Trial Outcomes & Findings for An Exploratory Study to Evaluate the Prophylactic Efficacy of a Single Immunization of Ad26.RSV.preF Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy 18 to 50 Year-old Adults (NCT NCT03334695)

Last Updated: 2025-02-04

Results Overview

VL-AUC for RSV was determined by qRT-PCR assay of nasal wash samples. Here, values below the lower limit of quantification (LLOQ) were imputed with zero.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

64 participants

Primary outcome timeframe

From Day 2 to Day 12

Results posted on

2025-02-04

Participant Flow

In total, 64 participants were screened. Of these, 63 participants were randomized and received the study vaccine. One participant was randomized in error and did not receive the study vaccine hence not included in the analyses.

Participant milestones

Participant milestones
Measure	Ad26.RSV.preF (110^11 vp) Participants received a single intramuscular injection of 1\10\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).	Placebo Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).
Overall Study STARTED	31	32
Overall Study COMPLETED	27	26
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Ad26.RSV.preF (110^11 vp) Participants received a single intramuscular injection of 1\10\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).	Placebo Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).
Overall Study Lost to Follow-up	3	3
Overall Study Physician Decision	1	2
Overall Study Protocol Violation	0	1

Baseline Characteristics

An Exploratory Study to Evaluate the Prophylactic Efficacy of a Single Immunization of Ad26.RSV.preF Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy 18 to 50 Year-old Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ad26.RSV.preF (110^11 vp) n=31 Participants Participants received a single intramuscular injection of 1\10\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).	Placebo n=32 Participants Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).	Total n=63 Participants Total of all reporting groups
Age, Continuous	25.9 years STANDARD_DEVIATION 6.19 • n=5 Participants	25.9 years STANDARD_DEVIATION 6.56 • n=7 Participants	25.9 years STANDARD_DEVIATION 6.33 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	26 Participants n=7 Participants	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	28 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment UNITED KINGDOM	31 Participants n=5 Participants	32 Participants n=7 Participants	63 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Day 2 to Day 12

VL-AUC for RSV was determined by qRT-PCR assay of nasal wash samples. Here, values below the lower limit of quantification (LLOQ) were imputed with zero.

Outcome measures

Outcome measures
Measure	Ad26.RSV.preF (110^11 vp) n=27 Participants Participants received a single intramuscular injection of 1\10\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).	Placebo n=26 Participants Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).
Area Under the Viral Load-Time Curve (VL-AUC) of Respiratory Syncytial Virus (RSV) by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR)	0 log10 copies*hour per millilitre (h/mL) Interval 0.0 to 268.8	236 log10 copies*hour per millilitre (h/mL) Interval 20.3 to 605.8

SECONDARY outcome

Timeframe: From Day 2 to Day 12

Peak viral load of RSV-A Memphis 37b was defined as the maximum viral load as determined by quantitative RT-PCR assay of nasal wash samples. Here, values below the lower limit of quantification (LLOQ) were imputed with zero.

Outcome measures

Outcome measures
Measure	Ad26.RSV.preF (110^11 vp) n=27 Participants Participants received a single intramuscular injection of 1\10\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).	Placebo n=26 Participants Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).
Peak Viral Load of RSV-A Memphis 37b	0.000 log10 copies per mL Interval 0.0 to 4.539	5.365 log10 copies per mL Interval 3.027 to 6.665

SECONDARY outcome

Timeframe: Day 6 (0 hour and 12 hours) and Day 7 (0 hour and 12 hours)

Population: The Intent-to-treat-Challenge (ITTc) population is a subset of the Full Analysis Set (FAS) (all participants who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) included all randomized, vaccinated and challenged participants. Here 'n' (number analyzed) signifies the number of participants analyzed for this outcome measure (OM) at specified timepoints.

Viral load determined by quantitative RT-PCR assay of nasal wash samples on Day 6 and Day 7 were reported. Here, values below the lower limit of quantification (LLOQ) were imputed with zero.

