History of Changes for Study: NCT06178991

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.

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Study Record Versions

Version	Submitted Date	Changes
1	December 20, 2023	None (earliest Version on record)
2	January 22, 2024	Recruitment Status, Contacts/Locations, Study Status and Oversight
3	February 6, 2024	Arms and Interventions, Study Status, Contacts/Locations, Outcome Measures, Study Design and Study Description
4	April 16, 2024	Study Status, Contacts/Locations and Study Design

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Study Identification


Unique Protocol ID:	C5261002
Brief Title:	A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.
Official Title:	A PHASE 3, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A COMBINED MODIFIED RNA VACCINE CANDIDATE AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALS
Secondary IDs:

Study Status


Record Verification:	December 2023 February 2024
Overall Status:	Not yet recruiting Recruiting
Study Start:	December 21 20, 2023
Primary Completion:	August 30 29, 2024 [Anticipated]
Study Completion:	August 30 29, 2024 [Anticipated]

First Submitted:	December 20, 2023
First Submitted that Met QC Criteria:	December 20, 2023
First Posted:	December 21, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	December 20, 2023 February 6, 2024
Last Update Posted:	December 21, 2023 [Actual] February 7, 2024 [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:

The purpose of this study is to understand the safety and effects of a combined influenza and COVID-19 vaccine. This combined vaccine is compared to separate vaccines for the protection against influenza and SARS-CoV-2. Influenza and COVID-19 are diseases that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. Giving both influenza and COVID-19 vaccines together against influenza and SARS-CoV-2 could provide great benefits to both patients and caregivers in terms of simple and easy care. Around 7500 9000 participants will be assigned into 1 of 4 vaccination groups (Group A, B, C or D) by chance.

Cohort 1: Around 4500 participants will be assigned by chance to one of the following:

Group A:Influenza and COVID-19 combination A vaccine, given at the same time in the right arm and placebo (an injection consisting of just salt water and no medicines in it) in the left arm.
Group B: Licensed influenza COVID-19 vaccine, given at the same time to the right arm and COVID-19 Vaccine licensed influenza vaccine in the left arm.

Cohort 2: Around 3000 4500 participants will be assigned by chance to one of the following:

Group C: Influenza and COVID-19 combination B vaccine, given at the same time in the right arm and placebo in the left arm.
Group D: Licensed influenza COVID-19 vaccine, given at the same time in the right arm and COVID-19 licenced influenza vaccine in the left arm.

All participants will receive 2 injections as per their assigned study group at Visit 1. The participants will be followed for about 6 months. During this time, the study will compare participant experiences when they receive a combined vaccination to when they receive separate vaccinations. This will help understand if the study medicine is safe.

Detailed Description:

Conditions


Conditions:	Influenza COVID-19
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Prevention
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	4
Masking:	Double (Participant, Investigator)
Allocation:	Randomized
Enrollment:	7500 9000 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Cohort 1 Arm A: Influenza and COVID-19 Combination A and Placebo Cohort 1 Arm A: Influenza and COVID-19 combination A vaccine and Placebo	Biological: Influenza and COVID-19 Combination A Combined influenza and Pfizer-BioNTech COVID-19 Vaccine Biological: Placebo Saline Solution
Active Comparator: Cohort 1 Arm B: Licensed COVID-19 vaccine and licensed influenza vaccine and COVID-19 concomitant administration group Cohort 1 Arm B: Licensed COVID-19 vaccine and licensed influenza vaccine and COVID-19 concomitant administration group	Biological: Licensed influenza vaccine Licensed influenza vaccine Biological: COVID-19 Vaccine Pfizer-BioNTech COVID-19 vaccine
Experimental: Cohort 2 Arm C:Influenza and COVID-19 Combination B and Placebo Cohort 2 Arm C: Influenza and COVID-19 Combination B vaccine and Placebo	Biological: Influenza and COVID-19 Combination B Combined influenza and Pfizer-BioNTech COVID-19 vaccine Biological: Placebo Saline Solution
Active Comparator: Cohort 2 Arm D: Licensed COVID-19 vaccine and licensed influenza vaccine and COVID-19 concomitant administration group Cohort 2 Arm D: Licensed COVID-19 vaccine and licensed influenza vaccine and COVID-19 concomitant administration group	Biological: Licensed influenza vaccine Licensed influenza vaccine Biological: COVID-19 Vaccine Pfizer-BioNTech COVID-19 vaccine

