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Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older (VAT00008)

Primary Purpose

COVID-19

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent D614) (primary series)
SARS-CoV-2 adjuvanted recombinant protein vaccine (bivalent D614 + B.1.351) (primary series)
Placebo
SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent B.1.351) (booster dose) >= 4 months after last vaccination
SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent D614)(primary series)& SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent B.1.351)(booster dose)>=4 months after last vaccination
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

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

Inclusion Criteria:

  • Aged 18 years or older on the day of inclusion.
  • For persons living with human immunodeficiency virus (HIV), stable HIV infection determined by participant currently on antiretrovirals with CD4 count > 200/mm3.
  • SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies.
  • Does not intend to receive an authorized/approved COVID-19 vaccine despite encouragement by the Investigator to receive the authorized vaccine available to them at the time of enrollment.
  • Informed consent form has been signed and dated
  • Able to attend all visits and to comply with all study procedures
  • Covered by health insurance, only if required by local, regional or national regulations

  • A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:

    • is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile, or
    • is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first study intervention administration until at least 12 weeks after the second study intervention administration.

A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 25 hours before any dose of study intervention.

Exclusion Criteria:

  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances.
  • Dementia or any other cognitive condition at a stage that could interfere with following the study procedures based on Investigator?s judgment.
  • Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based on Investigator?s judgment
  • Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on Investigator?s judgment.
  • Unstable acute or chronic illness that in the opinion of the Investigator or designee poses additional risk as a result of participation or that could interfere with the study procedures.
  • Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ? 38.0 C [? 100.4 F]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
  • Receipt of any vaccine in the 30 days preceding or on the day of the first study vaccination or planned receipt of any vaccine between the first study vaccination and in the 30 days following the second study vaccination except for influenza vaccination, which may be received at any time in relation to study intervention.
  • Prior administration of a coronavirus vaccine (SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome).
  • Receipt of solid-organ or bone marrow transplants in the past 180 days.
  • Receipt of anti-cancer chemotherapy in the last 90 days.
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
  • Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
  • Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.

Sites / Locations

  • AES - DRS - Simon Williamson Clinic, PC - Birmingham-Site Number:8400004
  • Optimal Research Alabama-Site Number:8400019
  • Peninsula Research Associates, Inc.-Site Number:8400021
  • Synexus Clinical Research US, Inc.-Site Number:8400013
  • Optimal Research, LLC-Site Number:8400002
  • Synexus Clinical Research US, Inc. - Orlando-Site Number:8400020
  • Synexus Research St Petersburg-Site Number:8400017
  • Synexus Clinical Research US, Inc. - Atlanta-Site Number:8400005
  • Synexus Clinical Research Chicago-Site Number:8400012
  • Chicago Clinical Research Institute, Inc.-Site Number:8400026
  • Synexus Clinical Research Evansville-Site Number:8400008
  • Synexus St. Louis-Site Number:8400006
  • Synexus Clinical Research US, Inc. - Henderson-Site Number:8400018
  • Rochester Clinical Research, Inc.-Site Number:8400023
  • Synexus Akon-Site Number:8400009
  • Synexus Clinical Research US, Inc. - Cincinnati-Site Number:8400010
  • Synexus US Columbus-Site Number:8400011
  • Synexus Clinical Research Anderson-Site Number:8400007
  • Coastal Carolina Research Center-Site Number:8400022
  • Black Hills Center for American Indian Health, Inc.-Site Number:8400025
  • Optimal Research Texas-Site Number:8400003
  • Synexus Dallas-Site Number:8400014
  • Synexus Clinical Research US, Inc. - San Antonio-Site Number:8400015
  • Synexus Clinical Research Murray-Site Number:8400016
  • Investigational Site Number :1700010
  • Investigational Site Number :1700002
  • Investigational Site Number :1700008
  • Investigational Site Number :1700001
  • Investigational Site Number :1700005
  • Investigational Site Number :1700006
  • Investigational Site Number :1700004
  • Investigational Site Number :1700007
  • Investigational Site Number :1700009
  • Investigational Site Number :1700015
  • Investigational Site Number :1700003
  • Investigational Site Number :2880002
  • Investigational Site Number :2880003
  • Investigational Site Number :2880001
  • Investigational Site Number :3400001
  • Investigational Site Number :3400002
  • Investigational Site Number :3560010
  • Investigational Site Number :3560002
  • Investigational Site Number :3560007
  • Investigational Site Number :3560001
  • Investigational Site Number :3560005
  • Investigational Site Number :3560009
  • Investigational Site Number :3560011
  • Investigational Site Number :3560004
  • Investigational Site Number :3560003
  • Investigational Site Number :3560006
  • Investigational Site Number :3920005
  • Investigational Site Number :3920004
  • Investigational Site Number :3920003
  • Investigational Site Number :3920001
  • Investigational Site Number :3920002
  • Investigational Site Number :4040008
  • Investigational Site Number :4040011
  • Investigational Site Number :4040006
  • Investigational Site Number :4040004
  • Investigational Site Number :4040002
  • Investigational Site Number :4040003
  • Investigational Site Number :4040012
  • Investigational Site Number :4040001
  • Investigational Site Number :4040007
  • Investigational Site Number :4040009
  • Investigational Site Number :4840009
  • Investigational Site Number :4840005
  • Investigational Site Number :4840004
  • Investigational Site Number :4840003
  • Investigational Site Number :4840008
  • Investigational Site Number :4840001
  • Investigational Site Number :4840006
  • Investigational Site Number :4840002
  • Investigational Site Number :5240002
  • Investigational Site Number :5240003
  • Investigational Site Number :5240001
  • Investigational Site Number :5660001
  • Investigational Site Number :1440002
  • Investigational Site Number :1440001
  • Investigational Site Number :8000002
  • Investigational Site Number :8000005
  • Investigational Site Number :8000001
  • Investigational Site Number :8000013
  • Investigational Site Number :8000007
  • Investigational Site Number :8000003
  • Investigational Site Number :8000004
  • Investigational Site Number :8000009
  • Investigational Site Number :8000014
  • Investigational Site Number :8000006
  • Investigational Site Number :8040002
  • Investigational Site Number :8040004
  • Investigational Site Number :8040003
  • Investigational Site Number :8040001
  • Investigational Site Number :8040005

