ClinicalTrials.gov

History of Changes for Study: NCT04368728
Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
Latest version (submitted February 27, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 29, 2020 None (earliest Version on record)
2 May 4, 2020 Recruitment Status, Study Status, Study Design, References, Contacts/Locations, Oversight and Study Identification
3 May 5, 2020 Study Design and Study Status
4 May 13, 2020 Study Status and Contacts/Locations
5 June 4, 2020 Study Status, Contacts/Locations, Study Design and Study Identification
6 June 26, 2020 Contacts/Locations, Study Design and Study Status
7 July 15, 2020 Recruitment Status, Arms and Interventions, Outcome Measures, Study Status, Contacts/Locations, Eligibility, Study Design, Study Description and Study Identification
8 July 21, 2020 Contacts/Locations, Study Design, Study Status and Study Identification
9 July 27, 2020 IPDSharing, References, Contacts/Locations, Study Design, Study Status and Study Identification
10 July 30, 2020 Recruitment Status, Study Status and Contacts/Locations
11 July 31, 2020 Arms and Interventions, Outcome Measures, Study Status, References, Contacts/Locations, Eligibility, Study Design and Study Description
12 August 6, 2020 Contacts/Locations and Study Status
13 August 17, 2020 Contacts/Locations and Study Status
14 September 3, 2020 Contacts/Locations and Study Status
15 September 25, 2020 Contacts/Locations, Eligibility, Study Status, Arms and Interventions, Study Identification, Study Design and Study Description
16 October 14, 2020 Contacts/Locations, Study Status and Eligibility
17 October 23, 2020 Contacts/Locations, Outcome Measures, Arms and Interventions, Eligibility, Study Description and Study Status
18 October 30, 2020 Contacts/Locations and Study Status
19 November 11, 2020 Study Status, Contacts/Locations and Outcome Measures
20 November 20, 2020 Study Status and Contacts/Locations
21 December 15, 2020 Study Status and Contacts/Locations
22 December 22, 2020 Arms and Interventions, Study Description and Study Status
23 January 8, 2021 Study Status, Contacts/Locations and Study Design
24 January 20, 2021 Recruitment Status, Study Status, Contacts/Locations, Outcome Measures and Study Design
25 February 9, 2021 Study Status
26 March 17, 2021 Contacts/Locations, Arms and Interventions, Study Status and Study Description
27 March 30, 2021 Contacts/Locations, Arms and Interventions, Study Status, Outcome Measures, Eligibility and Study Description
28 April 9, 2021 Recruitment Status, Study Status and Contacts/Locations
29 April 29, 2021 Arms and Interventions, Outcome Measures, Contacts/Locations, Eligibility, Study Design, Study Description and Study Status
30 May 28, 2021 Study Status, Contacts/Locations and Study Design
31 July 21, 2021 Study Status, Contacts/Locations and Eligibility
32 August 4, 2021 Study Status and Contacts/Locations
33 August 25, 2021 Contacts/Locations and Study Status
34 October 20, 2021 Outcome Measures, Study Status, Contacts/Locations, Study Design and Study Description
35 December 2, 2021 Contacts/Locations, Study Status and Study Design
36 December 21, 2021 Contacts/Locations and Study Status
37 February 1, 2022 Study Status and Contacts/Locations
38 February 17, 2022 IPDSharing, Study Status and Contacts/Locations
39 March 25, 2022 Contacts/Locations and Study Status
40 May 6, 2022 Contacts/Locations and Study Status
41 June 30, 2022 Recruitment Status, Contacts/Locations, Study Status and Study Design
42 August 8, 2022 Contacts/Locations and Study Status
43 September 14, 2022 Study Status, Contacts/Locations and Study Design
44 October 13, 2022 Study Status
45 November 22, 2022 Study Status and Study Design
46 January 23, 2023 Study Status, Contacts/Locations and Study Design
47 February 27, 2023 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT04368728
Submitted Date:  September 25, 2020 (v15)

Open or close this module Study Identification
Unique Protocol ID: C4591001
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
Secondary IDs: 2020-002641-42 [EudraCT Number]
Open or close this module Study Status
Record Verification: September 2020
Overall Status: Recruiting
Study Start: April 29, 2020
Primary Completion: June 13, 2021 [Anticipated]
Study Completion: December 11, 2022 [Anticipated]
First Submitted: April 27, 2020
First Submitted that
Met QC Criteria:
April 29, 2020
First Posted: April 30, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
September 25, 2020
Last Update Posted: September 29, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: BioNTech SE
Responsible Party: Sponsor
Collaborators: Pfizer
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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 2 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;
  • In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥16 years of age [stratified as ≤55 or >55 years of age]).

