To Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of BNT162b2 Boosting Strategies Against COVID-19 in Participants ≥12 Years of Age.

COVID-19 Clinical Trial

Official title:

A PHASE 3 MASTER PROTOCOL TO EVALUATE ADDITIONAL DOSE(S) OF BNT162B2 IN HEALTHY INDIVIDUALS PREVIOUSLY VACCINATED WITH BNT162B2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04955626
• Other study ID #: C4591031
• Secondary ID: 2021-005197-25
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2021
• Est. completion date: May 25, 2023

Study information

• Verified date: June 2023
• Source: BioNTech SE
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Substudy A: The study will evaluate the safety, tolerability, and efficacy of a booster dose of BNT162b2 when administered to participants having previously received 2 doses of BNT162b2 at least 6 months prior to randomization.

The study is designed to describe vaccine efficacy of a booster dose of BNT162b2 over time against COVID-19

• At a dose of 30µg (as studied in the Phase 2/3 study C4591001)

• In healthy adults 16 years of age and older

• The duration of the study for each participant will be up to approximately 12 months.

• The study will be conducted in the United States, Brazil and South Africa

Substudy B: The study will assess the safety and tolerability of a single dose of BNT162b2 as compared to placebo control, through the potential analysis of serum troponin levels, in participants ≥12 and ≤30 years of age who have received 2 or 3 prior doses of BNT162b2 (30-µg doses) with their last dose at least 4 months (120 days) prior to randomization.

• Blood samples will be collected for troponin testing

• The duration of the study for each participant will be up to approximately 2 months.

• The study will be conducted in the United States, Germany, Poland and South Africa

Substudy C: The study will assess the safety, tolerability, and immunogenicity of a booster (third) dose of BNT162b2 at doses of 10 µg or 30 µg in participants who have completed a 2-dose primary series of BNT162b2 (30 µg doses) at least 5 months (150 days) prior to randomization.

• In healthy adults 12 years of age and older

• The duration of the study for each participant will be up to approximately 12 months.

• The study will be conducted in the United States, Germany and South Africa

Substudy D: The study will assess the safety, tolerability, and immunogenicity of a 2-dose primary series of BNT162b2 OMI, and as a booster (third, fourth or fifth) dose

• Participants in Cohort 1 will have completed a 2-dose primary series of BNT162b2 (30-µg doses), with their last dose 90 to 240 days prior to enrolment

• Participants in Cohort 2 will be enrolled from Study C4591001 and C4591031 Substudy A and will have completed a 2-dose primary series and received a single booster (third) dose of BNT162b2, with their last dose 90 to 180 days prior to randomization

• Participants in Cohort 3 who are COVID-19 vaccine-naïve and have not experienced COVID-19 will be enrolled to receive 2 doses (primary series) of BNT162b2 OMI, 3 weeks apart, with a dose of BNT162b2 approximately 5 months (150 days) later. If participants do not consent to receive BNT162b2 as a third dose, they will not receive a third dose. No participants should receive BNT162b2 OMI as a third dose.

• In healthy adults 18 to 55 years of age

• The duration of the study for each participant will be up to approximately 12 months.

• The study will be conducted in the United States and South Africa

Substudy E: This study will assess the safety, tolerability, and immunogenicity of high-dose BNT162b2 (60 µg), high-dose BNT162b2 OMI (60 µg), and a high-dose combination of BNT162b2 and BNT162b2 OMI at 60 µg (30 µg each), given as a single dose

• In healthy adults 18 years of age and older who have received 3 prior doses of BNT162b2 (30 µg) with the most recent dose being 5 to 12 months (150 to 360 days) prior to randomization

• The duration of the study for each participant will be approximately 6 months.

• The study will be conducted in the United States

Substudy F: This study will assess the safety, tolerability, and immunogenicity of high-dose BNT162b2 (60 µg), high-dose BNT162b2 OMI (60 µg), and a high-dose combination of BNT162b2 and BNT162b2 OMI at 60 µg (30 µg each), given as a single dose.

• In healthy adults 60 years of age and older who have received 3 prior doses of BNT162b2 (30 µg) with the most recent dose being ≥4 months prior to randomization

• The duration of the study for each participant will be approximately 6 months.

