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 Adults
Latest version (submitted February 9, 2021) 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 and Oversight
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 Outcome Measures, Contacts/Locations, 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
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Changes (Merged) for Study: NCT04368728
April 29, 2020 (v1) -- July 21, 2020 (v8)

Changes in: Study Status, Arms and Interventions, Outcome Measures, Study Identification, Contacts/Locations, Study Design, References, Eligibility, Study Description and Oversight

Study Identification
Unique Protocol ID: C4591001
Brief Title: Study to Describe the Safety, Tolerability, Immunogenicity, and Potential Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Adults
Official Title: A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO DESCRIBE EVAUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND POTENTIAL EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY ADULTS
Secondary IDs: 2020-002641-42 [EudraCT Number]
Study Status
Record Verification: April 2020 July 2020
Overall Status: Active, not yet recruiting
Study Start: April 28 29, 2020
Primary Completion: January 27 June 28, 2023 2021 [Anticipated]
Study Completion: January 27 23, 2023 [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:
April 29, 2020 July 21, 2020
Last Update Posted: April 30 July 23, 2020 [Actual]
Sponsor/Collaborators
Sponsor: BioNTech SE
Responsible Party: Sponsor
Collaborators: Pfizer
Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Study Description
Brief Summary:

This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, and vaccine candidate-selection study in healthy adults.

The study will evaluate the safety, tolerability, immunogenicity, and potential efficacy of up to 4 3 different SARS-CoV-2 RNA vaccine candidates against COVID-19:

  • As a 2-dose or single-dose schedule
  • At up to 3 different dose levels
  • In 3 age groups (18 to 55 years of age, 65 to 85 years of age, and 18 to 85 years of age

The study consists of 3 stages. Stage 1: to identify preferred vaccine candidate(s), dose level(s), number of doses, and schedule of administration (with the first 15 participants at each dose level of each vaccine candidate comprising a sentinel cohort); Stage 2: an expanded-cohort stage; and Stage 3; a final candidate/dose large-scale an efficacy stage.

Detailed Description:
Conditions
Conditions: SARS-CoV-2 Infection
COVID-19
Keywords: COVID-19
Coronavirus
Vaccine
SARS-CoV-2
RNA Vaccine
Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 1 /Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 21 22
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 8640 32000 [Anticipated]
Arms and Interventions
Arms Assigned Interventions
Experimental: Low dose, 18-55 years of age (Single dose) Biological: BNT162b1
Intramuscular injection
Biological: BNT162b2
Intramuscular injection
Biological: BNT162b3
Intramuscular injection
Experimental: High- Low-mid dose, 18-55 years of age (Single dose) Biological: BNT162 a b1
0.5 mL Intramuscular injection
Biological: BNT162b2
0.5 mL Intramuscular injection
Biological: BNT162b 1 3
0.5 mL Intramuscular injection
Biological: BNT162c2
0.5 mL intramuscular injection
Experimental: Mid dose, 18-55 years of age (Single dose) Biological: BNT162 a b1
0.5 mL Intramuscular injection
Biological: BNT162b2
0.5 mL Intramuscular injection
Biological: BNT162b 1 3
0.5 mL Intramuscular injection
Experimental: Low dose, 65-85 years of age (Single dose) Biological: BNT162b1
Intramuscular injection
Biological: BNT162b2
Intramuscular injection
Biological: BNT162b3
Intramuscular injection
Experimental: High- Low-mid dose, 65-85 years of age (Single dose) Biological: BNT162 a b1
0.5 mL Intramuscular injection
Biological: BNT162b2
0.5 mL Intramuscular injection
Biological: BNT162b 1 3
0.5 mL Intramuscular injection
Biological: BNT162c2
0.5 mL intramuscular injection
Experimental: Mid dose, 65-85 years of age (Single dose) Biological: BNT162 a b1
0.5 mL Intramuscular injection
Biological: BNT162b2
0.5 mL Intramuscular injection
Biological: BNT162b 1 3
0.5 mL Intramuscular injection
Experimental: Low dose, 18-55 years of age (2 doses) Biological: BNT162b1
Intramuscular injection
Biological: BNT162b2
Intramuscular injection
Biological: BNT162b3
Intramuscular injection
Experimental: High- Low-mid dose, 18-55 years of age (2 doses) Biological: BNT162b1
Intramuscular injection
Biological: BNT162b2
0.5 mL Intramuscular injection
Biological: BNT162b 1 3
0.5 mL Intramuscular injection
Biological: BNT162c2
0.5 mL intramuscular injection
Experimental: Mid dose, 18-55 years of age (2 doses) Biological: BNT162 a b1
0.5 mL Intramuscular injection
Biological: BNT162b2
0.5 mL Intramuscular injection
Biological: BNT162b 1 3
0.5 mL Intramuscular injection
Experimental: Low dose, 65-85 years of age (2 doses) Biological: BNT162b1
Intramuscular injection
Biological: BNT162b2
Intramuscular injection
Biological: BNT162b3
Intramuscular injection
Experimental: High- Low-mid dose, 65-85 years of age (2 doses) Biological: BNT162 a b1
0.5 mL Intramuscular injection
Biological: BNT162b2
0.5 mL Intramuscular injection
Biological: BNT162b 1 3
0.5 mL Intramuscular injection
Biological: BNT162c2
0.5 mL intramuscular injection
Experimental: Mid dose, 65-85 years of age (2 doses) Biological: BNT162 a b1
0.5 mL Intramuscular injection
Biological: BNT162b2
0.5 mL Intramuscular injection
Biological: BNT162b 1 3
0.5 mL Intramuscular injection
Experimental: Low dose, 18-85 years of age (Single dose) Biological: BNT162b1
Intramuscular injection
Biological: BNT162b2
Intramuscular injection
Biological: BNT162b3
Intramuscular injection
Experimental: High- Low-mid dose, 18-85 years of age (Single dose) Biological: BNT162 a b1
0.5 mL Intramuscular injection
Biological: BNT162b2
0.5 mL Intramuscular injection
Biological: BNT162b 1 3
0.5 mL Intramuscular injection
Biological: BNT162c2
0.5 mL intramuscular injection
Experimental: Mid dose, 18-85 years of age (Single dose) Biological: BNT162 a b1
0.5 mL Intramuscular injection
Biological: BNT162b2
0.5 mL Intramuscular injection
Biological: BNT162b 1 3
0.5 mL Intramuscular injection
Experimental: Low dose, 18-85 years of age (2 doses) Biological: BNT162b1
Intramuscular injection
Biological: BNT162b2
Intramuscular injection
Biological: BNT162b3
Intramuscular injection
Experimental: High- Low-mid dose, 18-85 years of age (2 doses) Biological: BNT162 a b1
0.5 mL Intramuscular injection
Biological: BNT162b2
0.5 mL Intramuscular injection
Biological: BNT162b 1 3
0.5 mL Intramuscular injection
Biological: BNT162c2
0.5 mL intramuscular injection
Experimental: Mid dose, 18-85 years of age (2 doses) Biological: BNT162 a b1
0.5 mL Intramuscular injection
Biological: BNT162b2
0.5 mL Intramuscular injection
Biological: BNT162b 1 3
0.5 mL Intramuscular injection
Placebo Comparator: Placebo, 18-55 years of age Placebo
0.5 mL Intramuscular injection
Placebo Comparator: Placebo, 65-85 years of age Placebo
0.5 mL Intramuscular injection
Placebo Comparator: Placebo, 18-85 years of age Placebo
0.5 mL Intramuscular injection
Experimental: High dose, 18-55 years of age (2 doses) Biological: BNT162b1
Intramuscular injection
Outcome Measures
Primary Outcome Measures:
1. Percentage of participants in Stages 1 and 2 reporting local reactions
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]
2. Percentage of participants in Stages 1 and 2 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.

