Ebola Disease, Immunisation
Conditions
Keywords
Adenovirus vector, Ebola Virus, Immunogenicity, Non-Human Primates Vaccination/Challenge Studies, Phase 1, Reactogenicity, Safety, Zaire ebolavirus vaccine
Brief summary
This initial, proof of concept study will focus on identifying significant differences in response to the Ebolavirus Zaire vaccine (ChAd3-EBO-Z) when administered with placebo, MVA-BN(R)-Filo, or ChAd3-EBO-Z boosters after 8 days. All 60 participants will receive the ChAd3-EBO-Z vaccine and then randomized into each booster group (20 receiving each type of booster). Subjects will be followed-up for 6 months to monitor for safety outcomes and efficacy measures. There is no formal hypothesis for this study. The primary objective of this study is to assess the safety and reactogenicity of study products by study group when administered IM to healthy adults.
Detailed description
This is a Phase 1, randomized, double-blind trial of 60 evaluable males and non-pregnant females, 18-45 years old, inclusive, who are in good health, meet all eligibility criteria, and do not meet any exclusion criteria. This trial is designed to assess the safety, reactogenicity and immunogenicity of an Ebolavirus Zaire (ChAd3-EBO-Z) vaccine for the prevention of Ebola. ChAd3-EBO-Z will be administered intramuscularly into the deltoid of all participants on Day 1. On Day 8, subjects will receive either placebo, ChAd3-EBO-Z , or MVA- BN(R)-Filo boosters, administered intramuscularly into the deltoid of the arm opposite their first vaccination, based on study group. There will be 20 subjects in each group. Subjects will be monitored for 6 months after vaccination to assess safety and efficacy for ChA3d-EBO-Z with homologous and heterologous boosting. Differences between the homologous and heterologous arm represent potential points for further, more in depth assessment to determine if there is a correlation with efficacy. Long term goals include comparing results from this study with results from naturally infected individuals as well as non-human primate (NHP) vaccination/challenge studies. There is no formal hypothesis for this study. The primary objective of this study is to assess the safety and reactogenicity of study products by study group when administered IM to healthy adults. The secondary study objective is to assess the antibody response to Zaire ebolavirus (EBOV) glycoprotein (GP) by study group.
Interventions
Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10\^11 virus particles (vp)).
A booster vaccination of replication defective MVA-BN-Filo administered by an IM injection into the deltoid as a single dose of 1 x 10\^8 Infectious Units (IU).
0.5 mL normal saline administered via IM injection into the deltoid.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Provide written informed consent before initiation of any study procedures. 2. Are able to understand and comply with planned study procedures and be available for all study visits/phone calls. 3. Males or non-pregnant females ages 18-45, inclusive. 4. Subject must have a body mass index (BMI) \> / = 18.5 and \< 35 kg/m\^2. 5. Are in good health. * As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days (no hospitalizations, ER or urgent care for condition and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical, nasal, and inhaled medications (apart from steroids as outlined in the Subject
Exclusion criteria
), herbals, vitamins, and supplements are permitted. 6. Oral temperature is less than 100.0 degrees Fahrenheit (37.8 degrees Celsius). 7. Pulse is 47 to 105 beats per minute (bpm), inclusive. 8. Systolic blood pressure (BP) is 85 to 150 mm Hg, inclusive. 9. Diastolic blood pressure (BP) is 55 to 95 mm Hg, inclusive. 10. Have acceptable screening laboratories within 28 days prior to enrollment * Screening labs include white blood cell (WBC), Hgb, platelet count, ANC, sodium, potassium, creatinine, albumin, total protein, PT, PTT, alanine aminotransferase (ALT). Blood Urea Nitrogen (BUN) will be obtained only if creatinine is above normal range. * Screening laboratory values that are outside the range of eligibility but are thought to be due to an acute condition or due to laboratory error may be repeated once. 11. Have normal screening laboratories for urine protein. Trace protein is acceptable. 12. Drug screen for opiates is negative. 13. Hemoglobin A1C (HgbA1C) \< 6.3% at screening. 14. HIV 1/2 antibody negative. 15. HCV antibody negative. 16. HBsAg negative. 17. Women of childbearing potential, must be using an effective method of contraception from 30 days prior to the first study vaccination until 90 days after the second study vaccination. \- Women of childbearing potential are not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy, successful Essure(R) placement (permanent, non-surgical, non-hormonal sterilization) with history of documented radiological confirmation test at least 90 days after the procedure (or with use of another birth control method if history of confirmation test not confirmed), still menstruating, or \< 1 year of the last menses if menopausal. \-- Effective methods of contraception includes, but is not limited to, non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with a vasectomized partner, male condoms with the use of applied spermicide, intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables or oral contraceptives (the pill). 18. Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to each study vaccination. 19. Women agree to not donate eggs (ova, oocytes) from the start of screening onwards until at least 90 days after the second vaccination. 20. Agrees not to participate in another clinical trial during the study period. 21. Agrees not to donate blood to a blood bank for 3 months after receiving the second study vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Day 1 to approximately 28 Days Post Second Vaccination | 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. |
| Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 1 to approximately 28 Days Post Second Vaccination | 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. |
| Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 1 to approximately 28 Days Post Second Vaccination | 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. |
| Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 1 to approximately 28 Days Post Second Vaccination | 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. |
| Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 1 to approximately 28 Days Post Second Vaccination | 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. |
| Number of Participants by Severity of Solicited Local Reactogenicity | Day 1 to Day 8 Post First Vaccination | 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). |
| Number of Participants by Severity of Solicited Systemic Reactogenicity | Day 1 to Day 8 Post First Vaccination | 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). |
| Number of Participants With Clinical Safety Laboratory Adverse Events | Day 1 to approximately 28 Days Post Second Vaccination | 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. |
| Number of Participants Reporting Serious Adverse Events (SAEs) | Day 1 to Day 182 | 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. |
| Number of Participants Reporting Solicited Local Reactogenicity | Day 1 to Day 8 Post First Vaccination | 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. |
| Number of Participants Reporting Solicited Systemic Reactogenicity | Day 1 to Day 8 Post First Vaccination | 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. |
| Number of Participants Reporting Vaccine-related Medically Attended Adverse Events (MAAEs) | Day 1 to Day 182 | 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. |
| Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Day 1 to approximately 28 Days Post Second Vaccination | 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. |
| Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 1 to approximately 28 Days Post Second Vaccination | 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. |
| Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 1 to approximately 28 Days Post Second Vaccination | 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. |
| Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 1 to approximately 28 Days Post Second Vaccination | 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. |
| Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 1 to approximately 28 Days Post Second Vaccination | 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. |
| Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 1 to approximately 28 Days Post Second Vaccination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population | 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. | 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. |
| Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population | 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. | 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. |
| Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population | 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. | 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. |
| Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population | 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. | 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. |
| Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population | 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. | 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. |
| Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population | 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. | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were males and non-pregnant females in good health, aged 19 to 45, and recruited from the community at large at the participating site. Participants were enrolled between 12NOV2018 to 10JUL2019.
Participants by arm
| Arm | Count |
|---|---|
| ChAd3-EBO-Z + Placebo ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8.
ChAd3-EBO-Z: Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10\^11 virus particles (vp)).
Placebo: 0.5 mL normal saline administered via IM injection into the deltoid. | 22 |
| ChAd3-EBO-Z + ChAd3-EBO-Z ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8.
ChAd3-EBO-Z: Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10\^11 virus particles (vp)). | 20 |
| ChAd3-EBO-Z + MVA- BN-Filo ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8.
ChAd3-EBO-Z: Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10\^11 virus particles (vp)).