• The study will be conducted in Israel

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16385
• Est. completion date: May 25, 2023
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

Substudy A

Inclusion Criteria:

• Male or female participants =16 years of age at Visit 1 (Day 1) who participated in C4591001.

• Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.

• Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

• Capable of giving signed informed consent.

• Participants who have received 2 prior doses of 30 µg BNT162b2 19-42 days apart, with the second dose being at least 175 days before Visit 1 (Day 1).

Exclusion Criteria:

• Other 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 severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.

• Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19.

• 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.

• Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.

• Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before study intervention administration, or planned receipt throughout the study.

• Prior receipt of any COVID-19 vaccine other than BNT162b2.

• Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

• Receipt of medications intended to prevent COVID-19.

• Prior receipt of more than 2 doses of BNT162b2 30 µg.

• Participation in other studies involving study intervention within 28 days prior to study entry, other than C4591001, and/or within 28 days of confirmed receipt of BNT162b2 within the study.

Substudy B

Inclusion Criteria:

• Male or female participants 12 to 30 years of age, inclusive, who have received 2 prior doses of 30 µg BNT162b2 19 to 60 days apart, with the second dose being at least at least 4 months (120 days) before Visit 1 (Day 1)

• Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.

• Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

• Capable of giving signed informed consent.

Exclusion Criteria:

• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behaviour 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 severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.

• Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19.

• 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.

• Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.

• Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before study intervention administration, or planned receipt throughout the study.

• Prior receipt of any COVID-19 vaccine other than BNT162b2.

• Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

• Receipt of medications intended to prevent COVID-19.

• Prior receipt of more than 3 doses of BNT162b2 30 µg.

• Participation in other studies involving study intervention within 28 days prior to study entry through and including 28 days after the last dose of study intervention, with the exception of non-Pfizer interventional studies for prevention of COVID-19, which are prohibited throughout study participation.

Substudy C

Inclusion Criteria:

• Male or female participants =12 years of age, inclusive, who have received 2 prior doses of 30 µg BNT162b2 19 to 60 days apart, with the second dose being at least 150 days before Visit 301 (Day 1)

• Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.

• Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

• Capable of giving signed informed consent.

Exclusion Criteria:

• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behaviour 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 severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.

• Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19.

• 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.

• Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.

• Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before study intervention administration, or planned receipt throughout the study.

• Prior receipt of any COVID-19 vaccine other than BNT162b2.

• Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

• Receipt of medications intended to prevent COVID-19.

• Prior receipt of more than 2 doses of BNT162b2 30 µg.

• Participation in other studies involving study intervention within 28 days prior to study entry through and including 28 days after the last dose of study intervention, with the exception of non-Pfizer interventional studies for prevention of COVID-19, which are prohibited throughout study participation.

Substudy D

Inclusion Criteria:

• Male or female participants 18 to 55 years of age inclusive

• Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.

• Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

• Cohort 2: Participants who provided a serum sample at Visit 3 in Study C4591001, with Visit 3 occurring within the protocol-specified window.

• Capable of giving signed informed consent

• Cohort 1: Participants who have received 2 prior doses of 30 µg BNT162b2, with the second dose being 90 to 240 days before Visit 401 (Day 1) or Cohort 2: Participants who have received 3 prior doses of 30 µg BNT162b2, with the third dose being 90 to 180 days before Visit 401 (Day 1).

Exclusion Criteria:

• Other 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 severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.

• Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19.

• 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.

• Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.

• Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before study intervention administration, or planned receipt throughout the study.

• Cohorts 1 and 2: prior receipt of any COVID-19 vaccine other than BNT162b2.

• Cohort 3 only: prior receipt of any COVID-19 vaccine.

• Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

• Receipt of medications intended to prevent COVID 19.

• Participation in other studies involving study intervention within 28 days prior to study entry through and including 28 days after the last dose of study intervention, with the exception of non-Pfizer interventional studies for prevention of COVID-19, which are prohibited throughout study participation.

Substudy E

Inclusion Criteria:

• Groups 1-6: Male or female participants >55 years of age

• Groups 7-9: Male or female participants 18 to 55 years of age

• Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.

• Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

• Capable of giving signed informed consent.

• Participants who have received 3 prior doses of 30 µg BNT162b2, with the third dose being 5 to 12 months (150 to 360 days) before Visit 601 (Day 1).

