Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older (VAT00002)

• ClinicalTrials.gov Identifier: NCT04762680
• Recruitment Status: Active, not recruiting
• First Posted: February 21, 2021
• Last Update Posted: January 4, 2023
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Collaborator: GlaxoSmithKline
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description

Brief Summary:

The primary objectives of the study are:

To assess the safety profile of the study vaccines in each study intervention group.

To assess the neutralizing antibody profile after primary series vaccination in SARS-CoV-2-naïve adults.

To demonstrate that a booster dose of monovalent or bivalent SARS-CoV-2 vaccine given to adults previously vaccinated with an authorized/approved COVID-19 vaccine induces an immune response that is non-inferior to the response induced by a twodose priming series with the monovalent vaccine, and superior to that observed immediately before booster.

The secondary objectives of the study are:

To assess the neutralizing and binding antibody profiles after primary series vaccination at pre-defined time points during the study.

To assess the neutralizing and binding antibody responses of booster vaccination.

To describe the occurrences of laboratory-confirmed symptomatic COVID19 after primary series and booster vaccination.

To describe the occurrences of serologically-confirmed SARS-CoV-2 infection after primary series vaccination.

Condition or disease	Intervention/treatment	Phase
COVID-19	Biological: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 1; Biological: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2; Biological: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 3; Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A; Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03; Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage B; Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 1; Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 2; Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 3; Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 4; Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, bivalent (D614+B.1.351)-AS03	Phase 2; Phase 3

Detailed Description:

The duration of each participant's participation in the study will be approximately:

Original Phase 2 part: 365 days postinjection 2 (ie, 386 days total). Supplemental Cohorts 1 and 2: 365 days post-booster injection (ie, 366 days total).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3385 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: To address the emergence of variant strains, Sanofi Pasteur is developing monovalent and bivalent vaccines for use as universal late booster vaccines which will be studied in additional Phase 3 study cohorts that are added to the initial Phase 2 protocol cohorts. Supplemental Cohorts 1 and 2 will evaluate booster vaccine candidates.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

In the original Phase 2 part, participants, outcome assessors, Investigators, laboratory personnel, and sponsor study staff are blinded to intervention group; and those preparing the study interventions are unblinded to vaccine assignment group.

The supplemental Cohort 1 intervention group and Supplemental Cohorts Comparator Group will be open-label. Supplemental Cohort 2 will involve sequential randomization to main arms then exploratory arms, and the intervention will be modified double-blind (observer-blinded, as described).

