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Sanofi's COVID vaccine trial ends early – what we know

NCT ID NCT04904549

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 study tested two Sanofi COVID-19 vaccines (one targeting the original virus, another targeting two variants) in about 24,000 adults. The goal was to see if they could prevent COVID-19 safely. The trial was terminated early, so final results are limited, but the data may still help improve future vaccines.

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 adjuvanted recombinant protein vaccine (monovalent and bivalent)
What this could lead to
If successful, this could provide a new option for COVID-19 vaccination, potentially offering protection against multiple variants.
What could go wrong
The trial was terminated early, so data may be incomplete. As a Phase 3 study, it was large but results may not apply to newer variants.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

23,670 people

The number who actually took part.

Started

May 2021

Finished

Aug 2024

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. * 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.

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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 - DRS - Simon Williamson Clinic, PC - Birmingham- Site Number : 8400004

    Birmingham, Alabama, 35211, United States

  • AES Austin- Site Number : 8400003

    Austin, Texas, 78744, United States

  • AES Salt Lake City- Site Number : 8400016

    Murray, Utah, 84123, United States

  • AES St. Petersburg- Site Number : 8400017

    Pinellas Park, Florida, 33781, United States

  • American Indian Clinical Trials Research Network Site Number : 8400025

    Rapid City, South Dakota, 57701, United States

  • Coastal Carolina Research Center - N Charleston- Site Number : 8400022

    North Charleston, South Carolina, 29405, United States

  • Investigational Site Number : 1700001

    Bogotá, 111611, Colombia

  • Investigational Site Number : 1700002

    Barranquilla, 080020, Colombia

  • Investigational Site Number : 1700003

    Soledad, 083001, Colombia

  • Investigational Site Number : 1700004

    Floridablanca, 681004, Colombia

  • Investigational Site Number : 1700005

    Cali, 76001, Colombia

  • Investigational Site Number : 1700006

    Chía, 0000, Colombia

  • Investigational Site Number : 1700007

    Girardot, 252431, Colombia

  • Investigational Site Number : 1700008

    Barranquilla, 080020, Colombia

  • Investigational Site Number : 1700009

    Meta, 0000, Colombia

  • Investigational Site Number : 1700010

    Aguazul, 856018, Colombia

  • Investigational Site Number : 1700015

    Quindío, 630001, Colombia

  • Investigational Site Number : 2880001

    Navrongo, 114, Ghana

  • Investigational Site Number : 2880002

    Kintampo, P. O. Box 200, Ghana

  • Investigational Site Number : 2880003

    Kumasi, 00000, Ghana

  • Investigational Site Number : 3400001

    Municipio Del Distrito Central, 11101, Honduras

  • Investigational Site Number : 3400002

    San Pedro Sula, 21104, Honduras

  • Investigational Site Number : 3560001

    Jaipur, 302039, India

  • Investigational Site Number : 3560002

    Ambawadi, 380015, India

  • Investigational Site Number : 3560003

    Punjagutta, 500082, India

  • Investigational Site Number : 3560004

    Patna, 801507, India

  • Investigational Site Number : 3560005

    Kanpur, 208002, India

  • Investigational Site Number : 3560006

    Tamilnadu, 603203, India

  • Investigational Site Number : 3560007

    Belagavi, 590002, India

  • Investigational Site Number : 3560009

    Nagpur, 440001, India

  • Investigational Site Number : 3560010

    Ajmer, 305001, India

  • Investigational Site Number : 3560011

    Odisha, 751003, India

  • Investigational Site Number : 3920001

    Kyobashi Chuo-ku, Tokyo, 104-0031, Japan

  • Investigational Site Number : 3920002

    Ohta-ku, Tokyo, 143-0015, Japan

  • Investigational Site Number : 3920003

    Kouenji minami,Suginami-ku, Tokyo, 166-0003, Japan

  • Investigational Site Number : 3920004

    Haramachi,Shinjuku-ku, Tokyo, 162-0053, Japan

  • Investigational Site Number : 3920005

