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The main purpose of this study is to assess the efficacy of S-268019-b for the prevention of COVID-19 in the initial vaccination period prior to crossover in participants without evidence of infection before vaccination as compared to placebo.
Eligible participants will be randomized to receive either S-268019-b or placebo first and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods, an initial vaccination period (Day 1 to Day 224), and a crossover vaccination period (Day 225 to Day 435).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-268019-b, Then Placebo | Experimental | Participants will first receive a dose of S-268019-b via intramuscular (IM) injection on Day 1 and Day 29 during the initial vaccination period. After the initial vaccination period, participants will then receive a placebo IM injection (matching S-268019-b) on Day 225 and Day 253. |
|
| Placebo, Then S-268019-b | Experimental | Participants will first receive a dose of placebo IM injection (matching S-268019-b) on Day 1 and Day 29 during the initial vaccination period. After the initial vaccination period, participants will then receive S-268019-b IM injection on Day 225 and Day 253. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-268019-b | Drug | Solution for IM injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With First Occurrence of SARS-CoV-2 Reverse Transcription Polymerase Chain Reaction (RT-PCR)-Positive Symptomatic COVID-19 With Onset at Least 14 Days Following Second Vaccination During the Initial Vaccination Period | Participants without evidence of infection before vaccination (that is, seronegative and PCR-negative at baseline) were determined to have symptomatic COVID-19 when at least 1 protocol-specified COVID-19-related symptom and a positive RT-PCR test result were confirmed by the medical monitor within at least 14 days following the second vaccination. RT-PCR testing was based upon nasopharyngeal swab sampling at protocol-specified timepoints. | From Day 43 (14 days after the second dose administration) to Day 224 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Severe COVID-19 in the Initial Vaccination Period With Onset at Least 14 Days Following Second Vaccination | For participants without evidence of infection before vaccination (that is, seronegative and PCR-negative at baseline) who were confirmed to have symptomatic COVID-19 within at least 14 days following the second vaccination, the investigator evaluated if the maximum intensity during the course of the disease met protocol-specified criteria for severe COVID-19. |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buon Ma Thuot City Medical Center | Buon Ma Thuot | Dak Lak | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38734495 | Result | Dinh Thiem V, Van Anh PT, Van Men C, Hung DT, Pollard AJ, Kamitani A, Tada Y, Fukuyama H, Iwasaki Y, Ariyasu M, Sonoyama T. A SARS-CoV-2 recombinant spike protein vaccine (S-268019-b) for COVID-19 prevention during the Omicron-dominant period: A phase 3, randomised, placebo-controlled clinical trial. Vaccine. 2024 Jun 20;42(17):3699-3709. doi: 10.1016/j.vaccine.2024.04.084. Epub 2024 May 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | S-268019-b Then Placebo | Participants received a dose of S-268019-b via intramuscular injection on Day 1 and Day 29 during the Initial Vaccination Period. After the Initial Vaccination Period, participants received placebo via intramuscular injection (matching S-268019-b) on Day 225 and Day 253, during the Crossover Vaccination Period. |
| FG001 | Placebo Then S-268019-b | Participants received a dose of placebo via intramuscular injection (matching S-268019-b) on Day 1 and Day 29 during the Initial Vaccination Period. After the Initial Vaccination Period, participants received S-268019-b via intramuscular injection on Day 225 and Day 253, during the Crossover Vaccination Period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Vaccination Period |
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| Crossover Vaccination Period |
|
Full Analysis Set (FAS): all randomized participants who received at least 1 dose of the study intervention during the Initial Vaccination Period.
