Trial Outcomes & Findings for Study of RSVpreF Vaccination and RSV Challenge in Healthy Adults (NCT NCT04785612)

Results Overview

The VL-AUC of RSV determined by qRT-PCR from nasal wash samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

70 participants

Primary outcome timeframe

Day 2 to Day 12

Results posted on

2024-08-07

Participant Flow

70 participants were to be enrolled and vaccinated with the study vaccine, with 62 participants challenged with the study virus.

70 participants were consented and vaccinated to ensure that 62 were able to then be challenged with RSV-A Memphis 37b accounting for dropouts between vaccination and challenge.

Participant milestones

Participant milestones
Measure	RSVPreF A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine
Overall Study STARTED	35	35
Overall Study COMPLETED	31	31
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of RSVpreF Vaccination and RSV Challenge in Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RSVPreF n=35 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=35 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	Total n=70 Participants Total of all reporting groups
Age, Continuous	26.0 years STANDARD_DEVIATION 6.46 • n=93 Participants	27.1 years STANDARD_DEVIATION 6.78 • n=4 Participants	26.5 years STANDARD_DEVIATION 6.60 • n=27 Participants
Sex: Female, Male Female	10 Participants n=93 Participants	10 Participants n=4 Participants	20 Participants n=27 Participants
Sex: Female, Male Male	25 Participants n=93 Participants	25 Participants n=4 Participants	50 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) White	31 Participants n=93 Participants	34 Participants n=4 Participants	65 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants

PRIMARY outcome

Timeframe: Day 2 to Day 12

Population: The primary analysis used the ITT (Intent-to-Treat) Challenge Analysis Set which included all participants randomly assigned to study intervention and who took a dose of study vaccine/placebo and were given viral challenge.

The VL-AUC of RSV determined by qRT-PCR from nasal wash samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.

Outcome measures

Outcome measures
Measure	RSVPreF n=31 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=31 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Area Under the Viral Load-time Curve (VL-AUC) of RSV	0.00 h*log10 PFU/mL Interval 0.0 to 19.02	96.65 h*log10 PFU/mL Interval 0.0 to 675.32	—	—	—	—

PRIMARY outcome

Timeframe: Day 2 to Day 12

RT-PCR-confirmed symptomatic RSV infection defined as: \- Two detectable qRT-PCR reported on 2 or more consecutive days (any two detectable (≥LLOD) qRT-PCR measurements reported over 4 consecutive scheduled timepoints). and \- Either one or more positive clinical symptoms from different categories in the symptom scoring system or one Grade 2 symptom from any category

Outcome measures

Outcome measures
Measure	RSVPreF n=31 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=31 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Number of Participants With RT-PCR Confirmed (Detected) Incidence of Symptomatic Infection	2 Participants	15 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 to Day 12

The sum total symptoms score is the sum of all scores from the first assessment on Day 1 to the first assessment on Day 12 (34 assessments). Symptom scores were collected three times daily starting one day post-viral challenge (Day +1) up to discharge from quarantine using a participant self-reportable 13-symptoms card. Clinical symptoms include runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptoms from 0 (no symptoms) - 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. For each assessment, an individual total symptom score was derived as the total of the scores given to the 13 symptoms on that symptom score card. Individual 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

Outcome measures
Measure	RSVPreF n=31 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=31 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Sum Total Symptoms Diary Card Score (TSS)	2.1 score on a scale Geometric Coefficient of Variation 199.8	28.9 score on a scale Geometric Coefficient of Variation 120.2	—	—	—	—

SECONDARY outcome

Timeframe: Day 2 to Day 12

RT-PCR confirmed RSV infection defined as * Two quantifiable PCR measures reported on 2 or more consecutive days (any two quantifiable (≥LLOQ) qRT-PCR measurements reported over 4 consecutive scheduled timepoints), and * Either one or more positive clinical symptoms from different categories in the symptom scoring system or one Grade 2 symptom from any category

