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

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

The purpose of this clinical protocol is to learn about the safety, tolerability, and immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of SARS-CoV-2 in healthy people.

Substudy A:

• This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose,

  • in people who are 12 years of age and older,
  • who previously received at least 3 doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being an Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before the study vaccination (Visit 1).

• The study is about 6 months long for each participant.

• Participants will have at least 5 visits to the clinic.

• At each clinic visit a blood sample will be taken.

• At least 1 nasal swab will taken.

Substudy B:

• This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose,

  • in people who are 12 years of age and older,
  • who are COVID-19 vaccine-naïve
  • who have had any positive SARS-CoV-2 test result >28 days before study vaccine administration.

• The study is about 6 months long for each participant.

• Participants will have at least 5 visits to the clinic.

• At each clinic visit a blood sample will be taken.

• At least 1 nasal swab will taken.

Substudy C:

• This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi JN.1) and BNT162b2 (Omi KP.2) given as a single 30 µg dose to:

  • Cohort 1: people who are 18 years of age and older, who will receive BNT162b2 (Omi JN.1), and,
  • Cohort 2: people who are 12 years of age and older, who will receive BNT162b2 (Omi JN.1), and,
  • Cohort 3: people who are 18 years of age and older who will receive BNT162b2 (Omi KP.2).
  • Participants may have never received a COVID-19 vaccine or, may have previously received COVID-19 vaccine(s), with the most recent dose received at least 150 days before the study vaccination (Visit 1).

• The study is about 6 months long for each participant.

• Participants will have at least 6 visits (Cohorts 1 and 3) or at least 5 visits (Cohort 2) to the clinic.

• At each clinic visit a blood sample will be taken.

• At least 1 nasal swab will taken.

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.