Clinical trial NCT04368728: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: SARS-CoV-2 Infection
COVID-19
Keywords: COVID-19
Coronavirus
Vaccine
SARS-CoV-2
RNA Vaccine
Lead sponsor: BioNTech SE
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2020-04-30
Enrollment: 47079
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Percentage of participants in Phase 1 reporting local reactions
timeFrame: For 7 days after dose 1 and dose 2
measure: Percentage of participants in Phase 1 reporting systemic events
timeFrame: For 7 days after dose 1 and dose 2
measure: Percentage of participants in Phase 1 reporting adverse events
timeFrame: From dose 1 through 1 month after the last dose
measure: Percentage of participants in Phase 1 reporting serious adverse events
timeFrame: From dose 1 through 6 months after the last dose
measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values
timeFrame: 1 day after dose 1
measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values
timeFrame: 7 days after dose 1
measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values
timeFrame: 7 days after dose 2
measure: Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments
timeFrame: Between baseline and 1 day after dose 1
measure: Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments
timeFrame: Between baseline and 7 days after dose 1
measure: Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments
timeFrame: Between before dose 2 and 7 days after dose 2
measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting local reactions
timeFrame: For 7 days after dose 1 and dose 2
measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting systemic events
timeFrame: For 7 days after dose 1 and dose 2
measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting adverse events
timeFrame: From dose 1 through 1 month after the last dose
measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting serious adverse events
timeFrame: From dose 1 through 6 months after the last dose
measure: In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting local reactions
timeFrame: For 7 days after dose 1 and dose 2
measure: In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting systemic events
timeFrame: For 7 days after dose 1 and dose 2
measure: Percentage of participants in Phase 2/3 reporting adverse events
timeFrame: From dose 1 through 1 month after the last dose
measure: Percentage of participants in Phase 2/3 reporting serious adverse events
timeFrame: From dose 1 through 6 months after the last dose
measure: Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination
timeFrame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years
measure: Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination
timeFrame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years
measure: Percentage of participants 12-15 years of age in Phase 3 reporting adverse events
timeFrame: From dose 1 through 1 month after the last dose
measure: Percentage of participants 12-15 years of age in Phase 3 reporting adverse events
timeFrame: From dose 1 through 6 months after the last dose
measure: In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting local reactions
timeFrame: For 7 days after dose 1 and dose 2
measure: In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting systemic events
timeFrame: For 7 days after dose 1 and dose 2
measure: In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting adverse events
timeFrame: From dose 1 through 1 month after the last dose
measure: In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting serious adverse events
timeFrame: From dose 1 through 5 or 6 months after the last dose
measure: In participants, who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting local reactions
timeFrame: For 7 days after dose 1 (and dose 2)
measure: In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting systemic events
timeFrame: For 7 days after dose 1 (and dose 2)
measure: 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
timeFrame: From the third dose through 1 month after the third dose
measure: 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
timeFrame: From the third dose through 6 months after the third dose
measure: 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
timeFrame: For 7 days after the third dose
measure: 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
timeFrame: For 7 days after the third dose
measure: In participants who receive a third dose of BNT162b2 as a result of current or anticipated recommendations, percentage of participants reporting adverse events
timeFrame: From the third dose through 1 month after the third dose
measure: In participants who receive a third dose of BNT162b2 as a result of current or anticipated recommendations, percentage of participants reporting serious adverse events
timeFrame: From the third dose through 6 months after the third dose
measure: 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
timeFrame: 1 month after the third dose
measure: 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
timeFrame: 1 month after the third dose
measure: 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
timeFrame: 1 month after the second dose
Secondary outcomes:
measure: In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs
timeFrame: Through 2 years after the final dose
measure: In Phase 1 participants, GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point
timeFrame: Through 2 years after the final dose
measure: 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
timeFrame: Through 2 years after the final dose
measure: In Phase 1 participants, SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels, expressed as GMCs
timeFrame: Through 2 years after the final dose
measure: 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
timeFrame: Through 2 years after the final dose
measure: 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
timeFrame: Through 2 years after the final dose
measure: 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
timeFrame: Through 2 years after the final dose
measure: Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination
timeFrame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years
measure: Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination
timeFrame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years
measure: Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination
timeFrame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years
measure: Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination
timeFrame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years
measure: Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination
timeFrame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years
measure: Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination
timeFrame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years
measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination
timeFrame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years
measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination
timeFrame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years
measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination
timeFrame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years
measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination
timeFrame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years
measure: GMR of SARS CoV 2 neutralizing titers in the 2 age groups (12-15 years of age to 16-25 years of age)
timeFrame: 1 month after the second dose
measure: 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
timeFrame: Through 1 month after the second dose
measure: 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
timeFrame: Through 6 months after the second dose
measure: 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
timeFrame: 1 month after the third dose
measure: 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
timeFrame: 1 month after the first dose of BNT162b2SA
measure: 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
timeFrame: 1 month after the first dose of BNT162b2SA/third dose of BNT162b2
measure: 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
timeFrame: 1 month after the second dose of BNT162b2SA
measure: Comparison of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA to after 2 doses of BNT162b2
timeFrame: 1 month after the second dose
measure: Comparison of the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2SA to after 2 doses of BNT162b2
timeFrame: 1 month after the second dose
Other outcomes:
Locations:
city: Athens
country: United States
facility: North Alabama Research Center, LLC
state: Alabama
city: Birmingham
country: United States
facility: Birmingham Clinical Research Unit
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center
state: Alabama
city: Huntsville
country: United States
facility: Optimal Research, LLC
state: Alabama
city: Mobile
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Alabama
city: Chinle
country: United States
facility: Chinle Comprehensive Health Care Facility
state: Arizona
city: Chinle
country: United States
facility: Johns Hopkins Center for American Indian Health
state: Arizona
city: Phoenix
country: United States
facility: The Pain Center of Arizona
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Tempe
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Arizona
city: Whiteriver
country: United States
facility: Whiteriver Indian Hospital
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials Services Inc.
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: North Hollywood
country: United States
facility: Velocity Clinical Research, North Hollywood
state: California
city: Redding
country: United States
facility: Paradigm Clinical Research Center
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Sacramento
state: California
city: Sacramento
country: United States
facility: Clinical and Translational Science Center (CTSC) Clinical Research Center (CCRC)
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara
state: California
city: Valley Village
country: United States
facility: Bayview Research Group
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Aurora
country: United States
facility: Lynn Institute of Denver
state: Colorado
city: Milford
country: United States
facility: Clinical Research Consulting, LLC
state: Connecticut
city: New Haven
country: United States
facility: Yale Center for Clinical Investigations (CSRU)
state: Connecticut
city: Coral Gables
country: United States
facility: Alliance for Multispecialty Research
state: Florida
city: DeLand
country: United States
facility: DeLand Clinical Research Unit
state: Florida
city: Fleming Island
country: United States
facility: Fleming Island Center for Clinical Research
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research Associates
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Columbus
country: United States
facility: IACT Health
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research, LLC
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Peoria
country: United States
facility: Optimal Research
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics Investigational Drug Servces
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Sioux City
country: United States
facility: Meridian Clinical Research, LLC
state: Iowa
city: Newton
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Wichita
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric/ Adult Research
state: Kentucky
city: Metairie
country: United States
facility: Benchmark Research
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health Sciences Center at Shreveport Clinical Trials Office
state: Louisiana
city: Shreveport
country: United States
facility: LSUHSC-Shreveport
state: Louisiana
city: Baltimore
country: United States
facility: Pharmaron CPC, Inc.
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland Medical Center Investigational Drug Service Pharmacy
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland, Baltimore, Health Sciences Research Facility III
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland, Center for Vaccine Development and Global Health
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center - University Campus
state: Massachusetts
city: Farmington Hills
country: United States
facility: Michigan Center for Medical Research
state: Michigan
city: Gulfport
country: United States
facility: MedPharmics, LLC
state: Mississippi
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Bozeman
country: United States
facility: Bozeman Health Deaconess Hospital dba Bozeman Health Clinical Research
state: Montana
city: Bozeman
country: United States
facility: Bozeman Health Deaconess Hospital
state: Montana
city: Fremont
country: United States
facility: Methodist Physicians Clinic / CCT Research
state: Nebraska
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Wake Research-Clinical Research Center of Nevada, LLC
state: Nevada
city: Raritan
country: United States
facility: Amici Clinical Research
state: New Jersey
city: Somers Point
country: United States
facility: South Jersey Infectious Disease
state: New Jersey
city: Gallup
country: United States
facility: Johns Hopkins Center for American Indian Health
state: New Mexico
city: Shiprock
country: United States
facility: Johns Hopkins Center for American Indian Health
state: New Mexico
city: Binghamton
country: United States
facility: Meridian Clinical Research, LLC
state: New York
city: Endwell
country: United States
facility: Meridian Clinical Research LLC
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center- Kari Steinmetz
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University Global Health Research Unit
state: New York
city: Vestal
country: United States
facility: Meridian Clinical Research LLC
state: New York
city: Cary
country: United States
facility: PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
state: North Carolina
city: Charlotte
country: United States
facility: PMG Research of Charlotte LLC
state: North Carolina
city: Durham
country: United States
facility: Accessioning Unit and Repository
state: North Carolina
city: Durham
country: United States
facility: Duke Vaccine and Trials Unit
state: North Carolina
city: Durham
country: United States
facility: Clinical Research Pickett Road
state: North Carolina
city: Durham
country: United States
facility: Duke Investigational Drug Service Pharmacy
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Hickory
country: United States
facility: PMG Research of Hickory, LLC
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research of Raleigh, LLC
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research, Inc.
