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A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals

Primary Purpose

SARS-CoV-2 Infection, COVID-19

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BNT162b2 (Omi XBB.1.5)
Sponsored by
BioNTech SE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for SARS-CoV-2 Infection focused on measuring COVID-19, Coronavirus, Vaccine, SARS-CoV-2, RNA Vaccine, Vaccine-naïve

Eligibility Criteria

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

SSA Inclusion Criteria: Received at least 3 prior doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being a US-authorized Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before Visit 1 (Day 1). 12 years of age and older Healthy participants (stable pre-existing disease permitted). Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations. Capable of giving, or parent(s)/legal guardian capable of giving, signed informed consent. Exclusion Criteria History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines. Immunocompromised with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 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. Any medical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. History of myocarditis or pericarditis. Receipt of systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study. Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, used for the treatment or prevention of COVID-19 or those that are considered immunosuppressive, from 60 days before study vaccination or planned receipt throughout the study. Participation in other studies involving receipt of other study intervention within 28 days before enrollment. Anticipated participation in other studies involving other study intervention from enrollment through the end of this study. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members. SSB Inclusion Criteria: COVID-19 vaccine-naïve. Any positive SARS-CoV-2 test result >28 days before study intervention administration. 12 years of age and older. Healthy participants (stable pre-existing disease permitted). Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations. Capable of giving or parent(s)/legal guardian capable of giving, signed informed consent. Exclusion Criteria: History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 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. Any 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. History of myocarditis or pericarditis. Receipt of systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids*, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study. Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies used for the treatment or prevention of COVID-19 or those that are considered immunosuppressive, from 60 days before study intervention administration or planned receipt throughout the study. Participation in other studies involving receipt of other study intervention within 28 days before enrollment. Anticipated participation in other studies involving other study intervention from enrollment through the end of this study. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Sites / Locations

  • North Alabama Research Center
  • Medical Affiliated Research Center
  • Alliance for Multispecialty Research, LLC
  • Epic Medical Research - Surprise
  • Alliance for Multispecialty Research, LLC
  • West Coast Research
  • California Research Foundation
  • Bayview Research Group, LLC
  • Diablo Clinical Research, Inc.
  • Clinical Research Consulting
  • Indago Research & Health Center, Inc
  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
  • Care Research - West Flagler Street
  • Acevedo Clinical Research Associates
  • Clinical Neuroscience Solutions, Inc.
  • Clinical Research Atlanta
  • East-West Medical Research Institute
  • Kentucky Pediatric/ Adult Research
  • Alliance for Multispecialty Research, LLC
  • Ascension St. John Hospital
  • Bio-Kinetic Clinical Applications, LLD dba QPS-MO
  • M3 Wake Research, Inc.
  • Centricity Research Columbus Ohio Multispecialty
  • Dayton Clinical Research
  • Senders Pediatrics
  • Epic Medical Research-Oklahoma
  • Alliance for Multispecialty Research, LLC
  • Clinical Neuroscience Solutions Inc.
  • Elligo Clinical Research Center
  • Zenos Clinical Research
  • Epic Medical Research - DeSoto
  • DM Clinical Research - Bellaire
  • SMS Clinical Research
  • IMA Clinical Research San Antonio
  • DM Clinical Research
  • Alliance for Multispecialty Research, LLC
  • J. Lewis Research, Inc. / Foothill Family Clinic
  • J. Lewis Research, Inc. / Foothill Family Clinic South
  • Alliance for Multispecialty Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SSA: Group 1

SSB: Group 2

Arm Description

Participants 12 years of age and older, COVID-19 vaccine-experienced will receive 30 µg of BNT162b2 (Omi XBB.1.5) at Visit 1.

Participants 12 years of age and older who were previously exposed to SARS-CoV-2 and are COVID-19 vaccine-naïve will receive 30 μg of BNT162b2 (Omi XBB.1.5) at Visit 1

