Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older
NCT ID: NCT04798027
Last Updated: 2025-09-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
182 participants
INTERVENTIONAL
2021-03-12
2022-06-27
Brief Summary
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* To describe the safety profile of all participants in each age group and each study intervention group up to 12 months post-last dose.
* To describe the neutralizing antibody profile at Day 1, Day 22, and Day 36 of each study intervention group.
The secondary objectives of the study are:
* To describe binding antibody profile from Day 1 to Day 387 of each study intervention group.
* To describe the neutralizing antibody profile from Day 91 to Day 387 of each study intervention group.
* To describe the occurrence of virologically-confirmed coronavirus disease-2019 (COVID-19)-like illness and serologically-confirmed SARS-CoV-2 infection.
* To evaluate the correlation/association between antibody responses to SARS-CoV-2 messenger RNA (mRNA) vaccine and the risk of virologically-confirmed COVID-19-like illness and/or serologically-confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
The Sentinel Cohort was open-label (no blinding).
Study Groups
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Sentinel Cohort: SARS-CoV-2 Vaccine Ultra Low dose
Participants received two intramuscular (IM) injections of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) Vaccine ultra-low dose on Day 1 and at Day 22, respectively.
SARS-CoV-2 mRNA vaccine formulation 1
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
Sentinel Cohort: SARS-CoV-2 Vaccine Low dose
Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
SARS-CoV-2 mRNA vaccine formulation 2
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
Sentinel Cohort: SARS-CoV-2 Vaccine Medium dose
Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.
SARS-CoV-2 mRNA vaccine formulation 3
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
FEC Cohort 1: SARS-CoV-2 Vaccine Ultra Low dose
Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.
SARS-CoV-2 mRNA vaccine formulation 1
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
FEC Cohort 1: SARS-CoV-2 Vaccine Low dose
Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.
SARS-CoV-2 mRNA vaccine formulation 2
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
FEC Cohort 1: Placebo
Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.
Placebo (0.9% normal saline)
Pharmaceutical form: Liquid Route of administration: Intramuscular injection
FEC Cohort 2: SARS-CoV-2 Vaccine Ultra Low dose
Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.
SARS-CoV-2 mRNA vaccine formulation 1
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
FEC Cohort 2: SARS-CoV-2 Vaccine Low dose
Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
SARS-CoV-2 mRNA vaccine formulation 2
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
FEC Cohort 2: Placebo
Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.
Placebo (0.9% normal saline)
Pharmaceutical form: Liquid Route of administration: Intramuscular injection
Interventions
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SARS-CoV-2 mRNA vaccine formulation 1
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
SARS-CoV-2 mRNA vaccine formulation 2
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
SARS-CoV-2 mRNA vaccine formulation 3
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
Placebo (0.9% normal saline)
Pharmaceutical form: Liquid Route of administration: Intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* A female participant was eligible to participate if she was not pregnant or breastfeeding and one of the following conditions applies:
* Was of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile.
OR
* Was of childbearing potential and agreed 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.
A participant of childbearing potential must had a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours before the study intervention.
* Informed Consent Form had been signed and dated.
* Participant not eligible to receive, based on local guidance, or if eligible does not intend to receive an authorized/approved COVID-19 vaccine from first vaccination until completion of the key timepoint of Day 43 of follow-up of this study.
Exclusion Criteria
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
* Chronic illness or condition considered to potentially increase the risk for severe COVID illness or that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion.
* Known liver disease or fatty liver.
* Positive test for chronic active Hepatitis B surface antigen, Hepatitis B core antibody, Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody from blood work collected at screening visit.
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on Investigator's judgment.
* Receipt of immunoglobulins, blood or blood-derived products in the past 3 months.
* Prior administration of a coronavirus vaccine (SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome coronavirus \[MERS-CoV\]).
* Receipt of any vaccine in the 30 days preceding the first study vaccination or planned receipt of any vaccine in the 30 days following the last study vaccination except for influenza vaccination, which might be received at least 2 weeks before and a minimum of 2 weeks after study vaccines.
* Receipt of any therapy known to have in-vitro antiviral activity against SARS-CoV-2 within 72 hours prior to the first blood draw or planned use of such therapy 72 hours prior to study immunogenicity blood draws at Day 22 and Day 36.
* Residence in a nursing home or long-term care facility.
* Health care workers providing direct patient care for COVID-19 participants.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
18 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number :8400003
Rolling Hills Estates, California, United States
Investigational Site Number :8400002
Hollywood, Florida, United States
Investigational Site Number :8400006
Miami, Florida, United States
Investigational Site Number :8400017
Iowa City, Iowa, United States
Investigational Site Number :8400007
Kansas City, Missouri, United States
Investigational Site Number :8400008
Omaha, Nebraska, United States
Investigational Site Number :8400001
Rochester, New York, United States
Investigational Site Number :8400010
Philadelphia, Pennsylvania, United States
Investigational Site Number :8400004
North Charleston, South Carolina, United States
Investigational Site Number :8400015
Knoxville, Tennessee, United States
Investigational Site Number :8400009
Houston, Texas, United States
Investigational Site Number :8400005
Salt Lake City, Utah, United States
Investigational Site Number :0360003
Morayfield, Queensland, Australia
Investigational Site Number :0360005
South Brisbane, Queensland, Australia
Investigational Site Number :0360001
Melbourne, Victoria, Australia
Investigational Site Number :0360002
Nedlands, Western Australia, Australia
Investigational Site Number :0760001
Salvador, Estado de Bahia, Brazil
Investigational Site Number :0760004
Campo Grande, Mato Grosso do Sul, Brazil
Investigational Site Number :0760003
Belo Horizonte, Minas Gerais, Brazil
Investigational Site Number :3400002
Barrio del Centro, , Honduras
Investigational Site Number :3400001
San Pedro Sula, , Honduras
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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VAW00001 Plain Language Results Summary
Other Identifiers
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U1111-1251-5486
Identifier Type: REGISTRY
Identifier Source: secondary_id
VAW00001
Identifier Type: -
Identifier Source: org_study_id
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