Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
SARS-CoV-2 Infection, COVID-19
About this trial
This is an interventional prevention trial for SARS-CoV-2 Infection focused on measuring COVID-19, Coronavirus, Vaccine, SARS-CoV-2, RNA Vaccine
Eligibility Criteria
Inclusion Criteria:
• Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or ≥12 years, inclusive, at randomization (dependent upon study phase). For the boostability and protection-against-VOCs subset: Existing participants enrolled to receive a third dose of BNT162b2 at 30 µg or BNT162b2SA; male or female participants between the ages of 18 and 55 years, inclusive, at rerandomization.
Newly enrolled participants enrolled to receive 2 doses of BNT162b2SA; male or female participants between the ages of 18 and 55 years, inclusive, at enrollment.
Existing participants enrolled to receive a third dose of BNT162b2 at 5 or 10 µg; male or female participants ≥18 years at rerandomization.
Note that participants <18 years of age cannot be enrolled in the EU.
- 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, and clinical judgment of the investigator to be eligible for inclusion in the study.
- Participants who, in the judgment of the investigator, are at risk for acquiring COVID-19.
- Boostability and protection-against-VOCs existing participant subset only: Participants who provided a serum sample at Visit 3, with Visit 3 occurring within the protocol-specified window.
- Capable of giving personal signed informed consent
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.
- Phases 1 and 2 only: Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
- Receipt of medications intended to prevent COVID 19.
- 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
Phase 1 only: Individuals at high risk for severe COVID-19, including those with any of the following risk factors:
- Hypertension
- Diabetes mellitus
- Chronic pulmonary disease
- Asthma
- Current vaping or smoking
- History of chronic smoking within the prior year
- BMI >30 kg/m2
- Anticipating the need for immunosuppressive treatment within the next 6 months
- Phase 1 only: Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel).
- Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- Phase 1 only: Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention.
- 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.
- Previous vaccination with any coronavirus vaccine.
- Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
- Phase 1 only: Regular receipt of inhaled/nebulized corticosteroids.
- Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
- Participation in other studies involving study intervention within 28 days prior to study entry through and including 6 months 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.
- Previous participation in other studies involving study intervention containing lipid nanoparticles.
- Phase 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit.
- Phase 1 only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality.
- Phase 1 only: Positive test for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at the screening visit.
- Phase 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 hours before receipt of study intervention.
- Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Sites / Locations
- North Alabama Research Center, LLC
- Birmingham Clinical Research Unit
- Medical Affiliated Research Center
- Optimal Research, LLC
- Alliance for Multispecialty Research, LLC
- Chinle Comprehensive Health Care Facility
- Johns Hopkins Center for American Indian Health
- The Pain Center of Arizona
- HOPE Research Institute
- Alliance for Multispecialty Research, LLC
- Whiteriver Indian Hospital
- Anaheim Clinical Trials, LLC
- Collaborative Neuroscience Research, LLC
- Long Beach Clinical Trials Services Inc.
- Kaiser Permanente Los Angeles Medical Center
- National Research Institute
- Velocity Clinical Research, North Hollywood
- Paradigm Clinical Research Center
- Kaiser Permanente Sacramento
- Clinical and Translational Science Center (CTSC) Clinical Research Center (CCRC)
- UC Davis Medical Center
- California Research Foundation
- Kaiser Permanente Santa Clara
- Bayview Research Group
- Diablo Clinical Research, Inc.
- Lynn Institute of Denver
- Clinical Research Consulting, LLC
- Yale Center for Clinical Investigations (CSRU)
- Alliance for Multispecialty Research
- DeLand Clinical Research Unit
- Fleming Island Center for Clinical Research
- Indago Research & Health Center, Inc
- Research Centers of America
- Jacksonville Center for Clinical Research
- Clinical Neuroscience Solutions, Inc.
- Acevedo Clinical Research Associates
- Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
- Atlanta Center for Medical Research
- IACT Health
- Meridian Clinical Research, LLC
- Clinical Research Atlanta
- East-West Medical Research Institute
- Solaris Clinical Research
- Optimal Research
- University of Iowa Hospitals & Clinics Investigational Drug Servces
- University of Iowa Hospitals & Clinics
- Meridian Clinical Research, LLC
- Alliance for Multispecialty Research, LLC
- Alliance for Multispecialty Research, LLC
- Kentucky Pediatric/ Adult Research
- Benchmark Research
- Ochsner Clinic Foundation
- LSU Health Sciences Center at Shreveport Clinical Trials Office
- LSUHSC-Shreveport
- Pharmaron CPC, Inc.
- University of Maryland Medical Center Investigational Drug Service Pharmacy
- University of Maryland, Baltimore, Health Sciences Research Facility III
- University of Maryland, Center for Vaccine Development and Global Health
- Johns Hopkins Bayview Medical Center
- Boston Medical Center
- UMass Memorial Medical Center - University Campus
- Michigan Center for Medical Research
- MedPharmics, LLC
- Clinical Research Professionals
- Sundance Clinical Research, LLC
- Bozeman Health Deaconess Hospital dba Bozeman Health Clinical Research
- Bozeman Health Deaconess Hospital
- Methodist Physicians Clinic / CCT Research
- Meridian Clinical Research, LLC
- Quality Clinical Research, Inc.