Outcome measures

Outcome measures
Measure	Ad26.RSV.preF (110^11 vp) n=27 Participants Participants received a single intramuscular injection of 1\10\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).	Placebo n=26 Participants Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).
Viral Load by Quantitative RT-PCR Assay on Day 6 and 7 Day 6: 0 hour	0.821 log10 copies per mL Standard Error 0.349	2.898 log10 copies per mL Standard Error 0.630
Viral Load by Quantitative RT-PCR Assay on Day 6 and 7 Day 6: 12 hour	1.261 log10 copies per mL Standard Error 0.433	2.939 log10 copies per mL Standard Error 0.604
Viral Load by Quantitative RT-PCR Assay on Day 6 and 7 Day 7: 0 hour	1.761 log10 copies per mL Standard Error 0.436	3.072 log10 copies per mL Standard Error 0.586
Viral Load by Quantitative RT-PCR Assay on Day 6 and 7 Day 7: 12 hour	1.552 log10 copies per mL Standard Error 0.443	3.025 log10 copies per mL Standard Error 0.530

SECONDARY outcome

Timeframe: Day 6 (0 hour and 12 hours) and Day 7 (0 hour and 12 hours)

VL-AUC of RSV by the quantitative culture of nasal wash samples on Day 6 and Day 7 were determined. pfu\*h/mL stands for plaque-forming units hour per millilitre.

Outcome measures

Outcome measures
Measure	Ad26.RSV.preF (110^11 vp) n=27 Participants Participants received a single intramuscular injection of 1\10\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).	Placebo n=26 Participants Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).
VL-AUC of RSV by Quantitative Culture of RSV (Plaque Assay) on Day 6 and 7 Day 6: 0 hour	0.278 log10 pfu*h/mL Standard Error 0.1936	1.587 log10 pfu*h/mL Standard Error 0.4159
VL-AUC of RSV by Quantitative Culture of RSV (Plaque Assay) on Day 6 and 7 Day 6: 12 hour	0.304 log10 pfu*h/mL Standard Error 0.2198	1.737 log10 pfu*h/mL Standard Error 0.4320
VL-AUC of RSV by Quantitative Culture of RSV (Plaque Assay) on Day 6 and 7 Day 7: 0 hour	0.101 log10 pfu*h/mL Standard Error 0.1015	1.226 log10 pfu*h/mL Standard Error 0.3505
VL-AUC of RSV by Quantitative Culture of RSV (Plaque Assay) on Day 6 and 7 Day 7: 12 hour	0.276 log10 pfu*h/mL Standard Error 0.1931	1.237 log10 pfu*h/mL Standard Error 0.3891

SECONDARY outcome

Timeframe: From Day 2 to Day 12

Symptomatic RSV infection is defined in two ways (Conservative and Liberal). Conservative: participant had 2 or more quantifiable RT-PCR measurements on different samples, with one of following: symptoms of 2 different categories of subject symptom card (SSC) (Upper Respiratory \[runny/stuffy nose, sneezing, sore throat, earache\], Lower Respiratory \[cough, shortness of breath, chest tightness, wheeze\], Systemic \[malaise, headache, muscle and/or joint ache\]) regardless of grade and assessment timepoint or Grade 2 symptom from any category; Liberal (RT-PCR): had 2/more quantifiable RT-PCR measurements, with clinical symptom of any severity.

Outcome measures

Outcome measures
Measure	Ad26.RSV.preF (110^11 vp) n=27 Participants Participants received a single intramuscular injection of 1\10\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).	Placebo n=26 Participants Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).
Percentage of Participants With Symptomatic RSV Infections Conservative	22.2 Percentage of participants	46.2 Percentage of participants
Percentage of Participants With Symptomatic RSV Infections Liberal	33.3 Percentage of participants	61.5 Percentage of participants

SECONDARY outcome

Timeframe: Day 6 and 7: morning, afternoon and evening

The total clinical symptom score was determined as the sum of the scores (grades) ranges from 0 (no symptom) to 52 (severe symptoms) of the 13 self-reportable symptoms on the SSC. Clinical symptoms includes runny nose, stuffy nose, sneezing, sore throat, ear ache, malaise, headache, muscle and/or joint ache, chilliness/ feverishness, cough, chest tightness, shortness of breath and wheeze. For every separate symptom, the score ranges from 0 (I have no symptom) to 4 (its quite bothersome most of the times and stop from participating in activities).