The candidate selected for evaluation in Phase 2/3 is BNT162b2 (mid-dose).

Detailed Description:
Open or close this module Conditions
Conditions: SARS-CoV-2 Infection
COVID-19
Keywords: COVID-19
Coronavirus
Vaccine
SARS-CoV-2
RNA Vaccine
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 2/Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 11
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 43998 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Low dose, 18-55 years of age (2 doses) Biological: BNT162b1
Intramuscular injection
Biological: BNT162b2
Intramuscular injection
Experimental: Low-mid dose, 18-55 years of age (2 doses) Biological: BNT162b1
Intramuscular injection
Biological: BNT162b2
Intramuscular injection
Experimental: Mid dose, 18-55 years of age (2 doses) Biological: BNT162b1
Intramuscular injection
Biological: BNT162b2
Intramuscular injection
Experimental: Low dose, 65-85 years of age (2 doses) Biological: BNT162b1
Intramuscular injection
Biological: BNT162b2
Intramuscular injection
Experimental: Low-mid dose, 65-85 years of age (2 doses) Biological: BNT162b1
Intramuscular injection
Biological: BNT162b2
Intramuscular injection
Experimental: Mid dose, 65-85 years of age (2 doses) Biological: BNT162b1
Intramuscular injection
Biological: BNT162b2
Intramuscular injection
Experimental: Mid dose, ≥16 years of age (2 doses) Biological: BNT162b2
Intramuscular injection
Placebo Comparator: Placebo, 18-55 years of age
Placebo
Intramuscular injection
Placebo Comparator: Placebo, 65-85 years of age
Placebo
Intramuscular injection
Placebo Comparator: Placebo, ≥16 years of age
Placebo
Intramuscular injection
Experimental: High dose, 18-55 years of age (2 doses) Biological: BNT162b1
Intramuscular injection
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Percentage of participants in Phase 1 reporting local reactions
[ Time Frame: For 7 days after dose 1 and dose 2 ]

Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
2. Percentage of participants in Phase 1 reporting systemic events
[ Time Frame: For 7 days after dose 1 and dose 2 ]

Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
3. Percentage of participants in Phase 1 reporting adverse events
[ Time Frame: From dose 1 through 1 month after the last dose ]

As elicited by investigational site staff
4. Percentage of participants in Phase 1 reporting serious adverse events
[ Time Frame: From dose 1 through 6 months after the last dose ]

As elicited by investigational site staff
5. Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values
[ Time Frame: 1 day after dose 1 ]

As measured at the central laboratory
6. Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values
[ Time Frame: 7 days after dose 1 ]

As measured at the central laboratory
7. Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values
[ Time Frame: 7 days after dose 2 ]

As measured at the central laboratory
8. Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments
[ Time Frame: Between baseline and 1 day after dose 1 ]

As measured at the central laboratory
9. Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments
[ Time Frame: Between baseline and 7 days after dose 1 ]

As measured at the central laboratory
10. Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments
[ Time Frame: Between before dose 2 and 7 days after dose 2 ]

As measured at the central laboratory
11. In the first 360 participants randomized into Phase 2/3, percentage of participants reporting local reactions
[ Time Frame: For 7 days after dose 1 and dose 2 ]

Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
12. In the first 360 participants randomized into Phase 2/3, percentage of participants reporting systemic events
[ Time Frame: For 7 days after dose 1 and dose 2 ]

Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
13. In the first 360 participants randomized into Phase 2/3, percentage of participants reporting adverse events
[ Time Frame: From dose 1 through 1 month after the last dose ]

As elicited by investigational site staff
14. In the first 360 participants randomized into Phase 2/3, percentage of participants reporting serious adverse events
[ Time Frame: From dose 1 through 6 months after the last dose ]