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Stage 1: SARS-CoV-2 vaccine

Stage 1: Placebo

Stage 2: SARS-CoV-2 vaccine

Stage 2: Placebo

Arm Description

2 injections of monovalent SARS-CoV-2 vaccine at Day 1 and Day 22

2 injections of placebo at Day 1 and Day 22

2 injections of bivalent SARS-CoV-2 vaccine at Day 1 and Day 22

2 injections of placebo at Day 1 and Day 22

Outcomes

Primary Outcome Measures

Occurrences of symptomatic COVID-19
Symptomatic COVID-19 is defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness.
Presence of solicited injection site or systemic reactions (collected in the reactogenicity subset)
Injection site reactions: injection site pain, erythema and swelling. Systemic reactions: fever, headache, malaise, myalgia, arthralgia and chills.
Presence of non-serious unsolicited adverse events (collected in the reactogenicity subset)
Adverse events other than solicited reactions.
Presence of immediate adverse events
Immediate adverse events include unsolicited injection site and systemic adverse events occurring within 30 minutes after injection.
Presence of medically attended adverse events
Medically attended adverse events will be assessed throughout the study.
Presence of serious adverse events
Serious adverse events will be assessed throughout the study.
Presence of adverse events of special interest
Adverse events of special interest will be assessed throughout the study.
Presence of virologically-confirmed SARS-CoV-2 infections and/or symptomatic COVID-19
Percentage of participants with positive result for SARSCoV-2 infection by Nucleic Acid Amplification Test (NAAT) on at least one respiratory sample accompanied or not by protocol-defined clinical COVID-19 symptoms.

