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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04762680
Registration number
NCT04762680
Ethics application status
Date submitted
18/02/2021
Date registered
21/02/2021
Titles & IDs
Public title
Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older
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Scientific title
Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccines With AS03 Adjuvant in Adults 18 Years of Age and Older as a Primary Series and Immunogenicity and Safety of a Booster Dose of SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (Two Monovalent and One Bivalent)
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Secondary ID [1]
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0
U1111-1251-4616
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Secondary ID [2]
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VAT00002
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Universal Trial Number (UTN)
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Trial acronym
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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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Other infectious diseases
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Respiratory
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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
Treatment: Other - SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 1
Treatment: Other - SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2
Treatment: Other - SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 3
Treatment: Other - SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A
Treatment: Other - SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03
Treatment: Other - SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage B
Treatment: Other - SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 1
Treatment: Other - SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 2
Treatment: Other - SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 3
Treatment: Other - SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 4
Treatment: Other - SARS-CoV-2 adjuvanted recombinant protein vaccine, bivalent (D614+B.1.351)-AS03
Experimental: Phase 2 Cohort -SARS-CoV-2 vaccine Formulation 1 - 2 injections of SARS-CoV-2 vaccine Formulation 1 at Day 1 and Day 22
Experimental: Phase 2 Cohort - SARS-CoV-2 vaccine Formulation 2 - 2 injections of SARS-CoV-2 vaccine Formulation 2 at Day 1 and Day 22
Experimental: Phase 2 Cohort - SARS-CoV-2 vaccine Formulation 3 - 2 injections of SARS-CoV-2 vaccine Formulation 3 Day 1 and Day 22
Experimental: Supplemental Cohort 1 - Booster Monovalent (D614)-AS03 SARS-CoV-2 vaccine - Participants who were previously vaccinated 4 to \< 10 months prior with an authorized mRNA or adenovirus-vector COVID-19 vaccine will receive 1 booster injection of monovalent (D614)-AS03 SARS-CoV-2 vaccine
Experimental: Supplemental Cohort 2 - Booster Monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine - Participants who were vaccinated 4 to \< 10 months prior with an authorized mRNA or adenovirus-vector COVID-19 vaccine or SARS-Cov-2 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine
Experimental: Supplemental Cohort 2 - Booster Bivalent (D614 + B.1.351)-AS03 SARS-CoV-2 vaccine - Participants who were vaccinated 4 to \< 10 months prior with an authorized mRNA or adenovirus-vector COVID-19 vaccine will receive 1 booster injection of bivalent (D614+B.1.351)-AS03 SARS-CoV-2 vaccine
Experimental: Supplemental Cohort 2 - Booster Monovalent (D614)-AS03 SARS-CoV-2 vaccine - Participants who were vaccinated 4 to \< 10 months prior with SARS-Cov-2 vaccine will receive 1 booster injection of monovalent (D614)-AS03 SARS-CoV-2 vaccine
Active comparator: Supplemental Comparator for Cohort 1 and 2 Boosters - Monovalent (D614)-AS03 SARS-CoV-2 vaccine - 2 injections of monovalent (D614)-AS03 SARS-CoV-2 vaccine at Day 1 and Day 22 in previously unvaccinated, naïve participants
Experimental: Cohort 2 - Booster Exploratory 1 - Participants who were vaccinated 4 to \< 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine
Experimental: Cohort 2 - Booster Exploratory 2 - Participants who were vaccinated 4 to \< 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine
Experimental: Cohort 2 - Booster Exploratory 3 - Participants who were vaccinated 4 to \< 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine
Experimental: Cohort 2 - Booster Exploratory 4 - Participants who were vaccinated 4 to \< 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine
Treatment: Other: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 1
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Treatment: Other: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Treatment: Other: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 3
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Treatment: Other: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Treatment: Other: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Treatment: Other: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage B
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Treatment: Other: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 1
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Treatment: Other: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 2
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Treatment: Other: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 3
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Treatment: Other: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 4
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Treatment: Other: SARS-CoV-2 adjuvanted recombinant protein vaccine, bivalent (D614+B.1.351)-AS03
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
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Intervention code [1]
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Treatment: Other
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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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Presence of immediate adverse events
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Assessment method [1]
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Immediate adverse events include unsolicited adverse events occurring within 30 minutes after injection.