As elicited by investigational site staff
15. In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting local reactions
[ Time Frame: For 7 days after dose 1 and dose 2 ]

Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
16. In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting systemic events
[ Time Frame: For 7 days after dose 1 and dose 2 ]

Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
17. Percentage of participants in Phase 2/3 reporting adverse events
[ Time Frame: From dose 1 through 1 month after the last dose ]

As elicited by investigational site staff
18. Percentage of participants in Phase 2/3 reporting serious adverse events
[ Time Frame: From dose 1 through 6 months after the last dose ]

As elicited by investigational site staff
19. Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination
[ Time Frame: From 7 days after the last dose of study intervention to the end of the study, up to 2 years ]

Per 1000 person-years of follow-up
20. Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination
[ Time Frame: From 7 days after the last dose of study intervention to the end of the study, up to 2 years ]

Per 1000 person-years of follow-up
Secondary Outcome Measures:
1. In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs
[ Time Frame: Through 2 years after the final dose ]

As measured at the central laboratory
2. In Phase 1 participants, GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point
[ Time Frame: Through 2 years after the final dose ]

As measured at the central laboratory
3. 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
[ Time Frame: Through 2 years after the final dose ]

As measured at the central laboratory
4. In Phase 1 participants, SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels, expressed as GMCs
[ Time Frame: Through 2 years after the final dose ]

As measured at the central laboratory
5. 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
[ Time Frame: Through 2 years after the final dose ]

As measured at the central laboratory
6. 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
[ Time Frame: Through 2 years after the final dose ]

As measured at the central laboratory
7. 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
[ Time Frame: Through 2 years after the final dose ]

As measured at the central laboratory
8. Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination
[ Time Frame: From 7 days after the last dose of study intervention to the end of the study, up to 2 years ]

Per 1000 person-years of follow-up
9. Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination
[ Time Frame: From 7 days after the last dose of study intervention to the end of the study, up to 2 years ]

Per 1000 person-years of follow-up
10. Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination
[ Time Frame: From 7 days after the last dose of study intervention to the end of the study, up to 2 years ]

Per 1000 person-years of follow-up
11. Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination
[ Time Frame: From 7 days after the last dose of study intervention to the end of the study, up to 2 years ]