• Primary Purpose: Prevention
• Official Title: Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccines With AS03 Adjuvant in Adults 18 Years of Age and Older as a Primary Series and Immunogenicity and Safety of a Booster Dose of SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (Two Monovalent and One Bivalent)
• Actual Study Start Date: February 24, 2021
• Estimated Primary Completion Date: July 16, 2024
• Estimated Study Completion Date: July 16, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Phase 2 Cohort -SARS-CoV-2 vaccine Formulation 1; 2 injections of SARS-CoV-2 vaccine Formulation 1 at Day 1 and Day 22	Biological: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 1; Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Experimental: Phase 2 Cohort - SARS-CoV-2 vaccine Formulation 2; 2 injections of SARS-CoV-2 vaccine Formulation 2 at Day 1 and Day 22	Biological: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2; Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Experimental: Phase 2 Cohort - SARS-CoV-2 vaccine Formulation 3; 2 injections of SARS-CoV-2 vaccine Formulation 3 Day 1 and Day 22	Biological: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 3; Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Experimental: Supplemental Cohort 1 - Booster Monovalent (D614)-AS03 SARS-CoV-2 vaccine; Participants who were previously vaccinated 4 to < 10 months prior with an authorized mRNA or adenovirus-vector COVID-19 vaccine will receive 1 booster injection of monovalent (D614)-AS03 SARS-CoV-2 vaccine	Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A; Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Experimental: Supplemental Cohort 2 - Booster Monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine; Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA or adenovirus-vector COVID-19 vaccine or SARS-Cov-2 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine	Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03; Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Experimental: Supplemental Cohort 2 - Booster Bivalent (D614 + B.1.351)-AS03 SARS-CoV-2 vaccine; Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA or adenovirus-vector COVID-19 vaccine will receive 1 booster injection of bivalent (D614+B.1.351)-AS03 SARS-CoV-2 vaccine	Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, bivalent (D614+B.1.351)-AS03; Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Experimental: Supplemental Cohort 2 - Booster Monovalent (D614)-AS03 SARS-CoV-2 vaccine; Participants who were vaccinated 4 to < 10 months prior with SARS-Cov-2 vaccine will receive 1 booster injection of monovalent (D614)-AS03 SARS-CoV-2 vaccine	Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A; Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Active Comparator: Supplemental Comparator for Cohort 1 and 2 Boosters - Monovalent (D614)-AS03 SARS-CoV-2 vaccine; 2 injections of monovalent (D614)-AS03 SARS-CoV-2 vaccine at Day 1 and Day 22 in previously unvaccinated, naïve participants	Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage B; Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Experimental: Cohort 2 - Booster Exploratory 1; Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine	Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 1; Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Experimental: Cohort 2 - Booster Exploratory 2; Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine	Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 2; Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Experimental: Cohort 2 - Booster Exploratory 3; Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine	Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 3; Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Experimental: Cohort 2 - Booster Exploratory 4; Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine	Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 4; Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

Outcome Measures

Primary Outcome Measures :

1. Presence of immediate adverse events [ Time Frame: Within 30 minutes after vaccination ]
   Immediate adverse events include unsolicited adverse events occurring within 30 minutes after injection.
2. Presence of solicited injection site or systemic reactions [ Time Frame: Within 7 days after vaccination ]
   Injection site reactions: injection site pain, erythema and swelling. Systemic reactions: fever, headache, malaise and myalgia.
3. Presence of unsolicited adverse events [ Time Frame: Within 21 days after vaccination ]
   Adverse events other than solicited reactions.
4. Presence of serious adverse events [ Time Frame: From Day 1 to Day 387 ]
   Serious adverse events are reported throughout the study.
5. Presence of adverse events of special interest [ Time Frame: From Day 1 to Day 387 ]
   Adverse events of special interest are reported throughout the study.
6. Presence of medically-attended adverse events [ Time Frame: From Day 1 to Day 387 ]
   Medically-attended adverse events are new onset or a worsening of a condition that prompts the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or Emergency Department.
7. Neutralizing antibody titer at Day 1 [ Time Frame: Day 1 ]
   Neutralizing antibody titers are expressed as geometric mean titers.
8. Neutralizing antibody titer at Day 36 [ Time Frame: Day 36 ]
   Neutralizing antibody titers are expressed as geometric mean titers.
9. Neutralizing antibody titer fold-rise post-vaccination [ Time Frame: From Day 1 to Day 36 ]
   Neutralizing antibody titer fold-rise post-vaccination.
10. 2-fold rise and 4-fold-rise in neutralization antibody titer [ Time Frame: From Day 1 to Day 36 ]
    Fold-rise in antibody neutralization titer post-vaccination relative to Day 1.
11. Responders, as determined by neutralizing antibody titers at Day 36 [ Time Frame: From Day 1 to Day 36 ]
    Responders, defined as participants who had baseline values below lower limit of quantification (LLOQ) with detectable neutralization titer above assay LLOQ at each pre-defined time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titer at Day 36
12. Neutralizing antibody titer at Day 1 (pre-booster injection) [ Time Frame: Day 1 (pre-booster injection) ]
    Neutralizing antibody titers are expressed as geometric mean titers.
13. Neutralizing antibody titer at Day 15 (post-booster injection) [ Time Frame: Day 15 (post-booster injection) ]
    Neutralizing antibody titers are expressed as geometric mean titers.
14. Neutralizing antibody titer at Day 36 (Cohorts 1 and 2 Comparator Group) [ Time Frame: Day 36 ]
    Neutralizing antibody titers are expressed as geometric mean titers.
15. Responders, as determined by neutralizing antibody titers at Day 36 (Cohorts 1 and 2 Comparator Group) [ Time Frame: From Day 1 to Day 36 ]
    Responders are defined as participants with a 4-fold-or greater rise in serum neutralization titer [pre/post] at Day 36 relative to Day 1