[Time Frame: For 7 days after dose 1 and dose 2]
3. Percentage of participants in Stages 1 and 2 reporting adverse events
As elicited by investigational site staff

[Time Frame: From dose 1 through 1 month after the last dose]
4. Percentage of participants in Stages 1 and 2 reporting serious adverse events
As elicited by investigational site staff

[Time Frame: From dose 1 through 6 months after the last dose]
5. Percentage of sentinel cohort participants with abnormal hematology and chemistry laboratory values
As measured at the central laboratory

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

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

[Time Frame: 7 days after dose 2]
8. Percentage of sentinel cohort participants with grading shifts in hematology and chemistry laboratory assessments
As measured at the central laboratory

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

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

[Time Frame: Between before dose 2 and 7 days after dose 2]
11. In the first 360 participants randomized into Stage 3, percentage of participants reporting local reactions
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]
12. In the first 360 participants randomized into Stage 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.

[Time Frame: For 7 days after dose 1 and dose 2]
13. In the first 360 participants randomized into Stage 3, percentage of participants reporting adverse events
As elicited by investigational site staff

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

[Time Frame: From dose 1 through 6 months after the last dose]
15. In a subset of at least 6000 participants randomized in Stage 3, percentage of participants reporting local reactions
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]
16. In a subset of at least 6000 participants randomized in Stage 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.

[Time Frame: For 7 days after dose 1 and dose 2]
17. Percentage of participants in Stage 3 reporting adverse events
As elicited by investigational site staff

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

[Time Frame: From dose 1 through 6 months after the last dose]
19. Confirmed COVID-19 in participants without evidence of infection before vaccination
Per 1000 person-years of follow-up

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

[Time Frame: From 7 days after the last dose of study intervention to the end of the study, up to 2 years]
Secondary Outcome Measures:
21. In Stage 1 and 2 participants, SARS-CoV-2 specific WT serum neutralizing antibody levels, expressed as GMTs
As measured at the central laboratory

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

[Time Frame: Through 2 years after the final dose]
23. Proportion of participants in Stages 1 and 2 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 specific WT serum neutralizing antibody levels
As measured at the central laboratory

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

[Time Frame: Through 2 years after the final dose]
25. Proportion of participants in Stages 1 and 2 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 spike protein-specific anti-S1 binding antibody levels and anti-RBD specific binding antibody levels
As measured at the central laboratory