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Timepoint [1]
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Within 30 minutes after vaccination
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Primary outcome [2]
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Presence of solicited injection site or systemic reactions
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Assessment method [2]
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Injection site reactions: injection site pain, erythema and swelling. Systemic reactions: fever, headache, malaise and myalgia.
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Timepoint [2]
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Within 7 days after vaccination
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Primary outcome [3]
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Presence of unsolicited adverse events
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Assessment method [3]
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Adverse events other than solicited reactions.
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Timepoint [3]
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Within 21 days after vaccination
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Primary outcome [4]
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Presence of serious adverse events
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Assessment method [4]
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Serious adverse events are reported throughout the study.
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Timepoint [4]
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From Day 1 to Day 387
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Primary outcome [5]
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Presence of adverse events of special interest
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Assessment method [5]
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Adverse events of special interest are reported throughout the study.
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Timepoint [5]
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From Day 1 to Day 387
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Primary outcome [6]
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Presence of medically-attended adverse events
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Assessment method [6]
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Medically-attended adverse events are new onset or a worsening of a condition that prompts the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or Emergency Department.
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Timepoint [6]
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From Day 1 to Day 387
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Primary outcome [7]
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Neutralizing antibody titer at Day 1
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Assessment method [7]
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Neutralizing antibody titers are expressed as geometric mean titers.
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Timepoint [7]
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Day 1
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Primary outcome [8]
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Neutralizing antibody titer at Day 36
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Assessment method [8]
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Neutralizing antibody titers are expressed as geometric mean titers.
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Timepoint [8]
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Day 36
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Primary outcome [9]
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Neutralizing antibody titer fold-rise post-vaccination
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Assessment method [9]
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Neutralizing antibody titer fold-rise post-vaccination.
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Timepoint [9]
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From Day 1 to Day 36
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Primary outcome [10]
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2-fold rise and 4-fold-rise in neutralization antibody titer
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Assessment method [10]
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Fold-rise in antibody neutralization titer post-vaccination relative to Day 1.
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Timepoint [10]
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From Day 1 to Day 36
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Primary outcome [11]
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Responders, as determined by neutralizing antibody titers at Day 36
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Assessment method [11]
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Responders, defined as participants who had baseline values below lower limit of quantification (LLOQ) with detectable neutralization titer above assay LLOQ at each pre-defined time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titer at Day 36
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Timepoint [11]
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From Day 1 to Day 36
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Primary outcome [12]
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Neutralizing antibody titer at Day 1 (pre-booster injection)
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Assessment method [12]
0
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Neutralizing antibody titers are expressed as geometric mean titers.
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Timepoint [12]
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Day 1 (pre-booster injection)
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Primary outcome [13]
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Neutralizing antibody titer at Day 15 (post-booster injection)
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Assessment method [13]
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Neutralizing antibody titers are expressed as geometric mean titers.
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Timepoint [13]
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0
Day 15 (post-booster injection)
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Primary outcome [14]
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Neutralizing antibody titer at Day 36 (Cohorts 1 and 2 Comparator Group)
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Assessment method [14]
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Neutralizing antibody titers are expressed as geometric mean titers.