• Groups 7 to 9 (sentinel participants): Screening troponin levels must be within normal range prior to randomization.

Exclusion Criteria:

• Other 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 severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.

• Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19.

• 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.

• Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.

• Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before study intervention administration, or planned receipt throughout the study.

• Prior receipt of any COVID-19 vaccine other than BNT162b2.

• Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

• Receipt of medications intended to prevent COVID-19.

• Participation in other studies involving study intervention within 28 days prior to study entry through and including 28 days after the last dose of study intervention, with the exception of non-Pfizer interventional studies for prevention of COVID-19, which are prohibited throughout study participation.

Substudy F

Inclusion Criteria:

• Male or female participants =60 years of age

• Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.

• Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

• Capable of giving signed informed consent.

• Participants who have received 3 prior doses of 30 µg BNT162b2, with the third dose being =4 months before Visit 701 (Day 1).

Exclusion Criteria:

• Other 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 severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.

• Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19.

• 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.

• Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.

• Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before study intervention administration, or planned receipt throughout the study.

• Prior receipt of any COVID-19 vaccine other than BNT162b2.

• Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

• Receipt of medications intended to prevent COVID-19.

• Participation in other studies involving study intervention within 28 days prior to study entry through and including 28 days after the last dose of study intervention, with the exception of non-Pfizer interventional studies for prevention of COVID-19, which are prohibited throughout study participation.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

Biological:
• BNT162b2
Intramuscular Injection

Other:
• Placebo
Intramuscular Injection

Biological:
• BNT162b2 OMI
Intramuscular Injection
• Combination BNT162b2 and BNT162b2 OMI
30-µg (15-µg each) or 60-µg (30-µg each) Site prepared dosing suspension from 1 vial each of diluted BNT162b2 and BNT162b2 OMI Intramuscular Injection
• Combination (Bivalent) BNT162b2 and BNT162b2 OMI
30-µg (15-µg each) or 60-µg (30-µg each) Preformulated bivalent mixture (no dilution required) presented in a single vial Intramuscular Injection

