Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Number of Participants With Clinical Safety Laboratory Adverse Events |
Laboratory parameters include white blood cells (WBC), hemoglobin, platelet count, absolute neutrophil count, alanine aminotransferase (ALT), creatinine, sodium, potassium and blood urea nitrogen (BUN). Thresholds for adverse events were considered as WBC <= 4.4 K/mcL or >=13.1 K/mcL (18 to <21 years) or <= 4.4 K/mcL or >= 11.1 K/mcL (>=21 years), hemoglobin <= 11.6 g/dL (female) or <= 13.2 g/dL (male), platelet count <= 134 K/mcL or >= 467 K/mcL, absolute neutrophil count <1.8 K/mcL or <=0.7 K/mcL (benign ethnic neutropenia), ALT >= 50 unit/L, creatinine >= 0.81 mg/dL (female) or >= 1.11 mg/dL (male), sodium <= 135 mmol/L or >= 146 mmol/L, potassium <= 3.4 mmol/L or >= 5.2 mmol/L and BUN >= 24 mg/dL. If baseline clinical labs fell within Mild range, then a laboratory AE was reported only if the value changed such that it fell into Moderate range or higher when subsequent safety laboratory testing was done. |
Day 1 to approximately 28 Days Post Second Vaccination |
|
| Primary |
Number of Participants Reporting Serious Adverse Events (SAEs) |
SAEs included any AE that resulted in death, a life-threatening event, an inpatient hospitalization or prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. |
Day 1 to Day 182 |
|
| Primary |
Number of Participants Reporting Solicited Local Reactogenicity |
Local reactogenicity solicited on a memory aid provided to participants included pain, tenderness, erythema (redness) (functional grade based on interference with daily activities), induration (hardness/swelling) (functional grade), ecchymosis (bruising) (functional grade), pruritus (itching), erythema (redness) (any measured value), induration (hardness/swelling) (any measured value), ecchymosis (bruising) (any measured value). Participants are considered reporting the local reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination. |
Day 1 to Day 8 Post First Vaccination |
|
| Primary |
Number of Participants Reporting Solicited Local Reactogenicity |
Local reactogenicity solicited on a memory aid provided to participants included pain, tenderness, erythema (redness) (functional grade based on interference with daily activities), induration (hardness/swelling) (functional grade), ecchymosis (bruising) (functional grade), pruritus (itching), erythema (redness) (any measured value), induration (hardness/swelling) (any measured value), ecchymosis (bruising) (any measured value). Participants are considered reporting the local reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination. |
Day 1 to Day 8 Post Second Vaccination |
|
| Primary |
Number of Participants Reporting Solicited Local Reactogenicity |
Local reactogenicity solicited on a memory aid provided to participants included pain, tenderness, erythema (redness) (functional grade based on interference with daily activities), induration (hardness/swelling) (functional grade), ecchymosis (bruising) (functional grade), pruritus (itching), erythema (redness) (any measured value), induration (hardness/swelling) (any measured value), ecchymosis (bruising) (any measured value). Subjects are considered reporting the local reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination. |
Day 1 to Day 15 |
|
| Primary |
Number of Participants Reporting Solicited Systemic Reactogenicity |
Systemic reactogenicity solicited on a memory aid provided to participants included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Participants are considered reporting the systemic reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination. |
Day 1 to Day 8 Post First Vaccination |
|
| Primary |
Number of Participants Reporting Solicited Systemic Reactogenicity |
Systemic reactogenicity solicited on a memory aid provided to participants included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Participants are considered reporting the systemic reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination. |
Day 1 to Day 8 Post Second Vaccination |
|
| Primary |
Number of Participants Reporting Solicited Systemic Reactogenicity |
Systemic reactogenicity solicited on a memory aid provided to participants included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Participants are considered reporting the systemic reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination. |
Day 1 to Day 15 |
|