Secondary Outcome Measures :

1. Neutralizing antibody titer at all pre-defined time points [ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]
2. Neutralizing antibody titer fold-rise post-vaccination at all pre-defined time points [ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]
   Fold-rise in antibody neutralization titer post-vaccination relative to Day 1.
3. Responders, as determined by neutralizing antibody titers at each pre-defined time point [ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]
   Responders, defined as participants who had baseline values below LLOQ with detectable neutralization titer above assay LLOQ at each pre-defined time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titer at each pre-defined timepoint.
4. 2-fold rise and 4-fold-rise in neutralization antibody titer at all pre-defined time points [ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]
   Fold-rise in antibody neutralization titer post-vaccination relative to Day 1.
5. Binding antibody fold-rise [ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]
   Fold-rise in concentration relative to Day 1.
6. Binding antibody concentrations [ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]
7. 2-fold-rise and 4-fold rise in binding antibody concentration [ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]
   Fold-rise in concentration relative to Day 1.
8. Responders, as determined by binding antibody concentrations [ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]
   Responders are defined as participants who had baseline values below LLOQ with detectable anti concentration above assay LLOQ at each pre-defined time point and participants with baseline values above LLOQ with a 4-fold increase in anti-S antibody concentration at each pre-defined time point.
9. Occurrences of laboratory-confirmed symptomatic COVID-19 [ Time Frame: From Day 1 to Day 387 ]
   Symptomatic COVID-19 is defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness. Laboratory-confirmed SARS-CoV-2 infection is defined as a positive result for SARS CoV-2 by nucleic acid amplification test (NAAT), done by the central laboratory or locally, on at least one respiratory sample.
10. Occurrences of symptomatic COVID-19 episodes associated with hospitalization [ Time Frame: From Day 1 to Day 387 ]
    Symptomatic COVID-19 is defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness.
11. Occurrences of severe symptomatic COVID-19 [ Time Frame: From Day 1 to Day 387 ]
    Symptomatic COVID-19 is defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness with pre-defined criteria of severity.
12. Occurrences of death associated with symptomatic COVID-19 [ Time Frame: From Day 1 to Day 387 ]
    Symptomatic COVID-19 is defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness.
13. Occurrences of serologically-confirmed SARS-CoV-2 infection [ Time Frame: From Day 1 to Day 387 ]
    Serologically-confirmed SARS-CoV-2 infection is defined as a positive result in a serum sample for antibodies against SARS-CoV-2.
14. Neutralizing antibody titer at all pre-defined time points post-booster and booster comparator injection [ Time Frame: Day 1 and Day 15 (post-booster injection) and Day 36 ]
15. Neutralizing antibody titer fold-rise post-vaccination at all pre-defined time points post-booster and booster comparator injection [ Time Frame: Day 1 and Day 15 (post-booster injection) and Day 36 ]
    Neutralizing antibody titer fold-rise post-vaccination.
16. 2-fold rise and 4-fold-rise in neutralization antibody titer at all pre-defined time points post-booster and booster comparator injection [ Time Frame: Day 1 and Day 15 -post-booster injection) and Day 36 ]
    Neutralizing antibody titer fold-rise post-vaccination.
17. Seroresponse rate post-booster and booster comparator injection [ Time Frame: Day 1 and Day 15 (post-booster injection) and Day 36 ]
    Seroresponse rate is defined as the percentage or participants with 4-fold-or greater rise in serum neutralization titer [pre/post] at post-vaccination relative to pre-vaccination.
18. Binding antibody concentrations post-booster injection [ Time Frame: Day 1, Day 15, Day 29, Day 91, Day 181, and Day 366 (post-booster injection) ]
19. Binding antibody fold-rise post-booster injection [ Time Frame: Day 1, Day 15, Day 29, Day 91, Day 181, and Day 366 (post-booster injection) ]
    Fold-rise in concentration relative to Day 1.
20. 2-fold-rise and 4-fold rise in binding antibody concentration post-booster injection [ Time Frame: Day 1, Day 15, Day 29, Day 91, Day 181, and Day 366 (post-booster injection) ]
    Fold-rise in concentration relative to Day 1.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