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| ID | Title | Description |
|---|---|---|
| BG000 | S-268019-b Then Placebo | Participants received a dose of S-268019-b via intramuscular injection on Day 1 and Day 29 during the Initial Vaccination Period. After the Initial Vaccination Period, participants received placebo via intramuscular injection (matching S-268019-b) on Day 225 and Day 253, during the Crossover Vaccination Period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 With First Occurrence of SARS-CoV-2 Reverse Transcription Polymerase Chain Reaction (RT-PCR)-Positive Symptomatic COVID-19 With Onset at Least 14 Days Following Second Vaccination During the Initial Vaccination Period | Participants without evidence of infection before vaccination (that is, seronegative and PCR-negative at baseline) were determined to have symptomatic COVID-19 when at least 1 protocol-specified COVID-19-related symptom and a positive RT-PCR test result were confirmed by the medical monitor within at least 14 days following the second vaccination. RT-PCR testing was based upon nasopharyngeal swab sampling at protocol-specified timepoints. | Modified Intent to Treat (mITT) population: all participants who received at least 1 dose of the study intervention in the Initial Vaccination Period, excluding participants who had evidence of past or present SARS-CoV-2 infection at baseline. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. Only data collected during the Initial Vaccination Period reported for this outcome measure. | Posted | Count of Participants | Participants | From Day 43 (14 days after the second dose administration) to Day 224 |
Day 1 (Baseline) through Day 435
All reported safety data based upon Safety Analysis Set: all randomized participants who received at least 1 dose of study intervention. Safety data presented per pre-specified analysis plan. All deaths regardless of causality or whether they were reported as a reason for study discontinuation or as a serious adverse event are reported in the All-Cause Mortality section. Only deaths indicated as leading to study discontinuation are reported in the Participant Flow section.
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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 | S-268019-b | Participants received a dose of S-268019-b via intramuscular injection on Day 1 and Day 29 during the Initial Vaccination Period and then on Day 225 and Day 253 during the Crossover Vaccination Period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shionogi Clinical Trials Administrator Clinical Support Help Line | Shionogi | 1-800-849-9707 | Shionogiclintrials-admin@shionogi.co.jp |
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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 | Jul 8, 2022 | Aug 27, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 25, 2023 | Aug 27, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000722357 | S-268019-b COVID-19 vaccine |
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| Placebo | Drug | Saline solution for IM injection |
|
| From Day 43 (14 days after the second dose administration) to Day 224 |
| Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Symptomatic COVID-19 in the Initial Vaccination Period | Participants without evidence of infection before vaccination (that is, seronegative and PCR-negative at baseline) were determined to have symptomatic COVID-19 when at least 1 protocol-specified COVID-19-related symptom and a positive RT-PCR test result were confirmed by the medical monitor. RT-PCR testing was based upon nasopharyngeal swab sampling at protocol-specified timepoints. | Up to Day 224 |
| Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Severe COVID-19 in the Initial Vaccination Period | For participants without evidence of infection before vaccination (that is, seronegative and PCR-negative at baseline) who were confirmed to have symptomatic COVID-19, the investigator evaluated if the maximum intensity during the course of the disease met the protocol-specified criteria for severe COVID-19. | Up to Day 224 |
| Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Symptomatic COVID-19 in the Initial Vaccination Period Regardless of Serostatus or PCR Status at Baseline With Onset at Least 14 Days Following Second Vaccination | A participant was determined to have symptomatic COVID-19 when at least 1 protocol-specified COVID-19-related symptom and a positive RT-PCR test result were confirmed by the medical monitor within at least 14 days following the second vaccination. RT-PCR testing was based upon nasopharyngeal swab sampling at protocol-specified timepoints. | From Day 43 (14 days after the second dose administration) to Day 224 |
| Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Severe COVID-19 in the Initial Vaccination Period With Onset at Least 14 Days Following Second Vaccination Regardless of Serostatus or PCR Status at Baseline | For participants confirmed to have symptomatic COVID-19 within at least 14 days following the second vaccination, the investigator evaluated if the maximum intensity during the course of the disease met the protocol-specified criteria for severe COVID-19. | From Day 43 (14 days after the second dose administration) to Day 224 |
| Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Symptomatic COVID-19 in the Initial Vaccination Period Regardless of Serostatus or PCR Status at Baseline | A participant was determined to have symptomatic COVID-19 when the participant had at least 1 protocol-specified COVID-19-related symptom and a positive RT-PCR test result confirmed by the medical monitor. RT-PCR testing was based upon nasopharyngeal swab sampling at protocol-specified timepoints. | Up to Day 224 |
| Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Severe COVID-19 in the Initial Vaccination Period Regardless of Serostatus or PCR Status at Baseline | For participants confirmed to have symptomatic COVID-19, the investigator evaluated if the maximum intensity during the course of the disease met the protocol-specified criteria for severe COVID-19. | Up to Day 224 |
| Number of Participants With First Occurrence of Asymptomatic SARS-CoV-2 Infection in the Initial Vaccination Period | For participants without evidence of infection before vaccination (that is, seronegative and PCR-negative at baseline), asymptomatic SARS-CoV-2 infection was defined as having a positive result of anti-SARS-CoV-2 N-protein antibody test beginning 14 days following the second vaccination and not meeting the protocol-specified criteria of symptomatic COVID-19. Antibodies to SARS-CoV-2 N-protein were used to determine both natural infection and the incidence of asymptomatic infection acquired during the initial vaccination period of the study. | From Day 43 (14 days after the second dose administration) to Day 224 |
| Percentage of Participants Experiencing Solicited Systemic Adverse Events | An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs were defined as the AEs that occurred within the first 7 days after each vaccination and were classified as one of the following: fever, nausea/vomiting, diarrhea, headache, fatigue, and myalgia. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. | Up to Day 224 |
| Percentage of Participants Experiencing Solicited Local Adverse Events | An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited local AEs were defined as the AEs that occurred within the first 7 days after each vaccination and were classified as one of the following: pain, erythema/redness, induration, and swelling. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. | Up to Day 224 |
| Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody level against SARS-CoV-2 was measured by a live virus neutralization assay. The GMT was calculated by taking the back transformation of the arithmetic mean of log-transformed titers. The 95% confidence interval was calculated based on the Student's t distribution of the log-transformed values, then back transformed to the original scale. | Day 57 |
| Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Antibody | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody level against SARS-CoV-2 was measured by a live virus neutralization assay. The GMFR was calculated by taking the back transformation of the arithmetic mean of the change from baseline in log-transformed titers. The 95% confidence interval was calculated based on the Student's t distribution of the change from baseline in the log-transformed values, then back transformed to the original scale. | Day 57 |
| Seroconversion Rate of SARS-CoV-2 Neutralizing Antibody | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody level against SARS-CoV-2 was measured by a live virus neutralization assay. Seroconversion was defined as a 4-times or higher from baseline in SARS-CoV-2 neutralizing antibody titer, where titer values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Seroconversion rate was defined as the percentage of participants that underwent seroconversion. The 95% confidence interval was calculated using the Clopper-Pearson method. | Day 57 |
| GMT of Anti-SARS-CoV-2 S-protein Immunoglobulin G (IgG) Antibody | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody level against SARS-CoV-2 (anti-spike protein IgG antibody) was measured by a chemiluminescence immunoassay. The GMT was calculated by taking the back transformation of the arithmetic mean of log- transformed titers. The 95% confidence interval was calculated based on the Student's t distribution of the log-transformed values, then back transformed to the original scale. | Day 57 |
| GMFR of Anti-SARS-CoV-2 S-protein IgG Antibody | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The anti-spike protein IgG antibody was measured by a chemiluminescence immunoassay. The GMFR was calculated by taking the back transformation of the arithmetic mean of the change from baseline in log-transformed titers. The 95% confidence interval was calculated based on the Student's t distribution of the change from baseline in the log-transformed values, then back transformed to the original scale. | Day 57 |
| Seroconversion Rate of Anti-SARS-CoV-2 S-protein IgG Antibody | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The anti-spike protein IgG antibody was measured by a chemiluminescence immunoassay. Seroconversion was defined as a 4-times or higher from baseline in anti-spike protein IgG antibody titer, where titer values reported as below the LLOQ are replaced by 0.5*LLOQ and titer values reported as above the upper limit of quantification (ULOQ) are imputed at the ULOQ value. Seroconversion rate was defined as the percentage of participants that underwent seroconversion. The 95% confidence interval was calculated using the Clopper-Pearson method. | Day 57 |
