for Multispecialty Research, LLC
Layton 5777107, Utah 5549030, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City 5780993, Utah 5549030, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City 5780993, Utah 5549030, United States
Alliance for Multispecialty Research, LLC
Norfolk 4776222, Virginia 6254928, United States
Pfizer CT.gov Call Center, Study Director
Pfizer