Outcome Measures


Primary Outcome Measures:
1.	Percentage of participants reporting prompted local reactions within 7 days following investigational product administration in the right deltoid [ Time Frame: Day 7 ] Describe prompted local reactions following investigational product administration
2.	Percentage of participants reporting prompted systemic events within 7 days following investigational product administration [ Time Frame: Day 7 ] Describe prompted systemic events following investigational product administration
3.	Percentage of participants reporting adverse events (AEs) through 4 weeks following investigational product administration [ Time Frame: 4 weeks after vaccination ] Describe AEs occurring through 4 weeks following administration of investigational product
4.	Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration [ Time Frame: 6 months after vaccination ] Describe SAEs through 1 month 6 months following administration of investigational product
5.	GMR of HAI titers in Influenza and COVID-19 combination A recipients compared to licensed influenza vaccine recipients 4 weeks after vaccination [ Time Frame: 4 weeks after vaccination ] To demonstrate that the immune response elicited by Influenza and COVID-19 combination A is noninferior to that elicited by licensed influenza vaccine and COVID-19 concomitant administration group
6.	The difference in percentage of participants achieving seroconversion at 4 weeks after vaccination in Influenza and COVID-19 combination A recipients compared to licensed influenza vaccine recipients [ Time Frame: 4 weeks after vaccination ] To demonstrate that the immune response elicited by Influenza and COVID-19 combination A is noninferior to that elicited by Licensed influenza vaccine and COVID-19 concomitant administration group.
7.	GMR of SARS-CoV-2-neutralizing titers in Influenza and COVID-19 combination A recipients compared to participants having received licensed influenza vaccine and COVID-19 concomitant administration group at 4 weeks after vaccination [ Time Frame: 4 weeks after vaccination ] To demonstrate that the immune response elicited by Influenza and COVID-19 combination A is noninferior to that elicited by COVID-19 administered concomitantly with licensed influenza vaccine
8.	The difference in percentages of subjects with seroresponse at 4 weeks after vaccination in Influenza and COVID-19 combination A recipients compared to subjects having received licensed influenza vaccine and COVID-19 concomitant administration group [ Time Frame: 4 weeks after vaccination ] To demonstrate that the immune response elicited by Influenza and COVID-19 combination A is noninferior to that elicited by COVID-19 administered concomitantly with licensed influenza vaccine
9.	GMR of HAI titers in Influenza and COVID-19 combination B recipients compared to licensed influenza vaccine recipients 4 weeks after vaccination [ Time Frame: 4 weeks after vaccination ] To demonstrate that the immune response elicited by Influenza and COVID-19 combination B is noninferior to that elicited by licensed influenza vaccine administered concomitantly with COVID-19
10.	The difference in percentage of participants achieving seroconversion at 4 weeks after vaccination in Influenza and COVID-19 combination B recipients compared to licensed influenza vaccine recipients [ Time Frame: 4 weeks after vaccination ] To demonstrate that the immune response elicited by Influenza and COVID-19 combination B is noninferior to that elicited by licensed influenza vaccine administered concomitantly with COVID-19
11.	GMR of SARS-CoV-2-neutralizing titers in Influenza and COVID-19 combination B recipients compared to participants having received licensed influenza vaccine concurrently in the deltoid opposite to that used for COVID-19 at 4 weeks after vaccination [ Time Frame: 4 weeks after vaccination ] To demonstrate that the immune response elicited by Influenza and COVID-19 combination B is noninferior to that elicited by COVID-19 administered concomitantly with licensed influenza vaccine
12.	The difference in percentages of subjects with seroresponse at 4 weeks after vaccination in influenza and COVID-19 combination B recipients compared to subjects having received licensed influenza vaccine concurrently with COVID-19 [ Time Frame: 4 weeks after vaccination ] To demonstrate that the immune response elicited by Influenza and COVID-19 combination B is noninferior to that elicited by COVID-19 administered concomitantly with licensed influenza vaccine

Eligibility


Minimum Age:	18 Years
Maximum Age:	64 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
Criteria:	Inclusion Criteria: Participants 18 through 64 years of age (or the minimum age of consent in accordance with local regulations) at Visit 1. Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. Exclusion Criteria: Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration, or ongoing receipt of chronic antiviral therapy with activity against influenza. Vaccination with any investigational or licensed COVID-19 vaccine within 6 months (175 days) before study intervention administration. Please refer to the study contact for further eligibility details