    Chiyoda-ku,, Tokyo, 101-0041, Japan

  • Investigational Site Number : 4040001

    Nairobi, 00100GPO, Kenya

  • Investigational Site Number : 4040002

    Kisumu, 40100, Kenya

  • Investigational Site Number : 4040003

    Kisumu, 40100, Kenya

  • Investigational Site Number : 4040004

    Kericho, 00200, Kenya

  • Investigational Site Number : 4040006

    Eldoret, 30100, Kenya

  • Investigational Site Number : 4040007

    Nairobi, 00100, Kenya

  • Investigational Site Number : 4040008

    Mombasa, 80107 Ganjoni, Kenya

  • Investigational Site Number : 4040009

    Thika, 00202 Kiambu, Kenya

  • Investigational Site Number : 4040011

    Butere, 50101, Kenya

  • Investigational Site Number : 4040012

    Kisumu, 40123 Kisumu, Kenya

  • Investigational Site Number : 4840002

    Veracruz, 91910, Mexico

  • Investigational Site Number : 4840003

    Guadalajara, Jalisco, 44280, Mexico

  • Investigational Site Number : 4840004

    Acapulco de Juárez, Guerrero, 39670, Mexico

  • Investigational Site Number : 4840005

    León, Guanajuato, 37000, Mexico

  • Investigational Site Number : 4840006

    Temixco, 62587, Mexico

  • Investigational Site Number : 4840008

    Cuernavaca, Morelos, 62290, Mexico

  • Investigational Site Number : 4840009

    Mexico City, Mexico City, 04530, Mexico

  • Investigational Site Number : 5240001

    Nepalgunj, 21900, Nepal

  • Investigational Site Number : 5240002

    Dhulikhel, 45200, Nepal

  • Investigational Site Number : 5240003

    Kathmandu, 44600, Nepal

  • Investigational Site Number : 8000001

    Kampala, 0, Uganda

  • Investigational Site Number : 8000002

    Entebbe, 0, Uganda

  • Investigational Site Number : 8000003

    Kampala, 42 Nakasero Road, Uganda

  • Investigational Site Number : 8000004

    Kampala, Plot 101, Lubowa, Uganda

  • Investigational Site Number : 8000005

    Entebbe, 0, Uganda

  • Investigational Site Number : 8000007

    Kampala, 23491, Uganda

  • Investigational Site Number : 8000013

    Kampala, 10101, Uganda

  • Investigational Site Number : 8000014

    Lira, 10101, Uganda

  • Investigational Site Number : 8040001

    Kyiv, 03037, Ukraine

  • Investigational Site Number : 8040002

    Kiev, 04210, Ukraine

  • Investigational Site Number : 8040003

    Kyiv, 02002, Ukraine

  • Investigational Site Number : 8040004

    Kyiv, 01023, Ukraine

  • Optimal Research Alabama- Site Number : 8400019

    Huntsville, Alabama, 35802, United States

  • Optimal Research, LLC-Melbourne- Site Number : 8400002

    Melbourne, Florida, 32934, United States

  • Peninsula Research Associates, Inc.- Site Number : 8400021

    Rolling Hills Estates, California, 90274, United States

  • Rochester Clinical Research, Inc.- Site Number : 8400023

    Rochester, New York, 14609, United States

  • Synexus Akron- Site Number : 8400009

    Akron, Ohio, 44311, United States

  • Synexus Clinical Research Anderson- Site Number : 8400007

    Anderson, South Carolina, 29621, United States

  • Synexus Clinical Research Chicago- Site Number : 8400012

    Chicago, Illinois, 60602, United States

  • Synexus Clinical Research Evansville- Site Number : 8400008

    Evansville, Indiana, 47714, United States

  • Synexus Clinical Research US, Inc. - Atlanta- Site Number : 8400005

    Atlanta, Georgia, 30328, United States

  • Synexus Clinical Research US, Inc. - Cincinnati- Site Number : 8400010

    Cincinnati, Ohio, 45236, United States

  • Synexus Clinical Research US, Inc. - Henderson- Site Number : 8400018

    Henderson, Nevada, 89052, United States

  • Synexus Clinical Research US, Inc. - Orlando- Site Number : 8400020

    Orlando, Florida, 32806, United States

  • Synexus Clinical Research US, Inc. - San Antonio- Site Number : 8400015

    San Antonio, Texas, 78229, United States

  • Synexus Clinical Research US, Inc. Site Number : 8400013

    Centennial, Colorado, 80112, United States

  • Synexus Dallas- Site Number : 8400014

    Dallas, Texas, 75231, United States

  • Synexus St. Louis- Site Number : 8400006

    St Louis, Missouri, 63141, United States

  • Synexus US Columbus- Site Number : 8400011

    Columbus, Ohio, 43212, United States

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