Outcomes

Primary Outcome Measures

SSA: Percentage of participants reporting local reactions
Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
SSA: 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 in electronic diaries
SSA: Percentage of participants reporting adverse events
As elicited by the investigational staff
SSA: Percentage of participants reporting serious adverse events
As elicited by the investigational staff
SSA: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron XBB.1.5- and Omicron BA.4/BA.5-neutralizing antibody levels for BNT162b2 (Omi XBB.1.5) 30 µg
As measured at the central laboratory
SSA: Geometric Mean Fold Rise (GMFR; change between 2 timepoints) of SARS-CoV-2 Omicron XBB.1.5-and Omicron BA.4/BA.5-neutralizing antibody levels for BNT162b2 (Omi XBB.1.5) 30 µg
As measured at the central laboratory
SSA: Percentages of participants with seroresponse to BNT162b2 (Omi XBB.1.5) 30 µg in terms of GMTs of SARS-CoV-2 Omicron XBB.1.5- and Omicron BA.4/BA.5-neutralizing antibody levels
As measured at the central laboratory
SSB: Percentage of participants reporting local reactions
Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
SSB: 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 in electronic diaries.
SSB: Percentage of participants reporting adverse events
As elicited by the investigational staff.
SSB: Percentage of participants reporting serious adverse events
As elicited by the investigational staff.
SSB: Geometric Mean Ratio (GMR) of the SARS-CoV-2 XBB.1.5-neutralizing titers after BNT162b2 (Omi XBB.1.5) 30 μg given as single dose to COVID-19 vaccine-naïve subjects to BNT162b2 (Omi XBB.1.5) 30 μg given to vaccine-experienced participants in SSA.
As measured at the central laboratory
Difference in percentages of subjects with seroresponse to XBB.1.5 strain after BNT162b2 (Omi XBB.1.5) 30 μg given as single dose to COVID-19 vaccine-naïve subjects compared to BNT162b2 (Omi XBB.1.5) 30 μg given to vaccine experienced subjects in SSA
As measured at the central laboratory