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 [Not yet recruiting] Athens, Alabama, United States, 35611
	Accel Research Sites Network - Birmingham Clinical Research Unit [Not yet recruiting] Birmingham, Alabama, United States, 35216
	Medical Affiliated Research Center [Not yet recruiting] Huntsville, Alabama, United States, 35801
	Alliance for Multispecialty Research, LLC [Recruiting] Mobile, Alabama, United States, 36608
	United States, Arizona
	HOPE Research Institute [Not yet recruiting] Phoenix, Arizona, United States, 85018
	The Pain Center of Arizona [Not yet recruiting] Phoenix, Arizona, United States, 85018
	Foothills Research Center/ CCT Research [Not yet recruiting] Phoenix, Arizona, United States, 85044
	Scottsdale Clinical Trials [Not yet recruiting] Scottsdale, Arizona, United States, 85260
	Alliance for Multispecialty Research, LLC [Not yet recruiting] Tempe, Arizona, United States, 85281
	United States, Arkansas
	Baptist Health Center for Clinical Research [Not yet recruiting] Little Rock, Arkansas, United States, 72205
	United States, California
	Velocity Clinical Research, Banning [Not yet recruiting] Banning, California, United States, 92220
	Hope Clinical Research, Inc. [Not yet recruiting] Canoga Park, California, United States, 91303
	West Coast Research [Not yet recruiting] Dublin, California, United States, 94568
	Ascada Health PC dba Ascada Research [Not yet recruiting] Fullerton, California, United States, 92835
	Marvel Clinical Research [Not yet recruiting] Huntington Beach, California, United States, 92647
	Velocity Clinical Research, San Diego [Not yet recruiting] La Mesa, California, United States, 91942
	Ark Clinical Research [Not yet recruiting] Long Beach, California, United States, 90815
	Collaborative Neuroscience Research, LLC [Not yet recruiting] Los Alamitos, California, United States, 90720
	Velocity Clinical Research, Westlake Los Angeles, California, United States, 90057 Kaiser Permanente Los Angeles Medical Center [Not yet recruiting] Los Angeles, California, United States, 90027
	Kaiser Permanente [Not yet recruiting] Los Angeles, California, United States, 90027
	Velocity Clinical Research, Westlake [Not yet recruiting] Los Angeles, California, United States, 90057
	Velocity Clinical Research, North Hollywood [Not yet recruiting] North Hollywood, California, United States, 91606
	Pasadena Clinical Trials - South Arroyo Parkway [Not yet recruiting] Pasadena, California, United States, 91105
	Artemis Institute for Clinical Research [Not yet recruiting] Riverside, California, United States, 92503
	Benchmark Research [Not yet recruiting] Sacramento, California, United States, 95864
	Artemis Institute for Clinical Research [Not yet recruiting] San Diego, California, United States, 92103
	Optimal Research San Diego [Not yet recruiting] San Diego, California, United States, 92108
	Acclaim Clinical Research [Not yet recruiting] San Diego, California, United States, 92120
	Orange County Research Center [Recruiting] Tustin, California, United States, 92780
	Bayview Research Group, LLC [Not yet recruiting] Valley Village, California, United States, 91607
	Diablo Clinical Research, Inc. [Recruiting] Walnut Creek, California, United States, 94598
	United States, Connecticut
	Clinical Research Consulting [Not yet recruiting] Milford, Connecticut, United States, 06460
	United States, Florida
	Tampa Bay Medical Research [Not yet recruiting] Clearwater, Florida, United States, 33761
	Universal Axon Clinical Research, LLC [Not yet recruiting] Doral, Florida, United States, 33166
	Proactive Clinical Research,LLC [Not yet recruiting] Fort Lauderdale, Florida, United States, 33308
	Finlay Medical Research [Not yet recruiting] Greenacres City, Florida, United States, 33467
	Indago Research & Health Center, Inc [Recruiting] Hialeah, Florida, United States, 33012
	Best Quality Research,Inc. [Not yet recruiting] Hialeah, Florida, United States, 33016
	Research Centers of America ( Hollywood ) [Not yet recruiting] Hollywood, Florida, United States, 33024
	Clinical Neuroscience Solutions, Inc. dba CNS Healthcare [Not yet recruiting] Jacksonville, Florida, United States, 32256