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Timepoint [14]
0
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Day 36
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Primary outcome [15]
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0
Responders, as determined by neutralizing antibody titers at Day 36 (Cohorts 1 and 2 Comparator Group)
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Assessment method [15]
0
0
Responders are defined as participants with a 4-fold-or greater rise in serum neutralization titer \[pre/post\] at Day 36 relative to Day 1
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Timepoint [15]
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0
From Day 1 to Day 36
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Secondary outcome [1]
0
0
Neutralizing antibody titer at all pre-defined time points
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Assessment method [1]
0
0
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Timepoint [1]
0
0
Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387
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Secondary outcome [2]
0
0
Neutralizing antibody titer fold-rise post-vaccination at all pre-defined time points
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Assessment method [2]
0
0
Fold-rise in antibody neutralization titer post-vaccination relative to Day 1.
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Timepoint [2]
0
0
Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387
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Secondary outcome [3]
0
0
Responders, as determined by neutralizing antibody titers at each pre-defined time point
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Assessment method [3]
0
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Responders, defined as participants who had baseline values below LLOQ with detectable neutralization titer above assay LLOQ at each pre-defined time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titer at each pre-defined timepoint.
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Timepoint [3]
0
0
Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387
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Secondary outcome [4]
0
0
2-fold rise and 4-fold-rise in neutralization antibody titer at all pre-defined time points
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Assessment method [4]
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Fold-rise in antibody neutralization titer post-vaccination relative to Day 1.
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Timepoint [4]
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Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387
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Secondary outcome [5]
0
0
Binding antibody fold-rise
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Assessment method [5]
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Fold-rise in concentration relative to Day 1.
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Timepoint [5]
0
0
Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387
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Secondary outcome [6]
0
0
Binding antibody concentrations
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Assessment method [6]
0
0
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Timepoint [6]
0
0
Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387
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Secondary outcome [7]
0
0
2-fold-rise and 4-fold rise in binding antibody concentration
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Assessment method [7]
0
0
Fold-rise in concentration relative to Day 1.
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Timepoint [7]
0
0
Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387
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Secondary outcome [8]
0
0
Responders, as determined by binding antibody concentrations
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Assessment method [8]
0
0
Responders are defined as participants who had baseline values below LLOQ with detectable anti concentration above assay LLOQ at each pre-defined time point and participants with baseline values above LLOQ with a 4-fold increase in anti-S antibody concentration at each pre-defined time point.
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Timepoint [8]
0
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Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387
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Secondary outcome [9]
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Occurrences of laboratory-confirmed symptomatic COVID-19
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Assessment method [9]
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Symptomatic COVID-19 is defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness. Laboratory-confirmed SARS-CoV-2 infection is defined as a positive result for SARS CoV-2 by nucleic acid amplification test (NAAT), done by the central laboratory or locally, on at least one respiratory sample.
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Timepoint [9]
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From Day 1 to Day 387
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Secondary outcome [10]
0
0
Occurrences of symptomatic COVID-19 episodes associated with hospitalization
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Assessment method [10]
0
0
Symptomatic COVID-19 is defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness.
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Timepoint [10]
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From Day 1 to Day 387
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Secondary outcome [11]
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0
Occurrences of severe symptomatic COVID-19
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Assessment method [11]
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Symptomatic COVID-19 is defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness with pre-defined criteria of severity.
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Timepoint [11]
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From Day 1 to Day 387
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Secondary outcome [12]
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Occurrences of death associated with symptomatic COVID-19
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Assessment method [12]
0
0
Symptomatic COVID-19 is defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness.
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Timepoint [12]
0
0
From Day 1 to Day 387
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Secondary outcome [13]
0
0
Occurrences of serologically-confirmed SARS-CoV-2 infection
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Assessment method [13]
0
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Serologically-confirmed SARS-CoV-2 infection is defined as a positive result in a serum sample for antibodies against SARS-CoV-2.
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Timepoint [13]
0
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From Day 1 to Day 387
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Secondary outcome [14]
0
0
Neutralizing antibody titer at all pre-defined time points post-booster and booster comparator injection
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Assessment method [14]
0
0
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Timepoint [14]
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Day 1 and Day 15 (post-booster injection) and Day 36
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Secondary outcome [15]
0
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Neutralizing antibody titer fold-rise post-vaccination at all pre-defined time points post-booster and booster comparator injection
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Assessment method [15]
0
0
Neutralizing antibody titer fold-rise post-vaccination.