| Pregnancy |
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| Physician Decision |
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| Lost to Follow-up |
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| Death |
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| Coronavirus Disease 2019 (COVID-19) |
|
| Adverse Event |
|
| Safety Analysis Set (SAS) |
|
| COMPLETED | Only deaths indicated as leading to study discontinuation are reported in the Participant Flow section. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. |
|
| NOT COMPLETED |
|
|
| BG001 |
| Placebo Then S-268019-b |
Participants received a dose of placebo via intramuscular injection (matching S-268019-b) on Day 1 and Day 29 during the Initial Vaccination Period. After the Initial Vaccination Period, participants received S-268019-b via intramuscular injection on Day 225 and Day 253, during the Crossover Vaccination Period. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) N-protein Antibody Test | Positive = evidence of past or present SARS-CoV-2 infection. Negative = no evidence of past or present SARS-CoV-2 infection. | Participants in the Full Analysis Set (FAS) missing baseline N-protein antibody data have been excluded. | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | S-268019-b | Participants received a dose of S-268019-b via intramuscular injection on Day 1 and Day 29 during the Initial Vaccination Period. |
| OG001 | Placebo | Participants received a dose of placebo via intramuscular injection (matching S-268019-b) on Day 1 and Day 29 during the Initial Vaccination Period. |
|
|
|
| Secondary | Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Severe COVID-19 in the Initial Vaccination Period With Onset at Least 14 Days Following Second Vaccination | For participants without evidence of infection before vaccination (that is, seronegative and PCR-negative at baseline) who were confirmed to have symptomatic COVID-19 within at least 14 days following the second vaccination, the investigator evaluated if the maximum intensity during the course of the disease met protocol-specified criteria for severe COVID-19. | Modified Intent to Treat (mITT): participants who received at least 1 dose of study drug, excluding participants who had evidence of past or present SARS-CoV-2 infection at baseline. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. Only data collected during the Initial Vaccination Period reported for this outcome measure. | Posted | Count of Participants | Participants | From Day 43 (14 days after the second dose administration) to Day 224 |
|
|
|
| Secondary | Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Symptomatic COVID-19 in the Initial Vaccination Period | Participants without evidence of infection before vaccination (that is, seronegative and PCR-negative at baseline) were determined to have symptomatic COVID-19 when at least 1 protocol-specified COVID-19-related symptom and a positive RT-PCR test result were confirmed by the medical monitor. RT-PCR testing was based upon nasopharyngeal swab sampling at protocol-specified timepoints. | Modified Intent to Treat (mITT): participants who received at least 1 dose of study drug, excluding participants who had evidence of past or present SARS-CoV-2 infection at baseline. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. Only data collected during the Initial Vaccination Period reported for this outcome measure. | Posted | Count of Participants | Participants | Up to Day 224 |
|
|
|
| Secondary | Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Severe COVID-19 in the Initial Vaccination Period | For participants without evidence of infection before vaccination (that is, seronegative and PCR-negative at baseline) who were confirmed to have symptomatic COVID-19, the investigator evaluated if the maximum intensity during the course of the disease met the protocol-specified criteria for severe COVID-19. | Modified Intent to Treat (mITT): participants who received at least 1 dose of study drug, excluding participants who had evidence of past or present SARS-CoV-2 infection at baseline. Only data collected during the Initial Vaccination Period reported for this outcome measure. | Posted | Count of Participants | Participants | Up to Day 224 |
|
|
|
| Secondary | Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Symptomatic COVID-19 in the Initial Vaccination Period Regardless of Serostatus or PCR Status at Baseline With Onset at Least 14 Days Following Second Vaccination | A participant was determined to have symptomatic COVID-19 when at least 1 protocol-specified COVID-19-related symptom and a positive RT-PCR test result were confirmed by the medical monitor within at least 14 days following the second vaccination. RT-PCR testing was based upon nasopharyngeal swab sampling at protocol-specified timepoints. | Full Analysis Set (FAS): all randomized participants who received at least 1 dose of the study intervention during the Initial Vaccination Period. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. Only data collected during the Initial Vaccination Period reported for this outcome measure. | Posted | Count of Participants | Participants | From Day 43 (14 days after the second dose administration) to Day 224 |
|
|
|
