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
Brief Summary

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.

Detailed Description

Not Provided

Completed
SARS-CoV-2 Infection
COVID-19

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)

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 12 Years ~ Maximum: N/A
Countries
United States
Locations

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

Pfizer CT.gov Call Center, Study Director
Pfizer

NCT Number
Keywords
Covid-19
Coronavirus
Vaccine
SARS-CoV-2
RNA Vaccine
Vaccine-naïve
MeSH Terms
COVID-19