MVA Multi-Filo Ebola Vaccine: A booster vaccination of replication defective MVA-BN-Filo administered by an IM injection into the deltoid as a single dose of 1 x 10\^8 Infectious Units (IU). | 19 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Ineligible at baseline | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | ChAd3-EBO-Z + Placebo | ChAd3-EBO-Z + ChAd3-EBO-Z | ChAd3-EBO-Z + MVA- BN-Filo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 20 Participants | 19 Participants | 61 Participants |
| Age, Continuous | 33.8 Years STANDARD_DEVIATION 7.8 | 26.8 Years STANDARD_DEVIATION 5.3 | 31.4 Years STANDARD_DEVIATION 7.6 | 30.8 Years STANDARD_DEVIATION 7.5 |
| BMI | 26.35 kg/m^2 STANDARD_DEVIATION 3.96 | 25.19 kg/m^2 STANDARD_DEVIATION 3.77 | 25.49 kg/m^2 STANDARD_DEVIATION 4.06 | 25.70 kg/m^2 STANDARD_DEVIATION 3.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 19 Participants | 17 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 19 Participants | 15 Participants | 50 Participants |
| Region of Enrollment United States | 22 participants | 20 participants | 19 participants | 61 participants |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 13 Participants | 35 Participants |
| Sex: Female, Male Male | 11 Participants | 9 Participants | 6 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 21 / 21 | 20 / 20 | 19 / 19 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 | 0 / 19 |
Outcome results
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.
Time frame: Day 1 to approximately 28 Days Post Second Vaccination
Population: Safety Population: includes all participants who received at least one study vaccination
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 29 Post-Second Vaccination | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Max Severity Post Baseline | Moderate | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 29 Post-Second Vaccination | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 (Second Vaccination) | Moderate | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 22 Post-Second Vaccination | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 (Second Vaccination) | None | 19 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 22 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 22 Post-Second Vaccination | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Max Severity Post Baseline | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 22 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 22 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 (Second Vaccination) | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Max Severity Post Baseline | None | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 (Second Vaccination) | Missing | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Max Severity Post Baseline | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 29 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 Post-Second Vaccination | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 29 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 Post-Second Vaccination | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 (Second Vaccination) | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 29 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 29 Post-Second Vaccination | None | 17 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 (Second Vaccination) | None | 17 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 (Second Vaccination) | Mild | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 (Second Vaccination) | Moderate | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 (Second Vaccination) | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 (Second Vaccination) | Missing | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 Post-Second Vaccination | Mild | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 22 Post-Second Vaccination | None | 17 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 22 Post-Second Vaccination | Mild | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 22 Post-Second Vaccination | Moderate | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 22 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 22 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 29 Post-Second Vaccination | Mild | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 29 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 29 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 29 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Max Severity Post Baseline | None | 15 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Max Severity Post Baseline | Mild | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Max Severity Post Baseline | Moderate | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Max Severity Post Baseline | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 29 Post-Second Vaccination | Mild | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 Post-Second Vaccination | Mild | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 Post-Second Vaccination | None | 17 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 29 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Max Severity Post Baseline | Moderate | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 29 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 (Second Vaccination) | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 (Second Vaccination) | None | 17 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 29 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 (Second Vaccination) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Max Severity Post Baseline | None | 16 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 22 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 22 Post-Second Vaccination | Mild | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 (Second Vaccination) | Moderate | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 22 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 22 Post-Second Vaccination | None | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Max Severity Post Baseline | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 22 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Max Severity Post Baseline | Mild | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 29 Post-Second Vaccination | None | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Day 8 (Second Vaccination) | Mild | 0 Participants |
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.
Time frame: Day 1 to approximately 28 Days Post Second Vaccination
Population: Safety Population: includes all participants who received at least one study vaccination
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 (Second Vaccination) | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 29 Post-Second Vaccination | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 (Second Vaccination) | None | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 22 Post-Second Vaccination | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Max Severity Post Baseline | Mild | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 29 Post-Second Vaccination | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 22 Post-Second Vaccination | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 (Second Vaccination) | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 22 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 22 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Max Severity Post Baseline | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 22 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Max Severity Post Baseline | None | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 Post-Second Vaccination | None | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 (Second Vaccination) | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 29 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 Post-Second Vaccination | Mild | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 (Second Vaccination) | Mild | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 29 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Max Severity Post Baseline | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 29 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 29 Post-Second Vaccination | None | 18 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 (Second Vaccination) | None | 20 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 (Second Vaccination) | Mild | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 (Second Vaccination) | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 (Second Vaccination) | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 (Second Vaccination) | Missing | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 Post-Second Vaccination | Mild | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 22 Post-Second Vaccination | None | 17 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 22 Post-Second Vaccination | Mild | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 22 Post-Second Vaccination | Moderate | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 22 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 22 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 29 Post-Second Vaccination | Mild | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 29 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 29 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 29 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Max Severity Post Baseline | None | 18 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Max Severity Post Baseline | Mild | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Max Severity Post Baseline | Moderate | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Max Severity Post Baseline | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 29 Post-Second Vaccination | Mild | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 (Second Vaccination) | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 29 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 Post-Second Vaccination | Mild | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Max Severity Post Baseline | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 29 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 Post-Second Vaccination | None | 17 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 (Second Vaccination) | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 29 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 (Second Vaccination) | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Max Severity Post Baseline | None | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 (Second Vaccination) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 22 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Max Severity Post Baseline | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 22 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 22 Post-Second Vaccination | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Max Severity Post Baseline | Mild | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 22 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 22 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 29 Post-Second Vaccination | None | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Day 8 (Second Vaccination) | Moderate | 0 Participants |
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.
Time frame: Day 1 to approximately 28 Days Post Second Vaccination
Population: Safety Population: includes all participants who received at least one study vaccination
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Max Severity Post Baseline | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 29 Post-Second Vaccination | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 Post-Second Vaccination | Missing | 18 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Max Severity Post Baseline | None | 4 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 29 Post-Second Vaccination | None | 3 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 22 Post-Second Vaccination | None | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 (Second Vaccination) | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 22 Post-Second Vaccination | Missing | 19 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 22 Post-Second Vaccination | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Max Severity Post Baseline | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 22 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 22 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 (Second Vaccination) | Missing | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 (Second Vaccination) | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 29 Post-Second Vaccination | Missing | 18 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 Post-Second Vaccination | None | 3 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 (Second Vaccination) | None | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Max Severity Post Baseline | Missing | 17 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 Post-Second Vaccination | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Max Severity Post Baseline | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 29 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 (Second Vaccination) | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 29 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 29 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 (Second Vaccination) | None | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 (Second Vaccination) | Mild | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 (Second Vaccination) | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 (Second Vaccination) | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 (Second Vaccination) | Missing | 17 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 Post-Second Vaccination | None | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 Post-Second Vaccination | Mild | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 Post-Second Vaccination | Missing | 18 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 22 Post-Second Vaccination | None | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 22 Post-Second Vaccination | Mild | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 22 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 22 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 22 Post-Second Vaccination | Missing | 18 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 29 Post-Second Vaccination | None | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 29 Post-Second Vaccination | Mild | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 29 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 29 Post-Second Vaccination | Missing | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Max Severity Post Baseline | None | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Max Severity Post Baseline | Mild | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Max Severity Post Baseline | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Max Severity Post Baseline | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Max Severity Post Baseline | Missing | 17 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 (Second Vaccination) | None | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 29 Post-Second Vaccination | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Max Severity Post Baseline | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 29 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 Post-Second Vaccination | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 Post-Second Vaccination | None | 4 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 29 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 (Second Vaccination) | Missing | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Max Severity Post Baseline | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 29 Post-Second Vaccination | Missing | 17 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 (Second Vaccination) | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 (Second Vaccination) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Max Severity Post Baseline | None | 4 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 22 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 22 Post-Second Vaccination | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 (Second Vaccination) | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 22 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 22 Post-Second Vaccination | None | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Max Severity Post Baseline | Missing | 15 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 22 Post-Second Vaccination | Missing | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 Post-Second Vaccination | Missing | 15 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Max Severity Post Baseline | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 29 Post-Second Vaccination | None | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Day 8 Post-Second Vaccination | Severe | 0 Participants |
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.