Per 1000 person-years of follow-up
Open or close this module Eligibility
Minimum Age: 16 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or ≥16 years, inclusive, at randomization (dependent upon study phase).
  • 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.
  • 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 or microbiological 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 and/or during 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.
Open or close this module Contacts/Locations
Central Contact Person: Pfizer CT.gov Call Center
Telephone: 1-800-718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Study Officials: Pfizer CT.gov Call Center
Study Director
Pfizer
Locations: United States, Alabama
North Alabama Research Center, LLC
[Recruiting]
Athens, Alabama, United States, 35611
Birmingham Clinical Research Unit
[Recruiting]
Birmingham, Alabama, United States, 35216
Medical Affiliated Research Center
[Recruiting]
Huntsville, Alabama, United States, 35801
Optimal Research, LLC
[Recruiting]
Huntsville, Alabama, United States, 35802
Alliance for Multispecialty Research, LLC
[Recruiting]
Mobile, Alabama, United States, 36608
United States, Arizona
Chinle Comprehensive Health Care Facility
[Not yet recruiting]
Chinle, Arizona, United States, 86503
Johns Hopkins Center for American Indian Health
[Not yet recruiting]
Chinle, Arizona, United States, 86503
HOPE Research Institute
[Recruiting]
Phoenix, Arizona, United States, 85018
The Pain Center of Arizona
[Recruiting]
Phoenix, Arizona, United States, 85018
HOPE Research Institute
[Recruiting]
Phoenix, Arizona, United States, 85023
Alliance for Multispecialty Research, LLC
[Recruiting]
Tempe, Arizona, United States, 85283
United States, California
Anaheim Clinical Trials, LLC
[Recruiting]
Anaheim, California, United States, 92801
Collaborative Neuroscience Research, LLC
[Recruiting]
Garden Grove, California, United States, 92845
Collaborative Neuroscience Research, LLC
[Recruiting]
Long Beach, California, United States, 90806
Long Beach Clinical Trials Services Inc.
[Recruiting]
Long Beach, California, United States, 90806
Kaiser Permanente Los Angeles Medical Center
[Recruiting]
Los Angeles, California, United States, 90027
National Research Institute
[Recruiting]
Los Angeles, California, United States, 90057
Providence Clinical Research
[Recruiting]
North Hollywood, California, United States, 91606
Paradigm Clinical Research Center
[Recruiting]
Redding, California, United States, 96001
Kaiser Permanente Sacramento
[Recruiting]
Sacramento, California, United States, 95815
UC Davis Medical Center
[Recruiting]
Sacramento, California, United States, 95817
California Research Foundation
[Recruiting]
San Diego, California, United States, 92123-1881
Kaiser Permanente Santa Clara
[Recruiting]
Santa Clara, California, United States, 95051
Bayview Research Group
[Recruiting]
Valley Village, California, United States, 91607
Diablo Clinical Research, Inc.
[Recruiting]
Walnut Creek, California, United States, 94598
United States, Colorado
Lynn Institute of Denver
[Recruiting]
Aurora, Colorado, United States, 80012
United States, Connecticut
Clinical Research Consulting, LLC
[Recruiting]
Milford, Connecticut, United States, 06460
Yale University
[Recruiting]
New Haven, Connecticut, United States, 06510
Yale-New Haven Hospital; Investigational Drug Service
[Recruiting]
New Haven, Connecticut, United States, 06511
Yale Center for Clinical Investigations (CSRU)
[Recruiting]
New Haven, Connecticut, United States, 06519
United States, Florida
Alliance for Multispecialty Research, LLC-Coral Gable
[Recruiting]
Coral Gables, Florida, United States, 33134
DeLand Clinical Research Unit
[Recruiting]
DeLand, Florida, United States, 32720
Fleming Island Center for Clinical Research
[Recruiting]
Fleming Island, Florida, United States, 32003
Indago Research & Health Center, Inc.
[Recruiting]
Hialeah, Florida, United States, 33012
Research Centers of America
[Recruiting]
Hollywood, Florida, United States, 33024
Jacksonville Center for Clinical Research
[Recruiting]
Jacksonville, Florida, United States, 32216
Clinical Neuroscience Solutions, Inc.
[Recruiting]
Jacksonville, Florida, United States, 32256
Acevedo Clinical Research Associates
[Recruiting]