| Primary |
Number of Participants Reporting Vaccine-related Medically Attended Adverse Events (MAAEs) |
Vaccine-related MAAEs include any AEs for which the participant received medical attention, defined as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason for which there is evidence to suggest a causal relationship between the study product and the adverse event. |
Day 1 to Day 182 |
|
| Primary |
Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) |
Vaccine-related unsolicited AEs include any untoward medical occurrence in a participant for which there is evidence to suggest a causal relationship between the study product and the adverse event. |
Day 1 to approximately 28 Days Post Second Vaccination |
|
| Primary |
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells |
Thresholds for adverse events were considered as WBC 2.5 - 4.4 K/mcL or 13.1 - 15.0 K/mcL (18 to <21 years) or 2.5 - 4.4 K/mcL or 11.1 - 15.0 (>=21 years) (mild), 1.5 - 2.4 K/mcL or 15.1 - 20.0 K/mcL (moderate), <1.5 K/mcL or >20.0 K/mcL (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. |
Day 1 to approximately 28 Days Post Second Vaccination |
|
| Primary |
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin |
Thresholds for adverse events were considered as hemoglobin 10.1 - 11.6 g/dL (female) or 11.0 - 13.2 (male) (mild), 8.5 - 10 g/dL (female) or 9.5 - 10.9 g/dL (male) (moderate), <8.5 g/dL (female) or <9.5 g/dL (male) (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. |
Day 1 to approximately 28 Days Post Second Vaccination |
|
| Primary |
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count |
Thresholds for adverse events were considered as platelet count 125 - 134 K/mcL or 467 - 517 K/mcL (mild), 100 - 124 K/mcL or 518 - 750 K/mcL (moderate), <100 K/mcL or >750 K/mcL (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. |
Day 1 to approximately 28 Days Post Second Vaccination |
|
| Primary |
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count |
Thresholds for adverse events were considered as absolute neutrophil count 1.5 - <1.8 K/mcL or 0.6 - 0.7 K/mcL (benign ethnic neutropenia) (mild), 1.0 - <1.5 K/mcL or 0.4 - 0.5 K/mcL (benign ethnic neutropenia) (moderate), <1.0 K/mcL or <0.4 K/mcL (benign ethnic neutropenia) (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. |
Day 1 to approximately 28 Days Post Second Vaccination |
|
| Primary |
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT |
Thresholds for adverse events were considered as 50 - 123 unit/L (mild), 124 - 245 unit/L (moderate), >245 unit/L (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. |
Day 1 to approximately 28 Days Post Second Vaccination |
|
| Primary |
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) |
Thresholds for adverse events were considered as creatinine 0.81 - 1.70 mg/dL (female) or 1.11 - 1.70 mg/dL (male) (mild), 1.71 - 2.00 mg/dL (moderate), >2.00 mg/dL (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. |
Day 1 to approximately 28 Days Post Second Vaccination |
|
| Primary |
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium |
Thresholds for adverse events were considered as sodium 130 - 135 mmol/L or 146 - 150 mmol/L (mild), 123 - 129 mmol/L or 151 - 157 mmol/L (moderate), <123 mmol/L or >157 mmol/L (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. |
Day 1 to approximately 28 Days Post Second Vaccination |
|
| Primary |
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium |
Thresholds for adverse events were considered as potassium 3.0 - 3.4 mmol/L or 5.2 - 6.0 mmol/L (mild), 2.5 - 2.9 mmol/L or 6.1 - 6.5 mmol/L (moderate), <2.5 mmol/L or >6.5 mmol/L (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. |
Day 1 to approximately 28 Days Post Second Vaccination |
|
| Primary |
Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN |
Thresholds for adverse events were considered as BUN 24 - 26 mg/dL (mild), 27 - 31 mg/dL (moderate), >31 mg/dL (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. |
Day 1 to approximately 28 Days Post Second Vaccination |
|
| Primary |
Number of Participants by Severity of Solicited Local Reactogenicity |
