Prevention of Ebola Infection
Conditions
Brief summary
The study evaluated the safety and immunogenicity of 3 consistency lots and a high-dose lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in healthy adults. The primary purpose of this study was to demonstrate consistency in the immune responses of participants receiving 3 separate lots of V920 through 28 days postvaccination. In addition to the 3 lot groups, a high-dose group and a placebo group were studied. A subset of participants representative of all treatment groups continued through 24 months postvaccination in the extension study for the evaluation of long-term safety. The primary hypothesis states that the geometric mean titer of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibody at 28 days postvaccination is equivalent across the three consistency lots.
Interventions
BIOLOGICALV920 Consistency Lot A
V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot A, live, attenuated, sterile solution for intramuscular injection
BIOLOGICALV920 Consistency Lot B
V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot B, live, attenuated, sterile solution for intramuscular injection
BIOLOGICALV920 Consistency Lot C
V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot C, live, attenuated, sterile solution for intramuscular injection
BIOLOGICALV920 High-dose Lot
V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine high-dose lot, live, attenuated, sterile solution for intramuscular injection
BIOLOGICALPlacebo to V920
Sodium chloride 0.9%, sterile solution for intramuscular injection
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Not of reproductive potential, or of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner for 2 months following study vaccination.
Exclusion criteria
* Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 90 days of participation in this trial. * Has previously been randomized in another clinical trial and received V920 or any other Ebola vaccine. * Has been exposed to Ebola virus at any time prior to study entry. * Is pregnant or breastfeeding or plans to conceive within 2 months following study vaccination. * Has direct household exposure to a pregnant or lactating woman at the time of participation in this trial. * Has had a fever (≥100.5ºF/38.0ºC) within 48 hours prior to study entry. * Has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of prednisone or ≥20 mg/day for persons weighing \>10 kg) for ≥14 consecutive days and has not completed treatment at least 30 days prior to study entry. * Has received systemic corticosteroids exceeding physiologic replacement doses (\ 5 mg/day prednisone equivalent) within 14 days prior to study entry. * Has received any live virus vaccine within 30 days prior to study entry or any other (nonlive virus) vaccine within 14 days prior to study entry. * Has known or suspected impairment of immunological function (e.g., HIV positive). * Has direct household exposure to a person with known or suspected impairment of immunological function (e.g., HIV positive). * Has a clinically significant history of intravenous (IV) drug abuse within 12 months prior to study entry. * Has a known allergy/sensitivity or contraindication to investigational product(s) or its/their excipients (e.g., albumin). * Has a history of malignancy \<=5 years prior to study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. * Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody | Day 28 postvaccination | Serum was collected for determination of geometric mean titer (GMT) of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibodies using an enzyme-linked immunosorbent assay (GP-ELISA). The unit of measure is ELISA units/mL (EU/mL). The lower limit of quantification for the assay was 36.11 EU/mL. |
| Percentage of Participants Reporting Serious Adverse Events | Up to Month 6 postvaccination | An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is any other important medical event, is a cancer, or is associated with an overdose. |
| Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card | Up to Day 5 postvaccination | An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling. |
| Percentage of Participants With Elevated Maximum Temperature | Up to Day 42 postvaccination | Participants were instructed on the VRC to take and record their oral (or oral equivalent) temperature daily from the day of vaccination through Day 42. Elevated temperature was defined as ≥38.0° C (≥100.4° F). |
| Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card | From Day 5 to Day 42 postvaccination | An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Adverse events of arthralgia and arthritis were prompted on the VRC. |
| Percentage of Participants With Rash Adverse Events Prompted on the Vaccination Report Card | Up to Day 42 postvaccination | An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Rash AEs prompted on the VRC were petechial rash, purpuric rash, and vesicular-type rash. |
| Percentage of Participants With Vesicular Lesion Adverse Events Prompted on the Vaccination Report Card | Up to Day 42 postvaccination | An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Vesicular lesion AEs prompted on the VRC included blister and rash vesicular. |
Participant flow
Pre-assignment details
A total of 1261 participants were screened and 1197 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| V920 Consistency Lot A Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1 | 266 |
| V920 Consistency Lot B Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1 | 265 |
| V920 Consistency Lot C Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1 | 267 |
| V920 High-dose Lot Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1 | 266 |
| Placebo Participants received a 1.0-mL intramuscular injection of placebo on Day 1 | 133 |
| Total | 1,197 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Base Study: Up to Month 6 | Death | 1 | 1 | 0 | 0 | 0 |
| Base Study: Up to Month 6 | Lost to Follow-up | 11 | 8 | 10 | 5 | 1 |
| Base Study: Up to Month 6 | Physician Decision | 0 | 0 | 0 | 0 | 1 |
| Base Study: Up to Month 6 | Randomized not vaccinated | 0 | 0 | 1 | 2 | 0 |
| Base Study: Up to Month 6 | Withdrawal by Subject | 6 | 3 | 4 | 4 | 1 |
| Extension: Month 6 to 24 | Death | 1 | 0 | 0 | 0 | 0 |
| Extension: Month 6 to 24 | Lost to Follow-up | 4 | 8 | 6 | 10 | 1 |
| Extension: Month 6 to 24 | Physician Decision | 1 | 0 | 1 | 3 | 0 |
| Extension: Month 6 to 24 | Protocol Violation | 0 | 0 | 0 | 1 | 0 |
| Extension: Month 6 to 24 | Withdrawal by Subject | 5 | 8 | 2 | 4 | 0 |
Baseline characteristics
| Characteristic | V920 Consistency Lot A | V920 Consistency Lot B | V920 Consistency Lot C | V920 High-dose Lot | Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 41.3 Years STANDARD_DEVIATION 13.4 | 41.5 Years STANDARD_DEVIATION 12.4 | 40.9 Years STANDARD_DEVIATION 13.1 | 41.7 Years STANDARD_DEVIATION 13.4 | 41.1 Years STANDARD_DEVIATION 13.7 | 41.3 Years STANDARD_DEVIATION 13.1 |
| Sex: Female, Male Female | 143 Participants | 135 Participants | 138 Participants | 149 Participants | 72 Participants | 637 Participants |
| Sex: Female, Male Male | 123 Participants | 130 Participants | 129 Participants | 117 Participants | 61 Participants | 560 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 265 | 1 / 263 | 0 / 263 | 0 / 260 | 0 / 133 |
| other Total, other adverse events | 211 / 265 | 211 / 263 | 208 / 263 | 208 / 260 | 35 / 133 |
| serious Total, serious adverse events | 12 / 265 | 12 / 263 | 11 / 263 | 8 / 260 | 4 / 133 |
Outcome results
Primary
Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody
Serum was collected for determination of geometric mean titer (GMT) of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibodies using an enzyme-linked immunosorbent assay (GP-ELISA). The unit of measure is ELISA units/mL (EU/mL). The lower limit of quantification for the assay was 36.11 EU/mL.
Time frame: Day 28 postvaccination
Population: Participants who were compliant with the protocol, received vaccination, were seronegative at Day 1, and had a serum sample collected within the acceptable day range
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V920 Consistency Lot A | Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody | 1183.9 EU/mL |
| V920 Consistency Lot B | Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody | 1266.0 EU/mL |
| V920 Consistency Lot C | Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody | 1346.0 EU/mL |
| V920 High-dose Lot | Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody | 1291.9 EU/mL |
| Placebo | Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody | NA EU/mL |
p-value: <0.00195% CI: [0.77, 1.14]ANOVA
p-value: <0.00195% CI: [0.71, 1.09]ANOVA
p-value: <0.00195% CI: [0.77, 1.15]ANOVA
Primary
Percentage of Participants Reporting Serious Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is any other important medical event, is a cancer, or is associated with an overdose.
Time frame: Up to Month 6 postvaccination
Population: Randomized participants who received vaccination and had follow-up data for the outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V920 Consistency Lot A | Percentage of Participants Reporting Serious Adverse Events | 2.6 Percentage of participants |
| V920 Consistency Lot B | Percentage of Participants Reporting Serious Adverse Events | 1.5 Percentage of participants |
| V920 Consistency Lot C | Percentage of Participants Reporting Serious Adverse Events | 2.7 Percentage of participants |
| V920 High-dose Lot | Percentage of Participants Reporting Serious Adverse Events | 1.2 Percentage of participants |
| Placebo | Percentage of Participants Reporting Serious Adverse Events | 0.0 Percentage of participants |
p-value: 0.36895% CI: [-1.5, 4]Miettinen & Nurminen
p-value: 0.98995% CI: [-3.1, 3]Miettinen & Nurminen
p-value: 0.36195% CI: [-4.1, 1.5]Miettinen & Nurminen
p-value: 0.21495% CI: [-1.7, 3.3]Miettinen & Nurminen
Primary
Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Adverse events of arthralgia and arthritis were prompted on the VRC.
Time frame: From Day 5 to Day 42 postvaccination
Population: Randomized participants who received vaccination and had follow-up data for the outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V920 Consistency Lot A | Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card | Arthralgia AEs | 5.7 Percentage of participants |
| V920 Consistency Lot A | Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card | Arthritis AEs | 4.5 Percentage of participants |
| V920 Consistency Lot B | Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card | Arthralgia AEs | 5.7 Percentage of participants |
| V920 Consistency Lot B | Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card | Arthritis AEs | 3.8 Percentage of participants |
| V920 Consistency Lot C | Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card | Arthralgia AEs | 6.5 Percentage of participants |
| V920 Consistency Lot C | Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card | Arthritis AEs | 2.7 Percentage of participants |
| V920 High-dose Lot | Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card | Arthritis AEs | 3.1 Percentage of participants |
| V920 High-dose Lot | Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card | Arthralgia AEs | 7.7 Percentage of participants |
| Placebo | Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card | Arthralgia AEs | 1.5 Percentage of participants |
| Placebo | Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card | Arthritis AEs | 0.0 Percentage of participants |
Comparison: Arthralgiap-value: 0.98395% CI: [-4.2, 4.1]Miettinen & Nurminen
Comparison: Arthralgiap-value: 0.69995% CI: [-5.1, 3.4]Miettinen & Nurminen
Comparison: Arthralgiap-value: 0.71695% CI: [-5.1, 3.5]Miettinen & Nurminen
Comparison: Arthralgiap-value: 0.01295% CI: [1.8, 10.4]Miettinen & Nurminen
Comparison: Arthritisp-value: 0.67795% CI: [-2.9, 4.4]Miettinen & Nurminen
Comparison: Arthritisp-value: 0.2595% CI: [-1.4, 5.4]Miettinen & Nurminen
Comparison: Arthritisp-value: 0.4695% CI: [-2.1, 4.5]Miettinen & Nurminen
Comparison: Arthritisp-value: 0.04195% CI: [0.2, 6]Miettinen & Nurminen
Primary
Percentage of Participants With Elevated Maximum Temperature
Participants were instructed on the VRC to take and record their oral (or oral equivalent) temperature daily from the day of vaccination through Day 42. Elevated temperature was defined as ≥38.0° C (≥100.4° F).
Time frame: Up to Day 42 postvaccination
Population: Randomized participants who received vaccination and had follow-up data for the outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V920 Consistency Lot A | Percentage of Participants With Elevated Maximum Temperature | 21.4 Percentage of participants |
| V920 Consistency Lot B | Percentage of Participants With Elevated Maximum Temperature | 16.7 Percentage of participants |
| V920 Consistency Lot C | Percentage of Participants With Elevated Maximum Temperature | 22.4 Percentage of participants |
| V920 High-dose Lot | Percentage of Participants With Elevated Maximum Temperature | 32.2 Percentage of participants |
| Placebo | Percentage of Participants With Elevated Maximum Temperature | 0.8 Percentage of participants |
p-value: 0.17695% CI: [-2.1, 11.4]Miettinen & Nurminen
p-value: 0.76995% CI: [-8.2, 6]Miettinen & Nurminen
p-value: 0.195% CI: [-12.5, 1.1]Miettinen & Nurminen
p-value: <0.00195% CI: [25.6, 37.5]Miettinen & Nurminen
Primary
Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling.
Time frame: Up to Day 5 postvaccination
Population: Randomized participants who received vaccination and had follow-up data for the outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V920 Consistency Lot A | Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card | Injection-site swelling | 17.7 Percentage of participants |
| V920 Consistency Lot A | Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card | Injection-site pain | 66.8 Percentage of participants |
| V920 Consistency Lot A | Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card | Injection-site erythema | 14.7 Percentage of participants |
| V920 Consistency Lot B | Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card | Injection-site erythema | 10.6 Percentage of participants |
| V920 Consistency Lot B | Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card | Injection-site pain | 73.0 Percentage of participants |
| V920 Consistency Lot B | Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card | Injection-site swelling | 13.7 Percentage of participants |
| V920 Consistency Lot C | Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card | Injection-site swelling | 18.3 Percentage of participants |
| V920 Consistency Lot C | Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card | Injection-site pain | 70.3 Percentage of participants |
| V920 Consistency Lot C | Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card | Injection-site erythema | 14.8 Percentage of participants |
| V920 High-dose Lot | Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card | Injection-site pain | 67.7 Percentage of participants |
| V920 High-dose Lot | Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card | Injection-site erythema | 7.3 Percentage of participants |
| V920 High-dose Lot | Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card | Injection-site swelling | 16.2 Percentage of participants |
| Placebo | Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card | Injection-site erythema | 1.5 Percentage of participants |
| Placebo | Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card | Injection-site swelling | 3.0 Percentage of participants |
| Placebo | Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card | Injection-site pain | 12.8 Percentage of participants |
Comparison: Injection site erythemap-value: 0.1695% CI: [-1.6, 9.9]Miettinen & Nurminen
Comparison: Injection site erythemap-value: 0.97195% CI: [-6.2, 6]Miettinen & Nurminen
Comparison: Injection site erythemap-value: 0.15195% CI: [-10, 1.5]Miettinen & Nurminen
Comparison: Injection site erythemap-value: 0.01695% CI: [1.4, 9.9]Miettinen & Nurminen
Comparison: Injection site painp-value: 0.1295% CI: [-14, 1.6]Miettinen & Nurminen
Comparison: Injection site painp-value: 0.3894% CI: [-11.4, 4.4]Miettinen & Nurminen
Comparison: Injection site painp-value: 0.49995% CI: [-5.1, 10.4]Miettinen & Nurminen
Comparison: Injection site painp-value: <0.00195% CI: [46.2, 62.3]Miettinen & Nurminen
Comparison: Injection site swellingp-value: 0.20295% CI: [-2.2, 10.3]Miettinen & Nurminen
Comparison: Injection site swellingp-value: 0.87895% CI: [-7.1, 6.1]Miettinen & Nurminen
Comparison: Injection site swellingp-value: 0.15495% CI: [-10.9, 1.7]Miettinen & Nurminen
Comparison: Injection site swellingp-value: <0.00195% CI: [7.4, 18.6]Miettinen & Nurminen
Primary
Percentage of Participants With Rash Adverse Events Prompted on the Vaccination Report Card
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Rash AEs prompted on the VRC were petechial rash, purpuric rash, and vesicular-type rash.
Time frame: Up to Day 42 postvaccination
Population: Randomized participants who received vaccination and had follow-up data for the outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V920 Consistency Lot A | Percentage of Participants With Rash Adverse Events Prompted on the Vaccination Report Card | 3.0 Percentage of participants |
| V920 Consistency Lot B | Percentage of Participants With Rash Adverse Events Prompted on the Vaccination Report Card | 4.6 Percentage of participants |
| V920 Consistency Lot C | Percentage of Participants With Rash Adverse Events Prompted on the Vaccination Report Card | 3.8 Percentage of participants |
| V920 High-dose Lot | Percentage of Participants With Rash Adverse Events Prompted on the Vaccination Report Card | 3.8 Percentage of participants |
| Placebo | Percentage of Participants With Rash Adverse Events Prompted on the Vaccination Report Card | 1.5 Percentage of participants |
p-value: 0.35395% CI: [-5.1, 1.9]Miettinen & Nurminen
p-value: 0.6295% CI: [-4.2, 2.5]Miettinen & Nurminen
p-value: 0.66395% CI: [-2.9, 4.5]Miettinen & Nurminen
p-value: 0.20295% CI: [-1.8, 5.7]Miettinen & Nurminen
Primary
Percentage of Participants With Vesicular Lesion Adverse Events Prompted on the Vaccination Report Card
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Vesicular lesion AEs prompted on the VRC included blister and rash vesicular.
Time frame: Up to Day 42 postvaccination
Population: Randomized participants who received vaccination and had follow-up data for the outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V920 Consistency Lot A | Percentage of Participants With Vesicular Lesion Adverse Events Prompted on the Vaccination Report Card | 1.9 Percentage of participants |
| V920 Consistency Lot B | Percentage of Participants With Vesicular Lesion Adverse Events Prompted on the Vaccination Report Card | 1.1 Percentage of participants |
| V920 Consistency Lot C | Percentage of Participants With Vesicular Lesion Adverse Events Prompted on the Vaccination Report Card | 1.5 Percentage of participants |
| V920 High-dose Lot | Percentage of Participants With Vesicular Lesion Adverse Events Prompted on the Vaccination Report Card | 1.5 Percentage of participants |
| Placebo | Percentage of Participants With Vesicular Lesion Adverse Events Prompted on the Vaccination Report Card | 0.0 Percentage of participants |
p-value: 0.48395% CI: [-1.6, 3.3]Miettinen & Nurminen
p-value: 0.74695% CI: [-2.2, 3]Miettinen & Nurminen
p-value: 0.70495% CI: [-2.8, 2]Miettinen & Nurminen
p-value: 0.15195% CI: [-1.3, 3.9]Miettinen & Nurminen