	Optimal Research [Not yet recruiting] Melbourne, Florida, United States, 32934
	Angels Clinical Research Institute [Not yet recruiting] Miami, Florida, United States, 33122
	Miami Clinical Research [Recruiting] Miami, Florida, United States, 33155
	Gerardo Polanco, MD [Recruiting] Miami, Florida, United States, 33156
	Research Institute of South Florida [Not yet recruiting] Miami, Florida, United States, 33173
	Miami Dade Medical Research Institute, LLC Entrust Clinical Research [Not yet recruiting] Miami, Florida, United States, 33176
	Clinical Site Partners LLC, dba Flourish Research Miami, Florida, United States, 33186 Miami Dade Medical Research Institute, LLC [Recruiting] Miami, Florida, United States, 33176
	Clinical Site Partners LLC, dba Flourish Research [Not yet recruiting] Miami, Florida, United States, 33186
	Palm Springs Community Health Center [Recruiting] Miami Lakes, Florida, United States, 33014
	Panax Clinical Research [Not yet recruiting] Miami Lakes, Florida, United States, 33014
	Clinical Neuroscience Solutions, Inc. [Not yet recruiting] Orlando, Florida, United States, 32801
	Innovation Medical Research Center [Not yet recruiting] Palmetto Bay, Florida, United States, 33157
	DBC Research USA [Not yet recruiting] Pembroke Pines, Florida, United States, 33029
	United Medical Research [Not yet recruiting] Port Orange, Florida, United States, 32127
	Angels Clinical Research Institute [Not yet recruiting] Tampa, Florida, United States, 33614
	United States, Georgia
	Synexus Clinical Research US, Inc. [Not yet recruiting] Atlanta, Georgia, United States, 30328
	United States, Georgia
	Centricity Research Columbus Georgia Multispecialty [Recruiting] Columbus, Georgia, United States, 31904
	Tekton Research, LLC. [Not yet recruiting] Lawrenceville, Georgia, United States, 30043
	AGILE Clinical Research Trials, LLC [Not yet recruiting] Sandy Springs, Georgia, United States, 30328
	Velocity Clinical Research, Savannah [Not yet recruiting] Savannah, Georgia, United States, 31406
	Clinical Research Atlanta [Not yet recruiting] Stockbridge, Georgia, United States, 30281
	United States, Hawaii
	East-West Medical Research Institute [Recruiting] Honolulu, Hawaii, United States, 96814
	United States, Idaho
	Clinical Research Prime [Not yet recruiting] Idaho Falls, Idaho, United States, 83404
	Velocity Clinical Research, Boise [Not yet recruiting] Meridian, Idaho, United States, 83642
	Solaris Clinical Research [Not yet recruiting] Meridian, Idaho, United States, 83646
	United States, Illinois
	Synexus Clinical Research US, Inc. [Not yet recruiting] Chicago, Illinois, United States, 60602
	Great Lakes Clinical Trials - Ravenswood [Not yet recruiting] Chicago, Illinois, United States, 60640
	Great Lakes Clinical Trials - Gurnee [Not yet recruiting] Gurnee, Illinois, United States, 60031
	Koch Family Medicine [Not yet recruiting] Morton, Illinois, United States, 61550
	Affinity Health [Not yet recruiting] Oak Brook, Illinois, United States, 60523
	United States, Iowa
	Velocity Clinical Research, Sioux City [Not yet recruiting] Sioux City, Iowa, United States, 51106
	United States, Kansas
	Alliance for Multispecialty Research, LLC [Recruiting] Wichita, Kansas, United States, 67207
	United States, Maryland
	Pharmaron [Not yet recruiting] Baltimore, Maryland, United States, 21201
	Advanced Primary and Geriatric Care - CCT Research [Not yet recruiting] Rockville, Maryland, United States, 20850
	Jadestone Clinical Research [Not yet recruiting] Silver Spring, Maryland, United States, 20904
	United States, Michigan
	Michigan Center of Medical Research (MICHMER) [Not yet recruiting] Farmington Hills, Michigan, United States, 48334
	Headlands Research - Detroit [Not yet recruiting] Southfield, Michigan, United States, 48034
	Revival Research Institute [Not yet recruiting] Sterling Heights, Michigan, United States, 48312
	Oakland Medical Research [Not yet recruiting] Troy, Michigan, United States, 48085
	United States, Missouri
	Clinical Research Professionals [Recruiting] Chesterfield, Missouri, United States, 63005
	Alliance for Multispecialty Research, LLC [Recruiting] Kansas City, Missouri, United States, 64114