Outcome measures

Outcome measures
Measure	Ad26.RSV.preF (110^11 vp) n=27 Participants Participants received a single intramuscular injection of 1\10\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).	Placebo n=26 Participants Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).
Total Clinical Symptoms Score at Day 6 and 7 Day 6: Morning	0.6 Units on a scale Standard Error 0.18	2.6 Units on a scale Standard Error 0.64
Total Clinical Symptoms Score at Day 6 and 7 Day 6: Afternoon	0.4 Units on a scale Standard Error 0.18	2.8 Units on a scale Standard Error 0.74
Total Clinical Symptoms Score at Day 6 and 7 Day 6: Evening	0.5 Units on a scale Standard Error 0.28	2.5 Units on a scale Standard Error 0.65
Total Clinical Symptoms Score at Day 6 and 7 Day 7: Morning	0.6 Units on a scale Standard Error 0.23	2.5 Units on a scale Standard Error 0.70
Total Clinical Symptoms Score at Day 6 and 7 Day 7: Afternoon	0.6 Units on a scale Standard Error 0.32	2.5 Units on a scale Standard Error 0.70
Total Clinical Symptoms Score at Day 6 and 7 Day 7: Evening	0.6 Units on a scale Standard Error 0.32	2.5 Units on a scale Standard Error 0.63

SECONDARY outcome

Timeframe: Day 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

The weight mucous over time was determined in grams using eCRF forms. Participants were given pre-weighed packets of paper tissues. After each tissue was used for nose blowing or sneezing, the participants should store them in an airtight plastic bag to calculate the weight of mucus from Day 0 to Day 12. All paper tissues used by each participant were collected for each 24-hour period up to Day 12, to determine daily mucus weight.

Outcome measures

Outcome measures
Measure	Ad26.RSV.preF (110^11 vp) n=27 Participants Participants received a single intramuscular injection of 1\10\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).	Placebo n=26 Participants Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).
Weight of Mucus Secretions Over Time Day 0	0.586 Grams Standard Error 0.1883	0.175 Grams Standard Error 0.0913
Weight of Mucus Secretions Over Time Day 1	0.228 Grams Standard Error 0.0621	0.086 Grams Standard Error 0.0333
Weight of Mucus Secretions Over Time Day 2	0.997 Grams Standard Error 0.2350	0.428 Grams Standard Error 0.1459
Weight of Mucus Secretions Over Time Day 3	0.970 Grams Standard Error 0.2176	0.543 Grams Standard Error 0.1333
Weight of Mucus Secretions Over Time Day 4	1.164 Grams Standard Error 0.3535	0.714 Grams Standard Error 0.2123
Weight of Mucus Secretions Over Time Day 5	1.440 Grams Standard Error 0.8609	1.068 Grams Standard Error 0.3539
Weight of Mucus Secretions Over Time Day 6	1.226 Grams Standard Error 0.4925	3.132 Grams Standard Error 1.0991
Weight of Mucus Secretions Over Time Day 7	1.715 Grams Standard Error 0.7201	5.124 Grams Standard Error 1.3257
Weight of Mucus Secretions Over Time Day 8	0.799 Grams Standard Error 0.2960	3.230 Grams Standard Error 1.1022
Weight of Mucus Secretions Over Time Day 9	1.004 Grams Standard Error 0.4147	1.798 Grams Standard Error 0.4406
Weight of Mucus Secretions Over Time Day 10	0.907 Grams Standard Error 0.3457	1.785 Grams Standard Error 0.4838
Weight of Mucus Secretions Over Time Day 11	0.749 Grams Standard Error 0.2430	1.172 Grams Standard Error 0.3442
Weight of Mucus Secretions Over Time Day 12	0.622 Grams Standard Error 0.2647	0.990 Grams Standard Error 0.3005

SECONDARY outcome

Timeframe: Day 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

Number of tissues used by participant per time point were reported using eCRF forms. Participants were given pre-weighed packets of paper tissues. After each tissue was used for nose blowing or sneezing, the participants should store them in an airtight plastic bag to calculate the number of tissues used from Day 0 to Day 12. All paper tissues used by each participant were collected for each 24-hour period up to Day 12, to determine daily number of tissues used.

