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| Name | Class |
|---|---|
| Arcturus Therapeutics, Inc. | INDUSTRY |
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This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind study designed to evaluate the safety, immunogenicity and efficacy of ARCT-154 in adult participants to be enrolled in Vietnam.
This study consists of four parts:
Part 1 (Phase 1) will evaluate the safety of the study vaccines in 100 healthy individuals.
Part 2 (Phase 2) will evaluate the safety and immunogenicity of the study vaccines in 300 healthy individuals.
Part 3 (Phase 3a) will evaluate the safety, immunogenicity, and efficacy of the study vaccines in 600 individuals with and without underlying medical conditions.
Part 4 (Phase 3b) will evaluate the safety and efficacy of the study vaccines in 16,000 individuals with and without underlying medical conditions.
Part 5 (Phase 3c) will evaluate the safety and non-inferiority in immunogenicity of ARCT-154 vaccine vs. Astra Zeneca COVID-19 vaccine (ChAdOx1 nCoV-19) in 2400 individuals with and without underlying medical conditions.
In Phase 1, healthy individuals 18 to < 60 years of age will be enrolled. In Phase 2, 3a, and 3b, individuals 18 years of age and older will be enrolled including individuals with underlying medical conditions that put them at higher risk of complications of COVID-19 disease.
Phase 1, Phase 2, Phase 3a and Phase 3b participants will be randomly assigned to a study group that will receive up to 2 vaccination series. Each vaccination series comprises two vaccinations at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series around 2 months after the first series (on Day 92 and 120).
Participants of Phase 2, 3a who received 2 doses of ARCT-154 vaccine will be rerandomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120.
For Phase 1, Phase 3b and participants in Phase 2 and 3a that received placebo in the first vaccination series, the participants will be switched over to the opposite vaccine in the second series.
There is no second vaccination series for Phase 3c as all participants receive active vaccine in the initial series.
Phase 1 will enroll 100 healthy participants that are randomly assigned 3:1 to receive ARCT-154 or placebo (75:25) for the initial series of vaccinations.
In Phase 2, 300 participants will be randomly assigned 3:1 to receive ARCT-154 or placebo for the initial series of vaccinations. Participants that received ARCT-154 in the initial series will be rerandomized 3:1 to receive ARCT or placebo on Day 92 followed by placebo on Day 120.
In Phase 3a, 600 participants will be randomly assigned 3:1 to receive ARCT-154 or placebo for the initial series of vaccinations. Participants that received ARCT-154 in the initial series will be rerandomized 3:1 to receive ARCT or placebo on Day 92 followed by placebo on Day 120.
In Phase 3b, ~16,000 participants will be randomly assigned 1:1 to receive ARCT-154 or placebo for the initial series of vaccinations.
In Phase 3c, ~2,400 participants will be randomly assigned 1:1 to receive ARCT-154 or Astra Zeneca COVID-19 vaccine. Blood samples will be collected and reserved for Immunogenicity evaluation for the first 1500 participants (3c-1) and assays for immunogenicity evaluation will be performed for the first 800 participants.
Phase 1 participants must be <60 years of age and healthy. Phase 2, 3a, and 3b and 3c participants will include elderly (≥60 years) and those with comorbidities.
For Phase 2, 3a, 3b and 3c, prior to randomization, participants will be stratified by age (< 60 or ≥ 60 years of age) and for participants < 60 years of age by risk of severe COVID 19. Participants will be followed up for approximately 1 year after completion of the initial vaccination series.
An independent Data and Safety Monitoring Board (DSMB) will perform ongoing review of blinded and unblinded data.
