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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ChAd3-EBO-Z + ChAd3-EBO-Z | Experimental | 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, n = 20 |
|
| ChAd3-EBO-Z + Placebo | Experimental | 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, n = 20 |
|
| ChAd3-EBO-Z + MVA- BN-Filo | Experimental | 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, n = 20 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChAd3-EBO-Z | Biological | Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10^11 virus particles (vp)). |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Safety Laboratory Adverse Events | Laboratory parameters include white blood cells (WBC), hemoglobin, platelet count, absolute neutrophil count, alanine aminotransferase (ALT), creatinine, sodium, potassium and blood urea nitrogen (BUN). Thresholds for adverse events were considered as WBC <= 4.4 K/mcL or >=13.1 K/mcL (18 to <21 years) or <= 4.4 K/mcL or >= 11.1 K/mcL (>=21 years), hemoglobin <= 11.6 g/dL (female) or <= 13.2 g/dL (male), platelet count <= 134 K/mcL or >= 467 K/mcL, absolute neutrophil count <1.8 K/mcL or <=0.7 K/mcL (benign ethnic neutropenia), ALT >= 50 unit/L, creatinine >= 0.81 mg/dL (female) or >= 1.11 mg/dL (male), sodium <= 135 mmol/L or >= 146 mmol/L, potassium <= 3.4 mmol/L or >= 5.2 mmol/L and BUN >= 24 mg/dL. If baseline clinical labs fell within Mild range, then a laboratory AE was reported only if the value changed such that it fell into Moderate range or higher when subsequent safety laboratory testing was done. | Day 1 to approximately 28 Days Post Second Vaccination |
| Number of Participants Reporting Serious Adverse Events (SAEs) | SAEs included any AE that resulted in death, a life-threatening event, an inpatient hospitalization or prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. | Day 1 to Day 182 |
| Number of Participants Reporting Solicited Local Reactogenicity | Local reactogenicity solicited on a memory aid provided to participants included pain, tenderness, erythema (redness) (functional grade based on interference with daily activities), induration (hardness/swelling) (functional grade), ecchymosis (bruising) (functional grade), pruritus (itching), erythema (redness) (any measured value), induration (hardness/swelling) (any measured value), ecchymosis (bruising) (any measured value). Participants are considered reporting the local reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination. | Day 1 to Day 8 Post First Vaccination |
| Number of Participants Reporting Solicited Local Reactogenicity |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population | The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Geometric mean fold rise (GMFR) compared to baseline (Day 1) was calculated for each study arm. | Day 8, 15, 22, 29 and 36 compared to baseline (Day 1) reported as Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively. |
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Inclusion Criteria:
Provide written informed consent before initiation of any study procedures.
Are able to understand and comply with planned study procedures and be available for all study visits/phone calls.
Males or non-pregnant females ages 18-45, inclusive.
Subject must have a body mass index (BMI) > / = 18.5 and < 35 kg/m^2.
Are in good health.
Oral temperature is less than 100.0 degrees Fahrenheit (37.8 degrees Celsius).
Pulse is 47 to 105 beats per minute (bpm), inclusive.
Systolic blood pressure (BP) is 85 to 150 mm Hg, inclusive.
Diastolic blood pressure (BP) is 55 to 95 mm Hg, inclusive.
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.
Have normal screening laboratories for urine protein. Trace protein is acceptable.
Drug screen for opiates is negative.
Hemoglobin A1C (HgbA1C) < 6.3% at screening.
HIV 1/2 antibody negative.
HCV antibody negative.
HBsAg negative.
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").
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.
Women agree to not donate eggs (ova, oocytes) from the start of screening onwards until at least 90 days after the second vaccination.
Agrees not to participate in another clinical trial during the study period.
Agrees not to donate blood to a blood bank for 3 months after receiving the second study vaccine.
Exclusion Criteria:
Women who are pregnant, planning to become pregnant or lactating. - Includes breastfeeding or planning to breastfeed at any given time from the receipt of study vaccination through the 6-month trial period.
Known allergy or history of anaphylaxis, severe local or other serious adverse reactions to vaccines or vaccine products, or history of severe allergic reactions.
- Includes a known allergy to egg, egg products and aminoglycosides or any of the constituents of the study vaccines [e.g., polysorbate 80, ethylenediaminetetraacetic acid (EDTA), L-histidine, tris (hydroxymethyl)-amino methane (THAM)).
Received an experimental agent within 3 months prior to Day 1, or expects to receive an experimental agent (other than from participation in this study) during the 6-month trial-reporting period.
- Including vaccine, drug, biologic, device, blood product, or medication.
Received immunoglobulin or other blood product within 3 months before enrollment in this study.
Received any licensed live vaccine within 30 days prior to the first study vaccination through 30 days after the second study vaccination.
Received a licensed inactivated vaccine within 14 days prior to the first study vaccination through 14 days after the second study vaccination.
Has been vaccinated with an Ebola vaccine.
Has been diagnosed with Ebola disease, or exposed to Ebola virus including travel to West Africa in 2014-2016.
- West Africa includes but is not limited to the countries of Guinea, Liberia, Mali, Nigeria, and Sierra Leone.
Known or suspected receipt of ChAd3-EBO-Z or other ChAd3-vectored vaccine.
Known or suspected receipt of an adenovirus serotype 5 (Ad5)-based vaccine.
Known or suspected receipt of any licensed or investigational small pox (vaccinia)-based vaccine.
- Includes any MVA-based candidate vaccine (Imvamune or Imvanex), Dryvax, or Acam2000.
Has a typical vaccinia scar.
Confirmed Asplenia/Functional Asplenia.
A history of bleeding or clotting disorders.
Thyroidectomy or thyroid disease requiring medication during the last 12 months.
History of chronic urticaria (recurrent hives).
Individuals in whom the ability to observe possible local reactions at the eligible injection sites (left and right deltoid region) is, unacceptably obscured due to a physical condition or permanent body art.