Locations

Country	Name	City	State
Brazil	Obras Sociais Irma Dulce	Salvador	Bahia
Brazil	CEPIC - Centro Paulista de Investigação Clínica	São Paulo
Canada	MIC Medial Imaging Consultants	Edmonton	Alberta
Germany	IKF Pneumologie GmbH & Co. KG	Frankfurt
Germany	Studienzentrum Dr. Keller	Frankfurt
Israel	Sheba Medical Center	Ramat Gan	Hamerkaz
Israel	The Edmond and Lily Safra Children's Hospital The Chaim Sheba Medical Center Department of Pediatric	Ramat Gan	Hamerkaz
South Africa	Worthwhile Clinical Trials	Benoni	Gauteng
South Africa	Tiervlei Trial Centre	Cape Town	Western CAPE
South Africa	TREAD Research	Cape Town	Western CAPE
South Africa	Synergy Biomed Research Institute	East London	Eastern CAPE
South Africa	Newtown Clinical Research	Johannesburg	Gauteng
South Africa	Clinresco Centres	Kempton Park	Gauteng
South Africa	Dr A Jacovides & Partners Inc.	Midrand	Gauteng
South Africa	Botho Ke Bontle Health Services PTY LTD	Pretoria	Gauteng
South Africa	Jongaie Research	Pretoria
South Africa	Limpopo Clinical Research Initiative	Thabazimbi	Limpopo
United States	Lehigh Valley Health Network/Network Office of Research and Innovation	Allentown	Pennsylvania
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Clinical Alliance for Research & Education - Infectious Diseases (CARE-ID)	Annandale	Virginia
United States	North Alabama Research Center	Athens	Alabama
United States	Lynn Institute of Denver	Aurora	Colorado
United States	ARC Clinical Research at Four Points	Austin	Texas
United States	Benchmark Research	Austin	Texas
United States	Tekton Research, Inc	Austin	Texas
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Kentucky Pediatric/ Adult Research	Bardstown	Kentucky
United States	Meridian Clinical Research LLC	Binghamton	New York
United States	Accel Research Sites - Birmingham Clinical Research Unit	Birmingham	Alabama
United States	Boston Medical Center	Boston	Massachusetts
United States	Bozeman Health Deaconess Hospital	Bozeman	Montana
United States	Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research	Bozeman	Montana
United States	Holston Medical Group	Bristol	Tennessee
United States	Accellacare	Cary	North Carolina
United States	Accellacare	Charlotte	North Carolina
United States	Accellacare	Charlotte	North Carolina
United States	Clinical Research Professionals	Chesterfield	Missouri
United States	Johns Hopkins Center for American Indian Health	Chinle	Arizona
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Meridian Clinical Research	Cincinnati	Ohio
United States	Meridian Clinical Research, LLC	Cincinnati	Ohio
United States	Sterling Research Group, Ltd.	Cincinnati	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	VA Northeast Ohio Healthcare System	Cleveland	Ohio
United States	Velocity Clinical Research, Cleveland	Cleveland	Ohio
United States	Aventiv Research Inc	Columbus	Ohio
United States	IACT Health	Columbus	Georgia
United States	Alliance for Multispecialty Research, LLC	Coral Gables	Florida
United States	North Texas Infectious Diseases Consultants, P.A	Dallas	Texas
United States	Dayton Clinical Research	Dayton	Ohio
United States	Dayton Clinical Research	Dayton	Ohio
United States	PriMED Clinical Research	Dayton	Ohio
United States	PriMED Clinical Research	Dayton	Ohio
United States	Duke Vaccine and Trials Unit	Durham	North Carolina
United States	Velocity Clinical Research, Providence	East Greenwich	Rhode Island
United States	Lillestol Research	Fargo	North Dakota
United States	Michigan Center of Medical Research (MICHMER)	Farmington Hills	Michigan
United States	Benchmark Research	Fort Worth	Texas
United States	Ventavia Research Group	Fort Worth	Texas
United States	Methodist Physicians Clinic/CCT Research	Fremont	Nebraska
United States	Gallup Indian Medical Center	Gallup	New Mexico
United States	Johns Hopkins Center for American Indian Health	Gallup	New Mexico
United States	PharmQuest Life Sciences, LLC	Greensboro	North Carolina
United States	MedPharmics, LLC	Gulfport	Mississippi
United States	Indago Research & Health Center, Inc	Hialeah	Florida
United States	Accellacare	Hickory	North Carolina
United States	Research Centers of America ( Hollywood )	Hollywood	Florida
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	DM Clinical Research-Bellaire	Houston	Texas
United States	HG Pediatrics	Houston	Texas
United States	Renu Garg, MD Pediatrics	Houston	Texas
United States	Van Tran Family Practice	Houston	Texas
United States	Ventavia Research Group, LLC	Houston	Texas
United States	Medical Affiliated Research Center	Huntsville	Alabama
United States	University of Iowa	Iowa City	Iowa
United States	Clinical Neuroscience Solutions, Inc. dba CNS Healthcare	Jacksonville	Florida
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	SCR of Texas, LLC	Keller	Texas
United States	Ventavia Research Group	Keller	Texas
United States	Holston Medical Group	Kingsport	Tennessee
United States	Alliance for Multispecialty Research - Weisgarber Medical Park	Knoxville	Tennessee
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
United States	Wake Research - Clinical Research Center of Nevada, LLC	Las Vegas	Nevada