Time frame: Day 1 to approximately 28 Days Post Second Vaccination
Population: Safety Population: includes all participants who received at least one study vaccination
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 29 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 (Second Vaccination) | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 (Second Vaccination) | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Max Severity Post Baseline | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 (Second Vaccination) | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 22 Post-Second Vaccination | None | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 (Second Vaccination) | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 Post-Second Vaccination | Mild | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 22 Post-Second Vaccination | Mild | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Max Severity Post Baseline | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Max Severity Post Baseline | Mild | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 22 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 29 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 22 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 29 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 (Second Vaccination) | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 22 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 Post-Second Vaccination | None | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 29 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Max Severity Post Baseline | None | 19 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 29 Post-Second Vaccination | Mild | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Max Severity Post Baseline | Mild | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 29 Post-Second Vaccination | Mild | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 29 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 (Second Vaccination) | Missing | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 29 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 29 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Max Severity Post Baseline | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Max Severity Post Baseline | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Max Severity Post Baseline | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 Post-Second Vaccination | Mild | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 (Second Vaccination) | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 (Second Vaccination) | Mild | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 22 Post-Second Vaccination | None | 18 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 (Second Vaccination) | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 22 Post-Second Vaccination | Mild | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 22 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 22 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 22 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 (Second Vaccination) | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 29 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 (Second Vaccination) | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 22 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 (Second Vaccination) | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 (Second Vaccination) | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 (Second Vaccination) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 (Second Vaccination) | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 Post-Second Vaccination | None | 16 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 Post-Second Vaccination | Mild | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 8 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 22 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 22 Post-Second Vaccination | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 22 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 22 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 29 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 29 Post-Second Vaccination | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 29 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 29 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Day 29 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Max Severity Post Baseline | None | 17 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Max Severity Post Baseline | Mild | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Max Severity Post Baseline | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Max Severity Post Baseline | Severe | 0 Participants |
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.
Time frame: Day 1 to approximately 28 Days Post Second Vaccination
Population: Safety Population: includes all participants who received at least one study vaccination
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 29 Post-Second Vaccination | Mild | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Max Severity Post Baseline | Moderate | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 (Second Vaccination) | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 22 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Max Severity Post Baseline | Mild | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 29 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 22 Post-Second Vaccination | Mild | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 (Second Vaccination) | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 22 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 22 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 (Second Vaccination) | Mild | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 22 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Max Severity Post Baseline | None | 19 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 (Second Vaccination) | None | 19 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 29 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 Post-Second Vaccination | Mild | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Max Severity Post Baseline | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 29 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 (Second Vaccination) | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 29 Post-Second Vaccination | Moderate | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 29 Post-Second Vaccination | None | 16 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 (Second Vaccination) | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 (Second Vaccination) | None | 20 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 (Second Vaccination) | Mild | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 (Second Vaccination) | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 (Second Vaccination) | Missing | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 Post-Second Vaccination | None | 14 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 Post-Second Vaccination | Mild | 5 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 22 Post-Second Vaccination | None | 15 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 22 Post-Second Vaccination | Mild | 4 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 22 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 22 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 22 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 29 Post-Second Vaccination | Mild | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 29 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 29 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 29 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Max Severity Post Baseline | None | 14 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Max Severity Post Baseline | Mild | 6 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Max Severity Post Baseline | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Max Severity Post Baseline | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 29 Post-Second Vaccination | Mild | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 (Second Vaccination) | None | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 29 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 Post-Second Vaccination | Mild | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Max Severity Post Baseline | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 29 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 Post-Second Vaccination | None | 17 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 (Second Vaccination) | Mild | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 29 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 (Second Vaccination) | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Max Severity Post Baseline | None | 17 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 (Second Vaccination) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 22 Post-Second Vaccination | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Max Severity Post Baseline | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 22 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 22 Post-Second Vaccination | Mild | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Max Severity Post Baseline | Mild | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 22 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 22 Post-Second Vaccination | None | 17 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 29 Post-Second Vaccination | None | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Day 8 (Second Vaccination) | Moderate | 0 Participants |
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.
Time frame: Day 1 to approximately 28 Days Post Second Vaccination
Population: Safety Population: includes all participants who received at least one study vaccination
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 (Second Vaccination) | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 29 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 Post-Second Vaccination | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 (Second Vaccination) | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 29 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Max Severity Post Baseline | Mild (high) | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 22 Post-Second Vaccination | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 (Second Vaccination) | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 22 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 22 Post-Second Vaccination | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 22 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 22 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Max Severity Post Baseline | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 22 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 (Second Vaccination) | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Max Severity Post Baseline | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Max Severity Post Baseline | None | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 (Second Vaccination) | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 (Second Vaccination) | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 29 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 Post-Second Vaccination | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 29 Post-Second Vaccination | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 29 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Max Severity Post Baseline | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 29 Post-Second Vaccination | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 22 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 29 Post-Second Vaccination | None | 18 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 (Second Vaccination) | None | 20 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 (Second Vaccination) | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 (Second Vaccination) | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 (Second Vaccination) | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 (Second Vaccination) | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 (Second Vaccination) | Missing | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 Post-Second Vaccination | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 22 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 22 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 22 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 22 Post-Second Vaccination | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 22 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 29 Post-Second Vaccination | Mild (low) | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 29 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 29 Post-Second Vaccination | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 29 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 29 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Max Severity Post Baseline | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Max Severity Post Baseline | Mild (low) | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Max Severity Post Baseline | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Max Severity Post Baseline | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Max Severity Post Baseline | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 (Second Vaccination) | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 29 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 29 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Max Severity Post Baseline | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 29 Post-Second Vaccination | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 Post-Second Vaccination | None | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 (Second Vaccination) | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 29 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 (Second Vaccination) | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Max Severity Post Baseline | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 29 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 (Second Vaccination) | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Max Severity Post Baseline | Moderate (low) | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Max Severity Post Baseline | None | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 22 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 (Second Vaccination) | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 22 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 (Second Vaccination) | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 22 Post-Second Vaccination | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 22 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Max Severity Post Baseline | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 22 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 22 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 29 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Day 8 Post-Second Vaccination | Moderate (low) | 0 Participants |
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.
Time frame: Day 1 to approximately 28 Days Post Second Vaccination
Population: Safety Population: includes all participants who received at least one study vaccination
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 22 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 (Second Vaccination) | None | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 (Second Vaccination) | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 (Second Vaccination) | Mild (high) | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 (Second Vaccination) | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 (Second Vaccination) | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 (Second Vaccination) | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 Post-Second Vaccination | None | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 Post-Second Vaccination | Mild (high) | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 Post-Second Vaccination | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 22 Post-Second Vaccination | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 22 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 22 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 22 Post-Second Vaccination | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 22 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 29 Post-Second Vaccination | None | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 29 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 29 Post-Second Vaccination | Mild (high) | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 29 Post-Second Vaccination | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 29 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 29 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Max Severity Post Baseline | None | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Max Severity Post Baseline | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Max Severity Post Baseline | Mild (high) | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Max Severity Post Baseline | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Max Severity Post Baseline | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 22 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 Post-Second Vaccination | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 29 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 22 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Max Severity Post Baseline | None | 20 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 22 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 22 Post-Second Vaccination | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Max Severity Post Baseline | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 22 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Max Severity Post Baseline | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 29 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 29 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 22 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Max Severity Post Baseline | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 (Second Vaccination) | None | 20 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 (Second Vaccination) | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 29 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 (Second Vaccination) | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 (Second Vaccination) | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 (Second Vaccination) | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 29 Post-Second Vaccination | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 (Second Vaccination) | Missing | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Max Severity Post Baseline | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 29 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 (Second Vaccination) | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 29 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 (Second Vaccination) | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 Post-Second Vaccination | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Max Severity Post Baseline | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Max Severity Post Baseline | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 29 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 29 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 29 Post-Second Vaccination | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 22 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 (Second Vaccination) | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 22 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Max Severity Post Baseline | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 (Second Vaccination) | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 22 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Max Severity Post Baseline | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 (Second Vaccination) | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 22 Post-Second Vaccination | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 Post-Second Vaccination | None | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 22 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 22 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 8 (Second Vaccination) | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 29 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Day 29 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Max Severity Post Baseline | Mild (low) | 0 Participants |
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.