Have an acute illness, as determined by the site PI or appropriate sub-investigator, within 72 hours prior to study vaccination.
- An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol. Subjects may re-screen after an acute illness is resolved.
Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV infection) or use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination
Administration of chronic (defined as more than 14 days) immunosuppressants or other immune modifying drugs within 6 months of receipt of study vaccine.
Have taken oral or parenteral (including intraarticular) corticosteroids of any dose within 30 days prior to study vaccination.
Have taken high-dose dose inhaled corticosteroids within 30 days prior to study vaccination.
- High-dose defined using the inhaled high-dose reference chart.
Have a history of convulsions or encephalomyelitis within 90 days prior to study vaccination.
Current or past history of alcohol or drug abuse in the last 5 years.
Subjects with autoimmune disorders, chronic inflammatory disorders or neurological disorders with a potential autoimmune correlation.
Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations.
Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 10 years prior to study vaccination.
Have received any antiviral within 3 days of study vaccination
History of myocarditis, pericarditis, cardiomyopathy, transient ischemic attack or stroke, myocardial infarction, angina, coronary artery disease, congestive heart failure, clinically significant arrhythmia.
- Including any arrhythmia requiring medication, treatment, or clinical follow-up.
Electrocardiogram (ECG) with clinically significant findings.
- Clinically significant findings include the following:
A diagnosis of Type I or II diabetes. (A history of isolated gestational diabetes is not an exclusion criterion).
Current employee or staff paid entirely or partially by the contract for this trial, or staff who are supervised by the PI or Sub-Investigators.
Any condition that would, in the opinion of the Site Investigator or appropriate sub-investigator, is a contraindication to study participation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center Vaccine Research Center | Cincinnati | Ohio | 45229-3039 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 (+2). All participants in all Study Arms received the same product (ChAd3-EBO-Z) at Day 1. 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. |
| FG001 | 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 (+2). All participants in all Study Arms received the same product (ChAd3-EBO-Z) at Day 1. 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)). |
| FG002 | 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 (+2). All participants in all Study Arms received the same product (ChAd3-EBO-Z) at Day 1. 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With 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. | Safety Population: includes all participants who received at least one study vaccination. | Posted | Count of Participants | Participants | Day 1 to approximately 28 Days Post Second Vaccination |
Solicited events were collected from the time of each study vaccination through 7 days post-vaccination. Vaccine-related unsolicited events were collected from the first study vaccination through 28 days post second vaccination. Clinical safety laboratory events were collected from the time of first study vaccination through approximately 28 days after the second vaccination. SAEs and vaccine-related MAAEs were collected through 6 months post the first vaccination.
The solicited and unsolicited adverse events were assessed using MedDRA 23.0.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Spearman, MD | Cincinnati Children's Hospital | 513-636-4509 | paul.spearman@cchmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 30, 2019 | Jan 7, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 29, 2020 | Jan 7, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019142 | Hemorrhagic Fever, Ebola |
| ID | Term |
|---|---|
| D006482 | Hemorrhagic Fevers, Viral |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| MVA Multi-Filo Ebola Vaccine | Biological | 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). |
|
| Placebo | Other | 0.5 mL normal saline administered via IM injection into the deltoid. |
|
Local reactogenicity solicited on a memory aid provided to participants included pain, tenderness, erythema (redness) (functional grade based on interference with daily activities), induration (hardness/swelling) (functional grade), ecchymosis (bruising) (functional grade), pruritus (itching), erythema (redness) (any measured value), induration (hardness/swelling) (any measured value), ecchymosis (bruising) (any measured value). Participants are considered reporting the local reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination. |
| Day 1 to Day 8 Post Second Vaccination |
| Number of Participants Reporting Solicited Local Reactogenicity | Local reactogenicity solicited on a memory aid provided to participants included pain, tenderness, erythema (redness) (functional grade based on interference with daily activities), induration (hardness/swelling) (functional grade), ecchymosis (bruising) (functional grade), pruritus (itching), erythema (redness) (any measured value), induration (hardness/swelling) (any measured value), ecchymosis (bruising) (any measured value). Subjects are considered reporting the local reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination. | Day 1 to Day 15 |
| Number of Participants Reporting Solicited Systemic Reactogenicity | Systemic reactogenicity solicited on a memory aid provided to participants included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Participants are considered reporting the systemic reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination. | Day 1 to Day 8 Post First Vaccination |
| Number of Participants Reporting Solicited Systemic Reactogenicity | Systemic reactogenicity solicited on a memory aid provided to participants included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Participants are considered reporting the systemic reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination. | Day 1 to Day 8 Post Second Vaccination |
| Number of Participants Reporting Solicited Systemic Reactogenicity | Systemic reactogenicity solicited on a memory aid provided to participants included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Participants are considered reporting the systemic reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination. | Day 1 to Day 15 |
| Number of Participants Reporting Vaccine-related Medically Attended Adverse Events (MAAEs) | Vaccine-related MAAEs include any AEs for which the participant received medical attention, defined as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason for which there is evidence to suggest a causal relationship between the study product and the adverse event. | Day 1 to Day 182 |
| Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Vaccine-related unsolicited AEs include any untoward medical occurrence in a participant for which there is evidence to suggest a causal relationship between the study product and the adverse event. | Day 1 to approximately 28 Days Post Second Vaccination |
| Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Thresholds for adverse events were considered as WBC 2.5 - 4.4 K/mcL or 13.1 - 15.0 K/mcL (18 to <21 years) or 2.5 - 4.4 K/mcL or 11.1 - 15.0 (>=21 years) (mild), 1.5 - 2.4 K/mcL or 15.1 - 20.0 K/mcL (moderate), <1.5 K/mcL or >20.0 K/mcL (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. | Day 1 to approximately 28 Days Post Second Vaccination |
| Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Thresholds for adverse events were considered as hemoglobin 10.1 - 11.6 g/dL (female) or 11.0 - 13.2 (male) (mild), 8.5 - 10 g/dL (female) or 9.5 - 10.9 g/dL (male) (moderate), <8.5 g/dL (female) or <9.5 g/dL (male) (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. | Day 1 to approximately 28 Days Post Second Vaccination |
| Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Thresholds for adverse events were considered as platelet count 125 - 134 K/mcL or 467 - 517 K/mcL (mild), 100 - 124 K/mcL or 518 - 750 K/mcL (moderate), <100 K/mcL or >750 K/mcL (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. | Day 1 to approximately 28 Days Post Second Vaccination |
| Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Thresholds for adverse events were considered as absolute neutrophil count 1.5 - <1.8 K/mcL or 0.6 - 0.7 K/mcL (benign ethnic neutropenia) (mild), 1.0 - <1.5 K/mcL or 0.4 - 0.5 K/mcL (benign ethnic neutropenia) (moderate), <1.0 K/mcL or <0.4 K/mcL (benign ethnic neutropenia) (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. | Day 1 to approximately 28 Days Post Second Vaccination |
| Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Thresholds for adverse events were considered as 50 - 123 unit/L (mild), 124 - 245 unit/L (moderate), >245 unit/L (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. | Day 1 to approximately 28 Days Post Second Vaccination |
| Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Thresholds for adverse events were considered as creatinine 0.81 - 1.70 mg/dL (female) or 1.11 - 1.70 mg/dL (male) (mild), 1.71 - 2.00 mg/dL (moderate), >2.00 mg/dL (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. | Day 1 to approximately 28 Days Post Second Vaccination |
| Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Thresholds for adverse events were considered as sodium 130 - 135 mmol/L or 146 - 150 mmol/L (mild), 123 - 129 mmol/L or 151 - 157 mmol/L (moderate), <123 mmol/L or >157 mmol/L (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. | Day 1 to approximately 28 Days Post Second Vaccination |
| Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Thresholds for adverse events were considered as potassium 3.0 - 3.4 mmol/L or 5.2 - 6.0 mmol/L (mild), 2.5 - 2.9 mmol/L or 6.1 - 6.5 mmol/L (moderate), <2.5 mmol/L or >6.5 mmol/L (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. | Day 1 to approximately 28 Days Post Second Vaccination |
| Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Thresholds for adverse events were considered as BUN 24 - 26 mg/dL (mild), 27 - 31 mg/dL (moderate), >31 mg/dL (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. | Day 1 to approximately 28 Days Post Second Vaccination |
| Number of Participants by Severity of Solicited Local Reactogenicity | Local reactogenicity solicited on memory aid include pain; tenderness; pruritus (itch); erythema (redness), induration (hardness/swelling), and ecchymosis (bruising) (functional and measurement). Thresholds for severity were pain: aware, no interference with activity, no pain med (mild), aware, interferes with activity or requires repeated use of a non-narcotic pain reliever for >24 hr (moderate), aware, prevents activity or requires prescription med use (severe); tenderness: area surrounding injection hurts when touched or with arm motion, no interference with daily activity (mild), hurts when touched or with arm motion, interferes with activity (moderate), hurts when touched or with arm motion and prevents activity (severe); functional erythema, induration, ecchymosis, and pruritus: no activity interference (mild), interferes with activity (moderate), prevents activity (severe); erythema, induration, and ecchymosis (measurement): <20mm (mild), 20 - 50mm (moderate), >50mm (severe). | Day 1 to Day 8 Post First Vaccination |
| Number of Participants by Severity of Solicited Local Reactogenicity | Local reactogenicity solicited on memory aid include pain; tenderness; pruritus (itch); erythema (redness), induration (hardness/swelling), and ecchymosis (bruising) (functional and measurement). Thresholds for severity grading were pain: aware, no interference with activity, no pain med (mild), aware, interferes with activity or requires repeated use of a non-narcotic pain reliever for >24hr (moderate), aware, prevents activity or requires prescription med use (severe); tenderness: area surrounding injection hurts when touched or with arm motion, no interference with daily activity (mild), hurts when touched or with arm motion, interferes with activity (moderate), hurts when touched or with arm motion, prevents activity (severe); functional erythema, induration, ecchymosis, and pruritus: no activity interference (mild), interferes with activity (moderate), prevents activity (severe); erythema, induration, and ecchymosis (measurement): <20mm (mild), 20-50mm (moderate), >50mm (severe). | Day 1 to Day 8 Post Second Vaccination |
| Number of Participants by Severity of Solicited Local Reactogenicity | Local reactogenicity solicited on memory aid include pain; tenderness; pruritus (itch); erythema (redness), induration (hardness/swelling), and ecchymosis (bruising) (functional and measurement). Thresholds for severity grading were pain: aware, no interference with activity, no pain med (mild), aware, interferes with activity or requires repeated use of a non-narcotic pain reliever for >24hr (moderate), aware, prevents activity or requires prescription med use (severe); tenderness: area surrounding injection hurts when touched or with arm motion, no interference with daily activity (mild), hurts when touched or with arm motion, interferes with activity (moderate), hurts when touched or with arm motion, prevents activity (severe); functional erythema, induration, ecchymosis, and pruritus: no activity interference (mild), interferes with activity (moderate), prevents activity (severe); erythema, induration, and ecchymosis (measurement): <20mm (mild), 20-50mm (moderate), >50mm (severe). | Day 1 to Day 15 |
| Number of Participants by Severity of Solicited Systemic Reactogenicity | Systemic reactogenicity solicited on memory aid included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Thresholds for severity include feverishness, malaise, fatigue, myalgia, nausea, and loss of appetite: Noticeable but does not interfere with daily activity (Mild), Interferes with daily activity (Moderate), Significant interference, prevents daily activity (Severe); headache: Noticeable but does not interfere with daily activity (Mild), Any use of pain reliever or interferes with daily activity (Moderate), Significant interference, prevents daily activity, or requires any use of a prescription medication (Severe); elevated oral temperature: 37.8°C - 38.4°C or 100.00°F - 101.1°F (Mild), 38.5°C - 38.9°C or 101.2°F - 102.0°F (Moderate), >38.9°C or >102.0°F (Severe). | Day 1 to Day 8 Post First Vaccination |