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury, LLC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research Llc
state: North Dakota
city: Cincinnati
country: United States
facility: Meridian Clinical Research, LLC
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Meridian Clinical Research LLC
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: VA Northeast Ohio Healthcare System
state: Ohio
city: Cleveland
country: United States
facility: Velocity Clinical Research, Inc.
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research Inc.
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Dayton
country: United States
facility: PriMED Clinical Research
state: Ohio
city: South Euclid
country: United States
facility: Senders Pediatrics
state: Ohio
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Portland
country: United States
facility: Kaiser Permanente Northwest-Center for Health Research
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Health Network/Network Office of Research and Innovation
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research, Providence
state: Rhode Island
city: Little River
country: United States
facility: Main Street Physician's Care
state: South Carolina
city: Loris
country: United States
facility: Main Street Physician's Care
state: South Carolina
city: Bristol
country: United States
facility: Holston Medical Group
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Tennessee
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Tullahoma
country: United States
facility: Trinity Clinical Research
state: Tennessee
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Austin
country: United States
facility: ARC Clinical Research at Four Points
state: Texas
city: Austin
country: United States
facility: Tekton Research, Inc.
state: Texas
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Dallas
country: United States
facility: North Texas Infectious Diseases Consultants, P.A.
state: Texas
city: Fort Worth
country: United States
facility: Ventavia Research Group, LLC
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: Fort Worth
country: United States
facility: Texas Health Resources
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Ventavia Research Group, LLC
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc.
state: Texas
city: Keller
country: United States
facility: Ventavia Research Group, LLC
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research, LLC
state: Texas
city: Pearland
country: United States
facility: LinQ Research, LLC
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research.
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: Tomball
country: United States
facility: Martin Diagnostic Clinic
state: Texas
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic South
state: Utah
city: Annandale
country: United States
facility: Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
state: Virginia
city: Midlothian
country: United States
facility: Virginia Research Center LLC
state: Virginia
city: Seattle
country: United States
facility: Benaroya Research Institute at Virginia Mason
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital
state: Washington
city: Caba
country: Argentina
facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
city: Salvador
country: Brazil
facility: Hospital Santo Antonio/ Associacao Obras Sociais Irma Dulce
state: Bahia
city: Sao Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda (Casa Branca)
city: Berlin
country: Germany
facility: CRS Clinical Research Services Berlin GmbH
city: Essen
country: Germany
facility: Medizentrum Essen Borbeck
city: Frankfurt am Main
country: Germany
facility: IKF Pneumologie GmbH & Co KG
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Mannheim
country: Germany
facility: CRS Clinical Research Services Mannheim GmbH
city: Stuhr
country: Germany
facility: Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten Drescher
city: Johannesburg
country: South Africa
facility: Newtown Clinical Research Centre
state: Gauteng
city: Pretoria
country: South Africa
facility: Jongaie Research
state: Gauteng
city: Thabazimbi
country: South Africa
facility: Limpopo Clinical Research Initiative
state: Limpopo
city: Cape Town
country: South Africa
facility: Tiervlei Trial Centre, Basement Level, Karl Bremer Hospital
state: Western CAPE
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi, Ibni Sina Hastanesi
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi
city: Istanbul
country: Turkey
facility: Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Istanbul Tip Fakultesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi-Cerrahpasa, Cerrahpasa Tip Fakultesi
city: Istanbul
country: Turkey
facility: Medipol Mega Universite Hastanesi
city: Istanbul
country: Turkey
facility: Acibadem Atakent Hastanesi
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi
city: Sakarya
country: Turkey
facility: Sakarya Universitesi Egitim ve Arastirma Hastanesi
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
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