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NCT04904549

PHASE3

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

Sponsor: Sanofi Pasteur, a Sanofi Company

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

23670

Start Date

2021-05-26

Completion Date

2024-08-31

Last Updated

2026-06-03

Healthy Volunteers

Yes

Conditions

COVID-19

Interventions

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent D614) (primary series)

Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine (bivalent D614 + B.1.351) (primary series)

Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.

BIOLOGICAL

Placebo

Pharmaceutical form: liquid. Route of administration: intramuscular administration.

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent B.1.351) (booster dose) >= 4 months after last vaccination

Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.

BIOLOGICAL

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

Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.

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.

Locations (86)

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

Birmingham, Alabama, United States

Optimal Research Alabama- Site Number : 8400019

Huntsville, Alabama, United States

Peninsula Research Associates, Inc.- Site Number : 8400021

Rolling Hills Estates, California, United States

Synexus Clinical Research US, Inc. Site Number : 8400013

Centennial, Colorado, United States

Optimal Research, LLC-Melbourne- Site Number : 8400002

Melbourne, Florida, United States

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

Orlando, Florida, United States

AES St. Petersburg- Site Number : 8400017

Pinellas Park, Florida, United States

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

Atlanta, Georgia, United States

Synexus Clinical Research Chicago- Site Number : 8400012

Chicago, Illinois, United States

Synexus Clinical Research Evansville- Site Number : 8400008

Evansville, Indiana, United States

Synexus St. Louis- Site Number : 8400006

St Louis, Missouri, United States

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

Henderson, Nevada, United States

Rochester Clinical Research, Inc.- Site Number : 8400023

Rochester, New York, United States

Synexus Akron- Site Number : 8400009

Akron, Ohio, United States

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

Cincinnati, Ohio, United States

Synexus US Columbus- Site Number : 8400011

Columbus, Ohio, United States

Synexus Clinical Research Anderson- Site Number : 8400007

Anderson, South Carolina, United States

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

North Charleston, South Carolina, United States

American Indian Clinical Trials Research Network Site Number : 8400025

Rapid City, South Dakota, United States

AES Austin- Site Number : 8400003

Austin, Texas, United States

Synexus Dallas- Site Number : 8400014

Dallas, Texas, United States

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

San Antonio, Texas, United States

AES Salt Lake City- Site Number : 8400016

Murray, Utah, United States

Investigational Site Number : 1700010

Aguazul, Colombia

Investigational Site Number : 1700002

Barranquilla, Colombia

Investigational Site Number : 1700008

Barranquilla, Colombia

Investigational Site Number : 1700001

Bogotá, Colombia

Investigational Site Number : 1700005

Cali, Colombia

Investigational Site Number : 1700006

Chía, Colombia

Investigational Site Number : 1700004

Floridablanca, Colombia

Investigational Site Number : 1700007

Girardot, Colombia

Investigational Site Number : 1700009

Meta, Colombia

Investigational Site Number : 1700015

Quindío, Colombia

Investigational Site Number : 1700003

Soledad, Colombia

Investigational Site Number : 2880002

Kintampo, Ghana

Investigational Site Number : 2880003

Kumasi, Ghana

Investigational Site Number : 2880001

Navrongo, Ghana

Investigational Site Number : 3400001

Municipio Del Distrito Central, Honduras

Investigational Site Number : 3400002

San Pedro Sula, Honduras

Investigational Site Number : 3560010

Ajmer, India

Investigational Site Number : 3560002

Ambawadi, India

Investigational Site Number : 3560007

Belagavi, India

Investigational Site Number : 3560001

Jaipur, India

Investigational Site Number : 3560005

Kanpur, India

Investigational Site Number : 3560009

Nagpur, India

Investigational Site Number : 3560011

Odisha, India

Investigational Site Number : 3560004

Patna, India

Investigational Site Number : 3560003

Punjagutta, India

Investigational Site Number : 3560006

Tamilnadu, India

Investigational Site Number : 3920005

Chiyoda-ku,, Tokyo, Japan

Investigational Site Number : 3920004

Haramachi,Shinjuku-ku, Tokyo, Japan

Investigational Site Number : 3920003

Kouenji minami,Suginami-ku, Tokyo, Japan

Investigational Site Number : 3920001

Kyobashi Chuo-ku, Tokyo, Japan

Investigational Site Number : 3920002

Ohta-ku, Tokyo, Japan

Investigational Site Number : 4040011

Butere, Kenya

Investigational Site Number : 4040006

Eldoret, Kenya

Investigational Site Number : 4040004

Kericho, Kenya

Investigational Site Number : 4040002

Kisumu, Kenya

Investigational Site Number : 4040003

Kisumu, Kenya

Investigational Site Number : 4040012

Kisumu, Kenya

Investigational Site Number : 4040008

Mombasa, Kenya

Investigational Site Number : 4040001

Nairobi, Kenya

Investigational Site Number : 4040007

Nairobi, Kenya

Investigational Site Number : 4040009

Thika, Kenya

Investigational Site Number : 4840005

León, Guanajuato, Mexico

Investigational Site Number : 4840004

Acapulco de Juárez, Guerrero, Mexico

Investigational Site Number : 4840003

Guadalajara, Jalisco, Mexico

Investigational Site Number : 4840009

Mexico City, Mexico City, Mexico

Investigational Site Number : 4840008

Cuernavaca, Morelos, Mexico

Investigational Site Number : 4840006

Temixco, Mexico

Investigational Site Number : 4840002

Veracruz, Mexico

Investigational Site Number : 5240002

Dhulikhel, Nepal

Investigational Site Number : 5240003

Kathmandu, Nepal

Investigational Site Number : 5240001

Nepalgunj, Nepal

Investigational Site Number : 8000002

Entebbe, Uganda

Investigational Site Number : 8000005

Entebbe, Uganda

Investigational Site Number : 8000001

Kampala, Uganda

Investigational Site Number : 8000013

Kampala, Uganda

Investigational Site Number : 8000007

Kampala, Uganda

Investigational Site Number : 8000003

Kampala, Uganda

Investigational Site Number : 8000004

Kampala, Uganda

Investigational Site Number : 8000014

Lira, Uganda

Investigational Site Number : 8040002

Kiev, Ukraine

Investigational Site Number : 8040004

Kyiv, Ukraine

Investigational Site Number : 8040003

Kyiv, Ukraine

Investigational Site Number : 8040001

Kyiv, Ukraine

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (86)