Outcome measures

Outcome measures
Measure	RSVPreF n=31 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=31 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Number of Participants With RT-PCR Confirmed (Quantifiable) Incidence of Symptomatic Infection	0 Participants	13 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Day 2 to Day 12

Culture lab-confirmed symptomatic RSV infection defined as: * One quantifiable viral culture and * Either one or more positive clinical symptoms from different categories in the symptom scoring system or one Grade 2 symptom from any category

Outcome measures

Outcome measures
Measure	RSVPreF n=31 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=31 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Number of Participants With Culture Lab-confirmed Reduction of Symptomatic RSV Infection	0 Participants	11 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Day 2 to Day 12

Reduction in Peak viral load of RSV determined by quantifiable qRT-PCR from nasal samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.

Outcome measures

Outcome measures
Measure	RSVPreF n=31 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=31 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Peak Viral Load of RSV by qRT-PCR	0.00 log 10 copies/mL Interval 0.0 to 3.108	4.2 log 10 copies/mL Interval 0.0 to 6.999	—	—	—	—

SECONDARY outcome

Timeframe: Day 2 to Day 12

Peak viral load of RSV determined by quantifiable viral culture from nasal samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.

Outcome measures

Outcome measures
Measure	RSVPreF n=31 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=31 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Peak Viral Load of RSV by Viral Culture	0.00 log 10 PFU/mL Standard Deviation 0.00	1.921 log 10 PFU/mL Standard Deviation 2.3837	—	—	—	—

SECONDARY outcome

Timeframe: Day 2 to Day 12

Duration (time in hours) of quantifiable qRT-PCR measurements from nasal samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.

Outcome measures

Outcome measures
Measure	RSVPreF n=31 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=31 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Duration of Quantifiable qRT-PCR Measurements	18.0 hours Interval 11.8 to 54.4	131.6 hours Interval 72.1 to NA - the upper quartile was not estimable due to more than 25% of participants being censored, as they had not met the required criteria, at the end of their observation period.	—	—	—	—

SECONDARY outcome

Timeframe: Day 2 to Day 12

Population: Only infected subjects are included in the analysis, hence 0 for RSVPreF and 13 for Placebo

Duration (time in hours) of quantitative viral culture measurements from nasal samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.

Outcome measures

Outcome measures
Measure	RSVPreF A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=13 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Duration of Quantitative Viral Culture Measurements	—	83.1 hours Interval 60.2 to 95.8	—	—	—	—

SECONDARY outcome

Timeframe: Day 2 to Day 12

VL-AUC of RSV as determined by quantitative viral culture on nasal samples starting two days post-viral challenge (Day +2) up to discharge from quarantine

Outcome measures

Outcome measures
Measure	RSVPreF n=31 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=31 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
VL-AUC Determined by Quantitative Viral Culture	0.00 h*log10 PFU/mL Standard Deviation 0.00	91.91 h*log10 PFU/mL Standard Deviation 127.883	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 to Day 12

Data presented is hours \* score. TSS-AUC (trapezium rule) as measured by graded symptom scoring system collected 3 times daily starting Day +1 up to Day 12am using a participant self-reportable 13-symptoms card, the max number of diary cards included in the AUC calculation is 34, the maximum time period is 264hrs. Clinical symptoms included runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptom from 0 (no symptoms) - 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 10,824 hours\*score (maximum of 264x41).

Outcome measures

Outcome measures
Measure	RSVPreF n=31 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=31 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Area Under the Curve Over Time of Total Clinical Symptoms (TSS-AUC)	52.85 hours * score on a scale Standard Deviation 105.250	230.76 hours * score on a scale Standard Deviation 277.988	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 to Day 12

Peak 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 using a participant self-reportable 13-symptoms card. Clinical symptoms include runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptoms from 0 (no symptoms) - 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. For each assessment, an individual total symptom score was derived as the total of the scores given to the 13 symptoms on that symptom score card. Individual 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

Outcome measures
Measure	RSVPreF n=31 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=31 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Peak Symptoms Diary Card Score	1.3 score on a scale Standard Deviation 1.79	4.1 score on a scale Standard Deviation 3.92	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 to Day 12