United States	Wake Research - Clinical Research Center of Nevada, LLC	Las Vegas	Nevada
United States	Main Street Physician's Care	Little River	South Carolina
United States	Collaborative Neuroscience Research, LLC	Long Beach	California
United States	Kaiser Permanente	Los Angeles	California
United States	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California
United States	Kaiser Permenente Medical Center Infectious Disease	Los Angeles	California
United States	Velocity Clinical Research, Westlake	Los Angeles	California
United States	Clinical Neuroscience Solutions Inc.	Memphis	Tennessee
United States	Clinical Neuroscience Solutions, Inc. dba CNS Healthcare	Memphis	Tennessee
United States	Solaris Clinical Research	Meridian	Idaho
United States	SMS Clinical Research	Mesquite	Texas
United States	Acevedo Clinical Research Associates	Miami	Florida
United States	Virginia Research Center	Midlothian	Virginia
United States	Clinical Research Consulting	Milford	Connecticut
United States	Alliance for Multispecialty Research, LLC	Mobile	Alabama
United States	Clinical Research Associates Inc	Nashville	Tennessee
United States	Yale Center for Clinical Investigation	New Haven	Connecticut
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Yale-New Haven Hospital	New Haven	Connecticut
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	NYU Langone Health	New York	New York
United States	Alliance for Multispecialty Research, LLC	Newton	Kansas
United States	Meridian Clinical Research	Norfolk	Nebraska
United States	Meridian Clinical Research, LLC	Norfolk	Nebraska
United States	Lynn Institute of Norman	Norman	Oklahoma
United States	Velocity Clinical Research, North Hollywood	North Hollywood	California
United States	Kaiser Permanente Oakland	Oakland	California
United States	Quality Clinical Research	Omaha	Nebraska
United States	Velocity Clinical Research, Omaha	Omaha	Nebraska
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	LinQ Research, LLC	Pearland	Texas
United States	HOPE Research Institute	Phoenix	Arizona
United States	HOPE Research Institute	Phoenix	Arizona
United States	The Pain Center of Arizona	Phoenix	Arizona
United States	Kaiser Permanente Center for Health Research	Portland	Oregon
United States	Accellacare	Raleigh	North Carolina
United States	M3 Wake Research, Inc.	Raleigh	North Carolina
United States	M3 Wake Research, Inc.	Raleigh	North Carolina
United States	Amici Clinical Research LLC	Raritan	New Jersey
United States	Paradigm Clinical Research Centers, Inc	Redding	California
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	Rochester General Hospital Infectious Disease	Rochester	New York
United States	University of Rochester	Rochester	New York
United States	University of Rochester Medical Center	Rochester	New York
United States	University of Rochester Medical Center- Kari Steinmetz	Rochester	New York
United States	UC Davis Medical Center	Sacramento	California
United States	Sundance Clinical Research	Saint Louis	Missouri
United States	Accellacare - Salisbury	Salisbury	North Carolina
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	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Clinical Trials of Texas, LLC	San Antonio	Texas
United States	IMA Clinical Research San Antonio	San Antonio	Texas
United States	California Research Foundation	San Diego	California
United States	Kaiser Permanente Santa Clara	Santa Clara	California
United States	Meridian Clinical Research, LLC	Savannah	Georgia
United States	Benaroya Research Institute at Virginia Mason	Seattle	Washington
United States	Johns Hopkins Center for American Indian Health	Shiprock	New Mexico
United States	Northern Navajo Medical Center	Shiprock	New Mexico
United States	Louisiana State University Health Sciences Shreveport	Shreveport	Louisiana
United States	Velocity Clinical Research, Sioux City	Sioux City	Iowa
United States	South Jersey Infectious Disease	Somers Point	New Jersey
United States	Senders Pediatrics	South Euclid	Ohio
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Alliance for Multispecialty Research, LLC	Tempe	Arizona
United States	DM Clinical Research	Tomball	Texas
United States	Trinity Clinical Research	Tullahoma	Tennessee
United States	Bayview Research Group, LLC	Valley Village	California
United States	Meridian Clinical Research, LLC	Vestal	New York
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	IMA Clinical Research Warren	Warren	New Jersey
United States	Wenatchee Valley Hospital	Wenatchee	Washington
United States	Johns Hopkins Center for American Indian Health	Whiteriver	Arizona
United States	Whiteriver Indian Hospital	Whiteriver	Arizona
United States	Whiteriver Indian Hospital- Garrett Building	Whiteriver	Arizona
United States	Alliance for Multispecialty Research, LLC	Wichita	Kansas
United States	Accellacare	Wilmington	North Carolina
United States	Accellacare (formerly PMG Research of Wilmington, LLC)	Wilmington	North Carolina
United States	Accellacare	Winston-Salem	North Carolina
United States	University of Massachusetts Chan Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
BioNTech SE	Pfizer

