Trial Outcomes & Findings for A Study to Evaluate the Safety and Use of Human Rhinovirus in Healthy and Asthmatic Participants (MK-0000-218) (NCT NCT01866306)

Last Updated: 2018-09-04

Results Overview

ECI are selected non-serious and serious adverse events which include the following: an overdose of Sponsor's product; requirement for systemic steroids to treat asthma exacerbation related to virus challenge; acute reaction to virus challenge, confirmed through repeat measurement and when considered potentially associated with administration of virus; specified vital sign findings within 4hr of challenge; specified symptom findings within 24hr of challenge; \>20% decrease in Forced Expiratory Volume in 1 second (FEV1) relative to baseline within 4hr of challenge; dyspnea associated with drop in FEV1 (within 4hr of challenge) that is unresponsive to a bronchodilator rescue agent within 20 minutes; Grade 2+ deviation from normal values of liver-related laboratory parameters at any time between challenge and day 14.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

59 participants

Primary outcome timeframe

Up to Day 24

Results posted on

2018-09-04

Participant Flow

Male and female healthy participants, and participants with mild-moderate asthma between the ages of 18 and 55 years (inclusive) were enrolled in this trial.

Participant milestones

Participant milestones
Measure	Healthy 10 TCID50 (Part 1) Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 100 TCID50 (Part 1) Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 1000 TCID50 (Part 1) Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 10 TCID50 (Part 1) Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 1) Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic LABA 100 TCID50 (Part 1) Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 2) Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
Overall Study STARTED	6	6	6	6	6	6	23
Overall Study COMPLETED	6	6	6	6	6	6	23
Overall Study NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Safety and Use of Human Rhinovirus in Healthy and Asthmatic Participants (MK-0000-218)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy 10 TCID50 (Part 1) n=6 Participants Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 100 TCID50 (Part 1) n=6 Participants Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 1000 TCID50 (Part 1) n=6 Participants Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 10 TCID50 (Part 1) n=6 Participants Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 1) n=6 Participants Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic LABA 100 TCID50 (Part 1) n=6 Participants Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 2) n=23 Participants Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Total n=59 Participants Total of all reporting groups
Age, Continuous	31.5 Years STANDARD_DEVIATION 9.6 • n=5 Participants	39.7 Years STANDARD_DEVIATION 11.4 • n=7 Participants	31.7 Years STANDARD_DEVIATION 10.1 • n=5 Participants	31.7 Years STANDARD_DEVIATION 8.9 • n=4 Participants	32.0 Years STANDARD_DEVIATION 10.2 • n=21 Participants	31.7 Years STANDARD_DEVIATION 9.5 • n=10 Participants	28.9 Years STANDARD_DEVIATION 9.3 • n=115 Participants	31.4 Years STANDARD_DEVIATION 9.7 • n=6 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=10 Participants	13 Participants n=115 Participants	35 Participants n=6 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	10 Participants n=115 Participants	24 Participants n=6 Participants

PRIMARY outcome

Timeframe: Up to Day 24

Population: Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Participants from Part 2 were not analyzed.

Outcome measures

Outcome measures
Measure	Healthy 10 TCID50 (Part 1) n=6 Participants Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 100 TCID50 (Part 1) n=6 Participants Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 1000 TCID50 (Part 1) n=6 Participants Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 10 TCID50 (Part 1) n=6 Participants Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 1) n=6 Participants Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic LABA 100 TCID50 (Part 1) n=6 Participants Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 2) Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
Number of Healthy and Asthmatic Participants With Events of Clinical Interest (ECI) (Part 1)	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Up to Day 24

Population: Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.

A SAE is any adverse event occurring at any dose or during any use of the Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing in-patient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event.

Outcome measures

Outcome measures
Measure	Healthy 10 TCID50 (Part 1) n=6 Participants Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 100 TCID50 (Part 1) n=6 Participants Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 1000 TCID50 (Part 1) n=6 Participants Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 10 TCID50 (Part 1) n=6 Participants Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 1) n=6 Participants Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic LABA 100 TCID50 (Part 1) n=6 Participants Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 2) n=23 Participants Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
Number of Participants With Serious Adverse Events (SAE) (Parts 1 and 2)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 up to Day 7

Asthmatic participants from Part 1 were treated with RV16UB virus at a dose of 100 TCID50, and challenge induced upper airway symptoms were monitored with a diary recording Jackson Cold Symptom Score (CSS). The CSS measures 8 cold symptoms, with each symptom scored from 0 (absent) to 3 (severe). The total score ranges from 0-24, with higher scores reflecting greater severity. The number of participants with a CSS score equal or greater than 3 for two days in a row are presented.

Outcome measures

Outcome measures
Measure	Healthy 10 TCID50 (Part 1) Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 100 TCID50 (Part 1) Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 1000 TCID50 (Part 1) Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 10 TCID50 (Part 1) Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 1) n=6 Participants Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic LABA 100 TCID50 (Part 1) n=6 Participants Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 2) Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
Number of Asthmatic Participants Treated With a Viral Dose of 100 TCID50 With Challenge Induced Upper Airway Symptoms (Part 1)	—	—	—	—	6 Participants	5 Participants	—

PRIMARY outcome

Timeframe: Baseline and Days 1 - 7

Log-transformed FEV1 data were fit by Bayesian hierarchical longitudinal models, with a random participant effect and a fixed categorical effect for day. All baseline (day -7 to day -1) FEV1 were assumed to be with equal mean. FEV1 assessments obtained between 3 am to 3 pm were counted as morning measurements. The TWA CFB morning FEV1 on days 1-7 was calculated as the difference of the mean of estimated day 1-7 morning FEV1 value and the corresponding estimated baseline value. The 95% Confidence Interval actually refers to a 95% Credible Interval. The anticipated mean reduction from baseline is 10%.

Outcome measures

Outcome measures
Measure	Healthy 10 TCID50 (Part 1) Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 100 TCID50 (Part 1) Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 1000 TCID50 (Part 1) Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 10 TCID50 (Part 1) Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 1) Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic LABA 100 TCID50 (Part 1) Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 2) n=23 Participants Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
Time -Weighted Average (TWA) Percent Change From Baseline (CFB) in Morning FEV1 in Asthmatic Participants on Days 1-7 (Part 2)	—	—	—	—	—	—	-1.840 Percent change Interval -2.959 to -0.706

PRIMARY outcome

Timeframe: Baseline and Days 1- 7

Log-transformed FEV1 data were fit by Bayesian hierarchical longitudinal models, with a random participant effect and a fixed categorical effect for day. All baseline (day -7 to day -1) FEV1 were assumed to be with equal mean. FEV1 assessments obtained between 3 pm to next day 3 am were counted as evening measurements. The TWA CFB evening FEV1 on days 1-7 was calculated as the difference of the mean of estimated day 1-7 evening FEV1 value and the corresponding estimated baseline value. The FEV1 readings on the evenings of sputum inductions were excluded from the analyses. The 95% Confidence Interval actually refers to a 95% Credible Interval. The anticipated mean reduction from baseline is 10%.

Outcome measures

Outcome measures
Measure	Healthy 10 TCID50 (Part 1) Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 100 TCID50 (Part 1) Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 1000 TCID50 (Part 1) Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 10 TCID50 (Part 1) Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 1) Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic LABA 100 TCID50 (Part 1) Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 2) n=23 Participants Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
TWA Percent CFB in Evening FEV1 in Asthmatic Participants on Days 1-7 (Part 2)	—	—	—	—	—	—	-2.134 Percent change Interval -3.321 to -0.943

PRIMARY outcome

Timeframe: Baseline and Days 1 - 14

Asthmatic participants from Part 1 were treated with RV16UB virus, and challenge induced upper airway symptoms were monitored with a diary recording CSS. The CSS measures 8 cold symptoms, with each symptom scored from 0 (absent) to 3 (severe). The total score ranges from 0-24, with higher scores reflecting greater severity, and a positive change from baseline indicating worsening symptoms.

Outcome measures

Outcome measures
Measure	Healthy 10 TCID50 (Part 1) Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 100 TCID50 (Part 1) Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 1000 TCID50 (Part 1) Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 10 TCID50 (Part 1) n=6 Participants Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 1) n=6 Participants Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic LABA 100 TCID50 (Part 1) n=6 Participants Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 2) Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
Change From Baseline in Mean Maximum Jackson Cold Symptom Score (CSS) on Days 1 to 14 in Asthmatic Participants (Part 1)	—	—	—	6.05 Score on a scale Standard Deviation 3.18	6.99 Score on a scale Standard Deviation 3.22	9.56 Score on a scale Standard Deviation 4.76	—

PRIMARY outcome

Timeframe: Days 1 - 14

Viral RNA was measured by real time reverse transcriptase polymerase chain reaction (qRT-PCR) from nasal lavage fluid collected on day 3 and day 7 from asthmatic participants, and the number of participants with at least 10\^3 copies/ml was determined.

Outcome measures

Outcome measures
Measure	Healthy 10 TCID50 (Part 1) Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 100 TCID50 (Part 1) Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 1000 TCID50 (Part 1) Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 10 TCID50 (Part 1) n=6 Participants Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 1) n=6 Participants Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic LABA 100 TCID50 (Part 1) n=6 Participants Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 2) Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
Number of Asthmatic Participants Demonstrating at Least 10^3 Copies/ml of Viral RNA in Nasal Lavage Fluid on Days 1 to 14 (Part 1)	—	—	—	4 Participants	5 Participants	6 Participants	—

SECONDARY outcome

Timeframe: Baseline and up to day 7

Log-transformed FEV1 data were fit by Bayesian hierarchical longitudinal models, with a random participant effect and a fixed categorical effect for day. All baseline (day -7 to day -1) FEV1 were assumed to be with equal mean. The FEV1 readings on the evenings of sputum inductions were excluded from the analyses. The percent decrease of the lowest FEV1 measurement after viral challenge compared to the TWA of the baseline FEV1 is presented. The 95% Confidence Interval actually refers to a 95% Credible Interval. The mean percent decrease is anticipated to be different from zero.

Outcome measures

Outcome measures
Measure	Healthy 10 TCID50 (Part 1) Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 100 TCID50 (Part 1) Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 1000 TCID50 (Part 1) Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 10 TCID50 (Part 1) Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 1) Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic LABA 100 TCID50 (Part 1) Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 2) n=23 Participants Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
Mean Percent Change From Baseline in Maximum Drop FEV1 of Asthmatic Participants (Part 2)	—	—	—	—	—	—	-6.838 Percent change Interval -9.316 to -4.835

SECONDARY outcome

Timeframe: Baseline and Days 3 to 10

The ACD contains seven symptom questions (nocturnal awakening, waking in the morning with symptoms, activity limitation, shortness of breath and wheezing) which are answered on rising in the morning and retiring at bedtime. Missing scores are imputed by linear interpolation or extrapolation. Daily ACD score was fit by a Bayesian hierarchical longitudinal model with participant-specific intercept and a fixed categorical effect for day. All baseline (day -7 to day -1) ACD scores are assumed to be with equal mean. The ACD score is the sum of responses to the seven questions, with answers on a 7-point scale (0= no impairment; 6 = maximum impairment) with the score ranging from 0 to 42, and higher scores indicating greater impairment. The 95% Confidence Interval actually refers to a 95% Credible Interval. The mean percent increase is anticipated to be different from zero.

Outcome measures

Outcome measures
Measure	Healthy 10 TCID50 (Part 1) Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 100 TCID50 (Part 1) Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 1000 TCID50 (Part 1) Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 10 TCID50 (Part 1) Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 1) Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic LABA 100 TCID50 (Part 1) Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 2) n=23 Participants Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
Mean Change From Baseline in TWA Asthma Control Diary (ACD) Score of Asthmatic Participants on Days 3 to 10 (Part 2)	—	—	—	—	—	—	2.732 Score on a scale Interval 2.282 to 3.177

Adverse Events

Healthy 10 TCID50 (Part 1)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Healthy 100 TCID50 (Part 1)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Healthy 1000 TCID50 (Part 1)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Asthmatic Non-LABA 10 TCID50 (Part 1)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Asthmatic Non-LABA 100 TCID50 (Part 1)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Asthmatic LABA 100 TCID50 (Part 1)

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Asthmatic Non-LABA 100 TCID50 (Part 2)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Healthy 10 TCID50 (Part 1) n=6 participants at risk Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 100 TCID50 (Part 1) n=6 participants at risk Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 1000 TCID50 (Part 1) n=6 participants at risk Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 10 TCID50 (Part 1) n=6 participants at risk Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 1) n=6 participants at risk Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic LABA 100 TCID50 (Part 1) n=6 participants at risk Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 2) n=23 participants at risk Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	16.7% 1/6 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/23 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.

Other adverse events

Other adverse events
Measure	Healthy 10 TCID50 (Part 1) n=6 participants at risk Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 100 TCID50 (Part 1) n=6 participants at risk Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Healthy 1000 TCID50 (Part 1) n=6 participants at risk Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 10 TCID50 (Part 1) n=6 participants at risk Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 1) n=6 participants at risk Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic LABA 100 TCID50 (Part 1) n=6 participants at risk Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.	Asthmatic Non-LABA 100 TCID50 (Part 2) n=23 participants at risk Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	16.7% 1/6 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/23 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	16.7% 1/6 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/23 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.
Gastrointestinal disorders Nausea	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	16.7% 1/6 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/23 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.
General disorders Fatigue	16.7% 1/6 • Number of events 3 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/23 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.
Immune system disorders Hypersensitivity	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	4.3% 1/23 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.
Infections and infestations Bladder candidiasis	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	16.7% 1/6 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/23 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.
Infections and infestations Conjunctivitis	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	16.7% 1/6 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/23 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.
Infections and infestations Cystitis	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	16.7% 1/6 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	16.7% 1/6 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/23 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.
Infections and infestations Gastroenteritis viral	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	16.7% 1/6 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	4.3% 1/23 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.
Infections and infestations Nasopharyngitis	16.7% 1/6 • Number of events 2 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/23 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.
Infections and infestations Respiratory tract infection	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	16.7% 1/6 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/23 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	4.3% 1/23 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.
Injury, poisoning and procedural complications Laceration	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	4.3% 1/23 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.
Investigations Aspartate aminotransferase increased	16.7% 1/6 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/23 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.
Nervous system disorders Headache	16.7% 1/6 • Number of events 2 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	16.7% 1/6 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	16.7% 1/6 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	16.7% 1/6 • Number of events 2 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	4.3% 1/23 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.
Nervous system disorders Tension headache	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	16.7% 1/6 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/23 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.
Renal and urinary disorders Haematuria	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	16.7% 1/6 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/23 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	16.7% 1/6 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	8.7% 2/23 • Number of events 2 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Number of events 2 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	16.7% 1/6 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/23 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.7% 1/6 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/23 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.
Respiratory, thoracic and mediastinal disorders Epistaxis	16.7% 1/6 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	16.7% 1/6 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	8.7% 2/23 • Number of events 2 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	16.7% 1/6 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	4.3% 1/23 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/6 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	16.7% 1/6 • Number of events 1 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.	0.00% 0/23 • Up to day 24 Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Publication restrictions are in place

Restriction type: OTHER