Peak daily symptom score was derived, for each day from Day 1 to Day 12, as the maximum of the 3 total symptoms scores on that day, providing 11 scores each. The symptoms were collected three times daily starting one day post-viral challenge (Day +1) up to discharge from quarantine using a participant self-reportable 13-symptoms card. Clinical symptoms include runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptoms from 0 (no symptoms) - 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. For each assessment, an individual total symptom score was derived as the total of the scores given to the 13 symptoms on that symptom score card. Individual 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

Outcome measures
Measure	RSVPreF n=31 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=31 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Peak Daily Symptom Score Day 1	0.6 score on a scale Standard Deviation 1.38	0.2 score on a scale Standard Deviation 0.56	—	—	—	—
Peak Daily Symptom Score Day 2	0.4 score on a scale Standard Deviation 0.76	0.3 score on a scale Standard Deviation 0.70	—	—	—	—
Peak Daily Symptom Score Day 3	0.3 score on a scale Standard Deviation 0.69	0.2 score on a scale Standard Deviation 0.50	—	—	—	—
Peak Daily Symptom Score Day 4	0.3 score on a scale Standard Deviation 0.73	1.1 score on a scale Standard Deviation 2.16	—	—	—	—
Peak Daily Symptom Score Day 5	0.5 score on a scale Standard Deviation 1.48	1.6 score on a scale Standard Deviation 2.78	—	—	—	—
Peak Daily Symptom Score Day 6	0.6 score on a scale Standard Deviation 1.12	2.2 score on a scale Standard Deviation 2.77	—	—	—	—
Peak Daily Symptom Score Day 7	0.4 score on a scale Standard Deviation 0.71	2.5 score on a scale Standard Deviation 3.04	—	—	—	—
Peak Daily Symptom Score Day 8	0.3 score on a scale Standard Deviation 0.58	2.5 score on a scale Standard Deviation 3.30	—	—	—	—
Peak Daily Symptom Score Day 9	0.3 score on a scale Standard Deviation 0.51	1.3 score on a scale Standard Deviation 1.59	—	—	—	—
Peak Daily Symptom Score Day 10	0.2 score on a scale Standard Deviation 0.55	0.7 score on a scale Standard Deviation 1.03	—	—	—	—
Peak Daily Symptom Score Day 11	0.2 score on a scale Standard Deviation 0.75	0.8 score on a scale Standard Deviation 1.51	—	—	—	—
Peak Daily Symptom Score Day 12	0.0 score on a scale Standard Deviation 0.18	0.5 score on a scale Standard Deviation 1.89	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 to Day 12

Number (%) of participants with Grade 2 or higher symptoms (on any occasion from Day 1 to Day 12)

Outcome measures

Outcome measures
Measure	RSVPreF n=31 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=31 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Percentage Number of Participants With Grade 2 or Higher Symptoms	5 Participants	16 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Day 2 to Day 12

The number of participants with at least two quantifiable positive (≥LLOQ) qRT-PCR nasal sample measurements across 4 consecutive visits

Outcome measures

Outcome measures
Measure	RSVPreF n=31 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=31 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Number of Participants With an Occurrence of at Least Two Positive Quantifiable qRT-PCR Measurements on 2 or More Consecutive Days	4 Participants	16 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Day 2 to Day 12

The proportion of participants with at least two positive detectable qRT-PCR nasal sample measurements across 4 consecutive visits

Outcome measures

Outcome measures
Measure	RSVPreF n=31 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=31 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Number of Participants With an Occurrence of at Least Two Positive Detectable qRT-PCR Measurements on 2 or More Consecutive Days	10 Participants	23 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Day 2 to Day 12

The proportion of participants with at least one quantifiable positive (≥LLOQ) nasal sample viral culture starting two days post-viral challenge (Day+2) up to discharge from quarantine. Viral culture is only done for samples where qRT-PCR is positive (detectable), when the qRT-PCR is negative the viral culture is assumed to be 0 for any endpoint derivations.