Time frame: Day 1 to approximately 28 Days Post Second Vaccination
Population: Safety Population: includes all participants who received at least one study vaccination
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 29 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Max Severity Post Baseline | Mild (high) | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 29 Post-Second Vaccination | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 (Second Vaccination) | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 22 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 22 Post-Second Vaccination | None | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Max Severity Post Baseline | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 22 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 22 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Max Severity Post Baseline | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 22 Post-Second Vaccination | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 22 Post-Second Vaccination | Mild (high) | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 (Second Vaccination) | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 (Second Vaccination) | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Max Severity Post Baseline | None | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 (Second Vaccination) | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 (Second Vaccination) | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 29 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 Post-Second Vaccination | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 29 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Max Severity Post Baseline | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 29 Post-Second Vaccination | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 (Second Vaccination) | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 29 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 Post-Second Vaccination | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Max Severity Post Baseline | None | 20 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 (Second Vaccination) | None | 20 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 (Second Vaccination) | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 (Second Vaccination) | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 (Second Vaccination) | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 (Second Vaccination) | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 (Second Vaccination) | Missing | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 Post-Second Vaccination | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 22 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 22 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 22 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 22 Post-Second Vaccination | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 22 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 22 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 29 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 29 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 29 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 29 Post-Second Vaccination | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 29 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 29 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Max Severity Post Baseline | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Max Severity Post Baseline | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Max Severity Post Baseline | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Max Severity Post Baseline | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Max Severity Post Baseline | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 29 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 (Second Vaccination) | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 29 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Max Severity Post Baseline | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 29 Post-Second Vaccination | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 Post-Second Vaccination | None | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Max Severity Post Baseline | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 29 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 (Second Vaccination) | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 (Second Vaccination) | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 29 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 (Second Vaccination) | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 (Second Vaccination) | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 22 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 22 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 22 Post-Second Vaccination | Moderate (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 22 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Max Severity Post Baseline | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 22 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 (Second Vaccination) | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 22 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 Post-Second Vaccination | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Max Severity Post Baseline | Severe (low or high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 29 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Day 8 Post-Second Vaccination | Moderate (low or high) | 0 Participants |
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.
Time frame: Day 1 to approximately 28 Days Post Second Vaccination
Population: Safety Population: includes all Participants who received at least one study vaccination
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 29 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 Post-Second Vaccination | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 (Second Vaccination) | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 22 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 Post-Second Vaccination | Moderate (high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 (Second Vaccination) | None | 19 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 22 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Max Severity Post Baseline | None | 19 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 22 Post-Second Vaccination | Moderate (high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 (Second Vaccination) | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 22 Post-Second Vaccination | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 22 Post-Second Vaccination | None | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Max Severity Post Baseline | Mild (low) | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 22 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 22 Post-Second Vaccination | Mild (low) | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 29 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 (Second Vaccination) | Moderate (high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 (Second Vaccination) | Mild (low) | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 29 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 (Second Vaccination) | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Max Severity Post Baseline | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 29 Post-Second Vaccination | Moderate (high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 (Second Vaccination) | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Max Severity Post Baseline | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 29 Post-Second Vaccination | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 Post-Second Vaccination | None | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Max Severity Post Baseline | Moderate (high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 29 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 Post-Second Vaccination | Mild (low) | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 29 Post-Second Vaccination | Mild (low) | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Max Severity Post Baseline | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 (Second Vaccination) | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 (Second Vaccination) | None | 18 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 22 Post-Second Vaccination | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Max Severity Post Baseline | Mild (low) | 4 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 (Second Vaccination) | Mild (low) | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 (Second Vaccination) | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 (Second Vaccination) | Moderate (high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 (Second Vaccination) | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 (Second Vaccination) | Missing | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 Post-Second Vaccination | None | 17 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 Post-Second Vaccination | Mild (low) | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 Post-Second Vaccination | Mild (high) | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 Post-Second Vaccination | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 Post-Second Vaccination | Moderate (high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 22 Post-Second Vaccination | None | 16 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 22 Post-Second Vaccination | Mild (low) | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 22 Post-Second Vaccination | Mild (high) | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 22 Post-Second Vaccination | Moderate (high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 22 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 22 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 29 Post-Second Vaccination | None | 17 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 29 Post-Second Vaccination | Mild (low) | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 29 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 29 Post-Second Vaccination | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 29 Post-Second Vaccination | Moderate (high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 29 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 29 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Max Severity Post Baseline | None | 15 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Max Severity Post Baseline | Mild (high) | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Max Severity Post Baseline | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Max Severity Post Baseline | Moderate (high) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Max Severity Post Baseline | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 29 Post-Second Vaccination | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Max Severity Post Baseline | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 29 Post-Second Vaccination | Mild (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 Post-Second Vaccination | None | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Max Severity Post Baseline | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 29 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 (Second Vaccination) | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 (Second Vaccination) | Mild (low) | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 29 Post-Second Vaccination | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 (Second Vaccination) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Max Severity Post Baseline | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 29 Post-Second Vaccination | Moderate (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 (Second Vaccination) | Moderate (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 (Second Vaccination) | None | 17 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 29 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 (Second Vaccination) | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Max Severity Post Baseline | Moderate (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 22 Post-Second Vaccination | Mild (low) | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 22 Post-Second Vaccination | None | 17 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 29 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 22 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 Post-Second Vaccination | Missing | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 22 Post-Second Vaccination | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 (Second Vaccination) | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 22 Post-Second Vaccination | Moderate (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 Post-Second Vaccination | Moderate (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Max Severity Post Baseline | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 22 Post-Second Vaccination | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 Post-Second Vaccination | Moderate (low) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Max Severity Post Baseline | None | 15 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 22 Post-Second Vaccination | Missing | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Day 8 Post-Second Vaccination | Mild (high) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Max Severity Post Baseline | Mild (low) | 4 Participants |
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).
Time frame: Day 1 to Day 8 Post First Vaccination
Population: Safety Population: includes all participants who received at least one study vaccination. All participants in all Study Arms received the same product (ChAd3-EBO-Z) at Day 1.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | None | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | Mild | 17 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | Moderate | 3 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | None | 8 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Mild | 11 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Moderate | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | None | 4 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Mild | 16 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Moderate | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | None | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Mild | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | None | 14 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | Mild | 7 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | None | 14 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | Mild | 7 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | None | 15 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | Mild | 6 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | None | 15 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | Mild | 5 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | Moderate | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Moderate | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | Severe | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | None | 20 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | Mild | 5 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Mild | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | None | 13 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | Mild | 6 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | None | 18 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | Mild | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | Severe | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | Moderate | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | None | 9 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | Moderate | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | Mild | 10 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | Moderate | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | None | 18 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | Mild | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | None | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | None | 9 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | Mild | 17 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | Moderate | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | None | 13 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | Severe | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | Mild | 10 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | None | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Mild | 15 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Moderate | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | None | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Mild | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Moderate | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Severe | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | None | 17 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | None | 5 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | Mild | 10 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | Mild | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | None | 14 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | Mild | 4 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Mild | 12 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | Moderate | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Mild | 10 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | None | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | None | 17 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | Mild | 3 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | None | 14 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | Mild | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | None | 4 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | Mild | 11 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | Moderate | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | None | 8 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Moderate | 3 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | Moderate | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | Moderate | 5 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | None | 8 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | Moderate | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | Mild | 11 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | Severe | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Severe | 1 Participants |
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).
Time frame: Day 1 to Day 8 Post Second Vaccination
Population: Safety Population Subset: includes all participants who received the first and second study vaccination
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | None | 17 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | None | 12 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | None | 17 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | Mild | 5 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | None | 17 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Mild | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | None | 16 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | None | 17 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Mild | 3 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | None | 17 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | Mild | 6 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | None | 12 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | None | 14 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | None | 11 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | Mild | 5 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | Mild | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | Mild | 6 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | None | 16 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | None | 17 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | Mild | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | None | 17 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | Mild | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | None | 10 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | Mild | 7 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | None | 10 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | Moderate | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | None | 14 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | Mild | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | None | 14 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Mild | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | None | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | Mild | 10 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | Moderate | 6 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | Severe | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | None | 4 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Mild | 11 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Moderate | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | None | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Mild | 9 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Moderate | 5 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Severe | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | Mild | 6 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | None | 12 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | None | 17 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | None | 5 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | None | 6 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | Mild | 13 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | None | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Measurement grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Any Local Symptom | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Mild | 12 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | None | 13 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Mild | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Mild | 5 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | None | 17 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | Mild | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | Mild | 6 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Functional grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Measurement grade) | None | 12 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (Functional grade) | None | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | None | 17 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | Mild | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (Functional grade) | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (Measurement grade) | Moderate | 0 Participants |
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).