An independent blinded adjudication committee will adjudicate all suspected COVID-19 cases to determine if they meet the primary endpoint requirements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARCT-154 | Experimental | Each participant is planned to receive a two-dose vaccination series of ARCT-154 at a dose of 5 µg with 28 day interval in the first vaccination series. |
|
| Placebo | Placebo Comparator | Each participant is planned to receive a two-dose vaccination series of placebo (normal saline) with 28 day interval in the first vaccination series. |
|
| Astra Zeneca COVID-19 vaccine | Active Comparator | Each participant is planned to receive a two-dose vaccination series of Astra Zeneca COVID-19 vaccine with 28 day interval in the first vaccination series. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARCT-154 Self-Amplifying RNA SARS-CoV-2 Vaccine | Biological | ARCT-154 Self-Amplifying RNA SARS-CoV-2 Vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Solicited Local Adverse Reactions (ARs) | Solicited local ARs included injection site erythema, injection site pain, injection site induration/swelling, and injection site tenderness. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Within 7 days after Dose 1 and Dose 2 (up to Day 7 and 36) |
| Number of Participants Reporting Solicited Systemic ARs | Solicited systemic ARs included arthralgia, chills, diarrhea, dizziness, fatigue, fever (categorized by measured body temperature), headache, myalgia, and nausea/vomiting. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Within 7 days after Dose 1 and Dose 2 (up to Day 7 and 36) |
| Number of Participants Reporting Unsolicited Adverse Events (AEs) | Unsolicited AEs were defined as any spontaneously reported or discovered AE. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Approximately 28 days after Dose 1 and Dose 2 (Day 1 to Day 29 and Day 29 to Day 57) |
| Number of Participants Reporting Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation | An MAAE was defined as an AE that led to an unscheduled visit (including a telemedicine visit) with a healthcare provider ([HCP], e.g., nurse, nurse practitioner, physician's assistant, physician). An SAE was defined as any event that resulted in death, was immediately life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect arising from a pregnancy conceived after receipt of study vaccine. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers of SARS-CoV-2 Neutralizing Antibodies | Days 1, 29, 57 and 92 | |
| Geometric Mean Fold Rise in SARS-CoV-2 Neutralizing Antibody Titers | Days 29, 57, 92 | |
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Inclusion Criteria:
Individuals who:
Exclusion Criteria:
Individuals who:
Significant infection or other acute illness, including body temperature >100.4°F (>38.0°C) on the day prior to or Day 1. Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
Pregnant or breastfeeding.
Known history of COVID-19 (asymptomatic SARS-CoV-2 infection and/or nucleocapsid positive test is not exclusionary).
Close contact with a person known to be SARS-CoV-2 positive or with a clinical diagnosis of COVID-19 within 7 days prior to enrollment. Participants meeting this criterion who remain asymptomatic for 7 days may be rescheduled for enrollment within the relevant windows.
Known history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients.
Known history of anaphylaxis to other vaccines.
Bleeding disorder considered a contraindication to intramuscular (IM) injection or phlebotomy.
Immunosuppressive or immunodeficient state, asplenia, recurrent severe infections, or known to be HIV positive.
An underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
Prior/Concomitant Therapy
Has previously received investigational or approved MERS-CoV, SARS-CoV, SARS-CoV-2 vaccines or who have plans to receive off-study COVID-19 vaccines.
Has received a live replicating vaccine within 28 days prior to each study vaccination or a licensed inactivated or non-replicating vaccine within 14 days prior to first study vaccination.
Has received treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, within 6 months prior to Screening, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days prior to first study vaccine administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
Has received systemic immunoglobulins or blood products within 3 months prior to first study vaccine administration or plans to receive such products during the study.
Other Exclusions
Demonstrated inability to comply with the study procedures.
Investigator site staff members, employees of the Sponsor or the CRO directly involved in the conduct of the study, or site staff members otherwise supervised by the investigator, or immediate family members of any of the previously mentioned individuals.
Other restrictions apply to Phase 1 participants to ensure they are healthy.
Additional Exclusion Criteria for Phase 3c Participants Only:
No contraindications (as specified in the prescribing information) to receiving the ChAdOx1 vaccine.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanoi Medical University | Hanoi | Hanoi | 00000 | Vietnam | ||
| Military Medical University |
IPD is the sole property of VinBioCare. VinBioCare may share a copy of the study IPD with their collaborative partners if requested.
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As pre-specified, data were collected and are reported per vaccine group overall for all study phases combined. Data are reported per first treatment received.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine [ChAdOx1 nCoV-19). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per initial treatment received. Data in this arm are presented pooled for participants who initially received placebo in Phases 1, 2, 3a, 3b.](streamdown:incomplete-link) |
| FG001 | ARCT-154 | This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine [ChAdOx1 nCoV-19]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per initial treatment received. Data in this arm are presented pooled for participants who initially received ARCT-154 in Phases 1, 2, 3a, 3b, 3c. |
| FG002 | Astra Zeneca COVID-19 vaccine | Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine [ChAdOx1 nCoV-19]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set, which included all participants who received any dose of study vaccine (ARCT-154 or placebo or ChAdOx1). As pre-specified, data were collected and are reported according to the initial study vaccine received, pooled per treatment received for Phase 1/2/3a/3b (ARCT-154/placebo), and separately for ChAdOx1 and ARCT-154 for Phase 3c. Participants are counted only once, baseline data were collected and are reported based on initial treatment received.