	Sundance Clinical Research Saint Louis, Missouri, United States, 63141 Saint Louis University Center for Vaccine Development [Not yet recruiting] Saint Louis, Missouri, United States, 63104
	Sundance Clinical Research [Not yet recruiting] Saint Louis, Missouri, United States, 63141
	DelRicht Research - Springfield [Active, not recruiting] Springfield, Missouri, United States, 65807
	DelRicht Research [Active, not recruiting] Springfield, Missouri, United States, 65807
	United States, Nebraska
	Velocity Clinical Research, Grand Island [Not yet recruiting] Grand Island, Nebraska, United States, 68803
	Quality Clinical Research [Not yet recruiting] Omaha, Nebraska, United States, 68114
	Velocity Clinical Research, Omaha [Not yet recruiting] Omaha, Nebraska, United States, 68134
	McGill Family Practice [Recruiting] Papillion, Nebraska, United States, 68046
	United States, Nevada
	Excel Las Vegas Clinical Research, LLC Trials [Not yet recruiting] Las Vegas, Nevada, United States, 89109 89030
	Wr-Crcn, Llc [Not yet recruiting] Las Vegas, Nevada, United States, 89106
	Excel Clinical Research, LLC [Not yet recruiting] Las Vegas, Nevada, United States, 89109
	Las Vegas Clinical Trials [Not yet recruiting] North Las Vegas, Nevada, United States, 89030
	United States, New Hampshire
	ActivMed Practices & Research, LLC. [Not yet recruiting] Portsmouth, New Hampshire, United States, 03801
	United States, New Jersey
	IMA Clinical Research Warren [Not yet recruiting] Warren, New Jersey, United States, 07059
	United States, New Mexico
	Albuquerque Clinical Trials, Inc. [Not yet recruiting] Albuquerque, New Mexico, United States, 87102
	United States, New York
	NYU Langone Health [Not yet recruiting] New York, New York, United States, 10016
	United States, New York
	Rochester Clinical Research, LLC [Recruiting] Rochester, New York, United States, 14609
	United States, North Carolina
	Duke Vaccine and Trials Unit [Not yet recruiting] Durham, North Carolina, United States, 27703
	United States, North Carolina
	Accellacare - Hickory [Not yet recruiting] Hickory, North Carolina, United States, 28601
	Monroe Biomedical Research [Not yet recruiting] Monroe, North Carolina, United States, 28112
	M3 Wake Research, Inc. [Not yet recruiting] Raleigh, North Carolina, United States, 27612
	Accellacare - Rocky Mount [Not yet recruiting] Rocky Mount, North Carolina, United States, 27804
	Accellacare - Salisbury [Not yet recruiting] Salisbury, North Carolina, United States, 28144
	Accellacare - Wilmington [Not yet recruiting] Wilmington, North Carolina, United States, 28401
	Trial Management Associates - Wilmington - Floral Parkway [Not yet recruiting] Wilmington, North Carolina, United States, 28403
	Accellacare - Winston-Salem [Not yet recruiting] Winston-Salem, North Carolina, United States, 27103
	United States, Ohio
	Synexus CTI Clinical Research US, Inc. Center [Not yet recruiting] Cincinnati, Ohio, United States, 45236 45212
	Velocity Clinical Research, Mt. Auburn [Not yet recruiting] Cincinnati, Ohio, United States, 45219
	Synexus Clinical Research US, Inc. [Not yet recruiting] Cincinnati, Ohio, United States, 45236
	Centricity Research Columbus Ohio Multispecialty [Not yet recruiting] Columbus, Ohio, United States, 43213
	United States, Oklahoma
	Lynn Institute of Norman [Not yet recruiting] Norman, Oklahoma, United States, 73072
	Lynn Health Science Institute [Recruiting] Oklahoma City, Oklahoma, United States, 73112
	United States, Oregon
	Velocity Clinical Research, Medford [Not yet recruiting] Medford, Oregon, United States, 97504
	United States, Pennsylvania
	Capital Area Research, LLC [Not yet recruiting] Camp Hill, Pennsylvania, United States, 17011
	United States, Pennsylvania
	DM Clinical Research - Philadelphia [Not yet recruiting] Philadelphia, Pennsylvania, United States, 19107
	United States, South Carolina
	Main Street Physician's Care [Not yet recruiting] Little River, South Carolina, United States, 29566
	Trial Management Associates [Not yet recruiting] Myrtle Beach, South Carolina, United States, 29572
	Coastal Carolina Research Center [Not yet recruiting] North Charleston, South Carolina, United States, 29405