Miami, Florida, United States, 33142
Clinical Neuroscience Solutions, Inc
[Recruiting]
Orlando, Florida, United States, 32801
United States, Georgia
Atlanta Center for Medical Research
[Recruiting]
Atlanta, Georgia, United States, 30331
IACT Health
[Recruiting]
Columbus, Georgia, United States, 31904
Meridian Clinical Research, LLC
[Recruiting]
Savannah, Georgia, United States, 31406
Clinical Research Atlanta
[Recruiting]
Stockbridge, Georgia, United States, 30281
United States, Hawaii
East-West Medical Research Institute
[Recruiting]
Honolulu, Hawaii, United States, 96814
United States, Idaho
Solaris Clinical Research
[Recruiting]
Meridian, Idaho, United States, 83646
United States, Illinois
Optimal Research, LLC
[Recruiting]
Peoria, Illinois, United States, 61614
United States, Iowa
University of Iowa Hospitals & Clinics Investigational Drug Services
[Recruiting]
Iowa City, Iowa, United States, 52242
University of Iowa Hospitals & Clinics
[Recruiting]
Iowa City, Iowa, United States, 52242
United States, Kansas
Alliance for Multispecialty Research, LLC
[Recruiting]
Newton, Kansas, United States, 67114
Alliance for Multispecialty Research, LLC
[Recruiting]
Wichita, Kansas, United States, 67207
United States, Kentucky
Kentucky Pediatric/ Adult Research
[Recruiting]
Bardstown, Kentucky, United States, 40004
United States, Louisiana
Benchmark Research
[Recruiting]
Metairie, Louisiana, United States, 70006
Ochsner Clinic Foundation
[Recruiting]
New Orleans, Louisiana, United States, 70121
LSUHSC-Shreveport Clinical Trials Office
[Recruiting]
Shreveport, Louisiana, United States, 71101
LSUHSC-Shreveport
[Recruiting]
Shreveport, Louisiana, United States, 71103
United States, Maryland
Pharmaron CPC, Inc.
[Recruiting]
Baltimore, Maryland, United States, 21201
University of Maryland, Center for Vaccine Development and Global Health
[Active, not recruiting]
Baltimore, Maryland, United States, 21201
Center for Immunization Research Inpatient Unit
[Recruiting]
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Boston Medical Center
[Recruiting]
Boston, Massachusetts, United States, 02118
UMass Memorial Medical Center - University Campus
[Recruiting]
Worcester, Massachusetts, United States, 01655
UMass Memorial Medical Center
[Recruiting]
Worcester, Massachusetts, United States, 01655
United States, Michigan
Michigan Center for Medical Research
[Recruiting]
Farmington Hills, Michigan, United States, 48334
United States, Mississippi
MedPharmics, LLC
[Recruiting]
Gulfport, Mississippi, United States, 39503
United States, Missouri
Clinical Research Professionals
[Recruiting]
Chesterfield, Missouri, United States, 63005
Sundance Clinical Research, LLC
[Recruiting]
Saint Louis, Missouri, United States, 63141
United States, Montana
Bozeman Health Deaconess Hospital dba Bozeman Health Clinical Research
[Recruiting]
Bozeman, Montana, United States, 59715
United States, Nebraska
Methodist Physicians Clinic / CCT Research
[Recruiting]
Fremont, Nebraska, United States, 68025
Meridian Clinical Research, LLC
[Recruiting]
Norfolk, Nebraska, United States, 68701
Quality Clinical Research, Inc.
[Recruiting]
Omaha, Nebraska, United States, 68114
Meridian Clinical Research
[Recruiting]
Omaha, Nebraska, United States, 68134
United States, Nevada
Wr-Crcn, Llc
[Recruiting]
Las Vegas, Nevada, United States, 89104
United States, New Jersey
Amici Clinical Research
[Recruiting]
Raritan, New Jersey, United States, 08869
South Jersey Infectious Disease
[Recruiting]
Somers Point, New Jersey, United States, 08244
United States, New Mexico
Gallup Indian Medical Center
[Not yet recruiting]
Gallup, New Mexico, United States, 87301
Johns Hopkins Center for American Indian Health
[Not yet recruiting]
Gallup, New Mexico, United States, 87301
Johns Hopkins Center for American Indian Health
[Not yet recruiting]
Shiprock, New Mexico, United States, 87420
Northern Navajo Medical Center
[Not yet recruiting]
Shiprock, New Mexico, United States, 87420
United States, New York
Meridian Clinical Research, LLC
[Recruiting]
Binghamton, New York, United States, 13901
Meridian Clinical Research
[Recruiting]
Endwell, New York, United States, 13760
NYU Langone Health
[Active, not recruiting]
New York, New York, United States, 10016