Time frame: Day 1 to Day 15
Population: Safety Population: includes all participants who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Any local symptom | Moderate | 3 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Any local symptom | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Any local symptom | None | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Mild | 11 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Moderate | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | None | 8 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Mild | 16 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Moderate | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Any local symptom | Mild | 17 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | None | 4 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (functional) | Mild | 10 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (functional) | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (functional) | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (functional) | None | 11 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (measured) | Mild | 10 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (measured) | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (measured) | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (measured) | None | 11 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (functional) | Mild | 6 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (functional) | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (functional) | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (functional) | None | 15 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (measured) | Mild | 5 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (measured) | Moderate | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (measured) | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (measured) | None | 15 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (functional) | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (functional) | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (functional) | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (functional) | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (measured) | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (measured) | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (measured) | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (measured) | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Mild | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | None | 20 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (functional) | Moderate | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (functional) | None | 18 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (functional) | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (functional) | None | 9 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (measured) | Mild | 9 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (measured) | Mild | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (measured) | Moderate | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (measured) | Severe | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (measured) | None | 9 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (measured) | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (functional) | Mild | 7 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (functional) | Moderate | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (functional) | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (measured) | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (functional) | None | 12 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (measured) | Mild | 6 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (measured) | Moderate | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (measured) | None | 18 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (measured) | Severe | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Any local symptom | Mild | 11 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Any local symptom | Moderate | 7 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (measured) | None | 12 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Any local symptom | Severe | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Any local symptom | None | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Mild | 15 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (functional) | Mild | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Moderate | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Mild | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | None | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (functional) | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Mild | 12 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Moderate | 6 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Severe | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (functional) | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | None | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (functional) | Mild | 10 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (functional) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (functional) | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Severe | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Any local symptom | Mild | 11 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (functional) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (functional) | None | 17 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (measured) | None | 17 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (functional) | None | 7 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | None | 5 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Any local symptom | Moderate | 5 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (measured) | Mild | 11 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | None | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (functional) | Mild | 12 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (measured) | Moderate | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (measured) | Mild | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Any local symptom | Severe | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (measured) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (measured) | None | 14 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Erythema (measured) | None | 7 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Mild | 12 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Any local symptom | None | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (functional) | Mild | 3 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (measured) | Moderate | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (functional) | Moderate | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (functional) | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Mild | 10 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (functional) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | None | 4 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Tenderness | Moderate | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (functional) | None | 14 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (measured) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Moderate | 3 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (measured) | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (measured) | Mild | 4 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Ecchymosis (functional) | Mild | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pruritus | Mild | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Induration (measured) | Moderate | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Local Reactogenicity | Pain | Severe | 1 Participants |
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).
Time frame: Day 1 to Day 15
Population: Safety Population: includes all participants who received at least one study vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Mild | 6 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | None | 4 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Mild | 7 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | None | 14 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Moderate | 7 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Mild | 7 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Moderate | 7 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Mild | 10 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | None | 7 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Severe | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Mild | 13 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Moderate | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | None | 3 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Moderate | 5 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Moderate | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Severe | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Moderate | 8 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Mild | 6 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | None | 10 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Severe | 6 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | None | 8 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Mild | 7 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | None | 15 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Moderate | 8 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Mild | 4 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Moderate | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Severe | 3 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | None | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Mild | 11 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | None | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | None | 10 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Moderate | 9 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Mild | 6 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Severe | 7 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | None | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Mild | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Moderate | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Severe | 6 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | None | 8 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Mild | 7 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Moderate | 6 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Severe | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | None | 4 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Mild | 10 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Moderate | 5 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Severe | 4 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | None | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Mild | 9 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Moderate | 8 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Severe | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | None | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Mild | 8 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Severe | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | None | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Mild | 5 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Moderate | 7 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Severe | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | None | 7 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Mild | 7 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Moderate | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Moderate | 7 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Mild | 11 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Moderate | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | None | 8 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Severe | 4 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Severe | 6 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Mild | 8 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Moderate | 4 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Moderate | 4 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Mild | 5 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Mild | 5 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | None | 10 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Mild | 3 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | None | 7 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Severe | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Moderate | 6 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Mild | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Moderate | 3 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Moderate | 3 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Moderate | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Mild | 4 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Moderate | 5 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | None | 6 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Severe | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Mild | 7 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | None | 6 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Severe | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | None | 4 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Mild | 7 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Moderate | 5 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Moderate | 4 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Mild | 7 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | None | 11 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Severe | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | None | 6 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | None | 16 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | None | 7 Participants |
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).
Time frame: Day 1 to Day 8 Post First Vaccination
Population: Safety Population: includes all participants who received at least one study vaccination. All participants in all Study Arms received the same product (ChAd3-EBO-Z) at Day 1.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Severe | 3 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | None | 8 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | None | 17 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Moderate | 6 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Mild | 7 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | None | 10 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Mild | 11 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Moderate | 6 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Mild | 7 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | None | 4 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Severe | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | None | 4 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Mild | 7 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Moderate | 4 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Mild | 13 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | None | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Mild | 5 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Moderate | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Moderate | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | None | 15 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Severe | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Moderate | 7 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | None | 6 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Moderate | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Mild | 5 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Mild | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Mild | 9 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Moderate | 7 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Severe | 6 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | None | 11 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Severe | 7 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Mild | 8 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | None | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Mild | 8 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Moderate | 5 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | None | 11 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Mild | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Moderate | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Severe | 6 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | None | 6 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Mild | 6 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Moderate | 5 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Severe | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | None | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Mild | 8 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Moderate | 6 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Severe | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | None | 5 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Mild | 6 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Moderate | 7 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Severe | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | None | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Mild | 8 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Moderate | 7 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Severe | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | None | 10 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Mild | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Moderate | 6 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Severe | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | None | 11 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Mild | 7 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Moderate | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | None | 11 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Moderate | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Severe | 4 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Severe | 6 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Severe | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Moderate | 4 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | None | 4 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | None | 7 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Mild | 5 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | None | 11 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Mild | 8 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | None | 6 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Moderate | 6 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Moderate | 4 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Severe | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Mild | 5 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Moderate | 3 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Mild | 3 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | None | 16 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Mild | 4 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Mild | 7 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | None | 6 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Mild | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Moderate | 5 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Severe | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Moderate | 3 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Severe | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Moderate | 5 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Moderate | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | None | 7 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Mild | 7 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | None | 10 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Mild | 7 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | None | 6 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Moderate | 4 Participants |
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).
Time frame: Day 1 to Day 8 Post Second Vaccination
Population: Safety Population Subset: includes all participants who received the first and second study vaccination
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Moderate | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | None | 14 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Mild | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Mild | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | None | 10 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | None | 9 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Moderate | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | None | 14 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | None | 17 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | None | 10 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Mild | 6 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Mild | 6 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Moderate | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Moderate | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Mild | 3 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | None | 15 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Mild | 6 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | None | 14 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | None | 14 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Mild | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Moderate | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Moderate | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Mild | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Severe | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Moderate | 4 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | None | 8 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Severe | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Mild | 6 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Moderate | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | None | 6 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | None | 13 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Mild | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Moderate | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Mild | 7 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Moderate | 6 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | None | 10 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Moderate | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Mild | 7 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Severe | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Severe | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | None | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Severe | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Mild | 9 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Severe | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Severe | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | None | 9 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | None | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | None | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Mild | 9 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Moderate | 4 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Mild | 6 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Severe | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | None | 6 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Mild | 4 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Moderate | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Moderate | 6 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Mild | 5 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Mild | 4 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Moderate | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | None | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Elevated Oral Temperature | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | None | 17 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Mild | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Feverishness | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | None | 17 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Mild | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Malaise | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | None | 15 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Mild | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Moderate | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Fatigue | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | None | 14 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Mild | 4 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Myalgia | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | None | 14 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Mild | 3 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Moderate | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Headache | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | None | 17 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Moderate | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Nausea | Severe | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | None | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Loss of Appetite | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Solicited Systemic Reactogenicity | Any Systemic Symptom | None | 12 Participants |
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.