-Aged 18 years or older on the day of inclusion. - -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 mut 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 vaccination until at least 12 weeks after the last vaccination (ie, second dose of primary series or booster injection). A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 4 hours before any dose of study intervention. - -Informed consent form has been signed and dated.

Able to attend all scheduled visits and to comply with all study procedures. SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies (Original Phase 2 Cohort).

For persons living with human immunodeficiency virus (HIV), stable HIV infection determined by participant currently on antiretrovirals with CD4 count > 200/mm3.

Does not intend to receive an authorized/approved COVID-19 vaccine from first vaccination to 3 weeks after the second vaccination despite encouragement by the investigator to receive the authorized vaccine available to them at the time of enrollment.

Supplemental cohorts: for participants originally enrolled in the Phase II cohort of the study, informed consent has to be signed and dated for transitioning to Supplemental Cohort 2.

Supplemental cohorts, Booster arms: received a complete primary vaccination series with an authorized/conditionally approved mRNA COVID-19 vaccine (mRNA-1273 [Moderna] or BNT162b2 [Pfizer/BioNTech]) or adenovirus-vectored COVID-19 vaccine (ChAdOx1 nCoV-19 [Oxford University/AstraZeneca] or Ad26.CoV2.S [J&J/Janssen]), with the last dose administered a minimum of 4 months prior to inclusion but not longer than 10 months prior to inclusion.

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 trial procedures based on Investigator or designee'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.

Receipt of solid-organ or bone marrow transplants in the past 180 days. Receipt of anti-cancer chemotherapy in the last 90 days. Receipt of immunoglobulins, blood, or blood-derived products in the past 3 months.

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 trial 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.

Applicable to Original Phase II Cohort, Supplemental Cohort 1 and Cohort 2 Comparator Group: Prior administration of a coronavirus vaccine (SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome [MERS-CoV]). Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study trial period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. Exclusion criterion for the Supplemental Cohort 1 and Cohort 2 comparator group: positive rapid diagnostic test for SARS-CoV-2 antibodies at time of enrollment.

Exclusion criterion for participants in Supplemental Cohort 2 who were primed as participant in the Original Phase II Cohort of the present study: Receipt of authorized/conditionally approved COVID-19 vaccine after enrollment in Original Phase 2 Cohort.

Exclusion criterion for all Booster groups: Documented virologically-confirmed SARS-CoV-2 infection (by NAAT) after first dose of primary immunization.