Local reactogenicity solicited on memory aid include pain; tenderness; pruritus (itch); erythema (redness), induration (hardness/swelling), and ecchymosis (bruising) (functional and measurement). Thresholds for severity were pain: aware, no interference with activity, no pain med (mild), aware, interferes with activity or requires repeated use of a non-narcotic pain reliever for >24 hr (moderate), aware, prevents activity or requires prescription med use (severe); tenderness: area surrounding injection hurts when touched or with arm motion, no interference with daily activity (mild), hurts when touched or with arm motion, interferes with activity (moderate), hurts when touched or with arm motion and prevents activity (severe); functional erythema, induration, ecchymosis, and pruritus: no activity interference (mild), interferes with activity (moderate), prevents activity (severe); erythema, induration, and ecchymosis (measurement): <20mm (mild), 20 - 50mm (moderate), >50mm (severe). |
Day 1 to Day 8 Post First Vaccination |
|
| Primary |
Number of Participants by Severity of Solicited Local Reactogenicity |
Local reactogenicity solicited on memory aid include pain; tenderness; pruritus (itch); erythema (redness), induration (hardness/swelling), and ecchymosis (bruising) (functional and measurement). Thresholds for severity grading were pain: aware, no interference with activity, no pain med (mild), aware, interferes with activity or requires repeated use of a non-narcotic pain reliever for >24hr (moderate), aware, prevents activity or requires prescription med use (severe); tenderness: area surrounding injection hurts when touched or with arm motion, no interference with daily activity (mild), hurts when touched or with arm motion, interferes with activity (moderate), hurts when touched or with arm motion, prevents activity (severe); functional erythema, induration, ecchymosis, and pruritus: no activity interference (mild), interferes with activity (moderate), prevents activity (severe); erythema, induration, and ecchymosis (measurement): <20mm (mild), 20-50mm (moderate), >50mm (severe). |
Day 1 to Day 8 Post Second Vaccination |
|
| Primary |
Number of Participants by Severity of Solicited Local Reactogenicity |
Local reactogenicity solicited on memory aid include pain; tenderness; pruritus (itch); erythema (redness), induration (hardness/swelling), and ecchymosis (bruising) (functional and measurement). Thresholds for severity grading were pain: aware, no interference with activity, no pain med (mild), aware, interferes with activity or requires repeated use of a non-narcotic pain reliever for >24hr (moderate), aware, prevents activity or requires prescription med use (severe); tenderness: area surrounding injection hurts when touched or with arm motion, no interference with daily activity (mild), hurts when touched or with arm motion, interferes with activity (moderate), hurts when touched or with arm motion, prevents activity (severe); functional erythema, induration, ecchymosis, and pruritus: no activity interference (mild), interferes with activity (moderate), prevents activity (severe); erythema, induration, and ecchymosis (measurement): <20mm (mild), 20-50mm (moderate), >50mm (severe). |
Day 1 to Day 15 |
|
| Primary |
Number of Participants by Severity of Solicited Systemic Reactogenicity |
Systemic reactogenicity solicited on memory aid included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Thresholds for severity include feverishness, malaise, fatigue, myalgia, nausea, and loss of appetite: Noticeable but does not interfere with daily activity (Mild), Interferes with daily activity (Moderate), Significant interference, prevents daily activity (Severe); headache: Noticeable but does not interfere with daily activity (Mild), Any use of pain reliever or interferes with daily activity (Moderate), Significant interference, prevents daily activity, or requires any use of a prescription medication (Severe); elevated oral temperature: 37.8°C - 38.4°C or 100.00°F - 101.1°F (Mild), 38.5°C - 38.9°C or 101.2°F - 102.0°F (Moderate), >38.9°C or >102.0°F (Severe). |
Day 1 to Day 8 Post First Vaccination |
|
| Primary |
Number of Participants by Severity of Solicited Systemic Reactogenicity |
Systemic reactogenicity solicited on memory aid included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Thresholds for severity include feverishness, malaise, fatigue, myalgia, nausea, and loss of appetite: Noticeable but does not interfere with daily activity (Mild), Interferes with daily activity (Moderate), Significant interference, prevents daily activity (Severe); headache: Noticeable but does not interfere with daily activity (Mild), Any use of pain reliever or interferes with daily activity (Moderate), Significant interference, prevents daily activity, or requires any use of a prescription medication (Severe); elevated oral temperature: 37.8°C - 38.4°C or 100.00°F - 101.1°F (Mild), 38.5°C - 38.9°C or 101.2°F - 102.0°F (Moderate), >38.9°C or >102.0°F (Severe). |