Outcome measures

Outcome measures
Measure	RSVPreF n=31 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=31 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Number of Participants With an Occurrence of at Least One Positive Quantitative Cell Culture Measurements	0 Participants	13 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 to Day 12

Total weight of mucus produced starting one day post-viral challenge (Day +1) up to discharge from quarantine. The mean sum of all mucus produced from Day 1 to Day 12 is reported in data table.

Outcome measures

Outcome measures
Measure	RSVPreF n=31 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=31 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Total Mucus Weight	6.367 g Standard Deviation 9.8246	29.135 g Standard Deviation 36.2811	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 to Day 12

Total number of tissues used by participants starting one day post-viral challenge (Day +1) up to discharge from quarantine.

Outcome measures

Outcome measures
Measure	RSVPreF n=31 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=31 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Total Tissue Number	16.9 Tissues Standard Deviation 22.35	41.7 Tissues Standard Deviation 44.80	—	—	—	—

SECONDARY outcome

Timeframe: 7 days post vaccination

Population: The number of participants who completed the vaccination diary card

Local reactions include pain at injection site, redness and swelling

Outcome measures

Outcome measures
Measure	RSVPreF n=35 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=33 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Number of Solicited Local Reactions Within 7 Days After Vaccination	5 Participants	2 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 7 days post vaccination

Population: The number of participants who completed the vaccination diary card

Systemic reactions included fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain. Each of these items was collected on a four-point scale including, none, mild, moderate, and severe.

Outcome measures

Outcome measures
Measure	RSVPreF n=35 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=33 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Number of Systemic Events Within 7 Days After Vaccination	18 Participants	11 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 30 days

Number of participants with at least one unsolicited adverse events (AEs) within 30 days after vaccination. Unsolicited AEs were all AEs for which participants were not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	RSVPreF n=35 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=35 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Number of Participants With an Occurrence of Unsolicited Adverse Events (AEs) Post Vaccination	12 Participants	10 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Through study completion, an average of 6 months

Number of medically attended AEs from vaccination to study end

Outcome measures

Outcome measures
Measure	RSVPreF n=35 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=35 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) n=35 Participants Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) n=35 Participants Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) n=35 Participants Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) n=35 Participants Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Occurrence of Medically Attended AEs	1 Participants	2 Participants	2 Participants	1 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Through study completion, an average of 6 months

Number of SAEs from vaccination to study end

Outcome measures

Outcome measures
Measure	RSVPreF n=35 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=35 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Occurrence of SAEs	1 Participants	1 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Day 0 to Day 28

Population: All vaccinated participants were included in the Safety Analysis Set, irrespective of whether they received challenge virus.

Number of participants with at least one unsolicited AE within 30 days post-viral challenge (Day 0) up to Day +28 follow up. Unsolicited AEs were all AEs for which participants were not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	RSVPreF n=35 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=35 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Number of Participants With an Occurrence of Unsolicited AEs Related to Viral Challenge	14 Participants	17 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Day -2 to Day12

Number of hematological and biochemical laboratory assessment Abnormalities reported as AEs during the quarantine period.

Outcome measures

Outcome measures
Measure	RSVPreF n=35 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=35 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Occurrence of Haematological and Biochemical Laboratory Abnormalities During the Quarantine Period. Mild raised ALT	8 Participants	5 Participants	—	—	—	—
Occurrence of Haematological and Biochemical Laboratory Abnormalities During the Quarantine Period. Moderate raised ALT	1 Participants	1 Participants	—	—	—	—
Occurrence of Haematological and Biochemical Laboratory Abnormalities During the Quarantine Period. Mild raised AST	2 Participants	5 Participants	—	—	—	—
Occurrence of Haematological and Biochemical Laboratory Abnormalities During the Quarantine Period. Moderate raised AST	1 Participants	0 Participants	—	—	—	—
Occurrence of Haematological and Biochemical Laboratory Abnormalities During the Quarantine Period. Moderate raised CK	0 Participants	1 Participants	—	—	—	—
Occurrence of Haematological and Biochemical Laboratory Abnormalities During the Quarantine Period. Mild low platelets	0 Participants	1 Participants	—	—	—	—
Occurrence of Haematological and Biochemical Laboratory Abnormalities During the Quarantine Period. Mild low lymphocytes	0 Participants	1 Participants	—	—	—	—
Occurrence of Haematological and Biochemical Laboratory Abnormalities During the Quarantine Period. Moderate low neutrophils	0 Participants	1 Participants	—	—	—	—

SECONDARY outcome

Timeframe: From Vaccination (Day -28) until Viral Challenge (Day 0), and From Viral Challenge (Day 0) until Day 28

Concomitant medications (prescription and over the counter drugs and supplements that a study participant had taken alongside the study vaccination) were recorded for the period following vaccination (up to viral challenge) and from viral challenge until Day 28..

Outcome measures

Outcome measures
Measure	RSVPreF n=35 Participants A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection	Placebo n=35 Participants A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine	RSVPreF (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Use of Concomitant Medication Concomitant Medications from Vaccination (Day -28) until Viral Challenge (Day 0)	9 Participants	11 Participants	—	—	—	—
Use of Concomitant Medication Concomitant Medications from Viral Challenge (Day 0) until Day 28	14 Participants	14 Participants	—	—	—	—

Adverse Events

RSVPreF (From Vaccination Until Viral Challenge)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo (From Vaccination Until Viral Challenge)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

RSVPreF (From Viral Challenge Until Day 28)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo (From Viral Challenge Until Day 28)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

RSVPreF (From Day 28 Until Day155)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo (From Day 28 Until Day155)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RSVPreF (From Vaccination Until Viral Challenge) n=35 participants at risk A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection on Day -28	Placebo (From Vaccination Until Viral Challenge) n=35 participants at risk A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine on Day -28	RSVPreF (From Viral Challenge Until Day 28) n=35 participants at risk Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) n=35 participants at risk Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) n=35 participants at risk Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) n=35 participants at risk Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Cardiac disorders Myocarditis	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Infections and infestations Meningitis viral	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.

Other adverse events

Other adverse events
Measure	RSVPreF (From Vaccination Until Viral Challenge) n=35 participants at risk A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection on Day -28	Placebo (From Vaccination Until Viral Challenge) n=35 participants at risk A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine on Day -28	RSVPreF (From Viral Challenge Until Day 28) n=35 participants at risk Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28	Placebo (From Viral Challenge Until Day 28) n=35 participants at risk Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.	RSVPreF (From Day 28 Until Day155) n=35 participants at risk Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0	Placebo (From Day 28 Until Day155) n=35 participants at risk Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0
Infections and infestations Pharyngitis	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Blood and lymphatic system disorders Lymphadenopathy	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Cardiac disorders Palpitations	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Gastrointestinal disorders Abdominal pain	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Gastrointestinal disorders Nausea	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
General disorders Vessel puncture site bruise	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Infections and infestations Conjunctivitis	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Investigations Alanine aminotransferase increased	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Investigations Blood creatine phosphokinase increased	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Investigations Electrocardiogram QT prolonged	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Investigations SARS-CoV-2 test positive	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Musculoskeletal and connective tissue disorders Tendonitis	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Nervous system disorders Dizziness	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Nervous system disorders Headache	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Nervous system disorders Presyncope	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Skin and subcutaneous tissue disorders Dry skin	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	5.7% 2/35 • Number of events 2 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Skin and subcutaneous tissue disorders Rash	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Cardiac disorders Myocarditis	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Investigations Aspartate aminotransferase increased	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Infections and infestations Localised infection	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Infections and infestations Meningitis viral	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Infections and infestations Varicella zoster virus infection	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	2.9% 1/35 • Number of events 1 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.	0.00% 0/35 • Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.

Additional Information

Alex Mann

hVIVO

Phone: +44(0)7738321671

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place