Contacts and Locations

Locations

United States, Alabama

Synexus - Clinical Research Advantage, Inc.-Site Number:8400270

Birmingham, Alabama, United States, 35205

United States, Arizona

Synexus Chandler-Site Number:8400251

Chandler, Arizona, United States, 85225

Synexus - Clinical Research Advantage, Inc.-Site Number:8400271

Glendale, Arizona, United States, 85306

United States, Arkansas

Baptist Health Center for Clinical Research-Site Number:8400077

Little Rock, Arkansas, United States, 72205

United States, California

Charles R. Drew University of Medicine and Science-Site Number:8400220

Los Angeles, California, United States, 90059

Peninsula Research Associates, Inc.-Site Number:8400094

Rolling Hills Estates, California, United States, 90274

Optimal Research-Site Number:8400173

San Diego, California, United States, 92108

United States, Connecticut

Yale University-Site Number:8400239

New Haven, Connecticut, United States, 06510

United States, District of Columbia

The George Washington University-Site Number:8400212

Washington, District of Columbia, United States, 20037

United States, Florida

Research Centers of America-Site Number:8400089

Hollywood, Florida, United States, 33024

Optimal Research, LLC-Site Number:8400057

Melbourne, Florida, United States, 32934

Synexus Clinical Research US, Inc. - Orlando-Site Number:8400179

Orlando, Florida, United States, 32806

United States, Georgia

Emory University Decatur-Site Number:8400201

Decatur, Georgia, United States, 30030

United States, Illinois

Chicago Clinical Research Institute, Inc.-Site Number:8400269

Chicago, Illinois, United States, 60607

Optimal Research-Site Number:8400187

Peoria, Illinois, United States, 61614

United States, Indiana

Synexus Clinical Research Evansville-Site Number:8400272

Evansville, Indiana, United States, 47714

United States, Louisiana

Nola Research Works-Site Number:8400045

New Orleans, Louisiana, United States, 70125

United States, Maryland

Optimal Research, LLC Rockville-Site Number:8400048

Rockville, Maryland, United States, 20850

United States, Massachusetts

Brigham and Women's Hospital-Site Number:8400199

Boston, Massachusetts, United States, 02115

United States, Missouri

Synexus St. Louis-Site Number:8400100

Saint Louis, Missouri, United States, 63141

United States, Nebraska

Meridian Clinical Research-Site Number:8400030

Omaha, Nebraska, United States, 68134

United States, New Jersey

Holy Name Medical Center-Site Number:8400072

Teaneck, New Jersey, United States, 07666

United States, New York

NYU VC-Augustana-Site Number:8400267

Brooklyn, New York, United States, 11220

New York University Langone Vaccine Center-Site Number:8400230

New York, New York, United States, 10016

Columbia University Irving Medical Center-Site Number:8400203

New York, New York, United States, 10032

University of Rochester-Site Number:8400207

Rochester, New York, United States, 14642

United States, Pennsylvania

University of Pittsburgh-Site Number:8400233

Pittsburgh, Pennsylvania, United States, 15213

United States, South Carolina

Coastal Carolina Research Center-Site Number:8400097

North Charleston, South Carolina, United States, 29405

United States, South Dakota

Black Hills Center for American Indian Health, Inc.-Site Number:8400204

Rapid City, South Dakota, United States, 57701

United States, Texas

Optimal Research Texas-Site Number:8400191

Austin, Texas, United States, 78705

Australia, Queensland

Investigational Site Number :0360001

South Brisbane, Queensland, Australia, 4101

Australia

Investigational Site Number :0360003

Norwood, Australia, 5067

Investigational Site Number :0360002

Southport, Australia, 4215

Investigational Site Number :0360005

Westmead, Australia, 2145

Investigational Site Number :0360004

Woodville, Australia, 5011

France

Investigational Site Number :2500013

Dijon, France, 21079