Day 1 to Day 8 Post Second Vaccination |
|
| Primary |
Number of Participants by Severity of Solicited Systemic Reactogenicity |
Systemic reactogenicity solicited on memory aid included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Thresholds for severity include feverishness, malaise, fatigue, myalgia, nausea, and loss of appetite: Noticeable but does not interfere with daily activity (Mild), Interferes with daily activity (Moderate), Significant interference, prevents daily activity (Severe); headache: Noticeable but does not interfere with daily activity (Mild), Any use of pain reliever or interferes with daily activity (Moderate), Significant interference, prevents daily activity, or requires any use of a prescription medication (Severe); elevated oral temperature: 37.8°C - 38.4°C or 100.00°F - 101.1°F (Mild), 38.5°C - 38.9°C or 101.2°F - 102.0°F (Moderate), >38.9°C or >102.0°F (Severe). |
Day 1 to Day 15 |
|
| Primary |
Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) |
Vaccine-related unsolicited AEs include any untoward medical occurrence in a participant for which there is evidence to suggest a causal relationship between the study product and the adverse event. Thresholds for severity include events require minimal or no treatment and do not interfere with the subject's daily activities (mild), events result in a low level of inconvenience or concern with therapeutic measures and may cause some interference with functioning and daily activities (moderate), and events interrupt the subject's daily activities and may require systemic drug therapy or other treatment and are usually incapacitating (severe). Participants are counted once per preferred term and are summarized according to their highest severity. No severe events were reported. |
Day 1 to approximately 28 Days Post Second Vaccination |
|
| Secondary |
Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population |
The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Geometric mean fold rise (GMFR) compared to baseline (Day 1) was calculated for each study arm. |
Day 8, 15, 22, 29 and 36 compared to baseline (Day 1) reported as Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively. |
|
| Secondary |
Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population |
The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Geometric mean fold rise (GMFR) compared to baseline (Day 1) was calculated for each study arm. |
Day 8, 15, 22, 29 and 36 compared to baseline (Day 1) reported as Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively. |
|
| Secondary |
Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population |
The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Geometric Mean Titer (GMT) was calculated for each study arm. |
Day 1, 8, 15, 22, 29 and 36 reported as Day 1 first vaccination, Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively. |
|
| Secondary |
Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population |
The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Geometric Mean Titer (GMT) was calculated for each study arm. |
Day 1, 8, 15, 22, 29 and 36 reported as Day 1 first vaccination, Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively. |
|
| Secondary |
Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population |
The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Seroconversion was calculated for each study arm and was defined as anti-EBOV GP ELISA titer > 50 if baseline (Day 1) titer = 50 or fold rise > 4 as compared to baseline if baseline titer > 50. |
Day 8, 15, 22, 29 and 36 reported as Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively. |
|
| Secondary |
Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population |
The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Seroconversion was calculated for each study arm and was defined as anti-EBOV GP ELISA titer > 50 if baseline (Day 1) titer = 50 or fold rise > 4 as compared to baseline if baseline titer > 50. |
Day 8, 15, 22, 29 and 36 reported as Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively. |
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