[Time Frame: Through 2 years after the final dose]
26. In Stage 1 and 2 participants, GMFR in SARS-CoV-2 spike protein-specific anti-S1 binding antibody levels and anti-RBD specific binding antibody levels from before vaccination to each subsequent time point
As measured at the central laboratory

[Time Frame: Through 2 years after the final dose]
27. In Stage 1 and 2 participants, GMR of the geometric mean of SARS-CoV-2 specific WT serum neutralizing titers to the geometric mean of SARS CoV 2 ( spike protein anti-S1 and anti-RBD) specific binding antibody levels
As measured at the central laboratory

[Time Frame: Through 2 years after the final dose]
28. Confirmed COVID-19 incidence Confirmed severe COVID-19 in participants without evidence of infection before vaccination
Per 1000 person-years of follow-up

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

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

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

[Time Frame: From 7 days after the last dose of study intervention to the end of the study, up to 2 years]
32. In Stage 3 participants, SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels, expressed as GMTs
As measured at the central laboratory

[Time Frame: Through 2 years after the final dose]
33. In Stage 3 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs
As measured at the central laboratory

[Time Frame: Through 2 years after the final dose]
34. In Stage 3 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

[Time Frame: Through 2 years after the final dose]
35. In Stage 3 participants, GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point
As measured at the central laboratory

[Time Frame: Through 2 years after the final dose]
36. Percentage of participants in Stage 3 achieving titers greater than a specified threshold in SARS-CoV-2 anti-S1 binding antibody and anti-RBD binding antibody
As measured at the central laboratory

[Time Frame: Through 2 years after the final dose]
37. Percentage of participants in Stage 3 achieving a titer greater than a specified threshold in SARS-CoV-2 serum neutralizing antibody
As measured at the central laboratory

[Time Frame: Through 2 years after the final dose]
Eligibility
Minimum Age: 18 Years
Maximum Age: 85 Years
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 18 and 85 years, inclusive, at randomization (dependent upon study stage).
  • 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.
  • 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.
  • 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.
  • Stages 1 and 2 only: Previous clinical or microbiological diagnosis of COVID 19.
  • Sentinel participants in Stage 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
  • Sentinel participants in Stage 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.
  • Sentinel participants in Stage 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.
  • Sentinel participants in Stage 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.
  • Sentinel participants in Stage 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit.
  • Sentinel participants in Stage 1 only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality.
  • Sentinel participants in Stage 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.
  • Sentinel participants in Stage 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.
Contacts/Locations
Central Contact: 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
Alliance for Multispecialty Research, LLC
Mobile, Alabama, United States, 36608
United States, Arizona
HOPE Research Institute
Phoenix, Arizona, United States, 85018
Alliance for Multispecialty Research, LLC
Tempe, Arizona, United States, 85283
United States, Florida
Alliance for Multispecialty Research, LLC-Coral Gable
Coral Gables, Florida, United States, 33134
DeLand Clinical Research Unit
DeLand, Florida, United States, 32720
Fleming Island Center for Clinical Research
Fleming Island, Florida, United States, 32003
Research Centers of America
Hollywood, Florida, United States, 33024
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Clinical Neuroscience Solutions, Inc
Orlando, Florida, United States, 32801
United States, Georgia
Meridian Clinical Research, LLC
Savannah, Georgia, United States, 31406
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
United States, Iowa
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
United States, Kansas
Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States, 67207
United States, Kentucky
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States, 40004
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
University of Maryland, Center for Vaccine Development and Global Health
Baltimore, Maryland, United States, 21201
United States, Nebraska
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
United States, New York
NYU Langone Health
New York, New York, United States, 10016
Rochester Regional Health/Rochester General Hospital
Rochester, New York, United States, 14621
United States, North Carolina
PMG Research of Charlotte LLC
Charlotte, North Carolina, United States, 28209
Duke Vaccine and Trials Unit
Durham, North Carolina, United States, 27705
Duke University Medicine Circle- Duke Early Phase Clinical Research Unit
Durham, North Carolina, United States, 27710
M3 Wake Research, Inc.
Raleigh, North Carolina, United States, 27612
PMG Research of Salisbury, LLC
Salisbury, North Carolina, United States, 28144
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45206
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Aventiv Research Inc.
Columbus, Ohio, United States, 43213
United States, Tennessee
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, United States, 37920
United States, Texas
Benchmark Research
Austin, Texas, United States, 78705
Tekton Research, Inc.
Austin, Texas, United States, 78745
Ventavia Research Group, LLC
Fort Worth, Texas, United States, 76104
Benchmark Research
Fort Worth, Texas, United States, 76135
Texas Health Family Care
Fort Worth, Texas, United States, 76135
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Texas Center for Drug Development, Inc.
Houston, Texas, United States, 77081
Ventavia Research Group, LLC
Keller, Texas, United States, 76248
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
IPDSharing
Plan to Share IPD: No
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.
References
Citations:
Links: Description: To obtain contact information for a study center near you, click here.
Available IPD/Information:

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