| Secondary | Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Severe COVID-19 in the Initial Vaccination Period With Onset at Least 14 Days Following Second Vaccination Regardless of Serostatus or PCR Status at Baseline | For participants confirmed to have symptomatic COVID-19 within at least 14 days following the second vaccination, the investigator evaluated if the maximum intensity during the course of the disease met the protocol-specified criteria for severe COVID-19. | Full Analysis Set (FAS): all randomized participants who received at least 1 dose of the study intervention during the Initial Vaccination Period. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. Only data collected during the Initial Vaccination Period reported for this outcome measure. | Posted | Count of Participants | Participants | From Day 43 (14 days after the second dose administration) to Day 224 |
|
|
|
| Secondary | Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Symptomatic COVID-19 in the Initial Vaccination Period Regardless of Serostatus or PCR Status at Baseline | A participant was determined to have symptomatic COVID-19 when the participant had at least 1 protocol-specified COVID-19-related symptom and a positive RT-PCR test result confirmed by the medical monitor. RT-PCR testing was based upon nasopharyngeal swab sampling at protocol-specified timepoints. | Full Analysis Set (FAS): all randomized participants who received at least 1 dose of the study intervention during the Initial Vaccination Period. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. Only data collected during the Initial Vaccination Period reported for this outcome measure. | Posted | Count of Participants | Participants | Up to Day 224 |
|
|
|
| Secondary | Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Severe COVID-19 in the Initial Vaccination Period Regardless of Serostatus or PCR Status at Baseline | For participants confirmed to have symptomatic COVID-19, the investigator evaluated if the maximum intensity during the course of the disease met the protocol-specified criteria for severe COVID-19. | Full Analysis Set (FAS): all randomized participants who received at least 1 dose of the study intervention during the Initial Vaccination Period. Only data collected during the Initial Vaccination Period reported for this outcome measure. | Posted | Count of Participants | Participants | Up to Day 224 |
|
|
|
| Secondary | Number of Participants With First Occurrence of Asymptomatic SARS-CoV-2 Infection in the Initial Vaccination Period | For participants without evidence of infection before vaccination (that is, seronegative and PCR-negative at baseline), asymptomatic SARS-CoV-2 infection was defined as having a positive result of anti-SARS-CoV-2 N-protein antibody test beginning 14 days following the second vaccination and not meeting the protocol-specified criteria of symptomatic COVID-19. Antibodies to SARS-CoV-2 N-protein were used to determine both natural infection and the incidence of asymptomatic infection acquired during the initial vaccination period of the study. | Modified Intent to Treat (mITT) population: all participants who received at least 1 dose of the study intervention in the Initial Vaccination Period, excluding participants who had evidence of past or present SARS-CoV-2 infection at baseline. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. Only data collected during the Initial Vaccination Period reported for this outcome measure. | Posted | Count of Participants | Participants | From Day 43 (14 days after the second dose administration) to Day 224 |
|
|
|
| Secondary | Percentage of Participants Experiencing Solicited Systemic Adverse Events | An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs were defined as the AEs that occurred within the first 7 days after each vaccination and were classified as one of the following: fever, nausea/vomiting, diarrhea, headache, fatigue, and myalgia. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. | Safety Analysis Set (SAS): all randomized participants who received at least 1 dose of study intervention. Only data collected during the Initial Vaccination Period reported for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to Day 224 |
|
|
|
| Secondary | Percentage of Participants Experiencing Solicited Local Adverse Events | An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited local AEs were defined as the AEs that occurred within the first 7 days after each vaccination and were classified as one of the following: pain, erythema/redness, induration, and swelling. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. | Safety Analysis Set (SAS): all randomized participants who received at least 1 dose of study intervention. Only data collected during the Initial Vaccination Period reported for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to Day 224 |
|
|
|
| Secondary | Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody level against SARS-CoV-2 was measured by a live virus neutralization assay. The GMT was calculated by taking the back transformation of the arithmetic mean of log-transformed titers. The 95% confidence interval was calculated based on the Student's t distribution of the log-transformed values, then back transformed to the original scale. | Immunogenicity Subset: participants who received at least 1 dose of study drug, excluding participants with evidence of past or present SARS-CoV-2 infection at baseline, and had a valid immunogenicity test result prior to the first vaccination dose and at least 1 valid result after the first vaccination dose. 'Overall Number of Participants Analyzed' are participants evaluable for this outcome measure. Only data collected during the Initial Vaccination Period reported for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 57 |