Secondary Outcome Measures

Occurrences of SARS-CoV-2 infection
SARS-CoV-2 infection is defined as a serologically-confirmed SARS-CoV-2 infection or virologically-confirmed SARS-CoV-2 infection.
Occurrence of severe COVID-19
Occurrences of asymptomatic SARS-CoV-2 infection
Asymptomatic SARS-CoV-2 infection is defined as SARS-CoV-2 infection, with no reported COVID-19-like illness episodes between enrollment and 14 days after the timepoint at which SARS-CoV-2 infection is ascertained.
Number of days with positive NAAT
Viral copies/mL in respiratory samples
Occurrences of positive NAAT in respiratory samples at each follow-up timepoint during symptomatic COVID-19
Occurrences of CDC-defined COVID-19
Virologically-confirmed SARS-CoV-2 infection with at least one of CDC-defined clinical symptoms.
Occurrences of hospitalized COVID-19
Hospitalized COVID-19 is defined as an episode of symptomatic COVID-19 that requires inpatient hospitalization.
Occurrences of symptomatic COVID-19 with severity of moderate COVID-19 or worse.
Composite endpoint of at least one of moderate or severe COVID-19.
Neutralizing antibody titer
Responders, as determined by neutralizing antibody titers
Responders are defined as participants who had baseline values below lower limit of quantification (LLOQ) with quantifiable neutralization titer above assay LLOQ at each pre-defined post-vaccination time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody
Neutralizing antibody titer fold-rise post-vaccination at all pre-defined time points
Fold-rise in antibody neutralization titer post-vaccination relative to Day 1.
2-fold rise and 4-fold-rise in neutralization antibody titer at all pre-defined time points
Fold-rise in antibody neutralization titer post-vaccination relative to Day 1.
Severity of symptoms associated with symptomatic COVID-19 episode
Occurrences of COVID-19 in each severity rating
COVID-19 severity score based on the ordinal scale of clinical assessment (7-point ordinal scale)
Death associated with COVID-19