Time frame: Day 1 to approximately 28 Days Post Second Vaccination
Population: Safety Population: includes all participants who received at least one study vaccination
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Blood pressure diastolic decreased | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Acne | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Taste Disorder | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Transaminases increased | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Tachycardia | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Sinus headache | None | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Transaminases increased | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Any Event | Mild | 3 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Sinus headache | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Transaminases increased | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Tachycardia | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Sinus headache | Mild | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Dehydration | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Rash | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Dizziness | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Dehydration | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Acne | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Dizziness | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Dehydration | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Tachycardia | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Dizziness | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Back pain | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Rash | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Muscle Spasms | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Back pain | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Acne | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Muscle Spasms | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Back pain | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Any Event | Moderate | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Muscle Spasms | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Sinus Congestion | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Lymphadenopathy | None | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Sinus Congestion | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Diarrhea | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Rash | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Sinus Congestion | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Vomiting | Mild | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Ecchymosis | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Oropharyngeal pain | None | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Vomiting | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Oropharyngeal pain | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Any Event | None | 17 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Oropharyngeal pain | Mild | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Vomiting | None | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Ecchymosis | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Cough | None | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Chest discomfort | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Lymphadenopathy | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Cough | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Chest discomfort | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Diarrhea | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Cough | Mild | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Chest discomfort | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Lymphadenopathy | Moderate | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Blood pressure diastolic decreased | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Ecchymosis | Mild | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Taste Disorder | None | 21 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Blood pressure diastolic decreased | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Diarrhea | Moderate | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Taste Disorder | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Acne | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Lymphadenopathy | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Any Event | Mild | 7 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Any Event | Moderate | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Lymphadenopathy | Mild | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Lymphadenopathy | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Tachycardia | Mild | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Tachycardia | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Tachycardia | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Diarrhea | Mild | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Diarrhea | Moderate | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Diarrhea | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Vomiting | Mild | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Vomiting | Moderate | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Vomiting | None | 18 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Chest discomfort | Mild | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Chest discomfort | Moderate | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Chest discomfort | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Blood pressure diastolic decreased | Mild | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Blood pressure diastolic decreased | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Blood pressure diastolic decreased | None | 20 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Transaminases increased | Mild | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Transaminases increased | Moderate | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Transaminases increased | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Dehydration | Mild | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Dehydration | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Dehydration | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Back pain | Mild | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Back pain | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Back pain | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Muscle Spasms | Mild | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Muscle Spasms | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Muscle Spasms | None | 20 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Dizziness | Mild | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Dizziness | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Dizziness | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Sinus headache | Mild | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Sinus headache | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Sinus headache | None | 20 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Taste Disorder | Mild | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Taste Disorder | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Taste Disorder | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Cough | Mild | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Cough | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Cough | None | 20 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Oropharyngeal pain | Mild | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Oropharyngeal pain | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Oropharyngeal pain | None | 20 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Sinus Congestion | Mild | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Sinus Congestion | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Sinus Congestion | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Acne | Mild | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Any Event | None | 10 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Acne | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Ecchymosis | Mild | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Ecchymosis | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Ecchymosis | None | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Rash | Mild | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Rash | Moderate | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Rash | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Blood pressure diastolic decreased | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Rash | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Taste Disorder | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Blood pressure diastolic decreased | Mild | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Acne | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Taste Disorder | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Chest discomfort | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Lymphadenopathy | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Cough | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Chest discomfort | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Tachycardia | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Cough | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Vomiting | None | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Ecchymosis | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Cough | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Vomiting | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Any Event | None | 15 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Oropharyngeal pain | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Chest discomfort | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Rash | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Oropharyngeal pain | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Vomiting | Mild | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Ecchymosis | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Oropharyngeal pain | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Diarrhea | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Any Event | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Sinus Congestion | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Diarrhea | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Rash | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Sinus Congestion | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Back pain | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Diarrhea | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Muscle Spasms | Mild | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Back pain | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Ecchymosis | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Muscle Spasms | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Back pain | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Sinus Congestion | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Muscle Spasms | None | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Dehydration | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Tachycardia | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Dizziness | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Dehydration | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Any Event | Mild | 4 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Dizziness | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Dehydration | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Acne | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Dizziness | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Transaminases increased | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Tachycardia | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Sinus headache | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Transaminases increased | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Lymphadenopathy | Mild | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Sinus headache | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Transaminases increased | Mild | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Acne | Moderate | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Sinus headache | None | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Blood pressure diastolic decreased | None | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Lymphadenopathy | None | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Taste Disorder | Mild | 0 Participants |
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.
Time frame: Day 1 to Day 182
Population: Safety Population: includes all participants who received at least one study vaccination
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
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.
Time frame: Day 1 to Day 8 Post First Vaccination
Population: Safety Population: includes all participants who received at least one study vaccination. All participants in all Study Arms received the same product (ChAd3-EBO-Z) at Day 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Erythema (Functional Grade) | 7 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Tenderness | 17 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Erythema (Measurement Grade) | 7 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Induration (Functional Grade) | 6 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Induration (Measurement Grade) | 6 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Pruritus | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Any Local Symptom | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Ecchymosis (Functional Grade) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Pain | 13 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Ecchymosis (Measurement Grade) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Pain | 17 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Pruritus | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Erythema (Functional Grade) | 11 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Erythema (Measurement Grade) | 11 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Tenderness | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Ecchymosis (Measurement Grade) | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Induration (Functional Grade) | 7 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Any Local Symptom | 20 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Ecchymosis (Functional Grade) | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Induration (Measurement Grade) | 7 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Ecchymosis (Functional Grade) | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Induration (Measurement Grade) | 5 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Any Local Symptom | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Tenderness | 15 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Pruritus | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Pain | 14 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Ecchymosis (Measurement Grade) | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Erythema (Functional Grade) | 11 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Erythema (Measurement Grade) | 11 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Induration (Functional Grade) | 5 Participants |
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.
Time frame: Day 1 to Day 15
Population: Safety Population: includes all participants who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Erythema (functional grade) | 10 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Tenderness | 17 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Induration (functional grade) | 6 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Ecchymosis (functional grade) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Pruritus | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Any Local Symptom | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Ecchymosis (measurement grade) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Erythema (measurement grade) | 10 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Pain | 13 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Induration (measurement grade) | 6 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Ecchymosis (functional grade) | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Erythema (functional grade) | 11 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Any Local Symptom | 20 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Pain | 18 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Tenderness | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Pruritus | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Ecchymosis (measurement grade) | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Erythema (measurement grade) | 11 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Induration (functional grade) | 8 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Induration (measurement grade) | 8 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Pain | 14 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Erythema (functional grade) | 12 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Any Local Symptom | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Ecchymosis (functional grade) | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Erythema (measurement grade) | 12 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Induration (measurement grade) | 5 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Pruritus | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Tenderness | 15 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Induration (functional grade) | 5 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Ecchymosis (measurement grade) | 2 Participants |
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.
Time frame: Day 1 to Day 8 Post Second Vaccination
Population: Safety Population Subset: includes all participants who received the first and second study vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Ecchymosis (Measurement Grade) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Pruritus | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Induration (Functional Grade) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Erythema (Functional Grade) | 5 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Ecchymosis (Functional Grade) | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Pain | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Any Local Symptom | 6 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Erythema (Measurement Grade) | 5 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Tenderness | 3 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Local Reactogenicity | Induration (Measurement Grade) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Ecchymosis (Functional Grade) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Any Local Symptom | 17 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Pain | 13 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Tenderness | 15 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Pruritus | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Ecchymosis (Measurement Grade) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Erythema (Functional Grade) | 7 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Erythema (Measurement Grade) | 7 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Induration (Functional Grade) | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Local Reactogenicity | Induration (Measurement Grade) | 3 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Induration (Measurement Grade) | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Erythema (Functional Grade) | 6 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Pain | 5 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Induration (Functional Grade) | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Erythema (Measurement Grade) | 6 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Pruritus | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Ecchymosis (Functional Grade) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Tenderness | 12 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Any Local Symptom | 13 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Local Reactogenicity | Ecchymosis (Measurement Grade) | 0 Participants |
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.