Icahn School of Medicine at Mount Sinai - Investigational Drug Service
[Recruiting]
New York, New York, United States, 10029
Icahn School of Medicine at Mount Sinai
[Recruiting]
New York, New York, United States, 10029
Rochester Clinical Research, Inc.
[Recruiting]
Rochester, New York, United States, 14609
Rochester Regional Health/Rochester General Hospital
[Active, not recruiting]
Rochester, New York, United States, 14621
SUNY Upstate Medical University
[Recruiting]
Syracuse, New York, United States, 13210
United States, North Carolina
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
[Recruiting]
Cary, North Carolina, United States, 27518
PMG Research of Charlotte LLC
[Recruiting]
Charlotte, North Carolina, United States, 28209
Duke Vaccine and Trials Unit
[Active, not recruiting]
Durham, North Carolina, United States, 27705
Duke Investigational Drug Service Pharmacy
[Active, not recruiting]
Durham, North Carolina, United States, 27710
Duke University Medicine Circle- Duke Early Phase Clinical Research Unit
[Active, not recruiting]
Durham, North Carolina, United States, 27710
PharmQuest
[Recruiting]
Greensboro, North Carolina, United States, 27408
PMG Research of Hickory, LLC
[Recruiting]
Hickory, North Carolina, United States, 28601
PMG Research of Raleigh, LLC
[Recruiting]
Raleigh, North Carolina, United States, 27609
M3 Wake Research, Inc.
[Recruiting]
Raleigh, North Carolina, United States, 27612
PMG Research of Salisbury, LLC
[Recruiting]
Salisbury, North Carolina, United States, 28144
PMG Research of Wilmington, LLC
[Recruiting]
Wilmington, North Carolina, United States, 28401
PMG Research of Winston-Salem, LLC
[Recruiting]
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Lillestol Research LLC
[Recruiting]
Fargo, North Dakota, United States, 58104
United States, Ohio
Cincinnati Children's Hospital Medical Center
[Active, not recruiting]
Cincinnati, Ohio, United States, 45206
Sterling Research Group, Ltd.
[Recruiting]
Cincinnati, Ohio, United States, 45219
Cincinnati Children's Hospital Medical Center
[Active, not recruiting]
Cincinnati, Ohio, United States, 45229-3039
Sterling Research Group, Ltd.
[Recruiting]
Cincinnati, Ohio, United States, 45246
University Hospitals Cleveland Medical Center
[Recruiting]
Cleveland, Ohio, United States, 44106
VA Northeast Ohio Healthcare System
[Recruiting]
Cleveland, Ohio, United States, 44106
Rapid Medical Research, Inc.
[Recruiting]
Cleveland, Ohio, United States, 44122
Aventiv Research Inc.
[Recruiting]
Columbus, Ohio, United States, 43213
Dayton Clinical Research
[Recruiting]
Dayton, Ohio, United States, 45406
PriMED Clinical Research
[Recruiting]
Dayton, Ohio, United States, 45419
Senders Pediatrics
[Recruiting]
South Euclid, Ohio, United States, 44121
United States, Oklahoma
Lynn Institute of Norman
[Recruiting]
Norman, Oklahoma, United States, 73069
United States, Oregon
Kaiser Permanente Northwest-Center for Health Research
[Recruiting]
Portland, Oregon, United States, 97227
United States, Pennsylvania
Lehigh Valley Health Network/Network Office of Research and Innovation
[Recruiting]
Allentown, Pennsylvania, United States, 18102
United States, Rhode Island
Omega Medical Research
[Recruiting]
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Main Street Physician's Care
[Recruiting]
Little River, South Carolina, United States, 29566
Main Street Physician's Care
[Recruiting]
Loris, South Carolina, United States, 29569
United States, South Dakota
Meridian Clinical Research
[Recruiting]
Dakota Dunes, South Dakota, United States, 57049
United States, Tennessee
Holston Medical Group
[Recruiting]
Bristol, Tennessee, United States, 37620
Holston Medical Group
[Recruiting]
Kingsport, Tennessee, United States, 37660
Alliance for Multispecialty Research, LLC
[Recruiting]
Knoxville, Tennessee, United States, 37920
Clinical Neuroscience Solutions, Inc.
[Recruiting]
Memphis, Tennessee, United States, 38119
Clinical Research Associates, Inc.
[Recruiting]
Nashville, Tennessee, United States, 37203
Trinity Clinical Research
[Recruiting]
Tullahoma, Tennessee, United States, 37388
United States, Texas
Benchmark Research
[Recruiting]
Austin, Texas, United States, 78705
ARC Clinical Research at Wilson Parke
[Recruiting]
Austin, Texas, United States, 78726
Tekton Research, Inc.
[Recruiting]