Full Information

First Posted
May 26, 2021
Last Updated
January 3, 2023
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT04904549
Brief Title
Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older
Acronym
VAT00008
Official Title
A Parallel-group, Phase III, Multi-stage, Modified Double-blind, Multi-armed Study to Assess the Efficacy, Safety, and Immunogenicity of Two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (Monovalent and Bivalent) for Prevention Against COVID-19 in Adults 18 Years of Age and Older as a Primary Series and Open-label Extension to Assess Immunogenicity, Safety, Efficacy of a Monovalent Booster Dose of SARS-CoV2 Adjuvanted Recombinant Protein Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 26, 2021 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this Phase III study is to assess the efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) as part of primary series vaccinations in a multi-stage approach, as well as a booster injection of a CoV2 preS dTM-AS03 vaccine, in adults 18 years of age and older. A total of approximately 21 046 participants are planned to be enrolled (5080 per study intervention group in Stage 1 and 5443 per study intervention group in Stage 2). Initial, double-blind, primary series study design is planned for 365 days post-last Initial injection (ie, approximately 386 days total) for each participant. Based on decisions of the Study Oversight Group, Stage 1 and Stage 2 participants will be invited to participate in an unblinded Crossover / Booster study design with duration as follows: For participants who initially received vaccine: 12 months post-booster (ie, approximately 18 to 24 months) For participants who initially received placebo: ≥ 4 months post-last dose of the primary series + 12 months post-booster (ie, approximately 28 to 34 months) For participants who do not consent to continue in the unblinded Crossover / Booster part of the study, all study procedures will be stopped and participants will be discontinued from the study.
Detailed Description
The duration of participation in the initial, double-blind, primary series design of the study will be approximately 365 days post-last injection (ie, approximately 386 days total) for each participant. Based on decisions of the Study OG, Stage 1 and Stage 2 participants will be invited to participate in an unblinded Crossover / Booster study design with duration as follows: For participants who initially received vaccine: 12 months post-booster (ie, approximately 18 to 24 months) For participants who initially received placebo: ≥ 4 months post-last dose of the primary series + 12 months post-booster (ie, approximately 28 to 34 months) For participants who do not consent to continue in the unblinded Crossover / Booster part of the study, all study procedures will be stopped and participants will be discontinued from the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The study is designed to demonstrate clinical efficacy of each of the two SARS-CoV-2 adjuvanted recombinant protein vaccines (monovalent and bivalent). In Stage 1, the monovalent vaccine will be evaluated against a placebo control. In Stage 2, the bivalent vaccine will be assessed against a placebo control.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
For initial, double-blind, primary series design of study: participants, outcome assessors, Investigators, laboratory personnel, and sponsor trial staff are blinded to intervention group; and those preparing the study interventions are unblinded to vaccine assignment group. For crossover / booster design of study (Stage 1 and Stage 2): unblinded
Allocation
Randomized
Enrollment
23726 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stage 1: SARS-CoV-2 vaccine
Arm Type
Experimental
Arm Description
2 injections of monovalent SARS-CoV-2 vaccine at Day 1 and Day 22
Arm Title
Stage 1: Placebo
Arm Type
Placebo Comparator
Arm Description
2 injections of placebo at Day 1 and Day 22
Arm Title
Stage 2: SARS-CoV-2 vaccine
Arm Type
Experimental
Arm Description
2 injections of bivalent SARS-CoV-2 vaccine at Day 1 and Day 22
Arm Title
Stage 2: Placebo
Arm Type
Placebo Comparator
Arm Description
2 injections of placebo at Day 1 and Day 22
Intervention Type
Biological
Intervention Name(s)
SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent D614) (primary series)
Intervention Description
Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection
Intervention Type
Biological
Intervention Name(s)
SARS-CoV-2 adjuvanted recombinant protein vaccine (bivalent D614 + B.1.351) (primary series)
Intervention Description
Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form: liquid. Route of administration: intramuscular administration.
Intervention Type
Biological
Intervention Name(s)
SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent B.1.351) (booster dose) >= 4 months after last vaccination
Intervention Description
Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.
Intervention Type
Biological
Intervention Name(s)
SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent D614)(primary series)& SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent B.1.351)(booster dose)>=4 months after last vaccination
Intervention Description
Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.
Primary Outcome Measure Information:
Title
Occurrences of symptomatic COVID-19
Description
Symptomatic COVID-19 is defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness.
Time Frame
From ≥ 14 days after the second injection to Day 387
Title
Presence of solicited injection site or systemic reactions (collected in the reactogenicity subset)
Description
Injection site reactions: injection site pain, erythema and swelling. Systemic reactions: fever, headache, malaise, myalgia, arthralgia and chills.
Time Frame
Within 7 days after vaccination
Title
Presence of non-serious unsolicited adverse events (collected in the reactogenicity subset)
Description
Adverse events other than solicited reactions.
Time Frame
Within 21 days after vaccination
Title
Presence of immediate adverse events
Description
Immediate adverse events include unsolicited injection site and systemic adverse events occurring within 30 minutes after injection.
Time Frame
Within 30 minutes after vaccination
Title
Presence of medically attended adverse events
Description
Medically attended adverse events will be assessed throughout the study.
Time Frame
From Day 1 to Day 387
Title
Presence of serious adverse events
Description
Serious adverse events will be assessed throughout the study.
Time Frame
From Day 1 to Day 387
Title
Presence of adverse events of special interest
Description
Adverse events of special interest will be assessed throughout the study.
Time Frame
From Day 1 to Day 387
Title
Presence of virologically-confirmed SARS-CoV-2 infections and/or symptomatic COVID-19
Description
Percentage of participants with positive result for SARSCoV-2 infection by Nucleic Acid Amplification Test (NAAT) on at least one respiratory sample accompanied or not by protocol-defined clinical COVID-19 symptoms.
Time Frame
From Day 1 to Day 387
Secondary Outcome Measure Information:
Title
Occurrences of SARS-CoV-2 infection
Description
SARS-CoV-2 infection is defined as a serologically-confirmed SARS-CoV-2 infection or virologically-confirmed SARS-CoV-2 infection.
Time Frame
From ≥ 14 days after the second injection to Day 387
Title
Occurrence of severe COVID-19
Time Frame
From ≥ 14 days after the second injection to Day 387
Title
Occurrences of asymptomatic SARS-CoV-2 infection
Description
Asymptomatic SARS-CoV-2 infection is defined as SARS-CoV-2 infection, with no reported COVID-19-like illness episodes between enrollment and 14 days after the timepoint at which SARS-CoV-2 infection is ascertained.
Time Frame
From Day 1 to Day 387
Title
Number of days with positive NAAT
Time Frame
From Day 1 to Day 387
Title
Viral copies/mL in respiratory samples
Time Frame
From Day 1 to Day 387
Title
Occurrences of positive NAAT in respiratory samples at each follow-up timepoint during symptomatic COVID-19
Time Frame
From Day 1 to Day 387
Title
Occurrences of CDC-defined COVID-19
Description
Virologically-confirmed SARS-CoV-2 infection with at least one of CDC-defined clinical symptoms.
Time Frame
From Day 1 to Day 387
Title
Occurrences of hospitalized COVID-19
Description
Hospitalized COVID-19 is defined as an episode of symptomatic COVID-19 that requires inpatient hospitalization.
Time Frame
From Day 1 to Day 387
Title
Occurrences of symptomatic COVID-19 with severity of moderate COVID-19 or worse.
Description
Composite endpoint of at least one of moderate or severe COVID-19.
Time Frame
From Day 1 to Day 387
Title
Neutralizing antibody titer
Time Frame
Day 1, Day 22, Day 43, Day 78, Day 134, Day 202, Day 292, and Day 387
Title
Responders, as determined by neutralizing antibody titers
Description
Responders are defined as participants who had baseline values below lower limit of quantification (LLOQ) with quantifiable neutralization titer above assay LLOQ at each pre-defined post-vaccination time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody
Time Frame
Day 1, Day 22, Day 43, Day 78, Day 134, Day 202, Day 292, and Day 387
Title
Neutralizing antibody titer fold-rise post-vaccination at all pre-defined time points
Description
Fold-rise in antibody neutralization titer post-vaccination relative to Day 1.
Time Frame
Day 1, Day 22, Day 43, Day 78, Day 134, Day 202, Day 292, and Day 387
Title
2-fold rise and 4-fold-rise in neutralization antibody titer at all pre-defined time points
Description
Fold-rise in antibody neutralization titer post-vaccination relative to Day 1.
Time Frame
Day 1, Day 22, Day 43, Day 78, Day 134, Day 202, Day 292, and Day 387
Title
Severity of symptoms associated with symptomatic COVID-19 episode
Time Frame
From Day 1 to Day 387
Title
Occurrences of COVID-19 in each severity rating
Description
COVID-19 severity score based on the ordinal scale of clinical assessment (7-point ordinal scale)
Time Frame
From Day 1 to Day 387
Title
Death associated with COVID-19
Time Frame
From Day 1 to day 387