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Germany,  Israel,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SSA - Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection	per 1000 person-years of blinded follow-up	from 7 days after the booster dose through the blinded follow-up period, which may be from 2 to 12 months
Primary	SSA - Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection	per 1000 person-years of blinded follow-up	from 7 days after the booster dose through the blinded follow-up period, which may be from 2 to 12 months
Primary	SSA - Percentage of participants reporting adverse events	As elicited by investigational site staff	from the booster dose to 1 month after the booster dose
Primary	SSA - Percentage of participants reporting serious adverse events	As elicited by investigational site staff	from the booster dose to 6 months after the booster dose
Primary	SSB - Percentage of participants with elevated troponin I levels	Troponin I level	through 1 month after the second vaccination
Primary	SSB - Percentage of participants reporting local reactions	Pain at the injection site, redness, and swelling as self-reported on electronic diaries.	For 7 days following each vaccination
Primary	SSB - Percentage of participants reporting systemic events	Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.	For 7 days following each vaccination
Primary	SSB - Percentage of participants reporting adverse events	As elicited by investigational site staff	within 1 month after each vaccination
Primary	SSB - Percentage of participants reporting serious adverse events	As elicited by investigational site staff	within 1 month after each vaccination
Primary	SSC - Percentage of participants reporting local reactions	Pain at the injection site, redness, and swelling as self-reported on electronic diaries.	For 7 days following the booster dose
Primary	SSC - Percentage of participants reporting systemic events	Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.	For 7 days following the booster dose
Primary	SSC - Percentage of participants reporting adverse events	As elicited by investigational site staff	from the booster dose to 1 month after the booster dose
Primary	SSC - Percentage of participants reporting serious adverse events	As elicited by investigational site staff	from the booster dose to 6 months after the booster dose
Primary	SSC - the immune response to BNT162b2 10 µg and 30 µg given as the third dose in participants 12 through 17 years of age and a third dose of BNT162b2 30 µg in a randomly selected subset of participants 18 through 55 years of age from study C4591001	GMTs at each time point; GMFRs from baseline (before the third dose) to each subsequent time point after the third dose; Percentage of participants with seroresponse at each time point after the third dose	At baseline (before the third dose), 1 month and 6 months after the third dose
Primary	SSD - Percentage of participants reporting local reactions	Pain at the injection site, redness, and swelling as self-reported on electronic diaries.	For 7 days following each vaccination
Primary	SSD - Percentage of participants reporting systemic events	Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.	For 7 days following each vaccination
Primary	SSD - Percentage of participants reporting adverse events	As elicited by investigational site staff	from the first study vaccination (received in this study) through 1 month after the last study vaccination
Primary	SSD - Percentage of participants reporting serious adverse events	As elicited by investigational site staff	from the first study vaccination (received in this study) through 6 months after the last study vaccination
Primary	SSD-Superiority with respect to neutralizing titers and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as D3 in BNT162b2-experienced participants	GMR of the Omicron-neutralizing titers at 1 month after 1 dose of BNT162b2 OMI to those at 1 month after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants; The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 1 dose of BNT162b2 OMI and at 1 month after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants	1 month after receipt of 1 dose of study intervention
Primary	SSD-Superiority with respect to neutralizing titers and noninferiority with respect to seroresponse of anti-Omi immune response after 2 doses BNT162b2 OMI given as D3+D4 compared to after 1 dose BNT162b2 given as D3 in BNT162b2-experienced participants	GMR of the Omicron-neutralizing titers at 1 month after 2 doses of BNT162b2 OMI to those at 1 month after 1 dose of BNT162b2 given as the third (and fourth) dose in BNT162b2-experienced participants; The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 2 doses of BNT162b2 OMI and at 1 month after 1 dose of BNT162b2 given as the third (and fourth) dose in BNT162b2-experienced participants	1 month after receipt of 1 or 2 doses of intervention as appropriate
Primary	SSD-Superiority with respect to neutralizing titer and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 1 dose BNT162b2 OMI compared to after 1 dose BNT162b2 given as the D4 in BNT162b2-experienced participants	GMR of the Omicron-neutralizing titers at 1 month after 1 dose of BNT162b2 OMI to those at 1 month after 1 dose of BNT162b2 given as the fourth dose in BNT162b2-experienced participants; The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 1 dose of BNT162b2 OMI and at 1 month after 1 dose of BNT162b2 given as the fourth dose in BNT162b2-experienced participants	1 month after receipt of 1 dose of study intervention