| Number of Participants by Severity of Solicited Systemic Reactogenicity | Systemic reactogenicity solicited on memory aid included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Thresholds for severity include feverishness, malaise, fatigue, myalgia, nausea, and loss of appetite: Noticeable but does not interfere with daily activity (Mild), Interferes with daily activity (Moderate), Significant interference, prevents daily activity (Severe); headache: Noticeable but does not interfere with daily activity (Mild), Any use of pain reliever or interferes with daily activity (Moderate), Significant interference, prevents daily activity, or requires any use of a prescription medication (Severe); elevated oral temperature: 37.8°C - 38.4°C or 100.00°F - 101.1°F (Mild), 38.5°C - 38.9°C or 101.2°F - 102.0°F (Moderate), >38.9°C or >102.0°F (Severe). | Day 1 to Day 8 Post Second Vaccination |
| Number of Participants by Severity of Solicited Systemic Reactogenicity | Systemic reactogenicity solicited on memory aid included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Thresholds for severity include feverishness, malaise, fatigue, myalgia, nausea, and loss of appetite: Noticeable but does not interfere with daily activity (Mild), Interferes with daily activity (Moderate), Significant interference, prevents daily activity (Severe); headache: Noticeable but does not interfere with daily activity (Mild), Any use of pain reliever or interferes with daily activity (Moderate), Significant interference, prevents daily activity, or requires any use of a prescription medication (Severe); elevated oral temperature: 37.8°C - 38.4°C or 100.00°F - 101.1°F (Mild), 38.5°C - 38.9°C or 101.2°F - 102.0°F (Moderate), >38.9°C or >102.0°F (Severe). | Day 1 to Day 15 |
| Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Vaccine-related unsolicited AEs include any untoward medical occurrence in a participant for which there is evidence to suggest a causal relationship between the study product and the adverse event. Thresholds for severity include events require minimal or no treatment and do not interfere with the subject's daily activities (mild), events result in a low level of inconvenience or concern with therapeutic measures and may cause some interference with functioning and daily activities (moderate), and events interrupt the subject's daily activities and may require systemic drug therapy or other treatment and are usually incapacitating (severe). Participants are counted once per preferred term and are summarized according to their highest severity. No severe events were reported. | Day 1 to approximately 28 Days Post Second Vaccination |
| Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population | The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Geometric mean fold rise (GMFR) compared to baseline (Day 1) was calculated for each study arm. | Day 8, 15, 22, 29 and 36 compared to baseline (Day 1) reported as Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively. |
| Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population | The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Geometric Mean Titer (GMT) was calculated for each study arm. | Day 1, 8, 15, 22, 29 and 36 reported as Day 1 first vaccination, Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively. |
| Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population | The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Geometric Mean Titer (GMT) was calculated for each study arm. | Day 1, 8, 15, 22, 29 and 36 reported as Day 1 first vaccination, Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively. |
| Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population | The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Seroconversion was calculated for each study arm and was defined as anti-EBOV GP ELISA titer > 50 if baseline (Day 1) titer = 50 or fold rise > 4 as compared to baseline if baseline titer > 50. | Day 8, 15, 22, 29 and 36 reported as Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively. |
| Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population | The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Seroconversion was calculated for each study arm and was defined as anti-EBOV GP ELISA titer > 50 if baseline (Day 1) titer = 50 or fold rise > 4 as compared to baseline if baseline titer > 50. | Day 8, 15, 22, 29 and 36 reported as Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively. |
| BG001 | 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)). |
| BG002 | 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). |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| ID | Title | Description |
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| OG000 | 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. |
| OG001 | 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. |
| OG002 | 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. |
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| Primary | Number of Participants Reporting Serious Adverse Events (SAEs) | SAEs included any AE that resulted in death, a life-threatening event, an inpatient hospitalization or prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. | Safety Population: includes all participants who received at least one study vaccination | Posted | Count of Participants | Participants | Day 1 to Day 182 |
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| Primary | Number of Participants Reporting Solicited Local Reactogenicity | Local reactogenicity solicited on a memory aid provided to participants included pain, tenderness, erythema (redness) (functional grade based on interference with daily activities), induration (hardness/swelling) (functional grade), ecchymosis (bruising) (functional grade), pruritus (itching), erythema (redness) (any measured value), induration (hardness/swelling) (any measured value), ecchymosis (bruising) (any measured value). Participants are considered reporting the local reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination. | 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. | Posted | Count of Participants | Participants | Day 1 to Day 8 Post First Vaccination |
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| Primary | Number of Participants Reporting Solicited Local Reactogenicity | Local reactogenicity solicited on a memory aid provided to participants included pain, tenderness, erythema (redness) (functional grade based on interference with daily activities), induration (hardness/swelling) (functional grade), ecchymosis (bruising) (functional grade), pruritus (itching), erythema (redness) (any measured value), induration (hardness/swelling) (any measured value), ecchymosis (bruising) (any measured value). Participants are considered reporting the local reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination. | Safety Population Subset: includes all participants who received the first and second study vaccination | Posted | Count of Participants | Participants | Day 1 to Day 8 Post Second Vaccination |
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| Primary | Number of Participants Reporting Solicited Local Reactogenicity | Local reactogenicity solicited on a memory aid provided to participants included pain, tenderness, erythema (redness) (functional grade based on interference with daily activities), induration (hardness/swelling) (functional grade), ecchymosis (bruising) (functional grade), pruritus (itching), erythema (redness) (any measured value), induration (hardness/swelling) (any measured value), ecchymosis (bruising) (any measured value). Subjects are considered reporting the local reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination. | Safety Population: includes all participants who received at least one study vaccination. | Posted | Count of Participants | Participants | Day 1 to Day 15 |
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| Primary | Number of Participants Reporting Solicited Systemic Reactogenicity | Systemic reactogenicity solicited on a memory aid provided to participants included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Participants are considered reporting the systemic reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination. | 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. | Posted | Count of Participants | Participants | Day 1 to Day 8 Post First Vaccination |
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| Primary | Number of Participants Reporting Solicited Systemic Reactogenicity | Systemic reactogenicity solicited on a memory aid provided to participants included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Participants are considered reporting the systemic reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination. | Safety Population Subset: includes all participants who received the first and second study vaccination | Posted | Count of Participants | Participants | Day 1 to Day 8 Post Second Vaccination |
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| Primary | Number of Participants Reporting Solicited Systemic Reactogenicity | Systemic reactogenicity solicited on a memory aid provided to participants included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Participants are considered reporting the systemic reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination. | Safety Population: includes all participants who received at least one study vaccination. | Posted | Count of Participants | Participants | Day 1 to Day 15 |
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| Primary | Number of Participants Reporting Vaccine-related Medically Attended Adverse Events (MAAEs) | Vaccine-related MAAEs include any AEs for which the participant received medical attention, defined as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason for which there is evidence to suggest a causal relationship between the study product and the adverse event. | Safety Population: includes all participants who received at least one study vaccination. | Posted | Count of Participants | Participants | Day 1 to Day 182 |
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| Primary | Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs) | Vaccine-related unsolicited AEs include any untoward medical occurrence in a participant for which there is evidence to suggest a causal relationship between the study product and the adverse event. | Safety Population: includes all participants who received at least one study vaccination | Posted | Count of Participants | Participants | Day 1 to approximately 28 Days Post Second Vaccination |
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| Primary | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells | Thresholds for adverse events were considered as WBC 2.5 - 4.4 K/mcL or 13.1 - 15.0 K/mcL (18 to <21 years) or 2.5 - 4.4 K/mcL or 11.1 - 15.0 (>=21 years) (mild), 1.5 - 2.4 K/mcL or 15.1 - 20.0 K/mcL (moderate), <1.5 K/mcL or >20.0 K/mcL (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. | Safety Population: includes all Participants who received at least one study vaccination | Posted | Count of Participants | Participants | Day 1 to approximately 28 Days Post Second Vaccination |
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| Primary | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin | Thresholds for adverse events were considered as hemoglobin 10.1 - 11.6 g/dL (female) or 11.0 - 13.2 (male) (mild), 8.5 - 10 g/dL (female) or 9.5 - 10.9 g/dL (male) (moderate), <8.5 g/dL (female) or <9.5 g/dL (male) (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. | Safety Population: includes all participants who received at least one study vaccination | Posted | Count of Participants | Participants | Day 1 to approximately 28 Days Post Second Vaccination |
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| Primary | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count | Thresholds for adverse events were considered as platelet count 125 - 134 K/mcL or 467 - 517 K/mcL (mild), 100 - 124 K/mcL or 518 - 750 K/mcL (moderate), <100 K/mcL or >750 K/mcL (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. | Safety Population: includes all participants who received at least one study vaccination | Posted | Count of Participants | Participants | Day 1 to approximately 28 Days Post Second Vaccination |
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| Primary | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count | Thresholds for adverse events were considered as absolute neutrophil count 1.5 - <1.8 K/mcL or 0.6 - 0.7 K/mcL (benign ethnic neutropenia) (mild), 1.0 - <1.5 K/mcL or 0.4 - 0.5 K/mcL (benign ethnic neutropenia) (moderate), <1.0 K/mcL or <0.4 K/mcL (benign ethnic neutropenia) (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. | Safety Population: includes all participants who received at least one study vaccination | Posted | Count of Participants | Participants | Day 1 to approximately 28 Days Post Second Vaccination |
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| Primary | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT | Thresholds for adverse events were considered as 50 - 123 unit/L (mild), 124 - 245 unit/L (moderate), >245 unit/L (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. | Safety Population: includes all participants who received at least one study vaccination | Posted | Count of Participants | Participants | Day 1 to approximately 28 Days Post Second Vaccination |
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| Primary | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase) | Thresholds for adverse events were considered as creatinine 0.81 - 1.70 mg/dL (female) or 1.11 - 1.70 mg/dL (male) (mild), 1.71 - 2.00 mg/dL (moderate), >2.00 mg/dL (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. | Safety Population: includes all participants who received at least one study vaccination | Posted | Count of Participants | Participants | Day 1 to approximately 28 Days Post Second Vaccination |
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| Primary | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium | Thresholds for adverse events were considered as sodium 130 - 135 mmol/L or 146 - 150 mmol/L (mild), 123 - 129 mmol/L or 151 - 157 mmol/L (moderate), <123 mmol/L or >157 mmol/L (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. | Safety Population: includes all participants who received at least one study vaccination | Posted | Count of Participants | Participants | Day 1 to approximately 28 Days Post Second Vaccination |
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| Primary | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium | Thresholds for adverse events were considered as potassium 3.0 - 3.4 mmol/L or 5.2 - 6.0 mmol/L (mild), 2.5 - 2.9 mmol/L or 6.1 - 6.5 mmol/L (moderate), <2.5 mmol/L or >6.5 mmol/L (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. | Safety Population: includes all participants who received at least one study vaccination | Posted | Count of Participants | Participants | Day 1 to approximately 28 Days Post Second Vaccination |
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| Primary | Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN | Thresholds for adverse events were considered as BUN 24 - 26 mg/dL (mild), 27 - 31 mg/dL (moderate), >31 mg/dL (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done. | Safety Population: includes all participants who received at least one study vaccination | Posted | Count of Participants | Participants | Day 1 to approximately 28 Days Post Second Vaccination |
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| Primary | Number of Participants by Severity of Solicited Local Reactogenicity | Local reactogenicity solicited on memory aid include pain; tenderness; pruritus (itch); erythema (redness), induration (hardness/swelling), and ecchymosis (bruising) (functional and measurement). Thresholds for severity were pain: aware, no interference with activity, no pain med (mild), aware, interferes with activity or requires repeated use of a non-narcotic pain reliever for >24 hr (moderate), aware, prevents activity or requires prescription med use (severe); tenderness: area surrounding injection hurts when touched or with arm motion, no interference with daily activity (mild), hurts when touched or with arm motion, interferes with activity (moderate), hurts when touched or with arm motion and prevents activity (severe); functional erythema, induration, ecchymosis, and pruritus: no activity interference (mild), interferes with activity (moderate), prevents activity (severe); erythema, induration, and ecchymosis (measurement): <20mm (mild), 20 - 50mm (moderate), >50mm (severe). | 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. | Posted | Count of Participants | Participants | Day 1 to Day 8 Post First Vaccination |
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| Primary | Number of Participants by Severity of Solicited Local Reactogenicity | Local reactogenicity solicited on memory aid include pain; tenderness; pruritus (itch); erythema (redness), induration (hardness/swelling), and ecchymosis (bruising) (functional and measurement). Thresholds for severity grading were pain: aware, no interference with activity, no pain med (mild), aware, interferes with activity or requires repeated use of a non-narcotic pain reliever for >24hr (moderate), aware, prevents activity or requires prescription med use (severe); tenderness: area surrounding injection hurts when touched or with arm motion, no interference with daily activity (mild), hurts when touched or with arm motion, interferes with activity (moderate), hurts when touched or with arm motion, prevents activity (severe); functional erythema, induration, ecchymosis, and pruritus: no activity interference (mild), interferes with activity (moderate), prevents activity (severe); erythema, induration, and ecchymosis (measurement): <20mm (mild), 20-50mm (moderate), >50mm (severe). | Safety Population Subset: includes all participants who received the first and second study vaccination | Posted | Count of Participants | Participants | Day 1 to Day 8 Post Second Vaccination |
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| Primary | Number of Participants by Severity of Solicited Local Reactogenicity | Local reactogenicity solicited on memory aid include pain; tenderness; pruritus (itch); erythema (redness), induration (hardness/swelling), and ecchymosis (bruising) (functional and measurement). Thresholds for severity grading were pain: aware, no interference with activity, no pain med (mild), aware, interferes with activity or requires repeated use of a non-narcotic pain reliever for >24hr (moderate), aware, prevents activity or requires prescription med use (severe); tenderness: area surrounding injection hurts when touched or with arm motion, no interference with daily activity (mild), hurts when touched or with arm motion, interferes with activity (moderate), hurts when touched or with arm motion, prevents activity (severe); functional erythema, induration, ecchymosis, and pruritus: no activity interference (mild), interferes with activity (moderate), prevents activity (severe); erythema, induration, and ecchymosis (measurement): <20mm (mild), 20-50mm (moderate), >50mm (severe). | Safety Population: includes all participants who received at least one study vaccination. | Posted | Count of Participants | Participants | Day 1 to Day 15 |
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| Primary | Number of Participants by Severity of Solicited Systemic Reactogenicity | Systemic reactogenicity solicited on memory aid included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Thresholds for severity include feverishness, malaise, fatigue, myalgia, nausea, and loss of appetite: Noticeable but does not interfere with daily activity (Mild), Interferes with daily activity (Moderate), Significant interference, prevents daily activity (Severe); headache: Noticeable but does not interfere with daily activity (Mild), Any use of pain reliever or interferes with daily activity (Moderate), Significant interference, prevents daily activity, or requires any use of a prescription medication (Severe); elevated oral temperature: 37.8°C - 38.4°C or 100.00°F - 101.1°F (Mild), 38.5°C - 38.9°C or 101.2°F - 102.0°F (Moderate), >38.9°C or >102.0°F (Severe). | 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. | Posted | Count of Participants | Participants | Day 1 to Day 8 Post First Vaccination |
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| Primary | Number of Participants by Severity of Solicited Systemic Reactogenicity | Systemic reactogenicity solicited on memory aid included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Thresholds for severity include feverishness, malaise, fatigue, myalgia, nausea, and loss of appetite: Noticeable but does not interfere with daily activity (Mild), Interferes with daily activity (Moderate), Significant interference, prevents daily activity (Severe); headache: Noticeable but does not interfere with daily activity (Mild), Any use of pain reliever or interferes with daily activity (Moderate), Significant interference, prevents daily activity, or requires any use of a prescription medication (Severe); elevated oral temperature: 37.8°C - 38.4°C or 100.00°F - 101.1°F (Mild), 38.5°C - 38.9°C or 101.2°F - 102.0°F (Moderate), >38.9°C or >102.0°F (Severe). | Safety Population Subset: includes all participants who received the first and second study vaccination | Posted | Count of Participants | Participants | Day 1 to Day 8 Post Second Vaccination |
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| Primary | Number of Participants by Severity of Solicited Systemic Reactogenicity | Systemic reactogenicity solicited on memory aid included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Thresholds for severity include feverishness, malaise, fatigue, myalgia, nausea, and loss of appetite: Noticeable but does not interfere with daily activity (Mild), Interferes with daily activity (Moderate), Significant interference, prevents daily activity (Severe); headache: Noticeable but does not interfere with daily activity (Mild), Any use of pain reliever or interferes with daily activity (Moderate), Significant interference, prevents daily activity, or requires any use of a prescription medication (Severe); elevated oral temperature: 37.8°C - 38.4°C or 100.00°F - 101.1°F (Mild), 38.5°C - 38.9°C or 101.2°F - 102.0°F (Moderate), >38.9°C or >102.0°F (Severe). | Safety Population: includes all participants who received at least one study vaccination. | Posted | Count of Participants | Participants | Day 1 to Day 15 |
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| Primary | Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs) | Vaccine-related unsolicited AEs include any untoward medical occurrence in a participant for which there is evidence to suggest a causal relationship between the study product and the adverse event. Thresholds for severity include events require minimal or no treatment and do not interfere with the subject's daily activities (mild), events result in a low level of inconvenience or concern with therapeutic measures and may cause some interference with functioning and daily activities (moderate), and events interrupt the subject's daily activities and may require systemic drug therapy or other treatment and are usually incapacitating (severe). Participants are counted once per preferred term and are summarized according to their highest severity. No severe events were reported. | Safety Population: includes all participants who received at least one study vaccination | Posted | Count of Participants | Participants | Day 1 to approximately 28 Days Post Second Vaccination |
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| Secondary | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population | The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Geometric mean fold rise (GMFR) compared to baseline (Day 1) was calculated for each study arm. | 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 | Posted | Geometric Mean | 95% Confidence Interval | titer | 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. |
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| Secondary | Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population | The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Geometric mean fold rise (GMFR) compared to baseline (Day 1) was calculated for each study arm. | 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. | Posted | Geometric Mean | 95% Confidence Interval | titer | 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. |
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| Secondary | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population | The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Geometric Mean Titer (GMT) was calculated for each study arm. | 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 | Posted | Geometric Mean | 95% Confidence Interval | titer | 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. |
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| Secondary | Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population | The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Geometric Mean Titer (GMT) was calculated for each study arm. | 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. | Posted | Geometric Mean | 95% Confidence Interval | titer | 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. |
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| Secondary | Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population | The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Seroconversion was calculated for each study arm and was defined as anti-EBOV GP ELISA titer > 50 if baseline (Day 1) titer = 50 or fold rise > 4 as compared to baseline if baseline titer > 50. | 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 | Posted | Count of Participants | Participants | Day 8, 15, 22, 29 and 36 reported as Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively. |
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| Secondary | Seroconversion as Measured by Anti-EBOV GP ELISA - Per Protocol Population | The endpoint assessed antibodies against Ebola virus (EBOV) glycoproteins (GP) using an enzyme-linked immunosorbent assay (anti-EBOV GP ELISA). Venous blood samples for serum were used for this assay. Seroconversion was calculated for each study arm and was defined as anti-EBOV GP ELISA titer > 50 if baseline (Day 1) titer = 50 or fold rise > 4 as compared to baseline if baseline titer > 50. | 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. | Posted | Count of Participants | Participants | Day 8, 15, 22, 29 and 36 reported as Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively. |
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| 0 |
| 21 |
| 0 |
| 21 |
| 21 |
| 21 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 20 | 20 |
| EG002 | 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. | 0 | 19 | 0 | 19 | 19 | 19 |
| Malaise | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
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| Headache | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Nausea | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
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| Vulvovaginal Pruritus | Reproductive system and breast disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Blood Pressure Diastolic Decreased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
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| Chest Discomfort | General disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
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| Feeling Of Body Temperature Change | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Injection Site Haemorrhage | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Ligament Rupture | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
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| Limb Injury | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Muscle Injury | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Taste Disorder | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
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| Transaminases Increased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Vaccination Site Erythema | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Vaccination Site Induration | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Vaccination Site Pain | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Vaccination Site Pruritus | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Alanine Aminotransferase Increased | Investigations | MedDRA (23.0) | Systematic Assessment |
