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Sanofi's new COVID vaccine shows promise in large trial

NCT ID NCT04762680

Vaccine Sponsor: Sanofi Pasteur, a Sanofi Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This completed study tested Sanofi's experimental COVID-19 vaccines in over 3,000 adults aged 18 and older. The vaccines use a recombinant protein plus an adjuvant to boost immune response. The trial evaluated safety and immune responses for both a two-dose primary series and a booster dose, including versions targeting original and variant strains.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant
What this could lead to
If successful, this could provide an additional safe and effective COVID-19 vaccine option, including booster doses that protect against variants.
What could go wrong
This is a completed trial, but results may not show strong protection against newer variants. Vaccine effectiveness can vary by population and circulating strains.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

3,159 people

The number who actually took part.

Started

Feb 2021

Finished

Jun 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

COVID-19 prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19

Contacts and locations

Locations

  • AES Austin Site Number : 8400191

    Austin, Texas, 78744, United States

  • American Indian Clinical Trials Research Network Site Number : 8400204

    Rapid City, South Dakota, 57701, United States

  • Baptist Health Center for Clinical Research Site Number : 8400077

    Little Rock, Arkansas, 72205, United States

  • Brigham and Women's Hospital Site Number : 8400199

    Boston, Massachusetts, 02115, United States

  • Cenexel Research Centers of America Site Number : 8400089

    Hollywood, Florida, 33024, United States

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

    Los Angeles, California, 90059, United States

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

    Chicago, Illinois, 60607, United States

  • Coastal Carolina Research Center Site Number : 8400097

    North Charleston, South Carolina, 29405, United States

  • Columbia University Irving Medical Center Site Number : 8400203

    New York, New York, 10032, United States

  • Emory University Decatur Site Number : 8400201

    Decatur, Georgia, 30030, United States

  • Holy Name Medical Center Site Number : 8400072

    Teaneck, New Jersey, 07666, United States

  • Investigational Site Number : 0360001

    South Brisbane, Queensland, 4101, Australia

  • Investigational Site Number : 0360002

    Southport, 4215, Australia

  • Investigational Site Number : 0360003

    Norwood, 5067, Australia

  • Investigational Site Number : 0360004

    Woodville, 5011, Australia

  • Investigational Site Number : 0360005

    Westmead, 2145, Australia

  • Investigational Site Number : 2500002

    Tours, 37044, France

  • Investigational Site Number : 2500003

    Pessac, 33600, France

  • Investigational Site Number : 2500004

    Rennes, 35033, France

  • Investigational Site Number : 2500005

    Paris, 75679, France

  • Investigational Site Number : 2500006

    Nantes, 44093, France

  • Investigational Site Number : 2500007

    Pierre-Bénite, 69495, France

  • Investigational Site Number : 2500008

    Limoges, 87042, France

  • Investigational Site Number : 2500013

    Dijon, 21079, France

  • Investigational Site Number : 2500014

    Lyon, 69004, France

  • Investigational Site Number : 2500015

    Marseille, 13005, France

  • Investigational Site Number : 2500016

    Marseille, 13005, France

  • Investigational Site Number : 3400001

    San Pedro Sula, 21104, Honduras

  • Investigational Site Number : 3400002

    Municipio Del Distrito Central, 11101, Honduras

  • Investigational Site Number : 5540001

    Rotorua, 3010, New Zealand

  • Investigational Site Number : 5540002

    Christchurch, 8013, New Zealand

  • Investigational Site Number : 5540005

    New Lynn, Auckland, 0600, New Zealand

  • Investigational Site Number : 5540007

    Nawton, 3243, New Zealand

  • Investigational Site Number : 5540010

    Nelson, 7011, New Zealand

  • Investigational Site Number : 7240003

    Vigo, 36312, Spain

  • Investigational Site Number : 7240008

    Valencia, 46020, Spain

  • Investigational Site Number : 7240009

    Madrid, 28041, Spain

  • Investigational Site Number : 7240013

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

  • Investigational Site Number : 7240016

    Majadahonda, Madrid, 28222, Spain

  • Investigational Site Number : 8260010

    Harrow, HA1 3UJ, United Kingdom

  • Investigational Site Number : 8260011

    Runcorn, Halton, WA7 2DA, United Kingdom

  • Investigational Site Number : 8260012

    Southampton, SO16 6YD, United Kingdom

  • Investigational Site Number : 8260013

    Surrey, Sutton, SM2 5PT, United Kingdom

  • Investigational Site Number : 8260014

    Doncaster, DN4 8QN, United Kingdom

  • Investigational Site Number : 8260015

    London, SW10 0LR, United Kingdom

  • Investigational Site Number : 8260016

    Gloucester, GL1 3NN, United Kingdom

  • Investigational Site Number : 8260017

    Bath, Somerset, BA1 3NG, United Kingdom

  • NYU VC-Augustana Site Number : 8400267

    Brooklyn, New York, 11220, United States

  • New York University Langone Vaccine Center Site Number : 8400230

    New York, New York, 10016, United States

  • Optimal Research Site Number : 8400173

    San Diego, California, 92108, United States

  • Optimal Research Site Number : 8400187

    Peoria, Illinois, 61614, United States

  • Optimal Research, LLC Rockville Site Number : 8400048

    Rockville, Maryland, 20850, United States

  • Optimal Research, LLC Site Number : 8400057

    Melbourne, Florida, 32934, United States

  • Peninsula Research Associates, Inc. Site Number : 8400094

    Rolling Hills Estates, California, 90274, United States

  • Research Works INC Site Number : 8400045

    New Orleans, Louisiana, 70125, United States

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

    Birmingham, Alabama, 35205, United States

  • Synexus - Glendale. Site Number : 8400271

    Glendale, Arizona, 85306, United States

  • Synexus Chandler Site Number : 8400251

    Chandler, Arizona, 85225, United States

  • Synexus Clinical Research Evansville Site Number : 8400272

    Evansville, Indiana, 47714, United States

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

    Orlando, Florida, 32806, United States

  • Synexus St. Louis Site Number : 8400100

    St Louis, Missouri, 63141, United States

  • The George Washington University Site Number : 8400212

    Washington D.C., District of Columbia, 20037, United States

  • University of Pittsburgh Site Number : 8400233

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Rochester Site Number : 8400207

    Rochester, New York, 14642, United States

  • Velocity Clinical Research, Omaha Site Number : 8400030

    Omaha, Nebraska, 68134, United States

  • Yale University Site Number : 8400239

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.