|
|
|
| Secondary | Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Antibody | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody level against SARS-CoV-2 was measured by a live virus neutralization assay. The GMFR was calculated by taking the back transformation of the arithmetic mean of the change from baseline in log-transformed titers. The 95% confidence interval was calculated based on the Student's t distribution of the change from baseline in the log-transformed values, then back transformed to the original scale. | Immunogenicity Subset: participants who received at least 1 dose of study drug, excluding participants with evidence of past or present SARS-CoV-2 infection at baseline, and had a valid immunogenicity test result prior to the first vaccination dose and at least 1 valid result after the first vaccination dose. 'Overall Number of Participants Analyzed' are participants evaluable for this outcome measure. Only data collected during the Initial Vaccination Period reported for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | Fold Rise | Day 57 |
|
|
|
| Secondary | Seroconversion Rate of SARS-CoV-2 Neutralizing Antibody | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody level against SARS-CoV-2 was measured by a live virus neutralization assay. Seroconversion was defined as a 4-times or higher from baseline in SARS-CoV-2 neutralizing antibody titer, where titer values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Seroconversion rate was defined as the percentage of participants that underwent seroconversion. The 95% confidence interval was calculated using the Clopper-Pearson method. | Immunogenicity Subset: participants who received at least 1 dose of study drug, excluding participants with evidence of past or present SARS-CoV-2 infection at baseline, and had a valid immunogenicity test result prior to the first vaccination dose and at least 1 valid result after the first vaccination dose. 'Overall Number of Participants Analyzed' are participants evaluable for this outcome measure. Only data collected during the Initial Vaccination Period reported for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 57 |
|
|
|
| Secondary | GMT of Anti-SARS-CoV-2 S-protein Immunoglobulin G (IgG) Antibody | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody level against SARS-CoV-2 (anti-spike protein IgG antibody) was measured by a chemiluminescence immunoassay. The GMT was calculated by taking the back transformation of the arithmetic mean of log- transformed titers. The 95% confidence interval was calculated based on the Student's t distribution of the log-transformed values, then back transformed to the original scale. | Immunogenicity Subset: participants who received at least 1 dose of study drug, excluding participants with evidence of past or present SARS-CoV-2 infection at baseline, and had a valid immunogenicity test result prior to the first vaccination dose and at least 1 valid result after the first vaccination dose. 'Overall Number of Participants Analyzed' are participants evaluable for this outcome measure. Only data collected during the Initial Vaccination Period reported for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 57 |
|
|
|
| Secondary | GMFR of Anti-SARS-CoV-2 S-protein IgG Antibody | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The anti-spike protein IgG antibody was measured by a chemiluminescence immunoassay. The GMFR was calculated by taking the back transformation of the arithmetic mean of the change from baseline in log-transformed titers. The 95% confidence interval was calculated based on the Student's t distribution of the change from baseline in the log-transformed values, then back transformed to the original scale. | Immunogenicity Subset: participants who received at least 1 dose of study drug, excluding participants with evidence of past or present SARS-CoV-2 infection at baseline, and had a valid immunogenicity test result prior to the first vaccination dose and at least 1 valid result after the first vaccination dose. 'Overall Number of Participants Analyzed' are participants evaluable for this outcome measure. Only data collected during the Initial Vaccination Period reported for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | Fold Rise | Day 57 |
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|
|
| Secondary | Seroconversion Rate of Anti-SARS-CoV-2 S-protein IgG Antibody | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The anti-spike protein IgG antibody was measured by a chemiluminescence immunoassay. Seroconversion was defined as a 4-times or higher from baseline in anti-spike protein IgG antibody titer, where titer values reported as below the LLOQ are replaced by 0.5*LLOQ and titer values reported as above the upper limit of quantification (ULOQ) are imputed at the ULOQ value. Seroconversion rate was defined as the percentage of participants that underwent seroconversion. The 95% confidence interval was calculated using the Clopper-Pearson method. | Immunogenicity Subset: participants who received at least 1 dose of study drug, excluding participants with evidence of past or present SARS-CoV-2 infection at baseline, and had a valid immunogenicity test result prior to the first vaccination dose and at least 1 valid result after the first vaccination dose. 'Overall Number of Participants Analyzed' are participants evaluable for this outcome measure. Only data collected during the Initial Vaccination Period reported for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 57 |
