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

NCT ID: NCT04955626

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 16372 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2023-05-25

Brief 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

Conditions

SARS-CoV-2 Infection; COVID-19

Keywords

COVID-19; Coronavirus; Vaccine; SARS-CoV-2; RNA Vaccine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

10 µg dose

1 dose

Group Type: EXPERIMENTAL

BNT162b2

Intervention Type: BIOLOGICAL

Intramuscular Injection

Placebo

1 dose

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Intramuscular Injection

30 µg dose

1 dose

Group Type: EXPERIMENTAL

BNT162b2

Intervention Type: BIOLOGICAL

Intramuscular Injection

BNT162b2 OMI

Intervention Type: BIOLOGICAL

Intramuscular Injection

Combination BNT162b2 and BNT162b2 OMI

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

30-µg (15-µg each) or 60-µg (30-µg each)

Preformulated bivalent mixture (no dilution required) presented in a single vial

Intramuscular Injection

60 µg dose

1 dose

Group Type: EXPERIMENTAL

BNT162b2

Intervention Type: BIOLOGICAL

Intramuscular Injection

BNT162b2 OMI

Intervention Type: BIOLOGICAL

Intramuscular Injection

Combination BNT162b2 and BNT162b2 OMI

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

30-µg (15-µg each) or 60-µg (30-µg each)

Preformulated bivalent mixture (no dilution required) presented in a single vial

Intramuscular Injection

Interventions

BNT162b2

Intramuscular Injection

Intervention Type: BIOLOGICAL

Placebo

Intramuscular Injection

Intervention Type: OTHER

BNT162b2 OMI

Intramuscular Injection

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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).

• 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.

• 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.

• 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).

• 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.

• 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.
• 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

• 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

• 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

• 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

• 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

• 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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

BioNTech SE

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

North Alabama Research Center

Athens, Alabama, United States

Accel Research Sites - Birmingham Clinical Research Unit

Birmingham, Alabama, United States

Medical Affiliated Research Center

Huntsville, Alabama, United States

AMR Clinical

Mobile, Alabama, United States

Johns Hopkins Center for American Indian Health

Chinle, Arizona, United States

Hope Research Institute

Phoenix, Arizona, United States

The Pain Center of Arizona

Phoenix, Arizona, United States

HOPE Research Institute

Phoenix, Arizona, United States

Alliance for Multispecialty Research, LLC

Tempe, Arizona, United States

Johns Hopkins Center for American Indian Health

Whiteriver, Arizona, United States

Whiteriver Indian Hospital- Garrett Building

Whiteriver, Arizona, United States

Whiteriver Indian Hospital

Whiteriver, Arizona, United States

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Collaborative Neuroscience Research, LLC

Long Beach, California, United States

Collaborative Neuroscience Research, LLC

Los Alamitos, 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, Los Angeles

Los Angeles, California, United States

Velocity Clinical Research, North Hollywood

North Hollywood, California, United States

Kaiser Permanente Oakland

Oakland, California, United States

Paradigm Clinical Research Centers, Inc

Redding, California, United States

UC Davis Medical Center

Sacramento, California, United States

California Research Foundation

San Diego, California, United States

Kaiser Permanente Santa Clara

Santa Clara, California, United States

Bayview Research Group, LLC

Valley Village, California, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Lynn Institute of Denver

Aurora, Colorado, United States

Clinical Research Consulting

Milford, Connecticut, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Yale-New Haven Hospital

New Haven, Connecticut, United States

Yale Center for Clinical Investigation

New Haven, Connecticut, United States

Alliance for Multispecialty Research, LLC

Coral Gables, Florida, United States

Indago Research & Health Center, Inc

Hialeah, Florida, United States

Research Centers of America ( Hollywood )

Hollywood, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Jacksonville, Florida, United States

Acevedo Clinical Research Associates

Miami, Florida, United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

IACT Health

Columbus, Georgia, United States

Meridian Clinical Research

Savannah, Georgia, United States

Clinical Research Atlanta

Stockbridge, Georgia, United States

East-West Medical Research Institute

Honolulu, Hawaii, United States

Solaris Clinical Research

Meridian, Idaho, United States

University of Iowa

Iowa City, Iowa, United States

Velocity Clinical Research, Sioux City

Sioux City, Iowa, United States

AMR Clinical

Newton, Kansas, United States

AMR Clinical

Wichita, Kansas, United States

Kentucky Pediatric/ Adult Research

Bardstown, Kentucky, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Louisiana State University Health Sciences Shreveport