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| ID | Title | Description |
|---|---|---|
| BG000 | ARCT-154 | This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine [ChAdOx1 nCoV-19]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phases 1, 2, 3a, 3b. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Reporting Solicited Local Adverse Reactions (ARs) | Solicited local ARs included injection site erythema, injection site pain, injection site induration/swelling, and injection site tenderness. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Reactogenicity Analysis Set, all participants who received any dose of study vaccine (ARCT-154 or placebo or ChAdOx1) and provided at least 1 reactogenicity diary report. As pre-specified, data are presented pooled per treatment received for Phase 1/2/3a/3b, and separately for ARCT-154 for Phase 3c. Overall number of participants analyzed = number of participants evaluable for the endpoint. Number analyzed = number of participants with evaluable data at the specified timepoint. | Posted | Count of Participants | Participants | Within 7 days after Dose 1 and Dose 2 (up to Day 7 and 36) |
|
All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92&Day 92-End of Study (EOS) for mortality&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 &Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phases 1, 2, 3a, 3b: ARCT-154 Day 1-92 | This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine [ChAdOx1 nCoV-19]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data for Day 1-92 in this arm are presented for participants who initially received ARCT-154 in Phases 1, 2, 3a, 3b (pooled). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nguyen Xuan Hung | Vinmec Healthcare System | +84-865438388 | v.hungnx1@vinmec.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 7, 2022 | Jan 10, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 20, 2023 | Jan 10, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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Phase 1, 2, 3a, 3b: Participants will be randomly assigned to a study group that will receive up to 2 vaccination series. Each vaccination series comprises two vaccinations at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series at around 2 months after the first series on Day 92 and 120. Each participant is planned to receive a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series.
Participants in Phase 2, 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series will be rerandomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120.
Phase 3c: Participants will be randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine).
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Observer-blind design:
Investigators, site staff, participants, CRO staff, Sponsor representatives with oversight of study conduct or study-related assessments will remain blinded to vaccine assignments for the study duration.
| Placebo (normal saline) | Other | Normal saline with the same volume as of ARCT-154 |
|
| Astra Zeneca COVID-19 vaccine | Biological | Astra Zeneca COVID-19 vaccine (ChAdOx1 nCoV-19) |
|
| Day 1 to Day 92 |
| Number of Participants With Neutralizing Antibody (NAb) Responses | Data are presented for the number of participants with a NAb seroconversion response as determined by the surrogate virus neutralization test (sVNT). Seroconversion was defined as a ≥4-fold increase in antibody concentration from baseline. | Day 57 |
| Number of Participants With a First Occurrence of Coronavirus Disease 2019 (COVID-19) | COVID-19 was defined as a positive SARS-CoV-2 test and at least one of the following that was a new or worsening finding: ⦁ Fever or chills ⦁ Cough ⦁ Shortness of breath or difficulty breathing ⦁ Fatigue ⦁ Muscle or body aches ⦁ Headache ⦁ New loss of taste or smell ⦁ Sore throat ⦁ Congestion or runny nose ⦁ Nausea or vomiting ⦁ Diarrhea Data are presented for the number of participants with a first occurrence of COVID-19 with no evidence of prior infection. | Day 36 to Day 92 |
| Number of Participants Seroconverting for Neutralizing Antibodies |
Seroconversion was defined as a ≥4-fold increase in antibody concentration from baseline as measured by the sVNT test. Data are presented for the number of participants seroconverting for neutralizing antibodies. |
| Days 29, 57 and 92 |
| Geometric Mean Concentration of Spike Protein Immunoglobulin G (IgG) Binding Antibodies | Days 1, 29, 57, 92 |
| Geometric Mean Fold Ratio of Spike Protein IgG Binding Antibodies | Days 29, 57, 92 |
| Number of Participants Seroconverting for Spike Protein IgG Binding Antibodies | Seroconversion was defined as a ≥4-fold increase in antibody concentration from baseline. Data are presented for the number of participants seroconverting for spike protein IgG binding antibodies. | Days 29, 57, 92 |
| Number of Participants Seroconverting on Neutralizing Antibody Responses by Plaque Reduction Neutralization Test at 50% Reduction (PRNT50) | The plaque reduction neutralization test (PRNT) is a live virus assay. Neutralizing antibody titers were calculated as the highest serum dilution that resulted in 50% reduction in the number of virus plaques (PRNT50). Data presented is for the ancestral-clinical isolate variant. Data are presented for the number of participants that demonstrated seroconversion (as defined by 4-fold increase in neutralizing antibody concentration from baseline) on PRNT50. | Days 29 and 57 |