|
|
|
| 29 |
| 9,083 |
| 154 |
| 9,083 |
| 3,647 |
| 9,083 |
| EG001 | Placebo | Participants received a dose of placebo via intramuscular injection (matching S-268019-b) on Day 1 and Day 29 during the Initial Vaccination Period and then on Day 225 and Day 253 during the Crossover Vaccination Period. | 29 | 8,435 | 136 | 8,435 | 1,548 | 8,435 |
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Rickettsiosis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Dengue fever | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Encephalitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Hepatitis B | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Lung abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Fallopian tube abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment | Adverse event affected only female participants. |
|
| Febrile infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Abscess neck | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Shigella infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Dengue haemorrhagic fever | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Acarodermatitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Infectious pleural effusion | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Vulval abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment | Adverse event affected only female participants. |
|
| Bacterial infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Benign joint neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment | Adverse event affected only female participants. |
|
| Myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Squamous cell carcinoma of the cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment | Adverse event affected only female participants. |
|
| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
|
| Thyroid cyst | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Calcium deficiency | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Alcoholic psychosis | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Alcohol use disorder | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cerebrovascular disorder | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Chorea | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Paraplegia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Trigeminal neuralgia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Sciatic nerve neuropathy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haemorrhagic stroke | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hemiplegia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 24.1 | Systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA 24.1 | Systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cataract subcapsular | Eye disorders | MedDRA 24.1 | Systematic Assessment |
|
| Vestibular disorder | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Heart valve stenosis | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Intussusception | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Tooth socket haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Inguinal hernia, obstructive | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cirrhosis alcoholic | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hepatitis alcoholic | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pemphigoid | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Calculus bladder | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Systematic Assessment | Adverse event affected only female participants. |
|
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Systematic Assessment | Adverse event affected only female participants. |
|
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Systematic Assessment | Adverse event affected only female participants. |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment | Adverse event affected only female participants. |
|
| Hydrocele | Congenital, familial and genetic disorders | MedDRA 24.1 | Systematic Assessment |
|
| Talipes | Congenital, familial and genetic disorders | MedDRA 24.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Multi-organ disorder | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Chest injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Exposure to toxic agent | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Venom poisoning | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Electrical burn | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Chemical poisoning | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Spinal column injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Nasal injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
|
The sponsor can embargo results from a PIs center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 45 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|