Secondary Outcome Measures

Full Information

First Posted
August 10, 2023
Last Updated
October 20, 2023
Sponsor
BioNTech SE
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05997290
Brief Title
A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals
Official Title
A PHASE 2/3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b2 RNA-BASED VACCINE CANDIDATES FOR SARS-CoV-2 NEW VARIANTS IN HEALTHY INDIVIDUALS
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 10, 2023 (Actual)
Primary Completion Date
March 19, 2024 (Anticipated)
Study Completion Date
March 19, 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this clinical protocol is to learn about the safety, tolerability, and immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of SARS-CoV-2 in healthy people. Substudy A: This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose, in people who are 12 years of age and older, who previously received at least 3 doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being an Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before the study vaccination (Visit 1). The study is about 6 months long for each participant. Participants will have at least 5 visits to the clinic. At each clinic visit a blood sample will be taken. At least 1 nasal swab will taken. Substudy B: This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose, in people who are 12 years of age and older, who are COVID-19 vaccine-naïve who have had any positive SARS-CoV-2 test result >28 days before study vaccine administration. The study is about 6 months long for each participant. Participants will have at least 5 visits to the clinic. At each clinic visit a blood sample will be taken. At least 1 nasal swab will taken.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Phase 2/3, controlled study
Masking
None (Open Label)
Masking Description
Open-label
Allocation
N/A
Enrollment
731 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SSA: Group 1
Arm Type
Experimental
Arm Description
Participants 12 years of age and older, COVID-19 vaccine-experienced will receive 30 µg of BNT162b2 (Omi XBB.1.5) at Visit 1.
Arm Title
SSB: Group 2
Arm Type
Experimental
Arm Description
Participants 12 years of age and older who were previously exposed to SARS-CoV-2 and are COVID-19 vaccine-naïve will receive 30 μg of BNT162b2 (Omi XBB.1.5) at Visit 1
Intervention Type
Biological
Intervention Name(s)
BNT162b2 (Omi XBB.1.5)
Intervention Description
BNT162b2 monovalent (Omicron XBB.1.5)
Primary Outcome Measure Information:
Title
SSA: Percentage of participants reporting local reactions
Description
Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
Time Frame
For up to 7 days following the study vaccination
Title
SSA: Percentage of participants reporting systemic events
Description
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries
Time Frame
For up to 7 days following the study vaccination
Title
SSA: Percentage of participants reporting adverse events
Description
As elicited by the investigational staff
Time Frame
Through 1 month after the study vaccination
Title
SSA: Percentage of participants reporting serious adverse events
Description
As elicited by the investigational staff
Time Frame
Through 6 months after the study vaccination
Title
SSA: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron XBB.1.5- and Omicron BA.4/BA.5-neutralizing antibody levels for BNT162b2 (Omi XBB.1.5) 30 µg
Description
As measured at the central laboratory
Time Frame
At 1 month after the study vaccination
Title
SSA: Geometric Mean Fold Rise (GMFR; change between 2 timepoints) of SARS-CoV-2 Omicron XBB.1.5-and Omicron BA.4/BA.5-neutralizing antibody levels for BNT162b2 (Omi XBB.1.5) 30 µg
Description
As measured at the central laboratory
Time Frame
From before study vaccination (Day 1) to 1 month after study vaccination
Title
SSA: Percentages of participants with seroresponse to BNT162b2 (Omi XBB.1.5) 30 µg in terms of GMTs of SARS-CoV-2 Omicron XBB.1.5- and Omicron BA.4/BA.5-neutralizing antibody levels
Description
As measured at the central laboratory
Time Frame
At 1 month after the study vaccination
Title
SSB: Percentage of participants reporting local reactions
Description
Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
Time Frame
For up to 7 days following the study vaccination
Title
SSB: Percentage of participants reporting systemic events
Description
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries.
Time Frame
For up to 7 days following the study vaccination
Title
SSB: Percentage of participants reporting adverse events
Description
As elicited by the investigational staff.
Time Frame
Through 1 month after the study vaccination
Title
SSB: Percentage of participants reporting serious adverse events
Description
As elicited by the investigational staff.
Time Frame
Through 6 months after the study vaccination
Title
SSB: Geometric Mean Ratio (GMR) of the SARS-CoV-2 XBB.1.5-neutralizing titers after BNT162b2 (Omi XBB.1.5) 30 μg given as single dose to COVID-19 vaccine-naïve subjects to BNT162b2 (Omi XBB.1.5) 30 μg given to vaccine-experienced participants in SSA.
Description
As measured at the central laboratory
Time Frame
At 1 month after vaccination.
Title
Difference in percentages of subjects with seroresponse to XBB.1.5 strain after BNT162b2 (Omi XBB.1.5) 30 μg given as single dose to COVID-19 vaccine-naïve subjects compared to BNT162b2 (Omi XBB.1.5) 30 μg given to vaccine experienced subjects in SSA
Description
As measured at the central laboratory
Time Frame
At 1 month after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
SSA Inclusion Criteria: Received at least 3 prior doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being a US-authorized Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before Visit 1 (Day 1). 12 years of age and older Healthy participants (stable pre-existing disease permitted). Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations. Capable of giving, or parent(s)/legal guardian capable of giving, signed informed consent. Exclusion Criteria History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines. Immunocompromised with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 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. Any medical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. History of myocarditis or pericarditis. Receipt of systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study. Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, used for the treatment or prevention of COVID-19 or those that are considered immunosuppressive, from 60 days before study vaccination or planned receipt throughout the study. Participation in other studies involving receipt of other study intervention within 28 days before enrollment. Anticipated participation in other studies involving other study intervention from enrollment through the end of this study. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members. SSB Inclusion Criteria: COVID-19 vaccine-naïve. Any positive SARS-CoV-2 test result >28 days before study intervention administration. 12 years of age and older. Healthy participants (stable pre-existing disease permitted). Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations. Capable of giving or parent(s)/legal guardian capable of giving, signed informed consent. Exclusion Criteria: History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 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. Any 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. History of myocarditis or pericarditis. Receipt of systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids*, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study. Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies used for the treatment or prevention of COVID-19 or those that are considered immunosuppressive, from 60 days before study intervention administration or planned receipt throughout the study. Participation in other studies involving receipt of other study intervention within 28 days before enrollment. Anticipated participation in other studies involving other study intervention from enrollment through the end of this study. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
North Alabama Research Center
City
Athens
State/Province
Alabama
ZIP/Postal Code
35611
Country
United States
Facility Name
Medical Affiliated Research Center
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Epic Medical Research - Surprise
City
Surprise
State/Province
Arizona
ZIP/Postal Code
85378
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States
Facility Name
West Coast Research
City
Dublin
State/Province
California
ZIP/Postal Code
94568
Country
United States
Facility Name
California Research Foundation
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Bayview Research Group, LLC
City
Valley Village
State/Province
California
ZIP/Postal Code
91607
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Clinical Research Consulting
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
Indago Research & Health Center, Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Care Research - West Flagler Street
City
Miami
State/Province
Florida
ZIP/Postal Code
33130
Country
United States
Facility Name
Acevedo Clinical Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Kentucky Pediatric/ Adult Research
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Ascension St. John Hospital
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Bio-Kinetic Clinical Applications, LLD dba QPS-MO
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
Facility Name
M3 Wake Research, Inc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Centricity Research Columbus Ohio Multispecialty
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Dayton Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Senders Pediatrics
City
South Euclid
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Facility Name
Epic Medical Research-Oklahoma
City
Chickasha
State/Province
Oklahoma
ZIP/Postal Code
73018
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Clinical Neuroscience Solutions Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Elligo Clinical Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Facility Name
Zenos Clinical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Epic Medical Research - DeSoto
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
DM Clinical Research - Bellaire
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
SMS Clinical Research
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
IMA Clinical Research San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
J. Lewis Research, Inc. / Foothill Family Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis Research, Inc. / Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C4591054
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals

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