| Number of Participants With a First Occurrence of Severe COVID-19 | Number of participants with a first occurrence of severe COVID-19 in participants with no evidence of prior infection. Severe COVID-19 was defined as a positive SARS-CoV-2 test, symptoms per protocol-defined COVID-19 and any of the following: Clinical signs at rest indicative of severe systemic illness: - Respiratory rate ≥30 per minute, - Heart rate ≥125 per minute, - Oxygen saturation (SpO2) ≤93% on room air at sea level or partial pressure of oxygen (PO2)/fraction of inspired oxygen (FiO2) <300 millimeter of mercury (mm Hg) - Respiratory failure (defined as needing high flow oxygen, noninvasive ventilation, mechanical ventilation or extracorporeal membrane oxygenation [ECMO]); Evidence of shock: - Systolic blood pressure (SBP) <90 mm Hg, or - Diastolic blood pressure (DBP) <60 mm Hg, or requiring vasopressors, - Significant acute renal, hepatic, or neurologic dysfunction - Admission to an intensive care unit (ICU) - Death | Day 36 to Day 92 |
| Number of Participants With Death Due to COVID-19 | Number of participants with death due to COVID-19 in participants with no evidence of prior infection. | Day 36 to Day 92 |
| Number of Participants With a First Occurrence of COVID-19 Irrespective of Prior Infection | Number of participants with a first occurrence of COVID-19 irrespective of prior infection. | Day 36 to Day 92 |
| Number of Participants With a First Occurrence of COVID-19 | Number of participants with a first occurrence of COVID-19 in participants with no evidence of prior infection. | Day 1 to Day 92 |
| Hanoi |
| Hanoi |
| 00000 |
| Vietnam |
| Pasteur Institute | Ho Chi Minh City | Ho Chi Minh | 00000 | Vietnam |
| Death |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Other than Specified |
|
| BG001 | Placebo | This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine [ChAdOx1 nCoV-19). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for placebo received in Phases 1, 2, 3a, 3b.](streamdown:incomplete-link) |
| BG002 | Phase 3c: ARCT-154 | Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). Data in this arm are presented pooled for ARCT-154 vaccine received in Phase 3c. |
| BG003 | Astra Zeneca COVID-19 vaccine | Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine [ChAdOx1 nCoV-19]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine [ChAdOx1 nCoV-19]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phases 1, 2, 3a, 3b. |
| OG001 | Placebo | This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine [ChAdOx1 nCoV-19). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for placebo received in Phases 1, 2, 3a, 3b.](streamdown:incomplete-link) |
| OG002 | Phase 3c: ARCT-154 | Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). Data in this arm are presented pooled for ARCT-154 vaccine received in Phase 3c. |
| OG003 | Astra Zeneca COVID-19 vaccine | Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine [ChAdOx1 nCoV-19]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c. |
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| Primary | Number of Participants Reporting Solicited Systemic ARs | Solicited systemic ARs included arthralgia, chills, diarrhea, dizziness, fatigue, fever (categorized by measured body temperature), headache, myalgia, and nausea/vomiting. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Reactogenicity Analysis Set, all participants who received any dose of study vaccine (ARCT-154 or placebo or ChAdOx1) and provided at least 1 reactogenicity diary report. As pre-specified, data are presented pooled per treatment received for Phase 1/2/3a/3b, and separately for ARCT-154 for Phase 3c. Overall number of participants analyzed = number of participants evaluable for the endpoint. Number analyzed = number of participants with evaluable data at the specified timepoint. | Posted | Count of Participants | Participants | Within 7 days after Dose 1 and Dose 2 (up to Day 7 and 36) |
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| Primary | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Unsolicited AEs were defined as any spontaneously reported or discovered AE. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Safety Analysis Set, all participants who received any dose of study vaccine (ARCT-154 or placebo or ChAdOx1). Participants were analyzed according to the study vaccine received. As pre-specified, data are presented pooled per treatment received for Phase 1/2/3a/3b, and separately for ARCT-154 for Phase 3c. Overall number of participants analyzed = number of participants evaluable for the endpoint. Number analyzed = number of participants with evaluable data at the specified timepoint. | Posted | Count of Participants | Participants | Approximately 28 days after Dose 1 and Dose 2 (Day 1 to Day 29 and Day 29 to Day 57) |
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| Primary | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation | An MAAE was defined as an AE that led to an unscheduled visit (including a telemedicine visit) with a healthcare provider ([HCP], e.g., nurse, nurse practitioner, physician's assistant, physician). An SAE was defined as any event that resulted in death, was immediately life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect arising from a pregnancy conceived after receipt of study vaccine. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Safety Analysis Set, all participants who received any dose of study vaccine (ARCT-154 or placebo or ChAdOx1). Participants were analyzed according to the study vaccine received. As pre-specified, data are presented pooled per treatment received for Phase 1/2/3a/3b, and separately for ARCT-154 for Phase 3c. Overall number of participants analyzed = number of participants evaluable for the endpoint. | Posted | Count of Participants | Participants | Day 1 to Day 92 |
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| Primary | Number of Participants With Neutralizing Antibody (NAb) Responses | Data are presented for the number of participants with a NAb seroconversion response as determined by the surrogate virus neutralization test (sVNT). Seroconversion was defined as a ≥4-fold increase in antibody concentration from baseline. | Immunogenicity Analysis Set, all participants who received all protocol required doses of vaccine up to evaluation timepoint, no evidence of prior severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) infection at Day 1, at least 1 valid post-vaccination immunogenicity assay result. As pre-specified, data is pooled per treatment received for participants in Phase 1, 2, 3a. Overall number of participants analyzed=number of participants evaluable for the endpoint at the specified timepoint. | Posted | Count of Participants | Participants | Day 57 |
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| Primary | Number of Participants With a First Occurrence of Coronavirus Disease 2019 (COVID-19) | COVID-19 was defined as a positive SARS-CoV-2 test and at least one of the following that was a new or worsening finding: ⦁ Fever or chills ⦁ Cough ⦁ Shortness of breath or difficulty breathing ⦁ Fatigue ⦁ Muscle or body aches ⦁ Headache ⦁ New loss of taste or smell ⦁ Sore throat ⦁ Congestion or runny nose ⦁ Nausea or vomiting ⦁ Diarrhea Data are presented for the number of participants with a first occurrence of COVID-19 with no evidence of prior infection. | Modified Intent-to-Treat (mITT) Analysis Set (Phase 3b), which included all participants who received all protocol-required doses of study vaccine up to the evaluation timepoint concerned, and who had no evidence of SARS-CoV-2 infection on Day 1 or up to 7 days after the 2nd study vaccination. As pre-specified, data are presented pooled per treatment received and for participants in Phase 3b only. Number of participants analyzed = those with evaluable data for this endpoint. | Posted | Count of Participants | Participants | Day 36 to Day 92 |
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| Secondary | Geometric Mean Titers of SARS-CoV-2 Neutralizing Antibodies | Immunogenicity Analysis Set, all participants who received all protocol required doses of study vaccine up to evaluation timepoint, no evidence of prior SARS-CoV-2 infection at Day 1, with at least 1 valid post-vaccination immunogenicity assay result. As pre-specified, data is pooled per treatment received for participants in Phase 1, 2, 3a. Overall number of participants analyzed=participants evaluable for endpoint. Number analyzed=participants with evaluable data at the specified timepoints. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Days 1, 29, 57 and 92 |
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| Secondary | Geometric Mean Fold Rise in SARS-CoV-2 Neutralizing Antibody Titers | Immunogenicity Analysis Set, all participants who received all protocol required doses of study vaccine up to evaluation timepoint, no evidence of prior SARS-CoV-2 infection at Day 1, with at least 1 valid post-vaccination immunogenicity assay result. As pre-specified, data is pooled per treatment received for participants in Phase 1, 2, 3a. Overall number of participants analyzed=participants evaluable for endpoint. Number analyzed=participants with evaluable data at the specified timepoints. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Days 29, 57, 92 |
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| Secondary | Number of Participants Seroconverting for Neutralizing Antibodies | Seroconversion was defined as a ≥4-fold increase in antibody concentration from baseline as measured by the sVNT test. Data are presented for the number of participants seroconverting for neutralizing antibodies. | Immunogenicity Analysis Set, all participants who received all protocol required doses of study vaccine up to evaluation timepoint, no evidence of prior SARS-CoV-2 infection at Day 1, with at least 1 valid post-vaccination immunogenicity assay result. As pre-specified, data is pooled per treatment received for participants in Phase 1, 2, 3a. Overall number of participants analyzed=participants evaluable for the endpoint. Number analyzed=participants with evaluable data at specified timepoints. | Posted | Count of Participants | Participants | Days 29, 57 and 92 |
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| Secondary | Geometric Mean Concentration of Spike Protein Immunoglobulin G (IgG) Binding Antibodies | Immunogenicity Analysis Set, all participants who received all protocol required doses of study vaccine up to evaluation timepoint, no evidence of prior SARS-CoV-2 infection at Day 1, with at least 1 valid post-vaccination immunogenicity assay result. As pre-specified, data is pooled per treatment received for participants in Phase 1, 2, 3a. Overall number of participants analyzed=participants evaluable for the endpoint. Number analyzed=participants with evaluable data at specified timepoints. | Posted | Geometric Mean | 95% Confidence Interval | units (U)/ milliliter (mL) | Days 1, 29, 57, 92 |