- Meridian Clinical Research, LLC
- Wake Research-Clinical Research Center of Nevada, LLC
- Amici Clinical Research
- South Jersey Infectious Disease
- Johns Hopkins Center for American Indian Health
- Johns Hopkins Center for American Indian Health
- Meridian Clinical Research, LLC
- Meridian Clinical Research LLC
- NYU Langone Health
- Icahn School of Medicine at Mount Sinai
- Rochester Clinical Research, Inc.
- University of Rochester Medical Center- Kari Steinmetz
- University of Rochester Medical Center
- SUNY Upstate Medical University Global Health Research Unit
- Meridian Clinical Research LLC
- PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
- PMG Research of Charlotte LLC
- Accessioning Unit and Repository
- Duke Vaccine and Trials Unit
- Clinical Research Pickett Road
- Duke Investigational Drug Service Pharmacy
- PharmQuest
- PMG Research of Hickory, LLC
- PMG Research of Raleigh, LLC
- M3 Wake Research, Inc.
- PMG Research of Salisbury, LLC
- PMG Research of Wilmington, LLC
- PMG Research of Winston-Salem, LLC
- Lillestol Research Llc
- Meridian Clinical Research, LLC
- Cincinnati Children's Hospital Medical Center
- Meridian Clinical Research LLC
- University Hospitals Cleveland Medical Center
- VA Northeast Ohio Healthcare System
- Velocity Clinical Research, Inc.
- Aventiv Research Inc.
- Dayton Clinical Research
- Dayton Clinical Research
- PriMED Clinical Research
- Senders Pediatrics
- Lynn Institute of Norman
- Kaiser Permanente Northwest-Center for Health Research
- Lehigh Valley Health Network/Network Office of Research and Innovation
- Velocity Clinical Research, Providence
- Main Street Physician's Care
- Main Street Physician's Care
- Holston Medical Group
- Holston Medical Group
- Alliance for Multispecialty Research, LLC
- Alliance for Multispecialty Research, LLC
- Clinical Neuroscience Solutions, Inc.
- Clinical Research Associates, Inc.
- Trinity Clinical Research
- Benchmark Research
- ARC Clinical Research at Four Points
- Tekton Research, Inc.
- Tekton Research
- North Texas Infectious Diseases Consultants, P.A.
- Ventavia Research Group, LLC
- Benchmark Research
- Texas Health Resources
- University of Texas Medical Branch
- Ventavia Research Group, LLC
- Texas Center for Drug Development, Inc.
- Ventavia Research Group, LLC
- SMS Clinical Research, LLC
- LinQ Research, LLC
- Benchmark Research.
- Clinical Trials of Texas, Inc.
- Diagnostics Research Group
- Martin Diagnostic Clinic
- J. Lewis Research, Inc. / Foothill Family Clinic
- J. Lewis Research, Inc. / Foothill Family Clinic South
- Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
- Virginia Research Center LLC
- Benaroya Research Institute at Virginia Mason
- Wenatchee Valley Hospital
- Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
- Hospital Santo Antonio/ Associacao Obras Sociais Irma Dulce
- CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda (Casa Branca)
- CRS Clinical Research Services Berlin GmbH
- Medizentrum Essen Borbeck
- IKF Pneumologie GmbH & Co KG
- Universitätsklinikum Hamburg-Eppendorf
- CRS Clinical Research Services Mannheim GmbH
- Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten Drescher
- Newtown Clinical Research Centre
- Jongaie Research
- Limpopo Clinical Research Initiative
- Tiervlei Trial Centre, Basement Level, Karl Bremer Hospital
- Ankara Universitesi Tip Fakultesi, Ibni Sina Hastanesi
- Hacettepe Universitesi Tip Fakultesi
- Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi
- Istanbul Universitesi Istanbul Tip Fakultesi
- Istanbul Universitesi-Cerrahpasa, Cerrahpasa Tip Fakultesi
- Medipol Mega Universite Hastanesi
- Acibadem Atakent Hastanesi
- Kocaeli Universitesi Tip Fakultesi
- Sakarya Universitesi Egitim ve Arastirma Hastanesi
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Arm 16
Arm 17
Arm 18
Arm 19
Arm 20
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Placebo Comparator
Experimental
Other
Other
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
10 µg dose, 18-55 years of age (2 doses)
20 µg dose, 18-55 years of age (2 doses)
30 µg dose, 18-55 years of age (2 doses)
10 µg dose, 65-85 years of age (2 doses)
20 µg dose, 65-85 years of age (2 doses)
30 µg dose, 65-85 years of age (2 doses)
30 µg dose, ≥12 years of age (2 doses)
Placebo, 18-55 years of age
Placebo, 65-85 years of age
Placebo, ≥12 years of age
100 µg dose, 18-55 years of age (2 doses)
Vaccination of Placebo recipients with BNT162b2 - Stage 1
Vaccination of placebo recipients with BNT162b2 - Stage 2
Booster vaccination of Phase 1 participants with BNT162b2 at a dose of 30 µg
Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 30 µg
Booster vaccination of Phase 3 participants with BNT162b2SA at a dose of 30 µg
Vaccination of BNT162b2-naive participants with BNT162b2SA at a dose of 30 µg
Booster and further vaccination of Phase 3 participants with BNT162b2SA at a dose of 30 µg
Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 5 µg
Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 10 µg
Participants ≥16 years of age who originally received placebo and are eligible for COVID-19 vaccination following any local or national recommendations will be offered the opportunity to receive BNT162b2 as part of the study.
Participants ≥16 years of age who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study.