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Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals

Primary Purpose

SARS-CoV-2 Infection, COVID-19

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BNT162b1
BNT162b2
Placebo
BNT162b2SA
Sponsored by
BioNTech SE
About
Eligibility
Locations
Arms
Outcomes
Full info

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

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Experimental

Other

Other

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of participants in Phase 1 reporting local reactions
Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
Percentage of participants in Phase 1 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.
Percentage of participants in Phase 1 reporting adverse events
As elicited by investigational site staff
Percentage of participants in Phase 1 reporting serious adverse events
As elicited by investigational site staff
Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values
As measured at the central laboratory
Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values
As measured at the central laboratory
Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values
As measured at the central laboratory
Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments
As measured at the central laboratory
Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments
As measured at the central laboratory
Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments
As measured at the central laboratory
In the first 360 participants randomized into Phase 2/3, percentage of participants reporting local reactions
Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
In the first 360 participants randomized into Phase 2/3, 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.
In the first 360 participants randomized into Phase 2/3, percentage of participants reporting adverse events
As elicited by investigational site staff
In the first 360 participants randomized into Phase 2/3, percentage of participants reporting serious adverse events
As elicited by investigational site staff
In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting local reactions
Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
In a subset of at least 6000 participants randomized in Phase 2/3, 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.
Percentage of participants in Phase 2/3 reporting adverse events
As elicited by investigational site staff
Percentage of participants in Phase 2/3 reporting serious adverse events
As elicited by investigational site staff
Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination
Per 1000 person-years of follow-up
Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination
Per 1000 person-years of follow-up
Percentage of participants 12-15 years of age in Phase 3 reporting adverse events
As elicited by investigational site staff
Percentage of participants 12-15 years of age in Phase 3 reporting adverse events
As elicited by investigational site staff
In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting local reactions
Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
In participants 12-15 years of age randomized in Phase 3, 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.
In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting adverse events
As elicited by investigational site staff
In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting serious adverse events
As elicited by investigational site staff
In participants, who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting local reactions
Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
In participants who receive BNT162b2SA given as 1 or 2 doses, 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.
In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, percentage of participants reporting adverse events
As elicited by investigational site staff
In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, percentage of participants reporting serious adverse events
As elicited by investigational site staff
In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, percentage of participants reporting local reactions
Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, 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.
In participants who receive a third dose of BNT162b2 as a result of current or anticipated recommendations, percentage of participants reporting adverse events
As elicited by investigational site staff
In participants who receive a third dose of BNT162b2 as a result of current or anticipated recommendations, percentage of participants reporting serious adverse events
As elicited by investigational site staff
Noninferiority of the SARS-CoV-2 reference strain neutralizing titers after a third dose of BNT162b2 at 30 µg compared to after 2 doses of BNT162b2, in the same individuals
As measured at the central laboratory
Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after one dose of BNT162b2SA compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals
As measured at the central laboratory
Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2
As measured at the central laboratory

Secondary Outcome Measures

In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs
As measured at the central laboratory
In Phase 1 participants, GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point
As measured at the central laboratory
Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum neutralizing antibody levels
As measured at the central laboratory
In Phase 1 participants, SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels, expressed as GMCs
As measured at the central laboratory
Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels
As measured at the central laboratory
In Phase 1 participants, GMFR in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels from before vaccination to each subsequent time point
As measured at the central laboratory
In Phase 1 participants, GMR of the geometric mean of SARS-CoV-2 serum neutralizing titers to the geometric mean of SARS CoV 2 (anti-S1 and anti-RBD) binding antibody levels
As measured at the central laboratory
Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination
Per 1000 person-years of follow-up
Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination
Per 1000 person-years of follow-up
Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination
Per 1000 person-years of follow-up
Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination
Per 1000 person-years of follow-up
Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination
Per 1000 person-years of follow-up
Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination
Per 1000 person-years of follow-up
Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination
Per 1000 person-years of follow-up
Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination
Per 1000 person-years of follow-up
Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination
Per 1000 person-years of follow-up
Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination
Per 1000 person-years of follow-up
GMR of SARS CoV 2 neutralizing titers in the 2 age groups (12-15 years of age to 16-25 years of age)
As measured at the central laboratory
Incidence of asymptomatic SARS CoV-2 infection based on N binding antibody seroconversion in participants with no serological or virological evidence of past SARS CoV-2 infection or confirmed COVID-19 prior to 1 month after receipt of the second dose
Per 1000 person-years of follow-up
Incidence of asymptomatic SARS CoV-2 infection based on central laboratory-confirmed NAAT in participants with no serological or virological evidence (up to the start of the asymptomatic surveillance period) of past SARS-CoV-2 infection
Per 1000 person-years of follow-up
Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after a third dose of BNT162b2 at 30 µg compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals
As measured at the central laboratory
Noninferiority of the SARS-CoV-2 reference strain neutralizing titers after one dose of BNT162b2SA compared to after 2 doses of BNT162b2, in the same individuals
As measured at the central laboratory
Comparison of the SARS-CoV-2 SA strain neutralizing titers after 1 dose of BNT162b2SA to after a third dose of BNT162b2 at 30 µg
As measured at the central laboratory
Comparison of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals
As measured at the central laboratory
Comparison of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA to after 2 doses of BNT162b2
As measured at the central laboratory
Comparison of the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2SA to after 2 doses of BNT162b2
As measured at the central laboratory

Full Information

First Posted
April 27, 2020
Last Updated
February 27, 2023
Sponsor
BioNTech SE
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04368728
Brief Title
Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
Official Title
A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 29, 2020 (Actual)
Primary Completion Date
February 10, 2023 (Actual)
Study Completion Date
February 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioNTech SE
Collaborators
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part. The study will evaluate the safety, tolerability, and immunogenicity of 3 different SARS-CoV-2 RNA vaccine candidates against COVID-19 and the efficacy of 1 candidate: As a 2-dose (separated by 21 days) schedule; At various different dose levels in Phase 1; As a booster; In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age [stratified as 12-15, 16-55 or >55 years of age]). The candidate selected for efficacy evaluation in Phase 2/3 is BNT162b2 at a dose of 30 µg. Participants who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study. In order to describe the boostability of BNT162, and potential heterologous protection against emerging SARS-CoV-2 VOCs, an additional dose of BNT162b2 at 30 µg will be given to Phase 1 participants approximately 6 to 12 months after their second dose of BNT162b1 or BNT162b2. This will provide an early assessment of the safety of a third dose of BNT162, as well as its immunogenicity. The assessment of boostability will be further expanded in a subset of Phase 3 participants at selected sites in the US who will receive a third dose of BNT162b2 at 30 µg or a third and potentially a fourth dose of prototype BNT162b2VOC at 30 µg (BNT162b2s01, based upon the South African variant and hereafter referred to as BNT162b2SA). A further subset of Phase 3 participants will receive a third, lower, dose of BNT162b2 at 5 or 10 µg. To further describe potential homologous and heterologous protection against emerging SARS-CoV-2 VOCs, a new cohort of participants will be enrolled who are COVID-19 vaccine-naïve (ie, BNT162b2-naïve) and have not experienced COVID-19. They will receive BNT162b2SA given as a 2-dose series, separated by 21 days. To reflect current and anticipated recommendations for COVID 19 vaccine boosters, participants in C4591001 who meet specified recommendations and have not already received one, will be offered a third dose of BNT162b2 after their second dose of BNT162.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection, COVID-19
Keywords
COVID-19, Coronavirus, Vaccine, SARS-CoV-2, RNA Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
47079 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 µg dose, 18-55 years of age (2 doses)
Arm Type
Experimental
Arm Title
20 µg dose, 18-55 years of age (2 doses)
Arm Type
Experimental
Arm Title
30 µg dose, 18-55 years of age (2 doses)
Arm Type
Experimental
Arm Title
10 µg dose, 65-85 years of age (2 doses)
Arm Type
Experimental
Arm Title
20 µg dose, 65-85 years of age (2 doses)
Arm Type
Experimental
Arm Title
30 µg dose, 65-85 years of age (2 doses)
Arm Type
Experimental
Arm Title
30 µg dose, ≥12 years of age (2 doses)
Arm Type
Experimental
Arm Title
Placebo, 18-55 years of age
Arm Type
Placebo Comparator
Arm Title
Placebo, 65-85 years of age
Arm Type
Placebo Comparator
Arm Title
Placebo, ≥12 years of age
Arm Type
Placebo Comparator
Arm Title
100 µg dose, 18-55 years of age (2 doses)
Arm Type
Experimental
Arm Title
Vaccination of Placebo recipients with BNT162b2 - Stage 1
Arm Type
Other
Arm Description
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.