	United States, Tennessee
	Internal Medicine and Pediatric Associates of Bristol [Not yet recruiting] Bristol, Tennessee, United States, 37620
	Alliance for Multispecialty Research, LLC [Not yet recruiting] Knoxville, Tennessee, United States, 37909
	New Phase Research and Development [Not yet recruiting] Knoxville, Tennessee, United States, 37909
	Accellacare US Inc., d/b/a Accellacare of Knoxville [Not yet recruiting] Knoxville, Tennessee, United States, 37912
	Alliance for Multispecialty Research, LLC [Not yet recruiting] Knoxville, Tennessee, United States, 37920
	Clinical Neuroscience Solutions Inc. [Not yet recruiting] Memphis, Tennessee, United States, 38119
	United States, Texas
	Benchmark Research [Not yet recruiting] Austin, Texas, United States, 78705
	Tekton Optimal Research , LLC. [Not yet recruiting] Austin, Texas, United States, 78745 78744
	Orion Clinical Tekton Research, LLC. [Not yet recruiting] Austin, Texas, United States, 78759 78745
	Orion Clinical Research [Not yet recruiting] Austin, Texas, United States, 78759
	Orion Clinical Research [Recruiting] Austin, Texas, United States, 78759
	Headlands Research - Brownsville [Recruiting] Brownsville, Texas, United States, 78526
	ACRC TRIALS / Family Medicine Associates of Texas [Not yet recruiting] Carrollton, Texas, United States, 75010
	DFW Clinical Research [Not yet recruiting] Dallas, Texas, United States, 75234
	Synexus Clinical Research US, Inc. [Not yet recruiting] Dallas, Texas, United States, 75234
	North Texas Infectious Diseases Consultants, P.A [Not yet recruiting] Dallas, Texas, United States, 75246
	Benchmark Research [Not yet recruiting] Fort Worth, Texas, United States, 76135
	Texas Health Family Care [Not yet recruiting] Fort Worth, Texas, United States, 76135
	University of Texas Medical Branch [Not yet recruiting] Galveston, Texas, United States, 77555-1115
	Santa Clara Family Clinic Houston, Texas, United States, 77087 DM Clinical Research - Bellaire [Not yet recruiting] Houston, Texas, United States, 77081
	Santa Clara Family Clinic [Not yet recruiting] Houston, Texas, United States, 77087
	SMS Clinical Research [Not yet recruiting] Mesquite, Texas, United States, 75149
	ACRC Trials (Administrative Location) [Not yet recruiting] Plano, Texas, United States, 75024
	AIM Trials, LLC ACRC TRIALS / North Texas Family Medicine [Not yet recruiting] Plano, Texas, United States, 75093
	AIM Trials, LLC [Not yet recruiting] Plano, Texas, United States, 75093
	Clinical Trials of Texas, LLC [Not yet recruiting] San Antonio, Texas, United States, 78229
	IMA Clinical Research San Antonio [Not yet recruiting] San Antonio, Texas, United States, 78229
	Sugar Lakes Family Practice, PA [Not yet recruiting] Sugar Land, Texas, United States, 77479
	DM Clinical Research [Not yet recruiting] Tomball, Texas, United States, 77375
	Northwest Houston Heart Center [Not yet recruiting] Tomball, Texas, United States, 77375
	United States, Utah
	Alliance for Multispecialty Research, LLC [Not yet recruiting] Layton, Utah, United States, 84041
	United States, Utah
	J. Lewis Research, Inc. / Foothill Family Clinic [Not yet recruiting] Salt Lake City, Utah, United States, 84109
	J. Lewis Research, Inc. / Foothill Family Clinic South [Not yet recruiting] Salt Lake City, Utah, United States, 84121
	J. Lewis Research, Inc. / Jordan River Family Medicine [Not yet recruiting] South Jordan, Utah, United States, 84095
	Velocity Clinical Research, Salt Lake City [Not yet recruiting] West Jordan, Utah, United States, 84088
	United States, Virginia
	Charlottesville Medical Research [Not yet recruiting] Charlottesville, Virginia, United States, 22911
	Health Research of Hampton Roads, Inc. [Recruiting] Newport News, Virginia, United States, 23606
	Alliance for Multispecialty Research, LLC [Not yet recruiting] Norfolk, Virginia, United States, 23502
	Clinical Research Partners, LLC [Not yet recruiting] Richmond, Virginia, United States, 23226

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:	URL: https://pmiform.com/clinical-trial-info-request?StudyID=C5261002 Description: To obtain contact information for a study center near you, click here.
Available IPD/Information: