Trial Outcomes & Findings for Dose, Safety, and Pathogenicity of a New Influenza A H3N2 Challenge Strain (NCT NCT06613737)
NCT ID: NCT06613737
Last Updated: 2026-04-23
Results Overview
Occurrence of adverse events (AEs) related to the viral challenge from viral challenge (Day 0) to the Day 28 follow-up visit.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
Day 0 to Day 28
Results posted on
2026-04-23
Participant Flow
Participant milestones
| Measure |
Medium Dose, Pipette Administration.
Influenza A H3N2 virus dose arm 1: Medium dose, approximately 10\^4.5 TCID50/mL, pipette administration.
|
Medium Dose, MAD Administration.
Influenza A H3N2 virus dose arm 2: Medium dose, approximately 10\^4.5 TCID50/mL, Mucosal Atomization Device® \[MAD\] administration.
|
High Dose, Pipette Administration.
Influenza A H3N2 virus dose arm 3: High dose, approximately 10\^5.5 TCID50/mL, pipette administration.
|
High Dose, MAD Administration.
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, Mucosal Atomization Device® \[MAD\] administration.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
4
|
19
|
|
Overall Study
COMPLETED
|
5
|
5
|
4
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose, Safety, and Pathogenicity of a New Influenza A H3N2 Challenge Strain
Baseline characteristics by cohort
| Measure |
Medium Dose, Pipette Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 1: Medium dose, approximately 10\^4.5 TCID50/mL, pipette administration.
|
Medium Dose, MAD Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 2: Medium dose, approximately 10\^4.5 TCID50/mL, MAD administration.
|
High Dose, Pipette Administration.
n=4 Participants
Influenza A H3N2 virus dose arm 3: High dose, approximately 10\^5.5 TCID50/mL, pipette administration.
|
High Dose, MAD Administration.
n=19 Participants
Influenza A H3N2 virus dose arm 3: High dose, approximately 10\^5.5 TCID50/mL, MAD administration.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
29.60 years
STANDARD_DEVIATION 8.44 • n=60 Participants
|
29.60 years
STANDARD_DEVIATION 7.92 • n=56 Participants
|
25.75 years
STANDARD_DEVIATION 6.24 • n=116 Participants
|
29.37 years
STANDARD_DEVIATION 7.73 • n=7 Participants
|
29.00 years
STANDARD_DEVIATION 7.45 • n=3 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
2 Participants
n=116 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=60 Participants
|
5 Participants
n=56 Participants
|
2 Participants
n=116 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=60 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=60 Participants
|
4 Participants
n=56 Participants
|
4 Participants
n=116 Participants
|
19 Participants
n=7 Participants
|
32 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=60 Participants
|
3 Participants
n=56 Participants
|
3 Participants
n=116 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=60 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=60 Participants
|
1 Participants
n=56 Participants
|
1 Participants
n=116 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=3 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=60 Participants
|
5 participants
n=56 Participants
|
4 participants
n=116 Participants
|
19 participants
n=7 Participants
|
33 participants
n=3 Participants
|
|
Body Mass Index (BMI)
|
27.18 kg/m^2
STANDARD_DEVIATION 3.14 • n=60 Participants
|
25.82 kg/m^2
STANDARD_DEVIATION 2.67 • n=56 Participants
|
25.70 kg/m^2
STANDARD_DEVIATION 1.99 • n=116 Participants
|
26.34 kg/m^2
STANDARD_DEVIATION 3.38 • n=7 Participants
|
26.31 kg/m^2
STANDARD_DEVIATION 3.02 • n=3 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 28Occurrence of adverse events (AEs) related to the viral challenge from viral challenge (Day 0) to the Day 28 follow-up visit.
Outcome measures
| Measure |
Medium Dose, Pipette Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 1: Medium dose, approximately 10\^4.5 TCID50/mL, pipette administration.
|
Medium Dose, MAD Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 2: Medium dose, approximately 10\^4.5 TCID50/mL, MAD administration.
|
High Dose, Pipette Administration.
n=4 Participants
Influenza A H3N2 virus dose arm 3: High dose, approximately 10\^5.5 TCID50/mL, pipette administration.
|
High Dose, MAD Administration.
n=19 Participants
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration.
|
High Dose, MAD Administration (Part B Only) - Throat Samples
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration. Part B only.
|
|---|---|---|---|---|---|
|
Occurrence of Adverse Events Related to the Viral Challenge
|
0 Occurrence of adverse events
|
0 Occurrence of adverse events
|
1 Occurrence of adverse events
|
6 Occurrence of adverse events
|
—
|
PRIMARY outcome
Timeframe: Day 0 to Day 28Occurrence of serious adverse events (SAEs) related to the viral challenge from viral challenge (Day 0) to the Day 28 follow-up visit.
Outcome measures
| Measure |
Medium Dose, Pipette Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 1: Medium dose, approximately 10\^4.5 TCID50/mL, pipette administration.
|
Medium Dose, MAD Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 2: Medium dose, approximately 10\^4.5 TCID50/mL, MAD administration.
|
High Dose, Pipette Administration.
n=4 Participants
Influenza A H3N2 virus dose arm 3: High dose, approximately 10\^5.5 TCID50/mL, pipette administration.
|
High Dose, MAD Administration.
n=19 Participants
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration.
|
High Dose, MAD Administration (Part B Only) - Throat Samples
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration. Part B only.
|
|---|---|---|---|---|---|
|
Occurrence of Serious Adverse Events Related to the Viral Challenge
|
0 Occurrence of serious adverse events
|
0 Occurrence of serious adverse events
|
0 Occurrence of serious adverse events
|
0 Occurrence of serious adverse events
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 8Quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR)-confirmed influenza infection, defined as 2 quantifiable (≥ lower limit of quantification \[LLOQ\]) qRT-PCR measurements (reported over 4 planned consecutive assessments within 48 hours), from Day 1 pm to planned discharge from quarantine (Day 8 am).
Outcome measures
| Measure |
Medium Dose, Pipette Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 1: Medium dose, approximately 10\^4.5 TCID50/mL, pipette administration.
|
Medium Dose, MAD Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 2: Medium dose, approximately 10\^4.5 TCID50/mL, MAD administration.
|
High Dose, Pipette Administration.
n=4 Participants
Influenza A H3N2 virus dose arm 3: High dose, approximately 10\^5.5 TCID50/mL, pipette administration.
|
High Dose, MAD Administration.
n=19 Participants
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration.
|
High Dose, MAD Administration (Part B Only) - Throat Samples
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration. Part B only.
|
|---|---|---|---|---|---|
|
Induces Laboratory-confirmed Infection in ≥40% of Inoculated Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
12 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 8Viral culture-confirmed influenza infection, defined as a quantifiable viral culture measurement, from Day 1 pm to planned discharge from quarantine (Day 8 am).
Outcome measures
| Measure |
Medium Dose, Pipette Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 1: Medium dose, approximately 10\^4.5 TCID50/mL, pipette administration.
|
Medium Dose, MAD Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 2: Medium dose, approximately 10\^4.5 TCID50/mL, MAD administration.
|
High Dose, Pipette Administration.
n=4 Participants
Influenza A H3N2 virus dose arm 3: High dose, approximately 10\^5.5 TCID50/mL, pipette administration.
|
High Dose, MAD Administration.
n=19 Participants
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration.
|
High Dose, MAD Administration (Part B Only) - Throat Samples
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration. Part B only.
|
|---|---|---|---|---|---|
|
Incidence of Viral Culture-confirmed Influenza Infection.
|
2 Participants
|
2 Participants
|
1 Participants
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 8Area under the viral load-time curve (VL-AUC) of influenza challenge virus as determined by qRT-PCR on both nasal and throat (Part B only) samples, starting from Day 1 pm up to planned discharge from quarantine (Day 8 am)
Outcome measures
| Measure |
Medium Dose, Pipette Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 1: Medium dose, approximately 10\^4.5 TCID50/mL, pipette administration.
|
Medium Dose, MAD Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 2: Medium dose, approximately 10\^4.5 TCID50/mL, MAD administration.
|
High Dose, Pipette Administration.
n=4 Participants
Influenza A H3N2 virus dose arm 3: High dose, approximately 10\^5.5 TCID50/mL, pipette administration.
|
High Dose, MAD Administration.
n=19 Participants
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration.
|
High Dose, MAD Administration (Part B Only) - Throat Samples
n=12 Participants
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration. Part B only.
|
|---|---|---|---|---|---|
|
VL-AUC of Influenza Challenge Virus as Determined by qRT-PCR
|
20.03 log10 copies/mL*days
Standard Deviation 15.52
|
18.40 log10 copies/mL*days
Standard Deviation 12.50
|
14.61 log10 copies/mL*days
Standard Deviation 10.82
|
22.21 log10 copies/mL*days
Standard Deviation 14.30
|
10.10 log10 copies/mL*days
Standard Deviation 6.61
|
SECONDARY outcome
Timeframe: Day 1 to Day 8Peak viral load of influenza challenge virus defined as the maximum viral load, from qRT-PCR on nasal and throat (Part B only) samples from Day 1 pm to planned discharge from quarantine (Day 8 am).
Outcome measures
| Measure |
Medium Dose, Pipette Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 1: Medium dose, approximately 10\^4.5 TCID50/mL, pipette administration.
|
Medium Dose, MAD Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 2: Medium dose, approximately 10\^4.5 TCID50/mL, MAD administration.
|
High Dose, Pipette Administration.
n=4 Participants
Influenza A H3N2 virus dose arm 3: High dose, approximately 10\^5.5 TCID50/mL, pipette administration.
|
High Dose, MAD Administration.
n=19 Participants
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration.
|
High Dose, MAD Administration (Part B Only) - Throat Samples
n=12 Participants
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration. Part B only.
|
|---|---|---|---|---|---|
|
Peak Viral Load of Influenza Challenge Virus as Determined by qRT-PCR
|
4.69 log10 copies/mL
Standard Deviation 3.67
|
4.75 log10 copies/mL
Standard Deviation 3.77
|
4.26 log10 copies/mL
Standard Deviation 2.58
|
5.52 log10 copies/mL
Standard Deviation 320
|
3.86 log10 copies/mL
Standard Deviation 2.97
|
SECONDARY outcome
Timeframe: Day 1 to Day 8Area under the viral load-time curve (VL-AUC) of influenza challenge virus as determined by viral culture on both nasal and throat (Part B only) samples, starting from Day 1 pm up to planned discharge from quarantine (Day 8 am)
Outcome measures
| Measure |
Medium Dose, Pipette Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 1: Medium dose, approximately 10\^4.5 TCID50/mL, pipette administration.
|
Medium Dose, MAD Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 2: Medium dose, approximately 10\^4.5 TCID50/mL, MAD administration.
|
High Dose, Pipette Administration.
n=4 Participants
Influenza A H3N2 virus dose arm 3: High dose, approximately 10\^5.5 TCID50/mL, pipette administration.
|
High Dose, MAD Administration.
n=19 Participants
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration.
|
High Dose, MAD Administration (Part B Only) - Throat Samples
n=12 Participants
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration. Part B only.
|
|---|---|---|---|---|---|
|
VL-AUC of Influenza Challenge Virus as Determined by Viral Culture
|
9.72 log10TCID50/mL*days
Standard Deviation 7.26
|
6.05 log10TCID50/mL*days
Standard Deviation 2.66
|
6.19 log10TCID50/mL*days
Standard Deviation 3.53
|
7.50 log10TCID50/mL*days
Standard Deviation 3.95
|
5.36 log10TCID50/mL*days
Standard Deviation 2.26
|
SECONDARY outcome
Timeframe: Day 1 to Day 8Peak viral load of influenza challenge virus defined as the maximum viral load, from by viral culture on nasal and throat (Part B only) samples from Day 1 pm to planned discharge from quarantine (Day 8 am).
Outcome measures
| Measure |
Medium Dose, Pipette Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 1: Medium dose, approximately 10\^4.5 TCID50/mL, pipette administration.
|
Medium Dose, MAD Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 2: Medium dose, approximately 10\^4.5 TCID50/mL, MAD administration.
|
High Dose, Pipette Administration.
n=4 Participants
Influenza A H3N2 virus dose arm 3: High dose, approximately 10\^5.5 TCID50/mL, pipette administration.
|
High Dose, MAD Administration.
n=19 Participants
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration.
|
High Dose, MAD Administration (Part B Only) - Throat Samples
n=12 Participants
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration. Part B only.
|
|---|---|---|---|---|---|
|
Peak Viral Load of Influenza Challenge Virus as Determined by Viral Culture
|
2.35 log10TCID50/mL
Standard Deviation 1.99
|
2.20 log10TCID50/mL
Standard Deviation 1.95
|
1.52 log10TCID50/mL
Standard Deviation 1.68
|
2.66 log10TCID50/mL
Standard Deviation 1.89
|
1.50 log10TCID50/mL
Standard Deviation 1.63
|
SECONDARY outcome
Timeframe: Day 1 to Day 8Data presented is score\*days. TSS-AUC (trapezium rule) as measured by graded symptom scoring system collected 3 times daily starting Day 1 am up to Day 8 am using a participant self-reportable 13-symptoms card, the max number of diary cards included in the AUC calculation is 22, the maximum time period is 7 days. Clinical symptoms included runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle and/or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptom from 0 (no symptoms) to 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. Dairy card total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4). The range of TSS AUC scores are between 0 and 287 score\*days (maximum of 41\*7).
Outcome measures
| Measure |
Medium Dose, Pipette Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 1: Medium dose, approximately 10\^4.5 TCID50/mL, pipette administration.
|
Medium Dose, MAD Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 2: Medium dose, approximately 10\^4.5 TCID50/mL, MAD administration.
|
High Dose, Pipette Administration.
n=4 Participants
Influenza A H3N2 virus dose arm 3: High dose, approximately 10\^5.5 TCID50/mL, pipette administration.
|
High Dose, MAD Administration.
n=19 Participants
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration.
|
High Dose, MAD Administration (Part B Only) - Throat Samples
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration. Part B only.
|
|---|---|---|---|---|---|
|
Area Under the Total Clinical Symptoms Score-time Curve (TSS-AUC)
|
5.88 score*days
Standard Deviation 5.32
|
10.91 score*days
Standard Deviation 7.14
|
3.05 score*days
Standard Deviation 4.27
|
10.23 score*days
Standard Deviation 10.99
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 8Peak Total Symptom Score (TSS) for each participant is defined as the diary card total with the worst score (highest). The symptom scoring system was collected three times daily starting one day post-viral challenge (Day 1) up to discharge from quarantine (Day 8 am) using a participant self-reportable 13-symptoms card. Clinical symptoms included runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle and/or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptom from 0 (no symptoms) to 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. Dairy card total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4).
Outcome measures
| Measure |
Medium Dose, Pipette Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 1: Medium dose, approximately 10\^4.5 TCID50/mL, pipette administration.
|
Medium Dose, MAD Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 2: Medium dose, approximately 10\^4.5 TCID50/mL, MAD administration.
|
High Dose, Pipette Administration.
n=4 Participants
Influenza A H3N2 virus dose arm 3: High dose, approximately 10\^5.5 TCID50/mL, pipette administration.
|
High Dose, MAD Administration.
n=19 Participants
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration.
|
High Dose, MAD Administration (Part B Only) - Throat Samples
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration. Part B only.
|
|---|---|---|---|---|---|
|
Peak Total Symptoms Diary Card Score
|
3.20 Peak TSS
Standard Deviation 2.39
|
5.40 Peak TSS
Standard Deviation 2.97
|
2.75 Peak TSS
Standard Deviation 3.10
|
4.05 Peak TSS
Standard Deviation 3.70
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 8Peak daily symptom score was derived, for each day from Day 1 to Day 8, as the maximum of the 3 total symptoms scores on that day. The symptoms were collected three times daily starting one day post-viral challenge (Day 1) up to planned discharge from quarantine (Day 8 am) using a participant self-reportable 13-symptoms card. Clinical symptoms included runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle and/or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptom from 0 (no symptoms) to 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. Dairy card total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4).
Outcome measures
| Measure |
Medium Dose, Pipette Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 1: Medium dose, approximately 10\^4.5 TCID50/mL, pipette administration.
|
Medium Dose, MAD Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 2: Medium dose, approximately 10\^4.5 TCID50/mL, MAD administration.
|
High Dose, Pipette Administration.
n=4 Participants
Influenza A H3N2 virus dose arm 3: High dose, approximately 10\^5.5 TCID50/mL, pipette administration.
|
High Dose, MAD Administration.
n=19 Participants
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration.
|
High Dose, MAD Administration (Part B Only) - Throat Samples
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration. Part B only.
|
|---|---|---|---|---|---|
|
Peak Daily Symptoms Diary Card Score
Day 1
|
0.80 Peak TSS
Standard Deviation 0.84
|
0.40 Peak TSS
Standard Deviation 0.89
|
1.25 Peak TSS
Standard Deviation 2.50
|
0.95 Peak TSS
Standard Deviation 1.90
|
—
|
|
Peak Daily Symptoms Diary Card Score
Day 2
|
0.40 Peak TSS
Standard Deviation 0.89
|
2.80 Peak TSS
Standard Deviation 1.92
|
1.00 Peak TSS
Standard Deviation 2.00
|
2.84 Peak TSS
Standard Deviation 3.18
|
—
|
|
Peak Daily Symptoms Diary Card Score
Day 3
|
0.80 Peak TSS
Standard Deviation 0.45
|
2.20 Peak TSS
Standard Deviation 2.39
|
1.50 Peak TSS
Standard Deviation 1.29
|
3.16 Peak TSS
Standard Deviation 3.44
|
—
|
|
Peak Daily Symptoms Diary Card Score
Day 4
|
2.20 Peak TSS
Standard Deviation 1.48
|
3.00 Peak TSS
Standard Deviation 3.74
|
0.50 Peak TSS
Standard Deviation 1.00
|
2.63 Peak TSS
Standard Deviation 2.99
|
—
|
|
Peak Daily Symptoms Diary Card Score
Day 5
|
1.60 Peak TSS
Standard Deviation 1.14
|
2.40 Peak TSS
Standard Deviation 2.79
|
0 Peak TSS
Standard Deviation 0
|
2.32 Peak TSS
Standard Deviation 2.47
|
—
|
|
Peak Daily Symptoms Diary Card Score
Day 6
|
1.80 Peak TSS
Standard Deviation 3.03
|
2.00 Peak TSS
Standard Deviation 1.58
|
1.75 Peak TSS
Standard Deviation 3.50
|
1.26 Peak TSS
Standard Deviation 1.69
|
—
|
|
Peak Daily Symptoms Diary Card Score
Day 7
|
1.40 Peak TSS
Standard Deviation 2.61
|
2.00 Peak TSS
Standard Deviation 3.39
|
0.50 Peak TSS
Standard Deviation 1.00
|
1.00 Peak TSS
Standard Deviation 1.29
|
—
|
|
Peak Daily Symptoms Diary Card Score
Day 8
|
1.20 Peak TSS
Standard Deviation 2.68
|
1.60 Peak TSS
Standard Deviation 3.58
|
0 Peak TSS
Standard Deviation 0
|
0.26 Peak TSS
Standard Deviation 0.65
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 8A qRT-PCR-confirmed influenza infection, defined as 2 quantifiable (≥LLOQ) qRT-PCR measurements (reported on 2 or more independent samples over 4 planned consecutive assessments within 48 hours), from Day 1 pm to planned discharge from quarantine (Day 8 am) AND, a febrile episode, defined as a temperature of ≥37.9°C, from Day 1 am to planned discharge from quarantine (Day 8 am).
Outcome measures
| Measure |
Medium Dose, Pipette Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 1: Medium dose, approximately 10\^4.5 TCID50/mL, pipette administration.
|
Medium Dose, MAD Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 2: Medium dose, approximately 10\^4.5 TCID50/mL, MAD administration.
|
High Dose, Pipette Administration.
n=4 Participants
Influenza A H3N2 virus dose arm 3: High dose, approximately 10\^5.5 TCID50/mL, pipette administration.
|
High Dose, MAD Administration.
n=19 Participants
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration.
|
High Dose, MAD Administration (Part B Only) - Throat Samples
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration. Part B only.
|
|---|---|---|---|---|---|
|
Laboratory-confirmed Febrile Influenza Infection
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 8A qRT-PCR-confirmed influenza infection, defined as 2 quantifiable (≥LLOQ) qRT-PCR measurements (reported on 2 or more independent samples over 4 planned consecutive assessments within 48 hours), from Day 1 pm to planned discharge from quarantine (Day 8 am) AND, a febrile episode, defined as a temperature of ≥37.8ºC, and a cough and/or sore throat (symptoms and signs), from Day 1 am to planned discharge from quarantine (Day 8 am), in the absence of a known cause other than influenza.
Outcome measures
| Measure |
Medium Dose, Pipette Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 1: Medium dose, approximately 10\^4.5 TCID50/mL, pipette administration.
|
Medium Dose, MAD Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 2: Medium dose, approximately 10\^4.5 TCID50/mL, MAD administration.
|
High Dose, Pipette Administration.
n=4 Participants
Influenza A H3N2 virus dose arm 3: High dose, approximately 10\^5.5 TCID50/mL, pipette administration.
|
High Dose, MAD Administration.
n=19 Participants
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration.
|
High Dose, MAD Administration (Part B Only) - Throat Samples
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration. Part B only.
|
|---|---|---|---|---|---|
|
qRT-PCR-confirmed Influenza-like Illness (Centers for Disease and Control [CDC])
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 8A qRT-PCR-confirmed influenza infection, defined as 2 quantifiable (≥LLOQ) qRT-PCR measurements (reported on 2 or more independent samples over 4 planned consecutive assessments within 48 hours), from Day 1 pm to planned discharge from quarantine (Day 8 am) AND, a febrile episode, defined as a temperature of ≥38.0ºC and a cough, from Day 1 am to planned discharge from quarantine (Day 8 am).
Outcome measures
| Measure |
Medium Dose, Pipette Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 1: Medium dose, approximately 10\^4.5 TCID50/mL, pipette administration.
|
Medium Dose, MAD Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 2: Medium dose, approximately 10\^4.5 TCID50/mL, MAD administration.
|
High Dose, Pipette Administration.
n=4 Participants
Influenza A H3N2 virus dose arm 3: High dose, approximately 10\^5.5 TCID50/mL, pipette administration.
|
High Dose, MAD Administration.
n=19 Participants
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration.
|
High Dose, MAD Administration (Part B Only) - Throat Samples
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration. Part B only.
|
|---|---|---|---|---|---|
|
qRT-PCR-confirmed Influenza-like Illness (World Health Organization [WHO])
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 8A qRT-PCR-confirmed influenza infection, defined as 2 quantifiable (≥LLOQ) qRT-PCR measurements (reported on 2 or more independent samples over 4 planned consecutive assessments within 48 hours), from Day 1 pm to planned discharge from quarantine (Day 8 am) AND, any symptoms from the symptom diary card of grade ≥2 at a single time point, from Day 1 am to planned discharge from quarantine (Day 8 am).
Outcome measures
| Measure |
Medium Dose, Pipette Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 1: Medium dose, approximately 10\^4.5 TCID50/mL, pipette administration.
|
Medium Dose, MAD Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 2: Medium dose, approximately 10\^4.5 TCID50/mL, MAD administration.
|
High Dose, Pipette Administration.
n=4 Participants
Influenza A H3N2 virus dose arm 3: High dose, approximately 10\^5.5 TCID50/mL, pipette administration.
|
High Dose, MAD Administration.
n=19 Participants
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration.
|
High Dose, MAD Administration (Part B Only) - Throat Samples
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration. Part B only.
|
|---|---|---|---|---|---|
|
Laboratory-confirmed Moderately Severe Symptomatic Influenza Infection
|
1 Participants
|
3 Participants
|
0 Participants
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 8A qRT-PCR-confirmed influenza infection, defined as 2 quantifiable (≥LLOQ) qRT-PCR measurements (reported on 2 or more independent samples over 4 planned consecutive assessments within 48 hours), from Day 1 pm to planned discharge from quarantine (Day 8 am) AND, a total symptom score of ≥2 at a single time point, from Day 1 am to planned discharge from quarantine (Day 8 am).
Outcome measures
| Measure |
Medium Dose, Pipette Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 1: Medium dose, approximately 10\^4.5 TCID50/mL, pipette administration.
|
Medium Dose, MAD Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 2: Medium dose, approximately 10\^4.5 TCID50/mL, MAD administration.
|
High Dose, Pipette Administration.
n=4 Participants
Influenza A H3N2 virus dose arm 3: High dose, approximately 10\^5.5 TCID50/mL, pipette administration.
|
High Dose, MAD Administration.
n=19 Participants
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration.
|
High Dose, MAD Administration (Part B Only) - Throat Samples
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration. Part B only.
|
|---|---|---|---|---|---|
|
Laboratory-confirmed Symptomatic Influenza Infection
|
3 Participants
|
3 Participants
|
2 Participants
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 8Viral culture laboratory-confirmed infection, AND any symptoms from the symptom diary card of grade ≥2 at a single time point, from Day 1 am to planned discharge from quarantine (Day 8 am).
Outcome measures
| Measure |
Medium Dose, Pipette Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 1: Medium dose, approximately 10\^4.5 TCID50/mL, pipette administration.
|
Medium Dose, MAD Administration.
n=5 Participants
Influenza A H3N2 virus dose arm 2: Medium dose, approximately 10\^4.5 TCID50/mL, MAD administration.
|
High Dose, Pipette Administration.
n=4 Participants
Influenza A H3N2 virus dose arm 3: High dose, approximately 10\^5.5 TCID50/mL, pipette administration.
|
High Dose, MAD Administration.
n=19 Participants
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration.
|
High Dose, MAD Administration (Part B Only) - Throat Samples
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration. Part B only.
|
|---|---|---|---|---|---|
|
Viral Culture Laboratory-confirmed Moderately Severe Symptomatic Influenza Infection
|
1 Participants
|
2 Participants
|
0 Participants
|
7 Participants
|
—
|
Adverse Events
Medium Dose, Pipette Administration.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Medium Dose, MAD Administration.
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
High Dose, Pipette Administration.
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
High Dose, MAD Administration.
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Medium Dose, Pipette Administration.
n=5 participants at risk
Influenza A H3N2 virus dose arm 1: Medium dose, approximately 10\^4.5 TCID50/mL, pipette administration.
|
Medium Dose, MAD Administration.
n=5 participants at risk
Influenza A H3N2 virus dose arm 2: Medium dose, approximately 10\^4.5 TCID50/mL, MAD administration.
|
High Dose, Pipette Administration.
n=4 participants at risk
Influenza A H3N2 virus dose arm 3: High dose, approximately 10\^5.5 TCID50/mL, pipette administration.
|
High Dose, MAD Administration.
n=19 participants at risk
Influenza A H3N2 virus dose arm 4: High dose, approximately 10\^5.5 TCID50/mL, MAD administration.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/5 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/4 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
21.1%
4/19 • Number of events 4 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/5 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/5 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/4 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
5.3%
1/19 • Number of events 1 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/5 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/4 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
15.8%
3/19 • Number of events 3 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
20.0%
1/5 • Number of events 1 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/4 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
5.3%
1/19 • Number of events 1 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
|
Investigations
C-reactive protein increased
|
0.00%
0/5 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/5 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/4 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
5.3%
1/19 • Number of events 1 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
20.0%
1/5 • Number of events 1 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/4 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
5.3%
1/19 • Number of events 1 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
|
Infections and infestations
Tooth infection
|
0.00%
0/5 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/5 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
25.0%
1/4 • Number of events 1 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/19 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/5 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/5 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/4 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
5.3%
1/19 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/5 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/5 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
25.0%
1/4 • Number of events 1 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/19 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/5 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/5 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/4 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
5.3%
1/19 • Number of events 1 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/5 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/4 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
10.5%
2/19 • Number of events 2 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/5 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
20.0%
1/5 • Number of events 1 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/4 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/19 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
20.0%
1/5 • Number of events 1 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/4 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/19 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/5 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
20.0%
1/5 • Number of events 1 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/4 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
0.00%
0/19 • Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place