Arm Title
Vaccination of placebo recipients with BNT162b2 - Stage 2
Arm Type
Other
Arm Description
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.
Arm Title
Booster vaccination of Phase 1 participants with BNT162b2 at a dose of 30 µg
Arm Type
Experimental
Arm Title
Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 30 µg
Arm Type
Experimental
Arm Title
Booster vaccination of Phase 3 participants with BNT162b2SA at a dose of 30 µg
Arm Type
Experimental
Arm Title
Vaccination of BNT162b2-naive participants with BNT162b2SA at a dose of 30 µg
Arm Type
Experimental
Arm Title
Booster and further vaccination of Phase 3 participants with BNT162b2SA at a dose of 30 µg
Arm Type
Experimental
Arm Title
Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 5 µg
Arm Type
Experimental
Arm Title
Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 10 µg
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
BNT162b1
Intervention Description
Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
BNT162b2
Intervention Description
Intramuscular injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
BNT162b2SA
Intervention Description
Intramuscular injection
Primary Outcome Measure Information:
Title
Percentage of participants in Phase 1 reporting local reactions
Description
Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
Time Frame
For 7 days after dose 1 and dose 2
Title
Percentage of participants in Phase 1 reporting systemic events
Description
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
Time Frame
For 7 days after dose 1 and dose 2
Title
Percentage of participants in Phase 1 reporting adverse events
Description
As elicited by investigational site staff
Time Frame
From dose 1 through 1 month after the last dose
Title
Percentage of participants in Phase 1 reporting serious adverse events
Description
As elicited by investigational site staff
Time Frame
From dose 1 through 6 months after the last dose
Title
Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values
Description
As measured at the central laboratory
Time Frame
1 day after dose 1
Title
Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values
Description
As measured at the central laboratory
Time Frame
7 days after dose 1
Title
Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values
Description
As measured at the central laboratory
Time Frame
7 days after dose 2
Title
Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments
Description
As measured at the central laboratory
Time Frame
Between baseline and 1 day after dose 1
Title
Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments
Description
As measured at the central laboratory
Time Frame
Between baseline and 7 days after dose 1
Title
Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments
Description
As measured at the central laboratory
Time Frame
Between before dose 2 and 7 days after dose 2
Title
In the first 360 participants randomized into Phase 2/3, percentage of participants reporting local reactions
Description
Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
Time Frame
For 7 days after dose 1 and dose 2
Title
In the first 360 participants randomized into Phase 2/3, percentage of participants reporting systemic events
Description
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
Time Frame
For 7 days after dose 1 and dose 2
Title
In the first 360 participants randomized into Phase 2/3, percentage of participants reporting adverse events
Description
As elicited by investigational site staff
Time Frame
From dose 1 through 1 month after the last dose
Title
In the first 360 participants randomized into Phase 2/3, percentage of participants reporting serious adverse events
Description
As elicited by investigational site staff
Time Frame
From dose 1 through 6 months after the last dose
Title
In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting local reactions
Description
Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
Time Frame
For 7 days after dose 1 and dose 2
Title
In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting systemic events
Description
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
Time Frame
For 7 days after dose 1 and dose 2
Title
Percentage of participants in Phase 2/3 reporting adverse events
Description
As elicited by investigational site staff
Time Frame
From dose 1 through 1 month after the last dose
Title
Percentage of participants in Phase 2/3 reporting serious adverse events
Description
As elicited by investigational site staff
Time Frame
From dose 1 through 6 months after the last dose
Title
Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination
Description
Per 1000 person-years of follow-up
Time Frame
From 7 days after the second dose of study intervention to the end of the study, up to 2 years
Title
Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination
Description
Per 1000 person-years of follow-up
Time Frame
From 7 days after the second dose of study intervention to the end of the study, up to 2 years
Title
Percentage of participants 12-15 years of age in Phase 3 reporting adverse events
Description
As elicited by investigational site staff
Time Frame
From dose 1 through 1 month after the last dose
Title
Percentage of participants 12-15 years of age in Phase 3 reporting adverse events
Description
As elicited by investigational site staff
Time Frame
From dose 1 through 6 months after the last dose
Title
In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting local reactions
Description
Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
Time Frame
For 7 days after dose 1 and dose 2
Title
In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting systemic events
Description
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
Time Frame
For 7 days after dose 1 and dose 2
Title
In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting adverse events
Description
As elicited by investigational site staff
Time Frame
From dose 1 through 1 month after the last dose
Title
In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting serious adverse events
Description
As elicited by investigational site staff
Time Frame
From dose 1 through 5 or 6 months after the last dose
Title
In participants, who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting local reactions
Description
Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
Time Frame
For 7 days after dose 1 (and dose 2)
Title
In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting systemic events
Description
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
Time Frame
For 7 days after dose 1 (and dose 2)
Title
In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, percentage of participants reporting adverse events
Description
As elicited by investigational site staff
Time Frame
From the third dose through 1 month after the third dose
Title
In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, percentage of participants reporting serious adverse events
Description
As elicited by investigational site staff
Time Frame
From the third dose through 6 months after the third dose
Title
In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, percentage of participants reporting local reactions
Description
Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
Time Frame
For 7 days after the third dose
Title
In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, percentage of participants reporting systemic events
Description
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
Time Frame
For 7 days after the third dose
Title
In participants who receive a third dose of BNT162b2 as a result of current or anticipated recommendations, percentage of participants reporting adverse events
Description
As elicited by investigational site staff
Time Frame
From the third dose through 1 month after the third dose
Title
In participants who receive a third dose of BNT162b2 as a result of current or anticipated recommendations, percentage of participants reporting serious adverse events
Description
As elicited by investigational site staff
Time Frame
From the third dose through 6 months after the third dose
Title
Noninferiority of the SARS-CoV-2 reference strain neutralizing titers after a third dose of BNT162b2 at 30 µg compared to after 2 doses of BNT162b2, in the same individuals
Description
As measured at the central laboratory
Time Frame
1 month after the third dose
Title
Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after one dose of BNT162b2SA compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals
Description
As measured at the central laboratory
Time Frame
1 month after the third dose
Title
Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2
Description
As measured at the central laboratory
Time Frame
1 month after the second dose
Secondary Outcome Measure Information:
Title
In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs
Description
As measured at the central laboratory
Time Frame
Through 2 years after the final dose
Title
In Phase 1 participants, GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point
Description
As measured at the central laboratory
Time Frame
Through 2 years after the final dose
Title
Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum neutralizing antibody levels
Description
As measured at the central laboratory
Time Frame
Through 2 years after the final dose
Title
In Phase 1 participants, SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels, expressed as GMCs
Description
As measured at the central laboratory
Time Frame
Through 2 years after the final dose
Title
Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels
Description
As measured at the central laboratory
Time Frame
Through 2 years after the final dose
Title
In Phase 1 participants, GMFR in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels from before vaccination to each subsequent time point
Description
As measured at the central laboratory
Time Frame
Through 2 years after the final dose
Title
In Phase 1 participants, GMR of the geometric mean of SARS-CoV-2 serum neutralizing titers to the geometric mean of SARS CoV 2 (anti-S1 and anti-RBD) binding antibody levels
Description
As measured at the central laboratory
Time Frame
Through 2 years after the final dose
Title
Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination
Description
Per 1000 person-years of follow-up
Time Frame
From 14 days after the second dose of study intervention to the end of the study, up to 2 years
Title
Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination
Description
Per 1000 person-years of follow-up
Time Frame
From 14 days after the second dose of study intervention to the end of the study, up to 2 years
Title
Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination
Description
Per 1000 person-years of follow-up
Time Frame
From 7 days after the second dose of study intervention to the end of the study, up to 2 years
Title
Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination
Description
Per 1000 person-years of follow-up
Time Frame
From 14 days after the second dose of study intervention to the end of the study, up to 2 years
Title
Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination
Description
Per 1000 person-years of follow-up
Time Frame
From 7 days after the second dose of study intervention to the end of the study, up to 2 years
Title
Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination
Description
Per 1000 person-years of follow-up
Time Frame
From 14 days after the second dose of study intervention to the end of the study, up to 2 years
Title
Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination
Description
Per 1000 person-years of follow-up
Time Frame
From 7 days after the second dose of study intervention to the end of the study, up to 2 years
Title
Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination
Description
Per 1000 person-years of follow-up
Time Frame
From 14 days after the second dose of study intervention to the end of the study, up to 2 years
Title
Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination
Description
Per 1000 person-years of follow-up
Time Frame
From 7 days after the second dose of study intervention to the end of the study, up to 2 years
Title
Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination
Description
Per 1000 person-years of follow-up
Time Frame
From 14 days after the second dose of study intervention to the end of the study, up to 2 years
Title
GMR of SARS CoV 2 neutralizing titers in the 2 age groups (12-15 years of age to 16-25 years of age)
Description
As measured at the central laboratory
Time Frame
1 month after the second dose
Title
Incidence of asymptomatic SARS CoV-2 infection based on N binding antibody seroconversion in participants with no serological or virological evidence of past SARS CoV-2 infection or confirmed COVID-19 prior to 1 month after receipt of the second dose
Description
Per 1000 person-years of follow-up
Time Frame
Through 1 month after the second dose
Title
Incidence of asymptomatic SARS CoV-2 infection based on central laboratory-confirmed NAAT in participants with no serological or virological evidence (up to the start of the asymptomatic surveillance period) of past SARS-CoV-2 infection
Description
Per 1000 person-years of follow-up
Time Frame
Through 6 months after the second dose
Title
Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after a third dose of BNT162b2 at 30 µg compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals
Description
As measured at the central laboratory
Time Frame
1 month after the third dose
Title
Noninferiority of the SARS-CoV-2 reference strain neutralizing titers after one dose of BNT162b2SA compared to after 2 doses of BNT162b2, in the same individuals
Description
As measured at the central laboratory
Time Frame
1 month after the first dose of BNT162b2SA
Title
Comparison of the SARS-CoV-2 SA strain neutralizing titers after 1 dose of BNT162b2SA to after a third dose of BNT162b2 at 30 µg
Description
As measured at the central laboratory
Time Frame
1 month after the first dose of BNT162b2SA/third dose of BNT162b2
Title
Comparison of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals
Description
As measured at the central laboratory
Time Frame
1 month after the second dose of BNT162b2SA
Title
Comparison of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA to after 2 doses of BNT162b2
Description
As measured at the central laboratory
Time Frame
1 month after the second dose
Title
Comparison of the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2SA to after 2 doses of BNT162b2
Description
As measured at the central laboratory
Time Frame
1 month after the second dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
North Alabama Research Center, LLC
City
Athens
State/Province
Alabama
ZIP/Postal Code
35611
Country
United States
Facility Name
Birmingham Clinical Research Unit
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Medical Affiliated Research Center
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Optimal Research, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Chinle Comprehensive Health Care Facility
City
Chinle
State/Province
Arizona
ZIP/Postal Code
86503
Country
United States
Facility Name
Johns Hopkins Center for American Indian Health
City
Chinle
State/Province
Arizona
ZIP/Postal Code
86503
Country
United States
Facility Name
The Pain Center of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
HOPE Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States
Facility Name
Whiteriver Indian Hospital
City
Whiteriver
State/Province
Arizona
ZIP/Postal Code
85941
Country
United States
Facility Name
Anaheim Clinical Trials, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Collaborative Neuroscience Research, LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Long Beach Clinical Trials Services Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Velocity Clinical Research, North Hollywood
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Paradigm Clinical Research Center
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Facility Name
Kaiser Permanente Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Clinical and Translational Science Center (CTSC) Clinical Research Center (CCRC)
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
California Research Foundation
City
San Diego
State/Province
California
ZIP/Postal Code
92123-1881
Country
United States
Facility Name
Kaiser Permanente Santa Clara
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
Bayview Research Group
City
Valley Village
State/Province
California
ZIP/Postal Code
91607
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Lynn Institute of Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Clinical Research Consulting, LLC
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
Yale Center for Clinical Investigations (CSRU)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Alliance for Multispecialty Research
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
DeLand Clinical Research Unit
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Fleming Island Center for Clinical Research
City
Fleming Island
State/Province
Florida
ZIP/Postal Code
32003
Country
United States
Facility Name
Indago Research & Health Center, Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Research Centers of America
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Acevedo Clinical Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
IACT Health
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Solaris Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
Optimal Research
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
University of Iowa Hospitals & Clinics Investigational Drug Servces
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
42242
Country
United States
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51106
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Kentucky Pediatric/ Adult Research
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Benchmark Research
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
LSU Health Sciences Center at Shreveport Clinical Trials Office
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
LSUHSC-Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Pharmaron CPC, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Maryland Medical Center Investigational Drug Service Pharmacy
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Maryland, Baltimore, Health Sciences Research Facility III
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Maryland, Center for Vaccine Development and Global Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
UMass Memorial Medical Center - University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Michigan Center for Medical Research
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
MedPharmics, LLC
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39503
Country
United States
Facility Name
Clinical Research Professionals
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Facility Name
Sundance Clinical Research, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Bozeman Health Deaconess Hospital dba Bozeman Health Clinical Research
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Bozeman Health Deaconess Hospital
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Methodist Physicians Clinic / CCT Research
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
Quality Clinical Research, Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Wake Research-Clinical Research Center of Nevada, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Amici Clinical Research
City
Raritan
State/Province
New Jersey
ZIP/Postal Code
08869
Country
United States
Facility Name
South Jersey Infectious Disease
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
Johns Hopkins Center for American Indian Health
City
Gallup
State/Province
New Mexico
ZIP/Postal Code
87301
Country
United States
Facility Name
Johns Hopkins Center for American Indian Health
City
Shiprock
State/Province
New Mexico
ZIP/Postal Code
87420
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Binghamton
State/Province
New York
ZIP/Postal Code
13901
Country
United States
Facility Name
Meridian Clinical Research LLC
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Rochester Clinical Research, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
University of Rochester Medical Center- Kari Steinmetz
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY Upstate Medical University Global Health Research Unit
City
Syracuse
State/Province
New York
ZIP/Postal Code
13215
Country
United States
Facility Name
Meridian Clinical Research LLC
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Facility Name
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
PMG Research of Charlotte LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Accessioning Unit and Repository
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27703
Country
United States
Facility Name
Duke Vaccine and Trials Unit
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27703
Country
United States
Facility Name
Clinical Research Pickett Road
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke Investigational Drug Service Pharmacy
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
PharmQuest
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
PMG Research of Hickory, LLC
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
PMG Research of Raleigh, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
M3 Wake Research, Inc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
PMG Research of Salisbury, LLC
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
PMG Research of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
PMG Research of Winston-Salem, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Lillestol Research Llc
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Meridian Clinical Research LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
VA Northeast Ohio Healthcare System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Velocity Clinical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Aventiv Research Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Dayton Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
Dayton Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
PriMED Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45419
Country
United States
Facility Name
Senders Pediatrics
City
South Euclid
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Facility Name
Lynn Institute of Norman
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73072
Country
United States
Facility Name
Kaiser Permanente Northwest-Center for Health Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Lehigh Valley Health Network/Network Office of Research and Innovation
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18102
Country
United States
Facility Name
Velocity Clinical Research, Providence
City
East Greenwich
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Facility Name
Main Street Physician's Care
City
Little River
State/Province
South Carolina
ZIP/Postal Code
29566
Country
United States
Facility Name
Main Street Physician's Care
City
Loris
State/Province
South Carolina
ZIP/Postal Code
29569
Country
United States
Facility Name
Holston Medical Group
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Clinical Research Associates, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Trinity Clinical Research
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388
Country
United States
Facility Name
Benchmark Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
ARC Clinical Research at Four Points
City
Austin
State/Province
Texas
ZIP/Postal Code
78726
Country
United States
Facility Name
Tekton Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Tekton Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
North Texas Infectious Diseases Consultants, P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Ventavia Research Group, LLC
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Benchmark Research
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
Texas Health Resources
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Ventavia Research Group, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Texas Center for Drug Development, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Ventavia Research Group, LLC
City
Keller
State/Province
Texas
ZIP/Postal Code
76248
Country
United States
Facility Name
SMS Clinical Research, LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
LinQ Research, LLC
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
Benchmark Research.
City
San Angelo
State/Province
Texas
ZIP/Postal Code
76904
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Diagnostics Research Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Martin Diagnostic Clinic
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
J. Lewis Research, Inc. / Foothill Family Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis Research, Inc. / Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Virginia Research Center LLC
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Facility Name
Benaroya Research Institute at Virginia Mason
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Wenatchee Valley Hospital
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
City
Caba
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Hospital Santo Antonio/ Associacao Obras Sociais Irma Dulce
City
Salvador
State/Province
Bahia
ZIP/Postal Code
CEP: 40415-006
Country
Brazil
Facility Name
CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda (Casa Branca)
City
Sao Paulo
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
CRS Clinical Research Services Berlin GmbH
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Medizentrum Essen Borbeck
City
Essen
ZIP/Postal Code
45355
Country
Germany
Facility Name
IKF Pneumologie GmbH & Co KG
City
Frankfurt am Main
ZIP/Postal Code
60596
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20359
Country
Germany
Facility Name
CRS Clinical Research Services Mannheim GmbH
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten Drescher
City
Stuhr
ZIP/Postal Code
28816
Country
Germany
Facility Name
Newtown Clinical Research Centre
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2113
Country
South Africa
Facility Name
Jongaie Research
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0183
Country
South Africa
Facility Name
Limpopo Clinical Research Initiative
City
Thabazimbi
State/Province
Limpopo
ZIP/Postal Code
0380
Country
South Africa
Facility Name
Tiervlei Trial Centre, Basement Level, Karl Bremer Hospital
City
Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Ankara Universitesi Tip Fakultesi, Ibni Sina Hastanesi
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Hacettepe Universitesi Tip Fakultesi
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi
City
Istanbul
ZIP/Postal Code
34020
Country
Turkey
Facility Name
Istanbul Universitesi Istanbul Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Istanbul Universitesi-Cerrahpasa, Cerrahpasa Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Medipol Mega Universite Hastanesi
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
Acibadem Atakent Hastanesi
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Facility Name
Kocaeli Universitesi Tip Fakultesi
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Sakarya Universitesi Egitim ve Arastirma Hastanesi
City
Sakarya
ZIP/Postal Code
54100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36055877
Citation
Fraiman J, Erviti J, Jones M, Greenland S, Whelan P, Kaplan RM, Doshi P. Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults. Vaccine. 2022 Sep 22;40(40):5798-5805. doi: 10.1016/j.vaccine.2022.08.036. Epub 2022 Aug 31.
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35792746
Citation
Kurhade C, Zou J, Xia H, Liu M, Yang Q, Cutler M, Cooper D, Muik A, Sahin U, Jansen KU, Ren P, Xie X, Swanson KA, Shi PY. Neutralization of Omicron sublineages and Deltacron SARS-CoV-2 by three doses of BNT162b2 vaccine or BA.1 infection. Emerg Microbes Infect. 2022 Dec;11(1):1828-1832. doi: 10.1080/22221751.2022.2099305.
Results Reference
derived
PubMed Identifier
35739094
Citation
Kurhade C, Zou J, Xia H, Cai H, Yang Q, Cutler M, Cooper D, Muik A, Jansen KU, Xie X, Swanson KA, Shi PY. Neutralization of Omicron BA.1, BA.2, and BA.3 SARS-CoV-2 by 3 doses of BNT162b2 vaccine. Nat Commun. 2022 Jun 23;13(1):3602. doi: 10.1038/s41467-022-30681-1.
Results Reference
derived
PubMed Identifier
35131133
Citation
Thomas SJ, Perez JL, Lockhart SP, Hariharan S, Kitchin N, Bailey R, Liau K, Lagkadinou E, Tureci O, Sahin U, Xu X, Koury K, Dychter SS, Lu C, Gentile TC, Gruber WC. Efficacy and safety of the BNT162b2 mRNA COVID-19 vaccine in participants with a history of cancer: subgroup analysis of a global phase 3 randomized clinical trial. Vaccine. 2022 Mar 1;40(10):1483-1492. doi: 10.1016/j.vaccine.2021.12.046. Epub 2021 Dec 24.