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| Secondary | Geometric Mean Fold Ratio of Spike Protein IgG Binding Antibodies | Immunogenicity Analysis Set, all participants who received all protocol required doses of study vaccine up to evaluation timepoint, no evidence of prior SARS-CoV-2 infection at Day 1, with at least 1 valid post-vaccination immunogenicity assay result. As pre-specified, data is pooled per treatment received for participants in Phase 1, 2, 3a. Overall number of participants analyzed=participants evaluable for the endpoint. Number analyzed=participants with evaluable data at specified timepoints. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Days 29, 57, 92 |
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| Secondary | Number of Participants Seroconverting for Spike Protein IgG Binding Antibodies | Seroconversion was defined as a ≥4-fold increase in antibody concentration from baseline. Data are presented for the number of participants seroconverting for spike protein IgG binding antibodies. | Immunogenicity Analysis Set, all participants who received all protocol-required doses of study vaccine up to evaluation timepoint, no evidence of prior SARS-CoV-2 infection at Day 1, with at least 1 valid post-vaccination immunogenicity assay result. As pre-specified, data is pooled per treatment received for participants in Phase 1, 2, 3a. Overall number of participants analyzed=participants evaluable for the endpoint. Number analyzed=participants with evaluable data at specified timepoints. | Posted | Count of Participants | Participants | Days 29, 57, 92 |
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| Secondary | Number of Participants Seroconverting on Neutralizing Antibody Responses by Plaque Reduction Neutralization Test at 50% Reduction (PRNT50) | The plaque reduction neutralization test (PRNT) is a live virus assay. Neutralizing antibody titers were calculated as the highest serum dilution that resulted in 50% reduction in the number of virus plaques (PRNT50). Data presented is for the ancestral-clinical isolate variant. Data are presented for the number of participants that demonstrated seroconversion (as defined by 4-fold increase in neutralizing antibody concentration from baseline) on PRNT50. | Immunogenicity Analysis Set, all participants who received all protocol-required doses of study vaccine up to evaluation timepoint, no evidence of prior SARS-CoV-2 infection at Day 1, with at least 1 valid post-vaccination immunogenicity assay result. As pre-specified, data is pooled per treatment received for participants in Phases 1 and 2. Overall number of participants analyzed=participants evaluable for the endpoint. Number analyzed=participants with evaluable data at specified timepoints. | Posted | Count of Participants | Participants | Days 29 and 57 |
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| Secondary | Number of Participants With a First Occurrence of Severe COVID-19 | Number of participants with a first occurrence of severe COVID-19 in participants with no evidence of prior infection. Severe COVID-19 was defined as a positive SARS-CoV-2 test, symptoms per protocol-defined COVID-19 and any of the following: Clinical signs at rest indicative of severe systemic illness: - Respiratory rate ≥30 per minute, - Heart rate ≥125 per minute, - Oxygen saturation (SpO2) ≤93% on room air at sea level or partial pressure of oxygen (PO2)/fraction of inspired oxygen (FiO2) <300 millimeter of mercury (mm Hg) - Respiratory failure (defined as needing high flow oxygen, noninvasive ventilation, mechanical ventilation or extracorporeal membrane oxygenation [ECMO]); Evidence of shock: - Systolic blood pressure (SBP) <90 mm Hg, or - Diastolic blood pressure (DBP) <60 mm Hg, or requiring vasopressors, - Significant acute renal, hepatic, or neurologic dysfunction - Admission to an intensive care unit (ICU) - Death | Modified Intent-to-Treat (mITT) Analysis Set (pooled for Phases 1/2/3a/3b), which included all participants who received all protocol-required doses of study vaccine up to the evaluation timepoint concerned, and who had no evidence of SARS-CoV-2 infection on Day 1 or up to 7 days after the 2nd study vaccination. As pre-specified, data are presented pooled per treatment received for participants in Phases 1/2/3a/3b only. | Posted | Count of Participants | Participants | Day 36 to Day 92 |
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| Secondary | Number of Participants With Death Due to COVID-19 | Number of participants with death due to COVID-19 in participants with no evidence of prior infection. | Modified Intent-to-Treat (mITT) Analysis Set (pooled for Phases 1/2/3a/3b), which included all participants who received all protocol-required doses of study vaccine up to the evaluation timepoint concerned, and who had no evidence of SARS-CoV-2 infection on Day 1 or up to 7 days after the 2nd study vaccination. As pre-specified, data are presented pooled per treatment received for participants in Phases 1/2/3a/3b only. | Posted | Count of Participants | Participants | Day 36 to Day 92 |