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| Blood Creatinine Increased | Investigations | MedDRA (23.0) | Systematic Assessment |
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| Haemoglobin Decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
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| Neutrophil Count Decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
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| Platelet Count Decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
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| White Blood Cell Count Decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
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| White Blood Cell Count Increased | Investigations | MedDRA (23.0) | Systematic Assessment |
|
Not provided
| D018702 |
| Filoviridae Infections |
| D018701 | Mononegavirales Infections |
| Title | Measurements |
|---|---|
|
| Tenderness |
|
| Pruritus |
|
| Ecchymosis (Functional Grade) |
|
| Ecchymosis (Measurement Grade) |
|
| Erythema (Functional Grade) |
|
| Erythema (Measurement Grade) |
|
| Induration (Functional Grade) |
|
| Induration (Measurement Grade) |
|
| Title | Measurements |
|---|---|
|
| Tenderness |
|
| Pruritus |
|
| Ecchymosis (Functional Grade) |
|
| Ecchymosis (Measurement Grade) |
|
| Erythema (Functional Grade) |
|
| Erythema (Measurement Grade) |
|
| Induration (Functional Grade) |
|
| Induration (Measurement Grade) |
|
| Title | Measurements |
|---|---|
|
| Tenderness |
|
| Pruritus |
|
| Ecchymosis (functional grade) |
|
| Ecchymosis (measurement grade) |
|
| Erythema (functional grade) |
|
| Erythema (measurement grade) |
|
| Induration (functional grade) |
|
| Induration (measurement grade) |
|
|
| Feverishness |
|
| Malaise |
|
| Fatigue |
|
| Myalgia |
|
| Headache |
|
| Nausea |
|
| Loss of Appetite |
|
|
| Feverishness |
|
| Malaise |
|
| Fatigue |
|
| Myalgia |
|
| Headache |
|
| Nausea |
|
| Loss of Appetite |
|
|
| Feverishness |
|
| Malaise |
|
| Fatigue |
|
| Myalgia |
|
| Headache |
|
| Nausea |
|
| Loss of Appetite |
|
| Title | Measurements |
|---|---|
|
| Tachycardia |
|
| Diarrhea |
|
| Vomiting |
|
| Chest discomfort |
|
| Blood pressure diastolic decreased |
|
| Transaminases increased |
|
| Dehydration |
|
| Back pain |
|
| Muscle spasms |
|
| Dizziness |
|
| Sinus headache |
|
| Taste disorder |
|
| Cough |
|
| Oropharyngeal pain |
|
| Sinus congestion |
|
| Acne |
|
| Ecchymosis |
|
| Rash |
|
| Mild (high) |
|
| Moderate (low) |
|
| Moderate (high) |
|
| Severe |
|
| Missing |
|
| Day 8 Post-Second Vaccination |
|
| Day 22 Post-Second Vaccination |
|
| Day 29 Post-Second Vaccination |
|
| Max Severity Post Baseline |
|
| Moderate |
|
| Severe |
|
| Missing |
|
| Day 8 Post-Second Vaccination |
|
| Day 22 Post-Second Vaccination |
|
| Day 29 Post-Second Vaccination |
|
| Max Severity Post Baseline |
|
| Mild (high) |
|
| Moderate (low) |
|
| Severe (low or high) |
|
| Missing |
|
| Day 8 Post-Second Vaccination |
|
| Day 22 Post-Second Vaccination |
|
| Day 29 Post-Second Vaccination |
|
| Max Severity Post Baseline |
|
| Moderate |
|
| Severe |
|
| Missing |
|
| Day 8 Post-Second Vaccination |
|
| Day 22 Post-Second Vaccination |
|
| Day 29 Post-Second Vaccination |
|
| Max Severity Post Baseline |
|
| Moderate |
|
| Severe |
|
| Missing |
|
| Day 8 Post-Second Vaccination |
|
| Day 22 Post-Second Vaccination |
|
| Day 29 Post-Second Vaccination |
|
| Max Severity Post Baseline |
|
| Moderate |
|
| Severe |
|
| Missing |
|
| Day 8 Post-Second Vaccination |
|
| Day 22 Post-Second Vaccination |
|
| Day 29 Post-Second Vaccination |
|
| Max Severity Post Baseline |
|
| Mild (high) |
|
| Moderate (low or high) |
|
| Severe (low or high) |
|
| Missing |
|
| Day 8 Post-Second Vaccination |
|
| Day 22 Post-Second Vaccination |
|
| Day 29 Post-Second Vaccination |
|
| Max Severity Post Baseline |
|
| Mild (high) |
|
| Moderate (low or high) |
|
| Severe (low or high) |
|
| Missing |
|
| Day 8 Post-Second Vaccination |
|
| Day 22 Post-Second Vaccination |
|
| Day 29 Post-Second Vaccination |
|
| Max Severity Post Baseline |
|
| Moderate |
|
| Severe |
|
| Missing |
|
| Day 8 Post-Second Vaccination |
|
| Day 22 Post-Second Vaccination |
|
| Day 29 Post-Second Vaccination |
|
| Max Severity Post Baseline |
|
| Moderate |
|
| Severe |
|
| Pain |
|
| Tenderness |
|
| Pruritus |
|
| Ecchymosis (Functional grade) |
|
| Ecchymosis (Measurement grade) |
|
| Erythema (Functional grade) |
|
| Erythema (Measurement grade) |
|
| Induration (Functional grade) |
|
| Induration (Measurement grade) |
|
| Moderate |
|
| Severe |
|
| Pain |
|
| Tenderness |
|
| Pruritus |
|
| Ecchymosis (Functional grade) |
|
| Ecchymosis (Measurement grade) |
|
| Erythema (Functional grade) |
|
| Erythema (Measurement grade) |
|
| Induration (Functional grade) |
|
| Induration (Measurement grade) |
|
| Severe |
|
| None |
|
| Pain |
|
| Tenderness |
|
| Erythema (functional) |
|
| Erythema (measured) |
|
| Induration (functional) |
|
| Induration (measured) |
|
| Ecchymosis (functional) |
|
| Ecchymosis (measured) |
|
| Pruritus |
|
| Moderate |
|
| Severe |
|
| Elevated Oral Temperature |
|
| Feverishness |
|
| Malaise |
|
| Fatigue |
|
| Myalgia |
|
| Headache |
|
| Nausea |
|
| Loss of Appetite |
|
| Moderate |
|
| Severe |
|
| Elevated Oral Temperature |
|
| Feverishness |
|
| Malaise |
|
| Fatigue |
|
| Myalgia |
|
| Headache |
|
| Nausea |
|
| Loss of Appetite |
|
| Severe |
|
| None |
|
| Elevated Oral Temperature |
|
| Feverishness |
|
| Malaise |
|
| Fatigue |
|
| Myalgia |
|
| Headache |
|
| Nausea |
|
| Loss of Appetite |
|
| None |
|
| Lymphadenopathy |
|
| Tachycardia |
|
| Diarrhea |
|
| Vomiting |
|
| Chest discomfort |
|
| Blood pressure diastolic decreased |
|
| Transaminases increased |
|
| Dehydration |
|
| Back pain |
|
| Muscle Spasms |
|
| Dizziness |
|
| Sinus headache |
|
| Taste Disorder |
|
| Cough |
|
| Oropharyngeal pain |
|
| Sinus Congestion |
|
| Acne |
|
| Ecchymosis |
|
| Rash |
|
| Day 8 Post-Second Vaccination |
|
|
| Day 15 Post-Second Vaccination |
|
|
| Day 22 Post-Second Vaccination |
|
|
| Day 29 Post-Second Vaccination |
|
|
| Day 8 Post-Second Vaccination |
|
|
| Day 15 Post-Second Vaccination |
|
|
| Day 22 Post-Second Vaccination |
|
|
| Day 29 Post-Second Vaccination |
|
|
| Day 8 Post-First Vaccination (Second Vaccination) |
|
|
| Day 8 Post-Second Vaccination |
|
|
| Day 15 Post-Second Vaccination |
|
|
| Day 22 Post-Second Vaccination |
|
|
| Day 29 Post-Second Vaccination |
|
|
| Day 8 Post-First Vaccination (Second Vaccination) |
|
|
| Day 8 Post-Second Vaccination |
|
|
| Day 15 Post-Second Vaccination |
|
|
| Day 22 Post-Second Vaccination |
|
|
| Day 29 Post-Second Vaccination |
|
|
| Day 8 Post-Second Vaccination |
|
|
| Day 15 Post-Second Vaccination |
|
|
| Day 22 Post-Second Vaccination |
|
|
| Day 29 Post-Second Vaccination |
|
|
| Day 8 Post-Second Vaccination |
|
|
| Day 15 Post-Second Vaccination |
|
|
| Day 22 Post-Second Vaccination |
|
|
| Day 29 Post-Second Vaccination |
|
|