Time frame: Day 1 to Day 15
Population: Safety Population: includes all participants who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Malaise | 14 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Loss of Appetite | 6 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Myalgia | 17 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Fatigue | 18 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Nausea | 7 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Elevated Oral Temperature | 11 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Any Systemic Symptom | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Headache | 13 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Feverishness | 18 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Feverishness | 16 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Any Systemic Symptom | 20 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Elevated Oral Temperature | 12 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Malaise | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Fatigue | 19 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Myalgia | 20 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Headache | 13 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Nausea | 10 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Loss of Appetite | 12 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Elevated Oral Temperature | 9 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Feverishness | 13 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Headache | 12 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Any Systemic Symptom | 15 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Loss of Appetite | 8 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Fatigue | 13 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Malaise | 13 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Nausea | 3 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Myalgia | 12 Participants |
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.
Time frame: Day 1 to Day 8 Post Second Vaccination
Population: Safety Population Subset: includes all participants who received the first and second study vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Myalgia | 3 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Any Systemic Symptom | 8 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Elevated Oral Temperature | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Feverishness | 3 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Malaise | 3 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Fatigue | 7 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Headache | 7 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Nausea | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Loss of Appetite | 3 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Nausea | 4 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Myalgia | 11 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Malaise | 14 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Feverishness | 11 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Headache | 9 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Any Systemic Symptom | 14 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Loss of Appetite | 7 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Fatigue | 14 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Elevated Oral Temperature | 8 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Loss of Appetite | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Feverishness | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Malaise | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Nausea | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Elevated Oral Temperature | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Fatigue | 3 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Myalgia | 4 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Any Systemic Symptom | 6 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Headache | 4 Participants |
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.
Time frame: Day 1 to Day 8 Post First Vaccination
Population: Safety Population: includes all participants who received at least one study vaccination. All participants in all Study Arms received the same product (ChAd3-EBO-Z) at Day 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Malaise | 13 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Loss of Appetite | 4 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Myalgia | 17 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Fatigue | 17 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Any Systemic Symptom | 20 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Nausea | 6 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Feverishness | 15 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Elevated Oral Temperature | 11 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Solicited Systemic Reactogenicity | Headache | 10 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Fatigue | 15 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Any Systemic Symptom | 20 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Elevated Oral Temperature | 9 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Feverishness | 14 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Malaise | 17 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Myalgia | 17 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Headache | 10 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Nausea | 9 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Solicited Systemic Reactogenicity | Loss of Appetite | 9 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Feverishness | 13 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Any Systemic Symptom | 15 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Headache | 12 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Elevated Oral Temperature | 9 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Loss of Appetite | 8 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Fatigue | 13 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Malaise | 13 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Nausea | 3 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Solicited Systemic Reactogenicity | Myalgia | 12 Participants |
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.
Time frame: Day 1 to Day 182
Population: Safety Population: includes all participants who received at least one study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Vaccine-related Medically Attended Adverse Events (MAAEs) | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Vaccine-related Medically Attended Adverse Events (MAAEs) | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Vaccine-related Medically Attended Adverse Events (MAAEs) | 0 Participants |
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.
Time frame: Day 1 to approximately 28 Days Post Second Vaccination
Population: Safety Population: includes all participants who received at least one study vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Taste disorder | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Blood pressure diastolic decreased | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Ecchymosis | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Sinus headache | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Transaminases increased | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Lymphadenopathy | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Dizziness | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Dehydration | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Vomiting | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Muscle spasms | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Back pain | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Acne | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Tachycardia | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Rash | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Sinus congestion | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Diarrhea | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Any SOC | 4 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Cough | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Chest discomfort | 0 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Oropharyngeal pain | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Dizziness | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Vomiting | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Oropharyngeal pain | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Any SOC | 10 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Lymphadenopathy | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Tachycardia | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Diarrhea | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Chest discomfort | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Blood pressure diastolic decreased | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Transaminases increased | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Dehydration | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Back pain | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Muscle spasms | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Sinus headache | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Taste disorder | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Cough | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Sinus congestion | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Acne | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Ecchymosis | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Rash | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Ecchymosis | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Sinus headache | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Chest discomfort | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Acne | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Taste disorder | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Vomiting | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Any SOC | 4 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Cough | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Oropharyngeal pain | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Tachycardia | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Rash | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Sinus congestion | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Back pain | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Dehydration | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Lymphadenopathy | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Muscle spasms | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Transaminases increased | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Diarrhea | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Dizziness | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Blood pressure diastolic decreased | 1 Participants |
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.
Time frame: Day 1 to approximately 28 Days Post Second Vaccination
Population: Safety Population: includes all participants who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Number of Participants With Clinical Safety Laboratory Adverse Events | Creatinine | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants With Clinical Safety Laboratory Adverse Events | WBC | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants With Clinical Safety Laboratory Adverse Events | Hemoglobin | 2 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants With Clinical Safety Laboratory Adverse Events | Platelet count | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants With Clinical Safety Laboratory Adverse Events | Absolute neutrophil count | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants With Clinical Safety Laboratory Adverse Events | ALT | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants With Clinical Safety Laboratory Adverse Events | Sodium | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants With Clinical Safety Laboratory Adverse Events | Potassium | 1 Participants |
| ChAd3-EBO-Z + Placebo | Number of Participants With Clinical Safety Laboratory Adverse Events | BUN | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants With Clinical Safety Laboratory Adverse Events | ALT | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants With Clinical Safety Laboratory Adverse Events | Sodium | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants With Clinical Safety Laboratory Adverse Events | WBC | 5 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants With Clinical Safety Laboratory Adverse Events | Potassium | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants With Clinical Safety Laboratory Adverse Events | Creatinine | 1 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants With Clinical Safety Laboratory Adverse Events | Hemoglobin | 6 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants With Clinical Safety Laboratory Adverse Events | Absolute neutrophil count | 5 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants With Clinical Safety Laboratory Adverse Events | BUN | 0 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Number of Participants With Clinical Safety Laboratory Adverse Events | Platelet count | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants With Clinical Safety Laboratory Adverse Events | BUN | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants With Clinical Safety Laboratory Adverse Events | Absolute neutrophil count | 3 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants With Clinical Safety Laboratory Adverse Events | Potassium | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants With Clinical Safety Laboratory Adverse Events | ALT | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants With Clinical Safety Laboratory Adverse Events | Creatinine | 2 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants With Clinical Safety Laboratory Adverse Events | Platelet count | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants With Clinical Safety Laboratory Adverse Events | WBC | 4 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants With Clinical Safety Laboratory Adverse Events | Sodium | 0 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Number of Participants With Clinical Safety Laboratory Adverse Events | Hemoglobin | 2 Participants |
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.
Time frame: 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.
Population: ITT Population: includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination blood samples for immunogenicity testing for which valid results were reported
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 22 Post-Second Vaccination | 70.7 titer |
| ChAd3-EBO-Z + Placebo | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 15 Post-Second Vaccination | 54.3 titer |
| ChAd3-EBO-Z + Placebo | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 8 Post-First Vaccination (Second Vaccination) | 1.1 titer |
| ChAd3-EBO-Z + Placebo | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 8 Post-Second Vaccination | 21.5 titer |
| ChAd3-EBO-Z + Placebo | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 29 Post-Second Vaccination | 83.3 titer |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 15 Post-Second Vaccination | 54.9 titer |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 8 Post-First Vaccination (Second Vaccination) | 1.2 titer |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 8 Post-Second Vaccination | 21.0 titer |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 22 Post-Second Vaccination | 77.6 titer |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 29 Post-Second Vaccination | 97.8 titer |
| ChAd3-EBO-Z + MVA- BN-Filo | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 29 Post-Second Vaccination | 82.6 titer |
| ChAd3-EBO-Z + MVA- BN-Filo | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 22 Post-Second Vaccination | 74.1 titer |
| ChAd3-EBO-Z + MVA- BN-Filo | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 8 Post-First Vaccination (Second Vaccination) | 1.3 titer |
| ChAd3-EBO-Z + MVA- BN-Filo | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 15 Post-Second Vaccination | 49.6 titer |
| ChAd3-EBO-Z + MVA- BN-Filo | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 8 Post-Second Vaccination | 25.4 titer |
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.
Time frame: 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.