Shreveport, Louisiana, United States

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Michigan Center of Medical Research (MICHMER)

Farmington Hills, Michigan, United States

Velocity Clinical Research, Covington

Gulfport, Mississippi, United States

Clinical Research Professionals

Chesterfield, Missouri, United States

Sundance Clinical Research

St Louis, Missouri, United States

Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research

Bozeman, Montana, United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Methodist Physicians Clinic/CCT Research

Fremont, Nebraska, United States

Velocity Clinical Research, Norfolk

Norfolk, Nebraska, United States

Quality Clinical Research

Omaha, Nebraska, United States

Velocity Clinical Research, Omaha

Omaha, Nebraska, United States

Wake Research - Clinical Research Center of Nevada, LLC

Las Vegas, Nevada, United States

South Jersey Infectious Disease

Somers Point, New Jersey, United States

IMA Clinical Research Warren

Warren Township, New Jersey, United States

Gallup Indian Medical Center

Gallup, New Mexico, United States

Johns Hopkins Center for American Indian Health

Gallup, New Mexico, United States

Johns Hopkins Center for American Indian Health

Shiprock, New Mexico, United States

Northern Navajo Medical Center

Shiprock, New Mexico, United States

Meridian Clinical Research LLC

Binghamton, New York, United States

NYU Langone Health

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Rochester Clinical Research, Inc.

Rochester, New York, United States

University of Rochester Medical Center- Kari Steinmetz

Rochester, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Velocity Clinical Research, Vestal

Vestal, New York, United States

Accellacare

Cary, North Carolina, United States

Accellacare

Charlotte, North Carolina, United States

Duke University - Main Hospital and Clinics

Durham, North Carolina, United States

PharmQuest Life Sciences, LLC

Greensboro, North Carolina, United States

Accellacare

Hickory, North Carolina, United States

Accellacare

Raleigh, North Carolina, United States

M3 Wake Research, Inc.

Raleigh, North Carolina, United States

Accellacare - Salisbury

Salisbury, North Carolina, United States

Accellacare (formerly PMG Research of Wilmington, LLC)

Wilmington, North Carolina, United States

Accellacare

Wilmington, North Carolina, United States

Accellacare

Winston-Salem, North Carolina, United States

Lillestol Research

Fargo, North Dakota, United States

Meridian Clinical Research, LLC

Cincinnati, Ohio, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Meridian Clinical Research

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

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, United States

Dayton Clinical Research

Dayton, Ohio, United States

Dayton Clinical Research

Dayton, Ohio, United States

PriMED Clinical Research

Dayton, Ohio, United States

Senders Pediatrics

South Euclid, Ohio, United States

Lynn Institute of Norman

Norman, Oklahoma, United States

Kaiser Permanente Center for Health Research

Portland, Oregon, United States

Lehigh Valley Health Network/Network Office of Research and Innovation

Allentown, Pennsylvania, United States

Velocity Clinical Research, Providence

East Greenwich, Rhode Island, United States

Main Street Physician's Care

Little River, South Carolina, United States

Holston Medical Group

Bristol, Tennessee, United States

Holston Medical Group

Kingsport, Tennessee, United States

Alliance for Multispecialty Research - Weisgarber Medical Park

Knoxville, Tennessee, United States

Clinical Neuroscience Solutions Inc.

Memphis, Tennessee, United States

Clinical Research Associates Inc

Nashville, Tennessee, United States

Trinity Clinical Research

Tullahoma, Tennessee, United States

Benchmark Research

Austin, Texas, United States

Innovo Research - Austin Regional Clinic

Austin, Texas, United States

Tekton Research, Inc

Austin, Texas, United States

North Texas Infectious Diseases Consultants, P.A

Dallas, Texas, United States

Ventavia Research Group

Fort Worth, Texas, United States

Benchmark Research

Fort Worth, 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

DM Clinical Research - Bellaire

Houston, Texas, United States

SCR of Texas, LLC

Keller, Texas, United States

SMS Clinical Research

Mesquite, Texas, United States

LinQ Research, LLC

Pearland, Texas, 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

DM Clinical Research - Kool Kids Pediatrics

Tomball, Texas, United States

DM Clinical Research

Tomball, Texas, 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 Alliance for Research & Education - Infectious Diseases (CARE-ID)