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 18 years or older on the day of inclusion. For persons living with human immunodeficiency virus (HIV), stable HIV infection determined by participant currently on antiretrovirals with CD4 count > 200/mm3. SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies. Does not intend to receive an authorized/approved COVID-19 vaccine despite encouragement by the Investigator to receive the authorized vaccine available to them at the time of enrollment. Informed consent form has been signed and dated Able to attend all visits and to comply with all study procedures Covered by health insurance, only if required by local, regional or national regulations A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile, or is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first study intervention administration until at least 12 weeks after the second study intervention administration. A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 25 hours before any dose of study intervention. Exclusion Criteria: Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances. Dementia or any other cognitive condition at a stage that could interfere with following the study procedures based on Investigator?s judgment. Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based on Investigator?s judgment Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on Investigator?s judgment. Unstable acute or chronic illness that in the opinion of the Investigator or designee poses additional risk as a result of participation or that could interfere with the study procedures. Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ? 38.0 C [? 100.4 F]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. Receipt of any vaccine in the 30 days preceding or on the day of the first study vaccination or planned receipt of any vaccine between the first study vaccination and in the 30 days following the second study vaccination except for influenza vaccination, which may be received at any time in relation to study intervention. Prior administration of a coronavirus vaccine (SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome). Receipt of solid-organ or bone marrow transplants in the past 180 days. Receipt of anti-cancer chemotherapy in the last 90 days. Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
Facility Information:
Facility Name
AES - DRS - Simon Williamson Clinic, PC - Birmingham-Site Number:8400004
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Optimal Research Alabama-Site Number:8400019
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
Facility Name
Peninsula Research Associates, Inc.-Site Number:8400021
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Synexus Clinical Research US, Inc.-Site Number:8400013
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Optimal Research, LLC-Site Number:8400002
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32934
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Orlando-Site Number:8400020
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Synexus Research St Petersburg-Site Number:8400017
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Atlanta-Site Number:8400005
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Synexus Clinical Research Chicago-Site Number:8400012
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Chicago Clinical Research Institute, Inc.-Site Number:8400026
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Synexus Clinical Research Evansville-Site Number:8400008
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Synexus St. Louis-Site Number:8400006
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Henderson-Site Number:8400018
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Rochester Clinical Research, Inc.-Site Number:8400023
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Synexus Akon-Site Number:8400009
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Cincinnati-Site Number:8400010
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Synexus US Columbus-Site Number:8400011
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Synexus Clinical Research Anderson-Site Number:8400007
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Coastal Carolina Research Center-Site Number:8400022
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Black Hills Center for American Indian Health, Inc.-Site Number:8400025
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Optimal Research Texas-Site Number:8400003
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Synexus Dallas-Site Number:8400014
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - San Antonio-Site Number:8400015
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Synexus Clinical Research Murray-Site Number:8400016
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Investigational Site Number :1700010
City
Aguazul
Country
Colombia
Facility Name
Investigational Site Number :1700002
City
Barranquilla
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Investigational Site Number :1700008
City
Barranquilla
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Investigational Site Number :1700001
City
Bogota
ZIP/Postal Code
111611
Country
Colombia
Facility Name
Investigational Site Number :1700005
City
Cali
ZIP/Postal Code
760002
Country
Colombia
Facility Name
Investigational Site Number :1700006
City
Chia
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Investigational Site Number :1700004
City
Floridablanca
ZIP/Postal Code
681004
Country
Colombia
Facility Name
Investigational Site Number :1700007
City
Girardot
ZIP/Postal Code
00000
Country
Colombia
Facility Name
Investigational Site Number :1700009
City
Meta
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Investigational Site Number :1700015
City
Quindio
ZIP/Postal Code
630001
Country
Colombia
Facility Name
Investigational Site Number :1700003
City
Soledad
ZIP/Postal Code
083001
Country
Colombia
Facility Name
Investigational Site Number :2880002
City
Kintampo
ZIP/Postal Code
P. O. Box 200
Country
Ghana
Facility Name
Investigational Site Number :2880003
City
Kumasi
ZIP/Postal Code
00000
Country
Ghana