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| Secondary | Number of Participants With a First Occurrence of COVID-19 Irrespective of Prior Infection | Number of participants with a first occurrence of COVID-19 irrespective of prior infection. | Modified Intent-to-Treat (mITT) Analysis Set (pooled for Phases 1/2/3a/3b), including participants who received both doses of study vaccine and no infection between Day 1 and Day 35 but including those who were seropositive at baseline (Day 1). As pre-specified, data are presented pooled per treatment received for participants in Phases 1/2/3a/3b only. | Posted | Count of Participants | Participants | Day 36 to Day 92 |
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| Secondary | Number of Participants With a First Occurrence of COVID-19 | Number of participants with a first occurrence of COVID-19 in participants with no evidence of prior infection. | Intent-to-Treat (ITT) Analysis Set, which included all participants who received any dose of study vaccine. Participants were analyzed according to the vaccine to which the participant was randomly assigned. As pre-specified, data are presented for participants in the Phase 3b ITT. | Posted | Count of Participants | Participants | Day 1 to Day 92 |
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| 5 |
| 8,807 |
| 133 |
| 8,807 |
| 1,303 |
| 8,807 |
| EG001 | Phases 1, 2, 3a, 3b: Placebo Day 1-92 | This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine [ChAdOx1 nCoV-19]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data for Day 1-92 in this arm are presented for participants who initially received placebo in Phases 1, 2, 3a, 3b (pooled). | 16 | 8,294 | 217 | 8,294 | 1,489 | 8,294 |
| EG002 | Phases 1, 2, 3a, 3b: Placebo or ARCT-154 Day 92-End of Study (Day 394) | This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine [ChAdOx1 nCoV-19]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data for Day 92- End of Study (Day 394) in this arm are presented for participants who initially received ARCT-154 in Phases 1, 2, 3a, 3b (pooled), and then placebo or ARCT-154 from Day 92-EOS. | 12 | 8,161 | 180 | 8,161 | 1,618 | 8,161 |
| EG003 | Phases 1, 2, 3a, 3b: ARCT-154 Day 92-End of Study (Day 394) | This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine [ChAdOx1 nCoV-19]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data for Day 92- End of Study (Day 394) in this arm are presented for participants who initially received placebo in Phases 1, 2, 3a, 3b (pooled) and then ARCT-154 from Day 92-EOS. | 9 | 7,582 | 176 | 7,582 | 1,374 | 7,582 |
| EG004 | Phase 3c: ARCT-154 Day 1-92 | Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phase 3c from Day 1-92. | 0 | 1,186 | 22 | 1,186 | 0 | 0 |
| EG005 | Phase 3c: Astra Zeneca COVID-19 vaccine Day 1-92 | Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine [ChAdOx1 nCoV-19]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c from Day 1-92. | 1 | 1,180 | 35 | 1,180 | 0 | 0 |
| EG006 | Phase 3c: ARCT-154 Day 92- End of Study (Day 394) | Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phase 3c from Day 92- End of Study (Day 394). | 0 | 1,171 | 64 | 1,171 | 0 | 0 |
| EG007 | Phase 3c: Astra Zeneca COVID-19 vaccine Day 92-End of Study (Day 394) | Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine [ChAdOx1 nCoV-19]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c from Day 92- End of Study (Day 394). | 3 | 1,168 | 53 | 1,168 | 0 | 0 |
| EG008 | Phase 3c: ARCT-154 Day 1-57 | Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phase 3c from Day 1-57. | 0 | 0 | 0 | 0 | 339 | 1,186 |
| EG009 | Phase 3c: Astra Zeneca COVID-19 vaccine Day 1-57 | Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine [ChAdOx1 nCoV-19]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c from Day 1-57. | 0 | 0 | 0 | 0 | 304 | 1,180 |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Vertigo positional | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
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| Vestibular disorder | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
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| Angle closure glaucoma | Eye disorders | MedDRA 24.0 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA 24.0 | Systematic Assessment |
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| Pterygium | Eye disorders | MedDRA 24.0 | Systematic Assessment |
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| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Enteritis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
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| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