Austin, Texas, United States, 78745
North Texas Infectious Diseases Consultants, P.A.
[Recruiting]
Dallas, Texas, United States, 75246
Ventavia Research Group, LLC
[Recruiting]
Fort Worth, Texas, United States, 76104
Benchmark Research
[Recruiting]
Fort Worth, Texas, United States, 76135
Texas Health Family Care
[Recruiting]
Fort Worth, Texas, United States, 76135
University of Texas Medical Branch
[Recruiting]
Galveston, Texas, United States, 77555
Dr. Van Tran Family Practice
[Recruiting]
Houston, Texas, United States, 77008
Hany H. Ahmed, MD
[Recruiting]
Houston, Texas, United States, 77008
Ventavia Research Group, LLC
[Recruiting]
Houston, Texas, United States, 77008
Texas Center for Drug Development, Inc.
[Recruiting]
Houston, Texas, United States, 77081
Ventavia Research Group, LLC
[Recruiting]
Keller, Texas, United States, 76248
SMS Clinical Research, LLC
[Recruiting]
Mesquite, Texas, United States, 75149
LinQ Research, LLC
[Recruiting]
Pearland, Texas, United States, 77584
Benchmark Research - Intake Facility
[Active, not recruiting]
San Angelo, Texas, United States, 76904
Benchmark Research.
[Active, not recruiting]
San Angelo, Texas, United States, 76904
Clinical Trials of Texas, Inc.
[Recruiting]
San Antonio, Texas, United States, 78229
Diagnostics Research Group
[Recruiting]
San Antonio, Texas, United States, 78229
DM Clinical Research
[Recruiting]
Tomball, Texas, United States, 77375
Martin Diagnostic Clinic
[Recruiting]
Tomball, Texas, United States, 77375
United States, Utah
J. Lewis Research, Inc. / Foothill Family Clinic
[Recruiting]
Salt Lake City, Utah, United States, 84109
J. Lewis Research, Inc. / Foothill Family Clinic South
[Recruiting]
Salt Lake City, Utah, United States, 84121
United States, Virginia
Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
[Recruiting]
Annandale, Virginia, United States, 22003
Infectious Diseases Physicians, LLC
[Recruiting]
Annandale, Virginia, United States, 22003
Virginia Research Center LLC
[Recruiting]
Midlothian, Virginia, United States, 23114
United States, Washington
Benaroya Research Institute at Virginia Mason
[Recruiting]
Seattle, Washington, United States, 98101
Wenatchee Valley Hospital
[Recruiting]
Wenatchee, Washington, United States, 98801
Argentina
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
[Recruiting]
Caba, Argentina, 1426
Brazil
CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda (Casa Branca)
[Recruiting]
São Paulo, Brazil, 04266-010
Brazil, BA
Hospital Santo Antonio/ Associacao Obras Sociais Irma Dulce
[Recruiting]
Salvador, BA, Brazil, 40415-006
South Africa, Gauteng
Newtown Clinical Research Centre
[Not yet recruiting]
Johannesburg, Gauteng, South Africa, 2113
Jongaie Research
[Not yet recruiting]
Pretoria, Gauteng, South Africa, 0183
South Africa, Limpopo
Limpopo Clinical Research Initiative
[Not yet recruiting]
Thabazimbi, Limpopo, South Africa, 0380
South Africa, Western CAPE
Tiervlei Trial Centre, Basement Level, Karl Bremer Hospital
[Not yet recruiting]
Cape Town, Western CAPE, South Africa, 7530
Turkey
Ankara Universitesi Tip Fakultesi, Ibni Sina Hastanesi
[Not yet recruiting]
Ankara, Turkey, 06230
Hacettepe Universitesi Tip Fakultesi
[Not yet recruiting]
Ankara, Turkey, 06230
Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi
[Not yet recruiting]
Istanbul, Turkey, 34020
Istanbul Universitesi Istanbul Tip Fakultesi
[Not yet recruiting]
Istanbul, Turkey, 34093
Istanbul Universitesi-Cerrahpasa, Cerrahpasa Tip Fakultesi
[Not yet recruiting]
Istanbul, Turkey, 34098
Medipol Mega Universite Hastanesi
[Not yet recruiting]
Istanbul, Turkey, 34214
Acibadem Atakent Hastanesi
[Not yet recruiting]
Istanbul, Turkey, 34303
Kocaeli Universitesi Tip Fakultesi
[Not yet recruiting]
Kocaeli, Turkey, 41380
Sakarya Universitesi Egitim ve Arastirma Hastanesi
[Not yet recruiting]
Sakarya, Turkey, 54100
Open or close this module IPDSharing
Plan to Share IPD: Yes
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Supporting Information:
Time Frame:
Access Criteria:
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Open or close this module References
Links: Description: To obtain contact information for a study center near you, click here.
Available IPD/Information:

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