Outcome measures

Outcome measures
Measure	Ad26.RSV.preF (110^11 vp) n=27 Participants Participants received a single intramuscular injection of 1\10\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).	Placebo n=26 Participants Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).
Number of Tissues Used Over Time Day 5	2.1 Tissues Standard Error 0.81	2.3 Tissues Standard Error 0.68
Number of Tissues Used Over Time Day 8	2.0 Tissues Standard Error 0.71	5.2 Tissues Standard Error 1.38
Number of Tissues Used Over Time Day 0	1.8 Tissues Standard Error 0.53	0.7 Tissues Standard Error 0.33
Number of Tissues Used Over Time Day 1	1.7 Tissues Standard Error 0.41	0.7 Tissues Standard Error 0.27
Number of Tissues Used Over Time Day 2	2.9 Tissues Standard Error 0.65	1.2 Tissues Standard Error 0.32
Number of Tissues Used Over Time Day 3	1.9 Tissues Standard Error 0.45	1.3 Tissues Standard Error 0.28
Number of Tissues Used Over Time Day 4	2.3 Tissues Standard Error 0.49	1.5 Tissues Standard Error 0.31
Number of Tissues Used Over Time Day 6	2.4 Tissues Standard Error 0.77	5.1 Tissues Standard Error 1.59
Number of Tissues Used Over Time Day 7	2.8 Tissues Standard Error 0.92	8.1 Tissues Standard Error 1.94
Number of Tissues Used Over Time Day 9	2.3 Tissues Standard Error 0.72	2.8 Tissues Standard Error 0.53
Number of Tissues Used Over Time Day 10	1.8 Tissues Standard Error 0.61	2.7 Tissues Standard Error 0.61
Number of Tissues Used Over Time Day 11	1.6 Tissues Standard Error 0.47	2.0 Tissues Standard Error 0.50
Number of Tissues Used Over Time Day 12	1.4 Tissues Standard Error 0.40	1.7 Tissues Standard Error 0.45

SECONDARY outcome

Timeframe: Up to 28 days post-vaccination and up to 28 days post-challenge

Population: The Full Analysis Set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. Here 'n' (number analyzed) included all evaluable participants who were analyzed at specified categories.

Unsolicited AEs are all AEs for which participants were specifically not questioned in the participant diary. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product.

Outcome measures

Outcome measures
Measure	Ad26.RSV.preF (110^11 vp) n=31 Participants Participants received a single intramuscular injection of 1\10\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).	Placebo n=32 Participants Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).
Percentage of Participants With Unsolicited Adverse Events (AEs) Post-vaccination	35.5 Percentage of participants	46.9 Percentage of participants
Percentage of Participants With Unsolicited Adverse Events (AEs) Post-challenge	74.1 Percentage of participants	69.2 Percentage of participants

SECONDARY outcome

Timeframe: Up to 6 months post-vaccination and up to 6 months post-challenge

A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Outcome measures

Outcome measures
Measure	Ad26.RSV.preF (110^11 vp) n=31 Participants Participants received a single intramuscular injection of 1\10\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).	Placebo n=32 Participants Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).
Percentage of Participants With Serious Adverse Events (SAEs) Post-vaccination	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Serious Adverse Events (SAEs) Post-challenge	3.2 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: 7 days post-vaccination (Day -21)

Population: The Full Analysis Set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.

Solicited local AEs: erythema, swelling/induration, and pain/tenderness. Solicited systemic AEs: fatigue, headache, myalgia, arthralgia, chills, nausea and fever.

Outcome measures

Outcome measures
Measure	Ad26.RSV.preF (110^11 vp) n=31 Participants Participants received a single intramuscular injection of 1\10\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).	Placebo n=32 Participants Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).
Percentage of Participants With Solicited Local and Systemic AEs Solicited local AEs	100.0 Percentage of participants	18.8 Percentage of participants
Percentage of Participants With Solicited Local and Systemic AEs Solicited systemic AEs	100.0 Percentage of participants	50.0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 28 post-challenge

Percentage of participants with vital signs abnormalities were reported. Vital signs measurements included body temperature (measured in degree celsius from less than \[\<\] 37.5 to \<39.5), respiratory rate, systolic and diastolic blood pressure, and pulse rate, which were graded by FDA Toxicity Grading Scale Grade 0 (=no grade), Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening).