Results Reference
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PubMed Identifier
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Citation
Thomas SJ, Moreira ED Jr, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Perez Marc G, Polack FP, Zerbini C, Bailey R, Swanson KA, Xu X, Roychoudhury S, Koury K, Bouguermouh S, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Tureci O, Nell H, Schaefer A, Unal S, Yang Q, Liberator P, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Gruber WC, Jansen KU; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months. N Engl J Med. 2021 Nov 4;385(19):1761-1773. doi: 10.1056/NEJMoa2110345. Epub 2021 Sep 15.
Results Reference
derived
PubMed Identifier
34043894
Citation
Frenck RW Jr, Klein NP, Kitchin N, Gurtman A, Absalon J, Lockhart S, Perez JL, Walter EB, Senders S, Bailey R, Swanson KA, Ma H, Xu X, Koury K, Kalina WV, Cooper D, Jennings T, Brandon DM, Thomas SJ, Tureci O, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. N Engl J Med. 2021 Jul 15;385(3):239-250. doi: 10.1056/NEJMoa2107456. Epub 2021 May 27.
Results Reference
derived
PubMed Identifier
33524990
Citation
Vogel AB, Kanevsky I, Che Y, Swanson KA, Muik A, Vormehr M, Kranz LM, Walzer KC, Hein S, Guler A, Loschko J, Maddur MS, Ota-Setlik A, Tompkins K, Cole J, Lui BG, Ziegenhals T, Plaschke A, Eisel D, Dany SC, Fesser S, Erbar S, Bates F, Schneider D, Jesionek B, Sanger B, Wallisch AK, Feuchter Y, Junginger H, Krumm SA, Heinen AP, Adams-Quack P, Schlereth J, Schille S, Kroner C, de la Caridad Guimil Garcia R, Hiller T, Fischer L, Sellers RS, Choudhary S, Gonzalez O, Vascotto F, Gutman MR, Fontenot JA, Hall-Ursone S, Brasky K, Griffor MC, Han S, Su AAH, Lees JA, Nedoma NL, Mashalidis EH, Sahasrabudhe PV, Tan CY, Pavliakova D, Singh G, Fontes-Garfias C, Pride M, Scully IL, Ciolino T, Obregon J, Gazi M, Carrion R Jr, Alfson KJ, Kalina WV, Kaushal D, Shi PY, Klamp T, Rosenbaum C, Kuhn AN, Tureci O, Dormitzer PR, Jansen KU, Sahin U. BNT162b vaccines protect rhesus macaques from SARS-CoV-2. Nature. 2021 Apr;592(7853):283-289. doi: 10.1038/s41586-021-03275-y. Epub 2021 Feb 1.
Results Reference
derived
PubMed Identifier
33301246
Citation
Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Perez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Tureci O, Nell H, Schaefer A, Unal S, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10.
Results Reference
derived
PubMed Identifier
33053279
Citation
Walsh EE, Frenck RW Jr, Falsey AR, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Mulligan MJ, Bailey R, Swanson KA, Li P, Koury K, Kalina W, Cooper D, Fontes-Garfias C, Shi PY, Tureci O, Tompkins KR, Lyke KE, Raabe V, Dormitzer PR, Jansen KU, Sahin U, Gruber WC. Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates. N Engl J Med. 2020 Dec 17;383(25):2439-2450. doi: 10.1056/NEJMoa2027906. Epub 2020 Oct 14.
Results Reference
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PubMed Identifier
32785213
Citation
Mulligan MJ, Lyke KE, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Raabe V, Bailey R, Swanson KA, Li P, Koury K, Kalina W, Cooper D, Fontes-Garfias C, Shi PY, Tureci O, Tompkins KR, Walsh EE, Frenck R, Falsey AR, Dormitzer PR, Gruber WC, Sahin U, Jansen KU. Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults. Nature. 2020 Oct;586(7830):589-593. doi: 10.1038/s41586-020-2639-4. Epub 2020 Aug 12. Erratum In: Nature. 2021 Feb;590(7844):E26.
Results Reference
derived
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C4591001
Description
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Learn more about this trial

Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals

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