Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older (VAW00001)

Immunogenicity and Safety of the First-in-Human SARS-CoV-2 mRNA Vaccine Formulation in Healthy Adults 18 Years of Age and Older

The primary objectives of the study are:

• 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.

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Biological: SARS-CoV-2 mRNA vaccine formulation 1; Biological: SARS-CoV-2 mRNA vaccine formulation 2; Biological: SARS-CoV-2 mRNA vaccine formulation 3; Biological: Placebo (0.9% normal saline)

Detailed Description

The duration of each participant's participation in the study was approximately 365 days post-last injection: approximately 386 days duration for participants receiving 2 injections and approximately 365 days duration total for participants receiving a single injection.

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Morayfield, Queensland, Australia, 4506
      • Investigational Site Number :0360003
    • South Brisbane, Queensland, Australia, 4101
      • Investigational Site Number :0360005
  • Victoria
    • Melbourne, Victoria, Australia, 3010
      • Investigational Site Number :0360001
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Investigational Site Number :0360002
• Brazil
  • Bahia
    • Salvador, Bahia, Brazil, 40415-006
      • Investigational Site Number :0760001
  • Mato Grosso Do Sul
    • Campo Grande, Mato Grosso Do Sul, Brazil, 79070-900
      • Investigational Site Number :0760004
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30110-063
      • Investigational Site Number :0760003
• Honduras
  • Barrio Del Centro, Honduras, 11101
    • Investigational Site Number :3400002
  • San Pedro Sula, Honduras, 21104
    • Investigational Site Number :3400001
• United States
  • California
    • Rolling Hills Estates, California, United States, 90274
      • Investigational Site Number :8400003
  • Florida
    • Hollywood, Florida, United States, 33024
      • Investigational Site Number :8400002
    • Miami, Florida, United States, 33135
      • Investigational Site Number :8400006
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Investigational Site Number :8400017
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Investigational Site Number :8400007
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Investigational Site Number :8400008
  • New York
    • Rochester, New York, United States, 14609
      • Investigational Site Number :8400001
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Investigational Site Number :8400010
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Investigational Site Number :8400004
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Investigational Site Number :8400015
  • Texas
    • Houston, Texas, United States, 77081
      • Investigational Site Number :8400009
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Investigational Site Number :8400005

Participation Criteria

Eligibility Criteria

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

Description

Inclusion criteria:

• Aged >= 18 years on the day of inclusion.
• 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:

• History of COVID-19 disease or prior SARS-CoV-2 infection confirmed serologically.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: SARS-CoV-2 mRNA vaccine formulation 1; Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
Experimental: 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.	Biological: SARS-CoV-2 mRNA vaccine formulation 2; Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
Experimental: 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.	Biological: SARS-CoV-2 mRNA vaccine formulation 3; Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
Experimental: 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.	Biological: SARS-CoV-2 mRNA vaccine formulation 1; Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
Experimental: 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.	Biological: SARS-CoV-2 mRNA vaccine formulation 2; Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
Placebo Comparator: FEC Cohort 1: Placebo; Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Biological: Placebo (0.9% normal saline); Pharmaceutical form: Liquid Route of administration: Intramuscular injection
Experimental: 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.	Biological: SARS-CoV-2 mRNA vaccine formulation 1; Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
Experimental: 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.	Biological: SARS-CoV-2 mRNA vaccine formulation 2; Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
Placebo Comparator: 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.	Biological: Placebo (0.9% normal saline); Pharmaceutical form: Liquid Route of administration: Intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)	AE: any untoward medical occurrence in clinical investigation participant administered medicinal product & which did not have any causal relationship with the treatment. Unsolicited AE: observed AE that did not fulfill conditions prelisted in case report form (CRF) in terms of diagnosis &/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, & any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in CRF. Reported AEs were presented as pre-specified in protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.	Within 30 minutes post any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])
Number of Participants With Solicited Injection Site Reactions	Solicited reaction (SR): expected adverse reaction (sign or symptom) observed & reported under conditions (nature & onset) prelisted (i.e., solicited) in CRF and considered as related to product administered. Solicited injection site reactions included pain, erythema, & swelling. Reported AEs for each arm were presented as pre-specified in study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.	Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])
Number of Participants With Solicited Systemic Reactions	SR was an expected adverse reaction (sign or symptom) observed & reported under conditions (nature & onset) prelisted (i.e., solicited) in CRF & considered as related to product administered. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia & chills. Reported AEs for each arm were presented as pre-specified in study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.	Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])
Number of Participants With Unsolicited Adverse Events	An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not have any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.	Within 21 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])
Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)	SAEs: any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs: event for which ongoing monitoring & rapid communication by investigator to the sponsor was done. MAAE was a new onset or worsening of a condition that prompted participant or participant's parent/legally acceptable representative to seek unplanned medical advice at physician's office or emergency department. Reported AEs for each arm were presented as pre-specified in study protocol.	From Day 1 until 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups)
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance	Laboratory tests: hemoglobin (male & female), above & below normal white blood cell, lymphocytes, neutrophils & eosinophils, platelet count, creatinine & blood urea nitrogen, hyponatremia & hypernatremia, hyperkalemia & hypokalemia, hyperglycemia (non-fasting), hypoproteinemia, alkaline phosphate, alanine aminotransferase, aspartate aminotransferase, bilirubin (with any increase in liver function test [LFT], bilirubin (normal LFT), prothrombin & partial thromboplastin time (seconds), Urine: protein, glucose & blood. US FDA "Toxicity Grading Scale for Healthy Adults & Adolescent Volunteers" was used for grading; Grade 1=mild, Grade 2=moderate & Grade 3=severe. In the data table, 'number analyzed'=participants with available data for each specified category & '0'=none of participants were available for assessment for specified Group.	From Day 1 up to up to 8 days post last vaccination (i.e., up to Day 9 for Cohort 1 groups; up to Day 30 for Cohort 2 groups)
Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 1	GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. Data for this OM was planned to be collected and analyzed for combined population (FEC+ Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.	Day 1 (pre-vaccination)
Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 22	GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.	Day 22 (post-vaccination)
Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 36	GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.	Day 36 (post-vaccination)
Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22	SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 1.	Day 1 (pre-vaccination) and Day 22 (post-vaccination)
Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36	SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (Day 36) and pre-vaccination (on Day 1) i.e., Day 36/Day 1.	Day 1 (pre-vaccination) and Day 36 (post-vaccination)
Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 1.	Day 1 (pre-vaccination) and Day 22 (post-vaccination)
Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (on Day 36) and pre-vaccination (on Day 1) i.e., Day 36/Day 1.	Day 1 (pre-vaccination) and Day 36 (post-vaccination)
Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22	Seroconversion was defined as participants with a Baseline (Day 1) titer values below lower limit of quantification (LLOQ) with a detectable neutralization antibody titer above assay LLOQ post injection (at Day 22). LLOQ of the neutralization assay was a titer of 10.	Day 22 (post-vaccination)
Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36	Seroconversion was defined as participants with a Baseline (Day 1) titer values below LLOQ with a detectable neutralization antibody titer above assay LLOQ post injection (at Day 36). LLOQ of the neutralization assay was a titer of 10.	Day 36 (post-vaccination)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202	GMC of Anti-S binding antibodies were assessed using enzyme-linked immunosorbent assay (ELISA) and were measured in ELISA unit/mL (ELU/mL). Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.	Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2)
Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202	Binding antibody titers were evaluated by ELISA. Fold-rise was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 22/Day 1, Day 36/Day 1, Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.	Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2)
Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202	Binding antibody titers were evaluated by ELISA. Fold-rise (2-fold and 4-fold) was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 22/Day 1, Day 36/Day 1, Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.	Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2)
Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202	GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.	Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)
Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202	SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., for Cohort 1: Day 91/Day 1, Day 181/Day 1; Cohort 2: Day 112/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.	Day 1 (pre-vaccination), Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)
Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202	SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise (2-fold and 4-fold) was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.	Day 1 (pre-vaccination), Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)
Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens	Seroconversion was defined as participants with a Baseline (Day 1) titer values below lower limit of quantification (LLOQ) with a detectable neutralization antibody titer above assay LLOQ post injection. LLOQ of the neutralization assay was a titer of 10. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.	Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)
Number of Participants With Virologically-confirmed Coronavirus Disease (COVID-19)-Like Illness	Virologically-confirmed COVID-19-like illness was defined by specified clinical symptoms and signs and confirmed by positive result for SARS-CoV-2 by nucleic acid amplification test (NAAT) on a respiratory sample in association with a COVID-19-like illness.	Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)
Number of Participants With Serologically-confirmed SARS-CoV-2 Infection	Serologically-confirmed SARS-CoV-2 infection as defined by SARS-CoV-2 Nucleoprotein specific antibody detection immunoassay was reported in this outcome measure.	Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)
Correlates of Risk/Protection Based on Antibody Responses to SARS-CoV-2	Correlate of risk / protection based on antibody responses to SARS-CoV-2 was evaluated using virus neutralization or ELISA, considering virologically-confirmed COVID-19-like illness and/or serologically-confirmed SARS-CoV-2 infection.	Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2021
• Primary Completion (Actual): June 27, 2022
• Study Completion (Actual): June 27, 2022

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: VAW00001; U1111-1251-5486 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No