Outcome measures

Outcome measures
Measure	Ad26.RSV.preF (110^11 vp) n=31 Participants Participants received a single intramuscular injection of 1\10\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).	Placebo n=32 Participants Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).
Percentage of Participants With Vital Signs Abnormalities Post-dose: Temperature (38.0-<38.5)	6.5 Percentage of participants	0 Percentage of participants
Percentage of Participants With Vital Signs Abnormalities Post-dose: Temperature (<37.5)	64.5 Percentage of participants	93.8 Percentage of participants
Percentage of Participants With Vital Signs Abnormalities Post-dose: Temperature (37.5-<38.0)	22.6 Percentage of participants	3.1 Percentage of participants
Percentage of Participants With Vital Signs Abnormalities Post-dose: Temperature (38.5-<39.0)	6.5 Percentage of participants	3.1 Percentage of participants
Percentage of Participants With Vital Signs Abnormalities Post-dose: Bradycardia (pulse): Grade 1	12.9 Percentage of participants	3.1 Percentage of participants
Percentage of Participants With Vital Signs Abnormalities Post-dose: Bradycardia (pulse): Grade 2	6.5 Percentage of participants	6.3 Percentage of participants
Percentage of Participants With Vital Signs Abnormalities Post-dose: Bradycardia (pulse): Grade 3/4	3.2 Percentage of participants	0 Percentage of participants
Percentage of Participants With Vital Signs Abnormalities Post-dose: Hypertension (diastolic): Grade 1	0 Percentage of participants	3.1 Percentage of participants
Percentage of Participants With Vital Signs Abnormalities Post-dose: Hypertension (diastolic): Grade 2	6.5 Percentage of participants	0 Percentage of participants
Percentage of Participants With Vital Signs Abnormalities Post-dose: Hypertension (systolic): Grade 1	3.2 Percentage of participants	3.1 Percentage of participants
Percentage of Participants With Vital Signs Abnormalities Post-dose: Respiratory rate: Grade 1	25.8 Percentage of participants	18.8 Percentage of participants
Percentage of Participants With Vital Signs Abnormalities Post-dose: Tachycardia (pulse): Grade 1	3.2 Percentage of participants	0 Percentage of participants
Percentage of Participants With Vital Signs Abnormalities Post-challenge: Bradycardia (pulse): Grade 1	18.5 Percentage of participants	11.5 Percentage of participants
Percentage of Participants With Vital Signs Abnormalities Post-challenge: Bradycardia (pulse): Grade 2	3.7 Percentage of participants	3.8 Percentage of participants
Percentage of Participants With Vital Signs Abnormalities Post-challenge: Bradycardia (pulse): Grade 3/4	3.7 Percentage of participants	0 Percentage of participants
Percentage of Participants With Vital Signs Abnormalities Post-challenge: Hypertension (diastolic): Grade 1	3.7 Percentage of participants	0 Percentage of participants
Percentage of Participants With Vital Signs Abnormalities Post-challenge: Hypertension (systolic): Grade 1	0 Percentage of participants	7.7 Percentage of participants
Percentage of Participants With Vital Signs Abnormalities Post-challenge: Respiratory rate: Grade 1	25.9 Percentage of participants	26.9 Percentage of participants
Percentage of Participants With Vital Signs Abnormalities Post-challenge: Tachycardia (pulse): Grade 1	3.7 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 12 post challenge

ECG parameters included heart rate, PR, QRS, QTcB, QTcF, and the uncorrected QT interval which were graded by FDA Toxicity Grading Scale Grade 0 (=no grade), Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening).

Outcome measures

Outcome measures
Measure	Ad26.RSV.preF (110^11 vp) n=27 Participants Participants received a single intramuscular injection of 1\10\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).	Placebo n=26 Participants Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Heart rate: Abnormally low: Grade 1	0 Percentage of participants	3.8 Percentage of participants
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Heart rate: Abnormally low: Grade 2	0 Percentage of participants	3.8 Percentage of participants
Percentage of Participants With Electrocardiogram (ECG) Abnormalities QTc Bazett (450 millisecond [ms], 480 ms)	0 Percentage of participants	3.8 Percentage of participants
Percentage of Participants With Electrocardiogram (ECG) Abnormalities QTc Bazett (increase from baseline [30; 60] ms)	7.4 Percentage of participants	11.5 Percentage of participants
Percentage of Participants With Electrocardiogram (ECG) Abnormalities QTc Fridericia: (increase from baseline [30; 60] ms)	3.7 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 28 post-challenge

Population: The Full Analysis Set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. Here 'n' (number analyzed) signifies the number of participants analyzed for this OM at specified categories.