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| Type IV hypersensitivity reaction | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Biliary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Dengue fever | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Diarrhoea infectious | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Gastritis bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Gastrointestinal infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Peritonitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Pneumonia acinetobacter | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Sebaceous gland infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Skin infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Administration related reaction | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Foreign body in throat | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Poisoning | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Spondylopathy traumatic | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Intervertebral disc displacement | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Tenosynovitis stenosans | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Metastatic lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cerebrovascular disorder | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Facial paresis | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 24.0 | Systematic Assessment |
|
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 24.0 | Systematic Assessment |
|
| Bipolar I disorder | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Calculus bladder | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
|
| Genital prolapse | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Lung cyst | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pemphigus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Surgery | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Hyperglycaemic hyperosmolar nonketotic syndrome | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Thyroglossal cyst | Congenital, familial and genetic disorders | MedDRA 24.0 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Allergy to chemicals | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Snake bite | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Renal injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Conductive deafness | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
|
| Eye disorder | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Bone tuberculosis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Diabetic foot infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Laryngopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Tuberculous pleurisy | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Eye injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Spinal column injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Meningioma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Laryngeal polyp | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Wound abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Polymyositis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
|
| Parathyroid disorder | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
|
| Thyroid mass | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal adhesions | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Gastrointestinal polyp | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Intestinal mass | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pancreatic mass | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Salivary gland mass | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Accidental death | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Necrosis | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Dengue haemorrhagic fever | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Gastrointestinal bacterial infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Hepatitis B | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Lymph node tuberculosis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Mastoiditis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Necrotising fasciitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Pelvic inflammatory disease | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Peritonsillar abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Tuberculosis gastrointestinal | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Foreign body in mouth | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Injury corneal | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Soft tissue mass | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Lip and/or oral cavity cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Neoplasm of appendix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Ovarian neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Arachnoid cyst | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cerebrovascular insufficiency | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Anembryonic gestation | Pregnancy, puerperium and perinatal conditions | MedDRA 24.0 | Systematic Assessment |
|
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA 24.0 | Systematic Assessment |
|
| Risk of future pregnancy miscarriage | Pregnancy, puerperium and perinatal conditions | MedDRA 24.0 | Systematic Assessment |
|
| Nephritic syndrome | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Ureteric stenosis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Urinary tract inflammation | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vocal cord disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Title | Measurements |
|---|---|
|
|
| Dose 2 |
|
|
|
| Dose 2 |
|
|
| SAEs |
|
| AEs Leading to Discontinuation |
|
| Day 29 |
|
|
| Day 57 |
|
|
| Day 92 |
|
|
| Day 57 |
|
|
| Day 92 |
|
|
| Day 57 |
|
|
| Day 92 |
|
|
| Day 29 |
|
|
| Day 57 |
|
|
| Day 92 |
|
|
| Day 57 |
|
|
| Day 92 |
|
|
| Day 57 |
|
|
| Day 92 |
|
|