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Timepoint [15]
0
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Day 1 and Day 15 (post-booster injection) and Day 36
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Secondary outcome [16]
0
0
2-fold rise and 4-fold-rise in neutralization antibody titer at all pre-defined time points post-booster and booster comparator injection
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Assessment method [16]
0
0
Neutralizing antibody titer fold-rise post-vaccination.
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Timepoint [16]
0
0
Day 1 and Day 15 -post-booster injection) and Day 36
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Secondary outcome [17]
0
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Seroresponse rate post-booster and booster comparator injection
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Assessment method [17]
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Seroresponse rate is defined as the percentage or participants with 4-fold-or greater rise in serum neutralization titer \[pre/post\] at post-vaccination relative to pre-vaccination.
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Timepoint [17]
0
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Day 1 and Day 15 (post-booster injection) and Day 36
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Secondary outcome [18]
0
0
Binding antibody concentrations post-booster injection
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Assessment method [18]
0
0
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Timepoint [18]
0
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Day 1, Day 15, Day 29, Day 91, Day 181, and Day 366 (post-booster injection)
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Secondary outcome [19]
0
0
Binding antibody fold-rise post-booster injection
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Assessment method [19]
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Fold-rise in concentration relative to Day 1.
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Timepoint [19]
0
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Day 1, Day 15, Day 29, Day 91, Day 181, and Day 366 (post-booster injection)
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Secondary outcome [20]
0
0
2-fold-rise and 4-fold rise in binding antibody concentration post-booster injection
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Assessment method [20]
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Fold-rise in concentration relative to Day 1.
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Timepoint [20]
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Day 1, Day 15, Day 29, Day 91, Day 181, and Day 366 (post-booster injection)
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Eligibility
Key inclusion criteria
-Aged 18 years or older on the day of inclusion. - -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 mut 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 vaccination until at least 12 weeks after the last vaccination (ie, second dose of primary series or booster injection). A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 4 hours before any dose of study intervention. - -Informed consent form has been signed and dated.
Able to attend all scheduled visits and to comply with all study procedures. SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies (Original Phase 2 Cohort).
For persons living with human immunodeficiency virus (HIV), stable HIV infection determined by participant currently on antiretrovirals with CD4 count > 200/mm3.
Does not intend to receive an authorized/approved COVID-19 vaccine from first vaccination to 3 weeks after the second vaccination despite encouragement by the investigator to receive the authorized vaccine available to them at the time of enrollment.
Supplemental cohorts: for participants originally enrolled in the Phase II cohort of the study, informed consent has to be signed and dated for transitioning to Supplemental Cohort 2.
Supplemental cohorts, Booster arms: received a complete primary vaccination series with an authorized/conditionally approved mRNA COVID-19 vaccine (mRNA-1273 [Moderna] or BNT162b2 [Pfizer/BioNTech]) or adenovirus-vectored COVID-19 vaccine (ChAdOx1 nCoV-19 [Oxford University/AstraZeneca] or Ad26.CoV2.S [J&J/Janssen]), with the last dose administered a minimum of 4 months prior to inclusion but not longer than 10 months prior to inclusion.
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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
-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 trial procedures based on Investigator or designee'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.
Receipt of solid-organ or bone marrow transplants in the past 180 days. Receipt of anti-cancer chemotherapy in the last 90 days. Receipt of immunoglobulins, blood, or blood-derived products in the past 3 months.
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 trial 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.
Applicable to Original Phase II Cohort, Supplemental Cohort 1 and Cohort 2 Comparator Group: Prior administration of a coronavirus vaccine (SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome [MERS-CoV]). Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study trial period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. Exclusion criterion for the Supplemental Cohort 1 and Cohort 2 comparator group: positive rapid diagnostic test for SARS-CoV-2 antibodies at time of enrollment.
Exclusion criterion for participants in Supplemental Cohort 2 who were primed as participant in the Original Phase II Cohort of the present study: Receipt of authorized/conditionally approved COVID-19 vaccine after enrollment in Original Phase 2 Cohort.
Exclusion criterion for all Booster groups: Documented virologically-confirmed SARS-CoV-2 infection (by NAAT) after first dose of primary immunization.
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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 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
24/02/2021
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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
29/06/2023
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Sample size
Target
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Accrual to date
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Final
3385
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Investigational Site Number : 0360001 - South Brisbane
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Recruitment hospital [2]
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Investigational Site Number : 0360003 - Norwood
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Recruitment hospital [3]
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Investigational Site Number : 0360002 - Southport
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Recruitment hospital [4]
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Investigational Site Number : 0360005 - Westmead
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Recruitment hospital [5]
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Investigational Site Number : 0360004 - Woodville
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Recruitment postcode(s) [1]
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0
4101 - South Brisbane
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Recruitment postcode(s) [2]
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0
5067 - Norwood
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Recruitment postcode(s) [3]
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0
4215 - Southport
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Recruitment postcode(s) [4]
0
0
2145 - Westmead
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Recruitment postcode(s) [5]
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0
5011 - Woodville
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Arkansas
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Country [4]
0
0
United States of America
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State/province [4]
0
0
California
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Connecticut
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Country [6]
0
0
United States of America
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State/province [6]
0
0
District of Columbia
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Florida
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Georgia
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Illinois
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Country [10]
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France
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Galicia [Galicia]
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Spain
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London
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Southampton
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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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Commercial sector/industry
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GlaxoSmithKline
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Ethics approval
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Summary
Brief summary
The primary objectives of the study are: To assess the safety profile of the study vaccines in each study intervention group. To assess the neutralizing antibody profile after primary series vaccination in SARS-CoV-2-naïve adults. To demonstrate that a booster dose of monovalent or bivalent SARS-CoV-2 vaccine given to adults previously vaccinated with an authorized/approved COVID-19 vaccine induces an immune response that is non-inferior to the response induced by a twodose priming series with the monovalent vaccine, and superior to that observed immediately before booster. The secondary objectives of the study are: To assess the neutralizing and binding antibody profiles after primary series vaccination at pre-defined time points during the study. To assess the neutralizing and binding antibody responses of booster vaccination. To describe the occurrences of laboratory-confirmed symptomatic COVID19 after primary series and booster vaccination. To describe the occurrences of serologically-confirmed SARS-CoV-2 infection after primary series vaccination.
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Trial website
https://clinicaltrials.gov/study/NCT04762680
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Trial related presentations / publications
Sridhar S, Joaquin A, Bonaparte MI, Bueso A, Chabanon AL, Chen A, Chicz RM, Diemert D, Essink BJ, Fu B, Grunenberg NA, Janosczyk H, Keefer MC, Rivera M DM, Meng Y, Michael NL, Munsiff SS, Ogbuagu O, Raabe VN, Severance R, Rivas E, Romanyak N, Rouphael NG, Schuerman L, Sher LD, Walsh SR, White J, von Barbier D, de Bruyn G, Canter R, Grillet MH, Keshtkar-Jahromi M, Koutsoukos M, Lopez D, Masotti R, Mendoza S, Moreau C, Ceregido MA, Ramirez S, Said A, Tavares-Da-Silva F, Shi J, Tong T, Treanor J, Diazgranados CA, Savarino S. Safety and immunogenicity of an AS03-adjuvanted SARS-CoV-2 recombinant protein vaccine (CoV2 preS dTM) in healthy adults: interim findings from a phase 2, randomised, dose-finding, multicentre study. Lancet Infect Dis. 2022 May;22(5):636-648. doi: 10.1016/S1473-3099(21)00764-7. Epub 2022 Jan 25.
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Public notes
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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
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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
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When will data be available (start and end dates)?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04762680