Investigational Site Number :2500008

Limoges, France, 87042

Investigational Site Number :2500014

Lyon, France, 69004

Investigational Site Number :2500015

Marseille, France, 13005

Investigational Site Number :2500016

Marseille, France, 13005

Investigational Site Number :2500006

Nantes, France, 44093

Investigational Site Number :2500005

Paris, France, 75679

Investigational Site Number :2500003

Pessac, France, 33600

Investigational Site Number :2500007

Pierre Benite, France, 69495

Investigational Site Number :2500004

Rennes, France, 35033

Investigational Site Number :2500002

Tours Cedex 1, France, 37044

Honduras

Investigational Site Number :3400002

Municipio Del Distrito Central, Honduras, 11101

Investigational Site Number :3400001

San Pedro Sula, Honduras, 21104

Kenya

Investigational Site Number :4040006

Kericho, Kenya, 00200

Mexico

Investigational Site Number :4840011

Distrito Federal, Ciudad De Mexico, Mexico, 14080

Investigational Site Number :4840005

Guadalajara, Jalisco, Mexico, 44280

Investigational Site Number :4840013

Cuernavaca, Morelos, Mexico, 62290

New Zealand

Investigational Site Number :5540005

New Lynn, Auckland, New Zealand, 0600

Investigational Site Number :5540002

Christchurch, New Zealand, 8013

Investigational Site Number :5540007

Nawton, New Zealand, 3243

Investigational Site Number :5540010

Nelson, New Zealand, 7011

Investigational Site Number :5540008

Papamoa Beach, New Zealand, 5018

Investigational Site Number :5540001

Rotorua, New Zealand, 3010

Panama

Investigational Site Number :5910001

Panamá, Panama, 0843-01103

Spain

Investigational Site Number :7240013

Santiago De Compostela, Galicia [Galicia], Spain, 15706

Investigational Site Number :7240016

Majadahonda, Madrid, Spain, 28222

Investigational Site Number :7240009

Madrid, Spain, 28041

Investigational Site Number :7240008

Valencia, Spain, 46020

Investigational Site Number :7240003

Vigo, Spain, 36312

United Kingdom

Investigational Site Number :8260011

Runcorn, Cheshire West And Chester, United Kingdom, WA7 2DA

Investigational Site Number :8260017

Bath, Somerset, United Kingdom, BA1 3NG

Investigational Site Number :8260016

Gloucester, Somerset, United Kingdom, GL1 3NN

Investigational Site Number :8260013

Surrey, Sutton, United Kingdom, SM2 5PT

Investigational Site Number :8260014

Doncaster, United Kingdom, DN4 8QN

Investigational Site Number :8260010

Harrow, United Kingdom, HA1 3UJ

Investigational Site Number :8260015

London, United Kingdom, SW10 0LR

Investigational Site Number :8260012

Southampton, United Kingdom, SO16 6YD

Sponsors and Collaborators

Sanofi Pasteur, a Sanofi Company

GlaxoSmithKline

Investigators

• Study Director: Clinical Sciences & Operations; Sanofi

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sridhar S, Joaquin A, Bonaparte MI, Bueso A, Chabanon AL, Chen A, Chicz RM, Diemert D, Essink BJ, Fu B, Grunenberg NA, Janosczyk H, Keefer MC, Rivera M DM, Meng Y, Michael NL, Munsiff SS, Ogbuagu O, Raabe VN, Severance R, Rivas E, Romanyak N, Rouphael NG, Schuerman L, Sher LD, Walsh SR, White J, von Barbier D, de Bruyn G, Canter R, Grillet MH, Keshtkar-Jahromi M, Koutsoukos M, Lopez D, Masotti R, Mendoza S, Moreau C, Ceregido MA, Ramirez S, Said A, Tavares-Da-Silva F, Shi J, Tong T, Treanor J, Diazgranados CA, Savarino S. Safety and immunogenicity of an AS03-adjuvanted SARS-CoV-2 recombinant protein vaccine (CoV2 preS dTM) in healthy adults: interim findings from a phase 2, randomised, dose-finding, multicentre study. Lancet Infect Dis. 2022 May;22(5):636-648. doi: 10.1016/S1473-3099(21)00764-7. Epub 2022 Jan 25.

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT04762680
• Other Study ID Numbers: VAT00002; U1111-1251-4616 ( Registry Identifier: ICTRP ); 2020-003370-41 ( EudraCT Number )
• First Posted: February 21, 2021
• Last Update Posted: January 4, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs