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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04798027
Registration number
NCT04798027
Ethics application status
Date submitted
11/03/2021
Date registered
15/03/2021
Date last updated
15/12/2023
Titles & IDs
Public title
Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older
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Scientific title
Immunogenicity and Safety of the First-in-Human SARS-CoV-2 mRNA Vaccine Formulation in Healthy Adults 18 Years of Age and Older
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Secondary ID [1]
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0
U1111-1251-5486
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Secondary ID [2]
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0
VAW00001
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Universal Trial Number (UTN)
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Trial acronym
VAW00001
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
COVID-19
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0
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Condition category
Condition code
Infection
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0
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0
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Other infectious diseases
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Respiratory
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0
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - SARS-CoV-2 mRNA vaccine formulation 1
Other interventions - SARS-CoV-2 mRNA vaccine formulation 2
Other interventions - SARS-CoV-2 mRNA vaccine formulation 3
Other interventions - Placebo (0.9% normal saline)
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.
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.
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.
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.
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.
Placebo Comparator: FEC Cohort 1: Placebo - Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.
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.
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.
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.
Other interventions: SARS-CoV-2 mRNA vaccine formulation 1
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
Other interventions: SARS-CoV-2 mRNA vaccine formulation 2
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
Other interventions: SARS-CoV-2 mRNA vaccine formulation 3
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
Other interventions: Placebo (0.9% normal saline)
Pharmaceutical form: Liquid Route of administration: Intramuscular injection
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)
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Assessment method [1]
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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.
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Timepoint [1]
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Within 30 minutes post any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])
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Primary outcome [2]
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Number of Participants With Solicited Injection Site Reactions
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Assessment method [2]
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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.
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Timepoint [2]
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Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])
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Primary outcome [3]
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Number of Participants With Solicited Systemic Reactions
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Assessment method [3]
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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.
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Timepoint [3]
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Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])
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Primary outcome [4]
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Number of Participants With Unsolicited Adverse Events
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Assessment method [4]
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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.
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Timepoint [4]
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Within 21 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])
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Primary outcome [5]
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Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)
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Assessment method [5]
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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.
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Timepoint [5]
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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)
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Primary outcome [6]
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Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance
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Assessment method [6]
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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.
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Timepoint [6]
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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)
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Primary outcome [7]
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Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 1
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Assessment method [7]
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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.
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Timepoint [7]
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Day 1 (pre-vaccination)
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Primary outcome [8]
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Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 22
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Assessment method [8]
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GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.
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Timepoint [8]
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Day 22 (post-vaccination)
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Primary outcome [9]
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Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 36
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Assessment method [9]
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GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.
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Timepoint [9]
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Day 36 (post-vaccination)
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Primary outcome [10]
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Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22
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Assessment method [10]
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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.
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Timepoint [10]
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Day 1 (pre-vaccination) and Day 22 (post-vaccination)
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Primary outcome [11]
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Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36
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Assessment method [11]
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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.
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Timepoint [11]
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Day 1 (pre-vaccination) and Day 36 (post-vaccination)
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Primary outcome [12]
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Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22
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Assessment method [12]
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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.
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Timepoint [12]
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0
Day 1 (pre-vaccination) and Day 22 (post-vaccination)
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Primary outcome [13]
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Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36
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Assessment method [13]
0
0
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.
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Timepoint [13]
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0
Day 1 (pre-vaccination) and Day 36 (post-vaccination)
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Primary outcome [14]
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Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22
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Assessment method [14]
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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.
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Timepoint [14]
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0
Day 22 (post-vaccination)
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Primary outcome [15]
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Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36
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Assessment method [15]
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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.
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Timepoint [15]
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Day 36 (post-vaccination)
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Secondary outcome [1]
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Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202
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Assessment method [1]
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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.
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Timepoint [1]
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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)
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Secondary outcome [2]
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Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202
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Assessment method [2]
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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.
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Timepoint [2]
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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)
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Secondary outcome [3]
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0
Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202
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Assessment method [3]
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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.
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Timepoint [3]
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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)
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Secondary outcome [4]
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Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202
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Assessment method [4]
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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.
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Timepoint [4]
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Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)
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Secondary outcome [5]
0
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Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202
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Assessment method [5]
0
0
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.
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Timepoint [5]
0
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Day 1 (pre-vaccination), Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)
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Secondary outcome [6]
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0
Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202
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Assessment method [6]
0
0
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.
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Timepoint [6]
0
0
Day 1 (pre-vaccination), Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)
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Secondary outcome [7]
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0
Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens
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Assessment method [7]
0
0
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.
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Timepoint [7]
0
0
Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)
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Secondary outcome [8]
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0
Number of Participants With Virologically-confirmed Coronavirus Disease (COVID-19)-Like Illness
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Assessment method [8]
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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.
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Timepoint [8]
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Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)
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Secondary outcome [9]
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Number of Participants With Serologically-confirmed SARS-CoV-2 Infection
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Assessment method [9]
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Serologically-confirmed SARS-CoV-2 infection as defined by SARS-CoV-2 Nucleoprotein specific antibody detection immunoassay was reported in this outcome measure.
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Timepoint [9]
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Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)
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Secondary outcome [10]
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0
Correlates of Risk/Protection Based on Antibody Responses to SARS-CoV-2
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Assessment method [10]
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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.
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Timepoint [10]
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Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)
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Eligibility
Key inclusion criteria
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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/03/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
27/06/2022
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Sample size
Target
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Accrual to date
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Final
182
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Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
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Recruitment hospital [1]
0
0
Investigational Site Number :0360003 - Morayfield
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Recruitment hospital [2]
0
0
Investigational Site Number :0360005 - South Brisbane
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Recruitment hospital [3]
0
0
Investigational Site Number :0360001 - Melbourne
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Recruitment hospital [4]
0
0
Investigational Site Number :0360002 - Nedlands
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Recruitment postcode(s) [1]
0
0
4506 - Morayfield
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Recruitment postcode(s) [2]
0
0
4101 - South Brisbane
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Recruitment postcode(s) [3]
0
0
3010 - Melbourne
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Recruitment postcode(s) [4]
0
0
6009 - Nedlands
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Florida
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Iowa
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Missouri
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Nebraska
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Country [6]
0
0
United States of America
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State/province [6]
0
0
New York
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Pennsylvania
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Country [8]
0
0
United States of America
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State/province [8]
0
0
South Carolina
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Tennessee
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Texas
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Country [11]
0
0
United States of America
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Utah
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Brazil
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Bahia
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Brazil
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Mato Grosso Do Sul
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Brazil
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Minas Gerais
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Honduras
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Barrio Del Centro
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Honduras
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San Pedro Sula
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi Pasteur, a Sanofi Company
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Ethics approval
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04798027
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Contacts
Principal investigator
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Clinical Sciences & Operations
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Sanofi
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04798027
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