Primary	SSD-Superiority with respect to neutralizing titer and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 2 doses BNT162b2 OMI compared to after 2 doses BNT162b2 in participants from the C4591001 study	GMR of the Omicron-neutralizing titers 1 month after the second dose of BNT162b2 OMI to 1 month after the second dose of BNT162b2 in participants selected from the C4591001 study; The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after the second dose of BNT162b2 OMI and at 1 month after the second dose of BNT162b2 in participants selected from the C4591001 study	1 month after receipt of the second dose of BNT162b2 OMI or BNT162b2 as appropriate
Primary	SSE - Percentage of participants reporting local reactions	Pain at the injection site, redness, and swelling as self-reported on electronic diaries.	For 7 days following the study vaccination
Primary	SSE - Percentage of participants reporting systemic events	Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.	For 7 days following the study vaccination
Primary	SSE - Percentage of participants reporting adverse events	As elicited by investigational site staff	from the study vaccination through 1 month after the study vaccination
Primary	SSE - Percentage of participants reporting serious adverse events	As elicited by investigational site staff	from the study vaccination through 6 months after the study vaccination
Primary	SSE - Percentage of participants with elevated troponin I levels (18-55 years of age, sentinel cohort only)	Troponin I level	Before and 3 days after study vaccination
Primary	SSE - Superiority of neutralizing titer after 1 dose of BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age	GMR of the Omicron-neutralizing titers at 1 month after 1 dose of BNT162b2 OMI at 30 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants	1 month after receipt of 1 dose of study intervention given as a fourth dose
Primary	SSE - Noninferiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age	The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 1 dose of BNT162b2 OMI 30 µg and at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants	1 month after receipt of 1 dose of study intervention given as a fourth dose
Primary	SSE - Superiority of neutralizing titer after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age	GMR of the Omicron-neutralizing titers at 1 month after 1 dose of BNT162b2 OMI at 60 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants	1 month after receipt of 1 dose of study intervention given as a fourth dose
Primary	SSE - Noninferiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age	The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 1 dose of BNT162b2 OMI 60 µg and at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants	1 month after receipt of 1 dose of study intervention given as a fourth dose
Primary	SSE - Superiority of neutralizing titer after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age	GMR of the Omicron-neutralizing titers at 1 month after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants	1 month after receipt of 1 dose of study intervention given as a fourth dose
Primary	SSE - Noninferiority of anti-Omicron immune response after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age	The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg and at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants	1 month after receipt of 1 dose of study intervention given as a fourth dose
Primary	SSE - Superiority of neutralizing titer after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age	GMR of the Omicron-neutralizing titers at 1 month after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2	1 month after receipt of 1 dose of study intervention given as a fourth dose
Primary	SSE - Noninferiority of anti-Omicron immune response after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age	The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg and at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants	1 month after receipt of 1 dose of study intervention given as a fourth dose
Primary	SSF - Percentage of participants reporting local reactions	Pain at the injection site, redness, and swelling as self-reported on electronic diaries.	For 7 days following the study vaccination
Primary	SSF - Percentage of participants reporting systemic events	Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.	For 7 days following the study vaccination
Primary	SSF - Percentage of participants reporting adverse events	As elicited by investigational site staff	from the study vaccination through 1 month after the study vaccination
Primary	SSF - Percentage of participants reporting serious adverse events	As elicited by investigational site staff	from the study vaccination through 6 months after the study vaccination
Primary	SSF - To describe the immune response to BNT162b2 (30 µg or 60 µg), BNT162b2 OMI (30 µg or 60 µg), and a combination of BNT162b2 and BNT162b2 OMI (30 µg or 60 µg) given as a fourth dose in BNT162b2-experienced participants	GMT of Omicron and reference-strain neutralizing titers; GMFRs of Omicron and reference-strain neutralizing titers from before the study vaccination to subsequent time points; Percentages of participants with seroresponse for Omicron and reference-strain neutralizing titers at each time point; GMRs of Omicron and reference-strain neutralizing titers at each time point after the study vaccination between different vaccine groups	At each time point
Secondary	SSA - Confirmed severe COVID-19 (based on FDA definition) period in participants without evidence of past SARS-CoV-2 infection	per 1000 person-years of blinded follow-up	from 7 days after the booster dose through the blinded follow-up period, which may be from 2 to 12 months