Annandale, Virginia, United States

Virginia Research Center

Midlothian, Virginia, United States

Benaroya Research Institute at Virginia Mason

Seattle, Washington, United States

Research Building

Wenatchee, Washington, United States

Wenatchee Valley Hospital

Wenatchee, Washington, United States

Obras Sociais Irma Dulce

Salvador, Estado de Bahia, Brazil

CEPIC - Centro Paulista de Investigação Clínica

São Paulo, , Brazil

Studienzentrum Dr. Keller

Frankfurt, , Germany

IKF Pneumologie GmbH & Co. KG

Frankfurt, , Germany

Sheba Medical Center

Ramat Gan, Central District, Israel

Synergy Biomed Research Institute

East London, Eastern Cape, South Africa

Worthwhile Clinical Trials

Benoni, Gauteng, South Africa

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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

Limpopo Clinical Research Initiative

Thabazimbi, Limpopo, South Africa

TREAD Research

Cape Town, Parow, South Africa

Tiervlei Trial Centre

Cape Town, Western Cape, South Africa

Jongaie Research

Pretoria, , South Africa

Countries

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

References

Muik A, Lui BG, Quandt J, Diao H, Fu Y, Bacher M, Gordon J, Toker A, Grosser J, Ozhelvaci O, Grikscheit K, Hoehl S, Kohmer N, Lustig Y, Regev-Yochay G, Ciesek S, Beguir K, Poran A, Vogler I, Tureci O, Sahin U. Progressive loss of conserved spike protein neutralizing antibody sites in Omicron sublineages is balanced by preserved T cell immunity. Cell Rep. 2023 Aug 29;42(8):112888. doi: 10.1016/j.celrep.2023.112888. Epub 2023 Jul 31.

Reference Type: DERIVED

PMID: 37527039 (View on PubMed)

Winokur P, Gayed J, Fitz-Patrick D, Thomas SJ, Diya O, Lockhart S, Xu X, Zhang Y, Bangad V, Schwartz HI, Denham D, Cardona JF, Usdan L, Ginis J, Mensa FJ, Zou J, Xie X, Shi PY, Lu C, Buitrago S, Scully IL, Cooper D, Koury K, Jansen KU, Tureci O, Sahin U, Swanson KA, Gruber WC, Kitchin N; C4591031 Clinical Trial Group. Bivalent Omicron BA.1-Adapted BNT162b2 Booster in Adults Older than 55 Years. N Engl J Med. 2023 Jan 19;388(3):214-227. doi: 10.1056/NEJMoa2213082.

Reference Type: DERIVED

PMID: 36652353 (View on PubMed)

Moreira ED Jr, Kitchin N, Xu X, Dychter SS, Lockhart S, Gurtman A, Perez JL, Zerbini C, Dever ME, Jennings TW, Brandon DM, Cannon KD, Koren MJ, Denham DS, Berhe M, Fitz-Patrick D, Hammitt LL, Klein NP, Nell H, Keep G, Wang X, Koury K, Swanson KA, Cooper D, Lu C, Tureci O, Lagkadinou E, Tresnan DB, Dormitzer PR, Sahin U, Gruber WC, Jansen KU; C4591031 Clinical Trial Group. Safety and Efficacy of a Third Dose of BNT162b2 Covid-19 Vaccine. N Engl J Med. 2022 May 19;386(20):1910-1921. doi: 10.1056/NEJMoa2200674. Epub 2022 Mar 23.

Reference Type: DERIVED

PMID: 35320659 (View on PubMed)

Provided Documents

Document Type: Study Protocol

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Document Type: Statistical Analysis Plan: substudy A

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Document Type: Statistical Analysis Plan: substudy B

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Document Type: Statistical Analysis Plan: substudy C

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Document Type: Statistical Analysis Plan: substudy D

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Document Type: Statistical Analysis Plan: substudy E

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Document Type: Statistical Analysis Plan: substudy F

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Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C4591031

To obtain contact information for a study center near you, click here.

Other Identifiers

2021-005197-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C4591031

Identifier Type: -

Identifier Source: org_study_id