Population: Per Protocol population includes all participants who received at least one study vaccination, contributed both pre- and at least one post-study vaccination blood samples for immunogenicity testing for which valid results were reported, were eligible at baseline and have no major protocol deviations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population | Day 22 Post-Second Vaccination | 75.3 titer |
| ChAd3-EBO-Z + Placebo | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population | Day 15 Post-Second Vaccination | 61.3 titer |
| ChAd3-EBO-Z + Placebo | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population | Day 8 Post-First Vaccination (Second Vaccination) | 1.1 titer |
| ChAd3-EBO-Z + Placebo | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population | Day 8 Post-Second Vaccination | 25.1 titer |
| ChAd3-EBO-Z + Placebo | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population | Day 29 Post-Second Vaccination | 92.4 titer |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population | Day 15 Post-Second Vaccination | 45.3 titer |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population | Day 8 Post-First Vaccination (Second Vaccination) | 1.2 titer |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population | Day 8 Post-Second Vaccination | 17.4 titer |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population | Day 22 Post-Second Vaccination | 66.8 titer |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population | Day 29 Post-Second Vaccination | 83.0 titer |
| ChAd3-EBO-Z + MVA- BN-Filo | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population | Day 29 Post-Second Vaccination | 66.7 titer |
| ChAd3-EBO-Z + MVA- BN-Filo | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population | Day 22 Post-Second Vaccination | 64.0 titer |
| ChAd3-EBO-Z + MVA- BN-Filo | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population | Day 8 Post-First Vaccination (Second Vaccination) | 1.3 titer |
| ChAd3-EBO-Z + MVA- BN-Filo | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population | Day 15 Post-Second Vaccination | 43.5 titer |
| ChAd3-EBO-Z + MVA- BN-Filo | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population | Day 8 Post-Second Vaccination | 23.1 titer |
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.
Time frame: 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.
Population: ITT Population: includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination blood samples for immunogenicity testing for which valid results were reported
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 1 First Vaccination | 29.5 titer |
| ChAd3-EBO-Z + Placebo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 8 Post-First Vaccination (Second Vaccination) | 32.6 titer |
| ChAd3-EBO-Z + Placebo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 8 Post-Second Vaccination | 635.0 titer |
| ChAd3-EBO-Z + Placebo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 15 Post-Second Vaccination | 1600.0 titer |
| ChAd3-EBO-Z + Placebo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 22 Post-Second Vaccination | 2083.5 titer |
| ChAd3-EBO-Z + Placebo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 29 Post-Second Vaccination | 2457.4 titer |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 29 Post-Second Vaccination | 3325.6 titer |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 1 First Vaccination | 33.5 titer |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 15 Post-Second Vaccination | 1866.4 titer |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 22 Post-Second Vaccination | 2639.6 titer |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 8 Post-First Vaccination (Second Vaccination) | 40.2 titer |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 8 Post-Second Vaccination | 712.7 titer |
| ChAd3-EBO-Z + MVA- BN-Filo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 8 Post-First Vaccination (Second Vaccination) | 35.4 titer |
| ChAd3-EBO-Z + MVA- BN-Filo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 8 Post-Second Vaccination | 831.4 titer |
| ChAd3-EBO-Z + MVA- BN-Filo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 29 Post-Second Vaccination | 2666.4 titer |
| ChAd3-EBO-Z + MVA- BN-Filo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 15 Post-Second Vaccination | 1600.0 titer |
| ChAd3-EBO-Z + MVA- BN-Filo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 1 First Vaccination | 32.3 titer |
| ChAd3-EBO-Z + MVA- BN-Filo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population | Day 22 Post-Second Vaccination | 2390.0 titer |
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.
Time frame: 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.
Population: Per Protocol population includes all participants who received at least one study vaccination, contributed both pre- and at least one post-study vaccination blood samples for immunogenicity testing for which valid results were reported, were eligible at baseline and have no major protocol deviations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 1 First Vaccination | 29.5 titer |
| ChAd3-EBO-Z + Placebo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 8 Post-First Vaccination (Second Vaccination) | 32.6 titer |
| ChAd3-EBO-Z + Placebo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 8 Post-Second Vaccination | 679.6 titer |
| ChAd3-EBO-Z + Placebo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 15 Post-Second Vaccination | 1670.8 titer |
| ChAd3-EBO-Z + Placebo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 22 Post-Second Vaccination | 2043.5 titer |
| ChAd3-EBO-Z + Placebo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 29 Post-Second Vaccination | 2505.6 titer |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 29 Post-Second Vaccination | 2810.0 titer |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 1 First Vaccination | 33.5 titer |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 15 Post-Second Vaccination | 1532.2 titer |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 22 Post-Second Vaccination | 2262.7 titer |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 8 Post-First Vaccination (Second Vaccination) | 40.2 titer |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 8 Post-Second Vaccination | 590.7 titer |
| ChAd3-EBO-Z + MVA- BN-Filo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 8 Post-First Vaccination (Second Vaccination) | 35.4 titer |
| ChAd3-EBO-Z + MVA- BN-Filo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 8 Post-Second Vaccination | 768.0 titer |
| ChAd3-EBO-Z + MVA- BN-Filo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 29 Post-Second Vaccination | 2217.1 titer |
| ChAd3-EBO-Z + MVA- BN-Filo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 15 Post-Second Vaccination | 1425.4 titer |
| ChAd3-EBO-Z + MVA- BN-Filo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 1 First Vaccination | 32.3 titer |
| ChAd3-EBO-Z + MVA- BN-Filo | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 22 Post-Second Vaccination | 2128.5 titer |
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.
Time frame: 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.
Population: ITT Population: includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination blood samples for immunogenicity testing for which valid results were reported
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population | Day 22 Post-Second Vaccination | 21 Participants |
| ChAd3-EBO-Z + Placebo | Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population | Day 15 Post-Second Vaccination | 21 Participants |
| ChAd3-EBO-Z + Placebo | Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population | Day 8 Post-First Vaccination (Second Vaccination) | 1 Participants |
| ChAd3-EBO-Z + Placebo | Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population | Day 8 Post-Second Vaccination | 20 Participants |
| ChAd3-EBO-Z + Placebo | Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population | Day 29 Post-Second Vaccination | 21 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population | Day 15 Post-Second Vaccination | 17 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population | Day 8 Post-First Vaccination (Second Vaccination) | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population | Day 8 Post-Second Vaccination | 17 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population | Day 22 Post-Second Vaccination | 17 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population | Day 29 Post-Second Vaccination | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population | Day 29 Post-Second Vaccination | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population | Day 22 Post-Second Vaccination | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population | Day 8 Post-First Vaccination (Second Vaccination) | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population | Day 15 Post-Second Vaccination | 19 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population | Day 8 Post-Second Vaccination | 17 Participants |
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.
Time frame: 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.
Population: Per Protocol population includes all participants who received at least one study vaccination, contributed both pre- and at least one post-study vaccination blood samples for immunogenicity testing for which valid results were reported, were eligible at baseline and have no major protocol deviations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ChAd3-EBO-Z + Placebo | Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 22 Post-Second Vaccination | 17 Participants |
| ChAd3-EBO-Z + Placebo | Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 15 Post-Second Vaccination | 16 Participants |
| ChAd3-EBO-Z + Placebo | Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 8 Post-First Vaccination (Second Vaccination) | 1 Participants |
| ChAd3-EBO-Z + Placebo | Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 8 Post-Second Vaccination | 17 Participants |
| ChAd3-EBO-Z + Placebo | Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 29 Post-Second Vaccination | 17 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 15 Post-Second Vaccination | 15 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 8 Post-First Vaccination (Second Vaccination) | 2 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 8 Post-Second Vaccination | 15 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 22 Post-Second Vaccination | 15 Participants |
| ChAd3-EBO-Z + ChAd3-EBO-Z | Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 29 Post-Second Vaccination | 16 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 29 Post-Second Vaccination | 16 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 22 Post-Second Vaccination | 16 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 8 Post-First Vaccination (Second Vaccination) | 1 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 15 Post-Second Vaccination | 18 Participants |
| ChAd3-EBO-Z + MVA- BN-Filo | Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population | Day 8 Post-Second Vaccination | 16 Participants |