Secondary	SSA - Confirmed severe COVID-19 (based on FDA definition) in participants with and without evidence of past SARS-CoV-2 infection	per 1000 person-years of blinded follow-up	from 7 days after the booster dose through the blinded follow-up period, which may be from 2 to 12 months
Secondary	SSA - Confirmed severe COVID-19 (based on CDC definition) in participants without evidence of past SARS-CoV-2 infection	per 1000 person-years of blinded follow-up	from 7 days after the booster dose through the blinded follow-up period, which may be from 2 to 12 months
Secondary	SSA - Confirmed severe COVID-19 (based on CDC definition) in participants with and without evidence of past SARS-CoV-2 infection	per 1000 person-years of blinded follow-up	from 7 days after the booster dose through the blinded follow-up period, which may be from 2 to 12 months
Secondary	SSC - Immune responses to BNT162b2 10 µg and 30 µg given as the third dose in participants 12 through 17 years of age	GMTs at each time point; GMFRs from baseline (before the third dose) to 7 days after the third dose; Percentage of participants with seroresponse at 7 days after the third dose	At baseline (before the third dose) and 7 days after the third dose
Secondary	SSD - The "super" superiority of the anti-Omicron immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants	GMR of the Omicron-neutralizing titers at 1 month after 1 dose of BNT162b2 OMI to those at 1 month after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants	1 month after receipt of 1 dose of study intervention
Secondary	SSD - The "super" superiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI given as the third and fourth doses compared to after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants	GMR of the Omicron-neutralizing titers at 1 month after 2 doses of BNT162b2 OMI to those at 1 month after 1 dose of BNT162b2 given as the third (and fourth) dose in BNT162b2-experienced participants	1 month after receipt of 1 or 2 doses of intervention as appropriate
Secondary	SSD - The "super" superiority of the anti-Omicron immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as the fourth dose in BNT162b2-experienced participants	GMR of the Omicron-neutralizing titers at 1 month after 1 dose of BNT162b2 OMI to those at 1 month after 1 dose of BNT162b2 given as the fourth dose in BNT162b2-experienced participants	1 month after receipt of 1 dose of study intervention
Secondary	SSD - The noninferiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI compared to the anti-reference-strain immune response after 2 doses of BNT162b2 in participants selected from the C4591001 study	GMR of the Omicron-neutralizing titers 1 month after the second dose of BNT162b2 OMI to the reference-strain-neutralizing titers 1 month after the second dose of BNT162b2 in participants selected from the C4591001 study; The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after the second dose of BNT162b2 OMI and seroresponsea to the reference strain at 1 month after the second dose of BNT162b2 in participants selected from the C4591001 study	1 month after receipt of the second dose of BNT162b2 OMI or BNT162b2 as appropriate
Secondary	SSD - The "super" superiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI compared to after 2 doses of BNT162b2 in participants selected from the C4591001 study	GMR of the Omicron-neutralizing titers 1 month after the second dose of BNT162b2 OMI to 1 month after the second dose of BNT162b2 participants selected from the C4591001 study	1 month after receipt of the second dose of BNT162b2 OMI or BNT162b2 as appropriate
Secondary	SSE - Noninferiority of anti-reference-strain immune response after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age	GMR of the reference strain-neutralizing titers at 1 month after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants	1 month after receipt of 1 dose of study intervention given as a fourth dose
Secondary	SSE - Noninferiority of anti-reference strain immune response after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age	GMR of the reference strain-neutralizing titers at 1 month after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants	1 month after receipt of 1 dose of study intervention given as a fourth dose
Secondary	SSE - The "super" superiority of anti-Omicron immune responses after 1 dose of BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age	GMR of the Omicron-neutralizing titers at 1 month after 1 dose of BNT162b2 OMI at 30 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants	1 month after receipt of 1 dose of study intervention given as a fourth dose
Secondary	SSE - The "super" superiority of anti-Omicron immune responses after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age	GMR of the Omicron-neutralizing titers at 1 month after 1 dose of BNT162b2 OMI at 60 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants	1 month after receipt of 1 dose of study intervention given as a fourth dose
Secondary	SSE - The "super" superiority of anti-Omicron immune responses after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age	GMR of the Omicron-neutralizing titers at 1 month after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants	1 month after receipt of 1 dose of study intervention given as a fourth dose
Secondary	SSE - The "super" superiority of anti-Omicron immune responses after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age	GMR of the Omicron-neutralizing titers at 1 month after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants	1 month after receipt of 1 dose of study intervention given as a fourth dose

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