Facility Name
Investigational Site Number :2880001
City
Navrongo
ZIP/Postal Code
114
Country
Ghana
Facility Name
Investigational Site Number :3400001
City
Municipio Del Distrito Central
ZIP/Postal Code
11101
Country
Honduras
Facility Name
Investigational Site Number :3400002
City
San Pedro Sula
ZIP/Postal Code
21104
Country
Honduras
Facility Name
Investigational Site Number :3560010
City
Ajmer
ZIP/Postal Code
305001
Country
India
Facility Name
Investigational Site Number :3560002
City
Ambawadi
ZIP/Postal Code
380015
Country
India
Facility Name
Investigational Site Number :3560007
City
Belgaum
ZIP/Postal Code
590002
Country
India
Facility Name
Investigational Site Number :3560001
City
Jaipur
ZIP/Postal Code
302039
Country
India
Facility Name
Investigational Site Number :3560005
City
Kanpur
ZIP/Postal Code
208002
Country
India
Facility Name
Investigational Site Number :3560009
City
Nagpur
ZIP/Postal Code
440001
Country
India
Facility Name
Investigational Site Number :3560011
City
Odisha
ZIP/Postal Code
751003
Country
India
Facility Name
Investigational Site Number :3560004
City
Patna
ZIP/Postal Code
801507
Country
India
Facility Name
Investigational Site Number :3560003
City
Punjagutta
ZIP/Postal Code
500082
Country
India
Facility Name
Investigational Site Number :3560006
City
Tamilnadu
ZIP/Postal Code
603203
Country
India
Facility Name
Investigational Site Number :3920005
City
Chiyoda-ku,
State/Province
Tokyo
ZIP/Postal Code
101-0041
Country
Japan
Facility Name
Investigational Site Number :3920004
City
Haramachi,Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-0053
Country
Japan
Facility Name
Investigational Site Number :3920003
City
Kouenji minami,Suginami-ku
State/Province
Tokyo
ZIP/Postal Code
166-0003
Country
Japan
Facility Name
Investigational Site Number :3920001
City
Kyobashi Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Facility Name
Investigational Site Number :3920002
City
Ohta-ku
State/Province
Tokyo
ZIP/Postal Code
143-0015
Country
Japan
Facility Name
Investigational Site Number :4040008
City
Mombasa
State/Province
Washington
ZIP/Postal Code
80107 Ganjoni
Country
Kenya
Facility Name
Investigational Site Number :4040011
City
Butere
ZIP/Postal Code
50101
Country
Kenya
Facility Name
Investigational Site Number :4040006
City
Eldoret
ZIP/Postal Code
30100
Country
Kenya
Facility Name
Investigational Site Number :4040004
City
Kericho
ZIP/Postal Code
00200
Country
Kenya
Facility Name
Investigational Site Number :4040002
City
Kisumu
ZIP/Postal Code
40100
Country
Kenya
Facility Name
Investigational Site Number :4040003
City
Kisumu
ZIP/Postal Code
40100
Country
Kenya
Facility Name
Investigational Site Number :4040012
City
Kisumu
ZIP/Postal Code
40123 Kisumu
Country
Kenya
Facility Name
Investigational Site Number :4040001
City
Nairobi
ZIP/Postal Code
00100GPO
Country
Kenya
Facility Name
Investigational Site Number :4040007
City
Nairobi
ZIP/Postal Code
00100
Country
Kenya
Facility Name
Investigational Site Number :4040009
City
Thika
ZIP/Postal Code
00202 Kiambu
Country
Kenya
Facility Name
Investigational Site Number :4840009
City
Mexico City
State/Province
Ciudad De Mexico
ZIP/Postal Code
04530
Country
Mexico
Facility Name
Investigational Site Number :4840005
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Investigational Site Number :4840004
City
Acapulco
State/Province
Guerrero
ZIP/Postal Code
39670
Country
Mexico
Facility Name
Investigational Site Number :4840003
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Investigational Site Number :4840008
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62290
Country
Mexico
Facility Name
Investigational Site Number :4840001
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Investigational Site Number :4840006
City
Temixco
ZIP/Postal Code
62587
Country
Mexico
Facility Name
Investigational Site Number :4840002
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Facility Name
Investigational Site Number :5240002
City
Dhulikhel
ZIP/Postal Code
45200
Country
Nepal
Facility Name
Investigational Site Number :5240003
City
Kathmandu
ZIP/Postal Code
44600
Country
Nepal
Facility Name
Investigational Site Number :5240001
City
Nepalgunj
ZIP/Postal Code
21900
Country
Nepal
Facility Name
Investigational Site Number :5660001
City
Abuja
ZIP/Postal Code
900271
Country
Nigeria
Facility Name
Investigational Site Number :1440002
City
Angoda
ZIP/Postal Code
11010
Country
Sri Lanka
Facility Name
Investigational Site Number :1440001
City
Ragama
ZIP/Postal Code
11010
Country
Sri Lanka
Facility Name
Investigational Site Number :8000002
City
Entebbe
ZIP/Postal Code
0
Country
Uganda
Facility Name
Investigational Site Number :8000005
City
Entebbe
ZIP/Postal Code
0
Country
Uganda
Facility Name
Investigational Site Number :8000001
City
Kampala
ZIP/Postal Code
0
Country
Uganda
Facility Name
Investigational Site Number :8000013
City
Kampala
ZIP/Postal Code
10101
Country
Uganda
Facility Name
Investigational Site Number :8000007
City
Kampala
ZIP/Postal Code
23491
Country
Uganda
Facility Name
Investigational Site Number :8000003
City
Kampala
ZIP/Postal Code
42 Nakasero Road
Country
Uganda
Facility Name
Investigational Site Number :8000004
City
Kampala
ZIP/Postal Code
Plot 101, Lubowa
Country
Uganda
Facility Name
Investigational Site Number :8000009
City
Kampala
Country
Uganda
Facility Name
Investigational Site Number :8000014
City
Lira
ZIP/Postal Code
10101
Country
Uganda
Facility Name
Investigational Site Number :8000006
City
Tororo
ZIP/Postal Code
0000
Country
Uganda
Facility Name
Investigational Site Number :8040002
City
Kiev
ZIP/Postal Code
04210
Country
Ukraine
Facility Name
Investigational Site Number :8040004
City
Kyiv
ZIP/Postal Code
01023
Country
Ukraine
Facility Name
Investigational Site Number :8040003
City
Kyiv
ZIP/Postal Code
02002
Country
Ukraine
Facility Name
Investigational Site Number :8040001
City
Kyiv
ZIP/Postal Code
03037
Country
Ukraine
Facility Name
Investigational Site Number :8040005
City
Vinnytsia
ZIP/Postal Code
21050
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Learn more about this trial

Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older

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