Trial Outcomes & Findings for Efficacy of MVA-NP+M1 in the Influenza H3N2 Human Challenge Model (NCT NCT03883113)
NCT ID: NCT03883113
Last Updated: 2021-03-18
Results Overview
Measure of nasopharyngeal viral shedding during challenge; recorded as viral area under curve (vAUC) as determined by quantitative real time polymerase chain reaction (qRT-PCR). vAUC is calculated by plotting the log viral particles number/ml for each time point against time and is using the trapezoidal rule.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
145 participants
Primary outcome timeframe
Throughout 9 days (Day2, Day3, Day4, Day5, Day6, Day7, Day8, Day9, Day10) after viral Inoculation (Day1) of the challenge phase. Nasal swabs taken twice a day (b.i.d) at least 8 hours apart.
Results posted on
2021-03-18
Participant Flow
The study was conducted at the SGS Clinical Pharmacology Unit in Antwerp, Belgium.
Eight-hundred and nineteen (819) subjects were screened. One hundred and forty-five (145) subjects were actually enrolled and vaccinated. The study consisted of an outpatient vaccination phase and at least 6 weeks later an inpatient challenge phase.
Participant milestones
| Measure |
MVA-NP+M1 & H3N2 Challenge Virus
Vaccination administered: MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10\^8 pfu.); Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10\^6 TCID50/ml)
MVA-NP+M1: Trial Vaccine
H3N2 (A/Belgium/2417/2015): Challenge Agent
|
Saline Placebo & H3N2 Challenge Virus
Vaccination administered: Sodium Chloride (IM injection, 0.5 ml, 0.9%); Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10\^6 TCID50/ml)
Saline: Sodium Chloride Placebo
H3N2 (A/Belgium/2417/2015): Challenge Agent
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
58
|
|
Overall Study
COMPLETED
|
71
|
46
|
|
Overall Study
NOT COMPLETED
|
16
|
12
|
Reasons for withdrawal
| Measure |
MVA-NP+M1 & H3N2 Challenge Virus
Vaccination administered: MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10\^8 pfu.); Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10\^6 TCID50/ml)
MVA-NP+M1: Trial Vaccine
H3N2 (A/Belgium/2417/2015): Challenge Agent
|
Saline Placebo & H3N2 Challenge Virus
Vaccination administered: Sodium Chloride (IM injection, 0.5 ml, 0.9%); Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10\^6 TCID50/ml)
Saline: Sodium Chloride Placebo
H3N2 (A/Belgium/2417/2015): Challenge Agent
|
|---|---|---|
|
Overall Study
Physician Decision
|
4
|
2
|
|
Overall Study
Challenge Criteria Not Met / Sponsor Decision
|
9
|
7
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Efficacy of MVA-NP+M1 in the Influenza H3N2 Human Challenge Model
Baseline characteristics by cohort
| Measure |
MVA-NP+M1 & H3N2 Challenge Virus
n=87 Participants
Vaccination administered: MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10\^8 pfu.); Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10\^6 TCID50/ml)
MVA-NP+M1: Trial Vaccine
H3N2 (A/Belgium/2417/2015): Challenge Agent
|
Saline Placebo & H3N2 Challenge Virus
n=58 Participants
Vaccination administered: Sodium Chloride (IM injection, 0.5 ml, 0.9%); Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10\^6 TCID50/ml)
Saline: Sodium Chloride Placebo
H3N2 (A/Belgium/2417/2015): Challenge Agent
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
87 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
145 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
43.00 years
n=99 Participants
|
41.25 years
n=107 Participants
|
42.50 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
81 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
138 Participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
87 participants
n=99 Participants
|
58 participants
n=107 Participants
|
145 participants
n=206 Participants
|
|
Smoking Status
Ex-smoker
|
27 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Smoking Status
Non-smoker
|
60 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Height
|
172.40 cm
n=99 Participants
|
172.30 cm
n=107 Participants
|
172.40 cm
n=206 Participants
|
|
Weight
|
72.9 kg
n=99 Participants
|
75.15 kg
n=107 Participants
|
73.60 kg
n=206 Participants
|
|
BMI
|
24.7 kg/m^2
n=99 Participants
|
25.5 kg/m^2
n=107 Participants
|
24.90 kg/m^2
n=206 Participants
|
PRIMARY outcome
Timeframe: Throughout 9 days (Day2, Day3, Day4, Day5, Day6, Day7, Day8, Day9, Day10) after viral Inoculation (Day1) of the challenge phase. Nasal swabs taken twice a day (b.i.d) at least 8 hours apart.Population: End point values
Measure of nasopharyngeal viral shedding during challenge; recorded as viral area under curve (vAUC) as determined by quantitative real time polymerase chain reaction (qRT-PCR). vAUC is calculated by plotting the log viral particles number/ml for each time point against time and is using the trapezoidal rule.
Outcome measures
| Measure |
MVA-NP+M1 (ITT)
n=71 Participants
Intention-to-treat (the actually challenged with the virus)
|
Placebo (ITT)
n=47 Participants
Intention-to-treat (the actually challenged with the virus)
|
MVA-NP+M1 (PP)
n=70 Participants
Per protocol analysis set
|
Placebo (PP)
n=47 Participants
Per protocol analysis set
|
MVA-NP+M1 (Challenge)
n=71 Participants
Safety Analysis Set (challenged participants)
|
Placebo (Challenge)
n=47 Participants
Safety Analysis Set (challenged participants)
|
|---|---|---|---|---|---|---|
|
Degree of Nasopharyngeal Viral Shedding as Determined by Quantitative Polymerase Chain Reaction qPCR
|
649.7 hour*Log10 Viral Particles/ ml
Interval 552.7 to 746.7
|
726.1 hour*Log10 Viral Particles/ ml
Interval 604.0 to 848.2
|
646.5 hour*Log10 Viral Particles/ ml
Interval 548.3 to 744.7
|
726.1 hour*Log10 Viral Particles/ ml
Interval 604.0 to 848.2
|
649.7 hour*Log10 Viral Particles/ ml
Interval 552.7 to 746.7
|
726.1 hour*Log10 Viral Particles/ ml
Interval 604.0 to 848.2
|
SECONDARY outcome
Timeframe: 9 days from day 2 to day 10Incidence (frequency tabulation) of laboratory-confirmed influenza-like illness compared between vaccine and placebo arms Virologically confirmed influenza-like illness (ILI) is defined as having respiratory or flu-like symptom occurring on two consecutive days, along with a positive qPCR or qCulture result.
Outcome measures
| Measure |
MVA-NP+M1 (ITT)
n=71 Participants
Intention-to-treat (the actually challenged with the virus)
|
Placebo (ITT)
n=47 Participants
Intention-to-treat (the actually challenged with the virus)
|
MVA-NP+M1 (PP)
Per protocol analysis set
|
Placebo (PP)
Per protocol analysis set
|
MVA-NP+M1 (Challenge)
Safety Analysis Set (challenged participants)
|
Placebo (Challenge)
Safety Analysis Set (challenged participants)
|
|---|---|---|---|---|---|---|
|
Number and Percentage of Virologically Confirmed Influenza-Like Illness
Virologically confirmed Influenza-like Illness
|
43 Participants
|
29 Participants
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Virologically Confirmed Influenza-Like Illness
No Virologically Confirmed Influenza-like Illness
|
28 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 9 days from day 2 to day 10The attack rate is defined as the percentage of inoculated participants with at least two consecutive positive swabs as determined by qRT-PCR within the timespan of two consecutive days
Outcome measures
| Measure |
MVA-NP+M1 (ITT)
n=71 Participants
Intention-to-treat (the actually challenged with the virus)
|
Placebo (ITT)
n=47 Participants
Intention-to-treat (the actually challenged with the virus)
|
MVA-NP+M1 (PP)
Per protocol analysis set
|
Placebo (PP)
Per protocol analysis set
|
MVA-NP+M1 (Challenge)
Safety Analysis Set (challenged participants)
|
Placebo (Challenge)
Safety Analysis Set (challenged participants)
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Attack Rate of Challenge Agent (qRT-PCR)
qPCR-confirmed influenza
|
90.1 percentage of participants
Interval 80.7 to 95.9
|
97.9 percentage of participants
Interval 88.7 to 99.9
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Attack Rate of Challenge Agent (qRT-PCR)
No qPCR influenza
|
9.9 percentage of participants
Interval 4.1 to 19.3
|
2.1 percentage of participants
Interval 0.1 to 11.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 9 days from day 2 to day 10The attack rate is defined as the percentage of inoculated participants with at least two consecutive positive swabs as determined by qCulture within the timespan of two consecutive days
Outcome measures
| Measure |
MVA-NP+M1 (ITT)
n=71 Participants
Intention-to-treat (the actually challenged with the virus)
|
Placebo (ITT)
n=47 Participants
Intention-to-treat (the actually challenged with the virus)
|
MVA-NP+M1 (PP)
Per protocol analysis set
|
Placebo (PP)
Per protocol analysis set
|
MVA-NP+M1 (Challenge)
Safety Analysis Set (challenged participants)
|
Placebo (Challenge)
Safety Analysis Set (challenged participants)
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Quantitative Culture Attack Rate of Challenge Agent (qCulture)
qCulture confirmed influenza
|
77.5 percentage
Interval 66.0 to 86.5
|
85.1 percentage
Interval 71.7 to 93.8
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Quantitative Culture Attack Rate of Challenge Agent (qCulture)
No qCulture-confirmed influenza
|
22.5 percentage
Interval 13.5 to 34.0
|
14.9 percentage
Interval 6.2 to 28.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 9 days from day 2 to day 10Population: \[MVA-NP+M1 (ITT)\] - subjects assessed = 71 subjects with event = 64 subjects censored = 7 \[Placebo (ITT)\] - subjects assessed = 47 subjects with event = 46 subjects censored = 1
The Time to Start of Viral Shedding (qPCR) is calculated as (datetime of first of two positive swabs (qPCR) within 2 consecutive days - challenge datetime)/(60\*60)
Outcome measures
| Measure |
MVA-NP+M1 (ITT)
n=71 Participants
Intention-to-treat (the actually challenged with the virus)
|
Placebo (ITT)
n=47 Participants
Intention-to-treat (the actually challenged with the virus)
|
MVA-NP+M1 (PP)
Per protocol analysis set
|
Placebo (PP)
Per protocol analysis set
|
MVA-NP+M1 (Challenge)
Safety Analysis Set (challenged participants)
|
Placebo (Challenge)
Safety Analysis Set (challenged participants)
|
|---|---|---|---|---|---|---|
|
Time to Start of Viral Shedding (qPCR) From Virus Inoculation
|
24.40 hours
Interval 24.3 to 24.5
|
24.30 hours
Interval 24.2 to 24.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 9 days from day 2 to day 10Population: \[MVA-NP+M1(ITT)\] - Subjects assessed = 71 Subjects with event = 55 Subjects censored = 16; \[Placebo (ITT)\] - Subjects assessed = 47 Subjects with event = 40 Subjects censored = 7
Time to Start of Viral Shedding (qCulture) is calculated as (datetime of first of two positive swabs (qCulture) within 2 consecutive days - challenge datetime)/(60\*60)
Outcome measures
| Measure |
MVA-NP+M1 (ITT)
n=71 Participants
Intention-to-treat (the actually challenged with the virus)
|
Placebo (ITT)
n=47 Participants
Intention-to-treat (the actually challenged with the virus)
|
MVA-NP+M1 (PP)
Per protocol analysis set
|
Placebo (PP)
Per protocol analysis set
|
MVA-NP+M1 (Challenge)
Safety Analysis Set (challenged participants)
|
Placebo (Challenge)
Safety Analysis Set (challenged participants)
|
|---|---|---|---|---|---|---|
|
Time to Start of Viral Shedding (qCulture) From Virus Inoculation
|
35.9 hours
Interval 35.6 to 48.0
|
47.6 hours
Interval 24.7 to 48.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 9 days from Day 2 to Day 10This is measured by the highest viral load concentration by qPCR
Outcome measures
| Measure |
MVA-NP+M1 (ITT)
n=64 Participants
Intention-to-treat (the actually challenged with the virus)
|
Placebo (ITT)
n=46 Participants
Intention-to-treat (the actually challenged with the virus)
|
MVA-NP+M1 (PP)
Per protocol analysis set
|
Placebo (PP)
Per protocol analysis set
|
MVA-NP+M1 (Challenge)
Safety Analysis Set (challenged participants)
|
Placebo (Challenge)
Safety Analysis Set (challenged participants)
|
|---|---|---|---|---|---|---|
|
Peak Viral Shedding (qPCR) After the Virus Inoculation
|
5.876 Log10 Viral Particles/ ml
Interval 5.43 to 6.322
|
6.054 Log10 Viral Particles/ ml
Interval 5.521 to 6.587
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 9 days from day 2 to day 10This is measured by the highest viral load concentration by qCulture.
Outcome measures
| Measure |
MVA-NP+M1 (ITT)
n=55 Participants
Intention-to-treat (the actually challenged with the virus)
|
Placebo (ITT)
n=40 Participants
Intention-to-treat (the actually challenged with the virus)
|
MVA-NP+M1 (PP)
Per protocol analysis set
|
Placebo (PP)
Per protocol analysis set
|
MVA-NP+M1 (Challenge)
Safety Analysis Set (challenged participants)
|
Placebo (Challenge)
Safety Analysis Set (challenged participants)
|
|---|---|---|---|---|---|---|
|
Peak Viral Shedding (qCulture) After Virus Inoculation
|
4.073 Log10 Viral Particles/ ml
Interval 3.683 to 4.463
|
4.069 Log10 Viral Particles/ ml
Interval 3.442 to 4.695
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 9 days from day 2 to day 10Population: \[MVA-NP+M1 (ITT)\] - Subjects assessed = 71 Subjects with event = 64 Subjects censored = 7; \[Placebo (ITT)\] - Subjects assessed = 47 Subjects with event = 46 Subjects censored = 1
This is calculated as (datetime of highest viral load concentration (qPCR) - challenge datetime)/(60\*60)
Outcome measures
| Measure |
MVA-NP+M1 (ITT)
n=71 Participants
Intention-to-treat (the actually challenged with the virus)
|
Placebo (ITT)
n=47 Participants
Intention-to-treat (the actually challenged with the virus)
|
MVA-NP+M1 (PP)
Per protocol analysis set
|
Placebo (PP)
Per protocol analysis set
|
MVA-NP+M1 (Challenge)
Safety Analysis Set (challenged participants)
|
Placebo (Challenge)
Safety Analysis Set (challenged participants)
|
|---|---|---|---|---|---|---|
|
Time to Peak of Viral Shedding (qPCR) From the Viral Inoculation
|
72.20 hours
Interval 60.0 to 96.0
|
107.90 hours
Interval 72.2 to 119.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 9 days from day 2 to day 10Population: \[MVA-NP+M1 (ITT)\] - Subjects assessed = 71 Subjects with event = 55 Subjects censored = 16; \[Placebo (ITT)\] - Subjects assessed = 47 Subjects with event = 40 Subjects censored = 7
This is calculated as (datetime of highest viral load concentration (qCulture) - challenge datetime)/(60\*60)
Outcome measures
| Measure |
MVA-NP+M1 (ITT)
n=71 Participants
Intention-to-treat (the actually challenged with the virus)
|
Placebo (ITT)
n=47 Participants
Intention-to-treat (the actually challenged with the virus)
|
MVA-NP+M1 (PP)
Per protocol analysis set
|
Placebo (PP)
Per protocol analysis set
|
MVA-NP+M1 (Challenge)
Safety Analysis Set (challenged participants)
|
Placebo (Challenge)
Safety Analysis Set (challenged participants)
|
|---|---|---|---|---|---|---|
|
Time to Peak of Viral Shedding (qCulture) From the Viral Inoculation
|
83.40 hours
Interval 60.1 to 96.3
|
83.80 hours
Interval 60.1 to 96.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 9 days from day2 to day10Population: This endpoint is only calculated for the subset of participants with a successful attack.
It is calculated as (datetime of first negative swab (qPCR) following the last positive swab (qPCR) - datetime of first positive of two positive swabs (qPCR) within 2 consecutive days)/(60\*60)
Outcome measures
| Measure |
MVA-NP+M1 (ITT)
n=64 Participants
Intention-to-treat (the actually challenged with the virus)
|
Placebo (ITT)
n=46 Participants
Intention-to-treat (the actually challenged with the virus)
|
MVA-NP+M1 (PP)
Per protocol analysis set
|
Placebo (PP)
Per protocol analysis set
|
MVA-NP+M1 (Challenge)
Safety Analysis Set (challenged participants)
|
Placebo (Challenge)
Safety Analysis Set (challenged participants)
|
|---|---|---|---|---|---|---|
|
Duration of Viral Shedding (qPCR) After the Virus Inoculation
|
170.80 hours
Interval 157.08 to 184.52
|
172.47 hours
Interval 156.99 to 187.94
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 9 days from day 2 to day 10Population: This endpoint is only calculated for the subset of participants with a successful attack
It is calculated as (datetime of first negative swab (qCulture) following the last positive swab (qCulture) - datetime of first positive of two positive swabs (qCulture) within 2 consecutive days)/(60\*60)
Outcome measures
| Measure |
MVA-NP+M1 (ITT)
n=55 Participants
Intention-to-treat (the actually challenged with the virus)
|
Placebo (ITT)
n=40 Participants
Intention-to-treat (the actually challenged with the virus)
|
MVA-NP+M1 (PP)
Per protocol analysis set
|
Placebo (PP)
Per protocol analysis set
|
MVA-NP+M1 (Challenge)
Safety Analysis Set (challenged participants)
|
Placebo (Challenge)
Safety Analysis Set (challenged participants)
|
|---|---|---|---|---|---|---|
|
Duration of Viral Shedding (qCulture) After the Virus Inoculation
|
118.19 hours
Interval 105.07 to 131.31
|
121.78 hours
Interval 106.33 to 137.23
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 11 days from Day 1 to Day 11Total symptom scores were compared for MVA-NP+M1 vs. Placebo from Day1 to Day11 post-challenge as AUC of composite score. Symptoms were collected twice a day (lymphadenopathy once a day) on a Symptom Score Card(SSC). SSC recorded scores for each 16 general (gastrointestinal/body systemic) and 12 local (upper/lower respiratory tract) symptoms, on the scale per timepoint (for example Day2,AM). Participants rated the severity of symptoms, higher scores indicating a more severe symptom. The scores ranged from 0 to 3 (0:symptom free, 1:mild, 2:moderate, 3:severe).The SSC also contained the question whether the subject felt well to go to work "today" (yes/no). The Overall SSC score was calculated, as the Arithmetic Mean of the Scores collected across all 28 items on the card per Timepoint and ranged from 0 to maximum 3. The SSC AUC \[0-11 days\] was derived based on the Overall SSC score against time (\*hour), using the linear trapezoidal rule and it ranged from 0 to 110 Score\*hour.
Outcome measures
| Measure |
MVA-NP+M1 (ITT)
n=71 Participants
Intention-to-treat (the actually challenged with the virus)
|
Placebo (ITT)
n=47 Participants
Intention-to-treat (the actually challenged with the virus)
|
MVA-NP+M1 (PP)
Per protocol analysis set
|
Placebo (PP)
Per protocol analysis set
|
MVA-NP+M1 (Challenge)
Safety Analysis Set (challenged participants)
|
Placebo (Challenge)
Safety Analysis Set (challenged participants)
|
|---|---|---|---|---|---|---|
|
Total Area Under the Curve (AUC) of Self-reported Influenza Total Symptom Score (SSC AUC)
|
16.709 Composite symptom score on scale*hour
Interval 11.568 to 21.85
|
20.432 Composite symptom score on scale*hour
Interval 13.753 to 27.112
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 11 days from Day 1 to Day 11Total days of fever for MVA-NP+M1 vs. Placebo
Outcome measures
| Measure |
MVA-NP+M1 (ITT)
n=71 Participants
Intention-to-treat (the actually challenged with the virus)
|
Placebo (ITT)
n=47 Participants
Intention-to-treat (the actually challenged with the virus)
|
MVA-NP+M1 (PP)
Per protocol analysis set
|
Placebo (PP)
Per protocol analysis set
|
MVA-NP+M1 (Challenge)
Safety Analysis Set (challenged participants)
|
Placebo (Challenge)
Safety Analysis Set (challenged participants)
|
|---|---|---|---|---|---|---|
|
Total Days of Fever
|
0.0 days
Interval 0.0 to 0.1
|
0.0 days
Interval 0.0 to 0.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 11 days from Day 1 to Day 11Population: Total mucus production was only calculated for challenge cohorts 5 to 8 and only if all tissues (cleaned or used) were returned.
Total mucus weight of used tissue (regardless of take rate) for MVA-NP+M1 vs. Placebo. Total mucus production was only be calculated in case all tissues were returned (sum of clean and used tissues returned should be 20 tissues for each bag).
Outcome measures
| Measure |
MVA-NP+M1 (ITT)
n=26 Participants
Intention-to-treat (the actually challenged with the virus)
|
Placebo (ITT)
n=18 Participants
Intention-to-treat (the actually challenged with the virus)
|
MVA-NP+M1 (PP)
Per protocol analysis set
|
Placebo (PP)
Per protocol analysis set
|
MVA-NP+M1 (Challenge)
Safety Analysis Set (challenged participants)
|
Placebo (Challenge)
Safety Analysis Set (challenged participants)
|
|---|---|---|---|---|---|---|
|
Average Total Mucus Production
|
31.09 grams
Interval 16.23 to 45.85
|
38.21 grams
Interval 16.78 to 59.63
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 months (day 0, day 8 and day 28 of the vaccination period and day -1 and day 28 of the challenge period)T Cell Response was assessed for IFN gamma and granzyme B, on the peripheral blood mononuclear cell using a double-colour enzymatic ELISpot assay. For each of them, three stimulation antigens were assessed: nucleoprotein NP, matrix1 M1 and a negative control, dimethyl sulfoxide (DMSO). The number of spot-forming T cell colonies per well (i.e. 200,000 cells) +/- standard deviation for the total response to NP+M1 is reported. The endpoint was recorded as the mean spot-forming units per million peripheral blood mononuclear cells in the peptide-stimulated wells minus the mean DMSO control wells for the sample. T cell responses over time (sampling timepoints) were then assessed in relation to the primary endpoint, symptom scores, and influenza incidence.
Outcome measures
| Measure |
MVA-NP+M1 (ITT)
n=71 Participants
Intention-to-treat (the actually challenged with the virus)
|
Placebo (ITT)
n=47 Participants
Intention-to-treat (the actually challenged with the virus)
|
MVA-NP+M1 (PP)
Per protocol analysis set
|
Placebo (PP)
Per protocol analysis set
|
MVA-NP+M1 (Challenge)
Safety Analysis Set (challenged participants)
|
Placebo (Challenge)
Safety Analysis Set (challenged participants)
|
|---|---|---|---|---|---|---|
|
T Cell Responses as Defined by ELISpot Assay in Relation to the Primary Endpoint, Symptom Scores and Influenza Incidence
Baseline (Vaccination)
|
230 Spot-forming units per million
Standard Deviation 265
|
167 Spot-forming units per million
Standard Deviation 157
|
—
|
—
|
—
|
—
|
|
T Cell Responses as Defined by ELISpot Assay in Relation to the Primary Endpoint, Symptom Scores and Influenza Incidence
Day 8 (from Vaccination)
|
645 Spot-forming units per million
Standard Deviation 634
|
170 Spot-forming units per million
Standard Deviation 144
|
—
|
—
|
—
|
—
|
|
T Cell Responses as Defined by ELISpot Assay in Relation to the Primary Endpoint, Symptom Scores and Influenza Incidence
Day 28 (from Vaccination)
|
566 Spot-forming units per million
Standard Deviation 551
|
163 Spot-forming units per million
Standard Deviation 160
|
—
|
—
|
—
|
—
|
|
T Cell Responses as Defined by ELISpot Assay in Relation to the Primary Endpoint, Symptom Scores and Influenza Incidence
Day 0 Challenge Period
|
460 Spot-forming units per million
Standard Deviation 471
|
159 Spot-forming units per million
Standard Deviation 132
|
—
|
—
|
—
|
—
|
|
T Cell Responses as Defined by ELISpot Assay in Relation to the Primary Endpoint, Symptom Scores and Influenza Incidence
Day 28 Challenge Period
|
561 Spot-forming units per million
Standard Deviation 483
|
329 Spot-forming units per million
Standard Deviation 220
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 days following vaccinationPopulation: Safety Analysis Set
Occurrence of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination; self-reported symptoms recorded using paper diaries
Outcome measures
| Measure |
MVA-NP+M1 (ITT)
n=87 Participants
Intention-to-treat (the actually challenged with the virus)
|
Placebo (ITT)
n=58 Participants
Intention-to-treat (the actually challenged with the virus)
|
MVA-NP+M1 (PP)
Per protocol analysis set
|
Placebo (PP)
Per protocol analysis set
|
MVA-NP+M1 (Challenge)
Safety Analysis Set (challenged participants)
|
Placebo (Challenge)
Safety Analysis Set (challenged participants)
|
|---|---|---|---|---|---|---|
|
Number of Participants With MVA-NP+M1 Vaccination Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
TEAE
|
36 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With MVA-NP+M1 Vaccination Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Solicited symptom
|
84 Participants
|
24 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With MVA-NP+M1 Vaccination Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
TEAE or solicited symptom
|
85 Participants
|
34 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With MVA-NP+M1 Vaccination Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Local solicited symptom
|
80 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With MVA-NP+M1 Vaccination Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Local Grade 3 solicited symptom
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With MVA-NP+M1 Vaccination Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Systemic solicited symptom
|
72 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With MVA-NP+M1 Vaccination Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Systemic Grade 3 solicited symptom
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With MVA-NP+M1 Vaccination Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
TEAE of special interest
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With MVA-NP+M1 Vaccination Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Serious TEAE
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With MVA-NP+M1 Vaccination Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Non-serious TEAE
|
36 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With MVA-NP+M1 Vaccination Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Grade ≥3 TEAE
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With MVA-NP+M1 Vaccination Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Grade ≥3 TE laboratory toxicity
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With MVA-NP+M1 Vaccination Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Fatal TEAE
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With MVA-NP+M1 Vaccination Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
TEAE related to treatment
|
10 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With MVA-NP+M1 Vaccination Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Serious TEAE related to treatment
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With MVA-NP+M1 Vaccination Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Grade ≥3 TEAE related to treatment
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With MVA-NP+M1 Vaccination Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
TEAE for which the study was discontinued
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 17 days following vaccinationOccurrence of solicited local and systemic reactogenicity signs and symptoms; self-reported symptoms recorded using questionnaires and adverse event monitoring
Outcome measures
| Measure |
MVA-NP+M1 (ITT)
n=71 Participants
Intention-to-treat (the actually challenged with the virus)
|
Placebo (ITT)
n=47 Participants
Intention-to-treat (the actually challenged with the virus)
|
MVA-NP+M1 (PP)
Per protocol analysis set
|
Placebo (PP)
Per protocol analysis set
|
MVA-NP+M1 (Challenge)
Safety Analysis Set (challenged participants)
|
Placebo (Challenge)
Safety Analysis Set (challenged participants)
|
|---|---|---|---|---|---|---|
|
Number of Participants With H3N2 Challenge Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
TEAE
|
30 Participants
|
21 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With H3N2 Challenge Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Solicited symptom
|
62 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With H3N2 Challenge Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
TEAE or solicited symptom
|
65 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With H3N2 Challenge Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Local solicited symptom
|
59 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With H3N2 Challenge Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Local Grade 3 solicited symptom
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With H3N2 Challenge Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Systemic solicited symptom
|
45 Participants
|
32 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With H3N2 Challenge Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Systemic Grade 3 solicited symptom
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With H3N2 Challenge Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
TEAE of special interest
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With H3N2 Challenge Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Serious TEAE
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With H3N2 Challenge Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Non-serious TEAE
|
30 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With H3N2 Challenge Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Grade ≥3 TEAE
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With H3N2 Challenge Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Grade ≥3 TE laboratory toxicity
|
7 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With H3N2 Challenge Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Fatal TEAE
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With H3N2 Challenge Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
TEAE related to challenge
|
7 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With H3N2 Challenge Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Serious TEAE related to challenge
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With H3N2 Challenge Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Grade ≥3 TEAE related to challenge
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With H3N2 Challenge Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
TEAE for which the study was discontinued
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 11 daysSeverity of individual self-reported symptoms for MVA-NP+M1 vs. Placebo
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 11 daysTime to start; time to peak and duration of total self-reported symptom score, regardless of take rate Influenza Symptom Score Card of FLU010 - Solicited symptoms for generalized, and upper and lower respiratory tract symptoms scored by severity (0: absent, 1: mild, 2: moderate, or 3: severe).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsCorrelation of antigen specific T Cell phenotypes with illness outcomes
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsAntibody responses of MVA-NP+M1 vs Placebo following influenza challenge measured by ELISpot and Intracellular Cytokine Staining (ICS)
Outcome measures
Outcome data not reported
Adverse Events
MVA-NP+M1 (Vaccination Phase)
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Saline Placebo (Vaccination Phase)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
MVA-NP+M1 (Challenge Phase)
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Saline Placebo (Challenge Phase)
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MVA-NP+M1 (Vaccination Phase)
n=87 participants at risk
Vaccination administered: MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10\^8 pfu.);
MVA-NP+M1: Trial Vaccine
|
Saline Placebo (Vaccination Phase)
n=58 participants at risk
Vaccination administered: Sodium Chloride (IM injection, 0.5 ml, 0.9%);
Saline: Sodium Chloride Placebo
|
MVA-NP+M1 (Challenge Phase)
n=71 participants at risk
Vaccination administered: MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10\^8 pfu.);
MVA-NP+M1: Trial Vaccine
Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10\^6 TCID50/ml)
|
Saline Placebo (Challenge Phase)
n=47 participants at risk
Vaccination administered: Sodium Chloride (IM injection, 0.5 ml, 0.9%);
Saline: Sodium Chloride Placebo
Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10\^6 TCID50/ml)
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
1.1%
1/87 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Psychiatric disorders
Acute Psychosis
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
2.1%
1/47 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
Other adverse events
| Measure |
MVA-NP+M1 (Vaccination Phase)
n=87 participants at risk
Vaccination administered: MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10\^8 pfu.);
MVA-NP+M1: Trial Vaccine
|
Saline Placebo (Vaccination Phase)
n=58 participants at risk
Vaccination administered: Sodium Chloride (IM injection, 0.5 ml, 0.9%);
Saline: Sodium Chloride Placebo
|
MVA-NP+M1 (Challenge Phase)
n=71 participants at risk
Vaccination administered: MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10\^8 pfu.);
MVA-NP+M1: Trial Vaccine
Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10\^6 TCID50/ml)
|
Saline Placebo (Challenge Phase)
n=47 participants at risk
Vaccination administered: Sodium Chloride (IM injection, 0.5 ml, 0.9%);
Saline: Sodium Chloride Placebo
Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10\^6 TCID50/ml)
|
|---|---|---|---|---|
|
Infections and infestations
Rhinitis
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.7%
1/58 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
6/87 • Number of events 7 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
6.9%
4/58 • Number of events 4 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
3.4%
2/58 • Number of events 2 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Infections and infestations
Oral Herpes
|
2.3%
2/87 • Number of events 2 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.4%
1/71 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
2.1%
1/47 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Infections and infestations
Conjunctivitis
|
1.1%
1/87 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
2.1%
1/47 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
3.4%
3/87 • Number of events 3 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
3.4%
2/58 • Number of events 2 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.4%
3/87 • Number of events 3 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
2.8%
2/71 • Number of events 2 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.3%
2/87 • Number of events 2 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.7%
1/58 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.1%
1/87 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.7%
1/58 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.7%
1/58 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
1.1%
1/87 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.7%
1/58 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
5/87 • Number of events 5 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
5.2%
3/58 • Number of events 3 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
4.2%
3/71 • Number of events 3 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.7%
1/58 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.1%
1/87 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
4.3%
2/47 • Number of events 2 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.1%
1/87 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/87 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.4%
1/71 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.7%
1/58 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
2.1%
1/47 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.4%
1/71 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
2.1%
1/47 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.4%
1/71 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.4%
1/71 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.4%
1/71 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
2.1%
1/47 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Nervous system disorders
Headache
|
5.7%
5/87 • Number of events 5 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
3.4%
2/58 • Number of events 2 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
2.8%
2/71 • Number of events 2 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
2.1%
1/47 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Nervous system disorders
Dizziness Postural
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.7%
1/58 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.4%
1/71 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.4%
3/87 • Number of events 3 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.7%
1/58 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
2.8%
2/71 • Number of events 2 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
2.3%
2/87 • Number of events 2 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.7%
1/58 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
4.2%
3/71 • Number of events 3 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
2.1%
1/47 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.1%
1/87 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.4%
1/71 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
2.1%
1/47 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.4%
3/87 • Number of events 4 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
5.6%
4/71 • Number of events 4 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
12.8%
6/47 • Number of events 6 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.3%
2/87 • Number of events 2 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.7%
1/58 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
2.1%
1/47 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.4%
1/71 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
2.1%
1/47 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.4%
1/71 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.4%
1/71 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Injury, poisoning and procedural complications
Subcutaneous Haematoma
|
1.1%
1/87 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.7%
1/58 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.7%
1/58 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.7%
1/58 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.4%
1/71 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
1.1%
1/87 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.7%
1/58 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Injury, poisoning and procedural complications
Skin Wound
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
2.1%
1/47 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Eye disorders
Lacrimation Increased
|
1.1%
1/87 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Eye disorders
Swelling of Eyelid
|
1.1%
1/87 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Eye disorders
Eye Irritation
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
2.8%
2/71 • Number of events 2 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Eye disorders
Conjunctival Hyperaemia
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
2.1%
1/47 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Ear and labyrinth disorders
Ear Discomfort
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.7%
1/58 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
2.8%
2/71 • Number of events 2 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
General disorders
Inflammation
|
1.1%
1/87 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
General disorders
Asthenia
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
1.4%
1/71 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
1.1%
1/87 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.1%
1/87 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
2.8%
2/71 • Number of events 2 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
2.1%
1/47 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Surgical and medical procedures
Scar Excision
|
1.1%
1/87 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/47 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/87 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/58 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
0.00%
0/71 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
2.1%
1/47 • Number of events 1 • Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer)
Treatment-emergent adverse events (TEAE) are defined as the Adverse Events starting during or after first administration of any study drug to the end of the study independently of their intensity and if they are related or not to the study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60