Percentage of participants with clinical laboratory abnormalities were reported. The biochemical and hematological parameters analyzed were- Alanine aminotransferase (AA), Alkaline phosphatase (AP), Aspartate aminotransferase (AsP), Hyperkalemia, Hypernatremia, Hypoglycemia, Hypophosphatemia, Hemoglobin, Neutrophils, White blood cell (WBC) - increase and Urine protein, which were graded by FDA Toxicity Grading Scale Grade 0 (=no grade), Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening).

Outcome measures

Outcome measures
Measure	Ad26.RSV.preF (110^11 vp) n=31 Participants Participants received a single intramuscular injection of 1\10\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).	Placebo n=32 Participants Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Dose: Hypoglycemia: Grade 2	0 Percentage of participants	3.1 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Dose: Hypophosphatemia:Grade 1	3.2 Percentage of participants	0 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Dose: Hypophosphatemia:Grade 2	9.7 Percentage of participants	0 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Dose: Hemoglobin: Grade 1	3.2 Percentage of participants	3.1 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Dose: Hemoglobin: Grade 2	3.2 Percentage of participants	0 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Dose: Neutrophils: Grade 1	12.9 Percentage of participants	6.3 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Dose: AA: Grade 1	9.7 Percentage of participants	0 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Dose: AP: Grade 1	0 Percentage of participants	3.1 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Dose: AsA: Grade 1	6.5 Percentage of participants	0 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Dose: AsA: Grade 2	0 Percentage of participants	3.1 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Dose: Hyperkalemia: Grade 2	3.2 Percentage of participants	0 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Dose: Hypernatremia: Grade 2	3.2 Percentage of participants	0 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Dose: WBC increase: Grade 1	0 Percentage of participants	3.1 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Dose: Urine Protein: Grade 1	3.2 Percentage of participants	3.1 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Challenge: AA: Grade 1	25.9 Percentage of participants	15.4 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Challenge: AA: Grade 2	7.4 Percentage of participants	3.8 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Challenge: AP: Grade 1	0 Percentage of participants	3.8 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Challenge: AsA: Grade 1	14.8 Percentage of participants	15.4 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Challenge: AsA: Grade 2	3.7 Percentage of participants	3.8 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Challenge: AsA: Grade 4	0 Percentage of participants	3.8 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Challenge: Bilirubin: Grade 2	3.7 Percentage of participants	0 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Challenge: Hyperglycemia: Grade 1	0 Percentage of participants	3.8 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Challenge: Hyperkalemia: Grade 1	3.7 Percentage of participants	3.8 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Challenge: Hypernatremia: Grade 2	3.7 Percentage of participants	0 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Challenge: Hypophosphatemia:Grade 1	3.7 Percentage of participants	0 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Challenge: Hypoproteinemia:Grade 1	11.1 Percentage of participants	0 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Challenge: Eosinophils: Grade 1	0 Percentage of participants	7.7 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Challenge: Hemoglobin: Grade 1	7.4 Percentage of participants	0 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Challenge: Neutrophils: Grade 1	7.4 Percentage of participants	0 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Challenge: Platelets: Grade 1	3.7 Percentage of participants	3.8 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Challenge: Platelets: Grade 20	0 Percentage of participants	3.8 Percentage of participants
Percentage of Participants With Clinical Laboratory Abnormalities (Graded) Post Challenge: WBC increase: Grade 1	3.7 Percentage of participants	0 Percentage of participants

Adverse Events

Post-dose: Ad26.RSV.preF (1x10^11 vp)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Post-dose: Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Post-challenge: Challenge After Ad26.RSV.preF

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Post-challenge: Challenge After Placebo

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Post-dose: Ad26.RSV.preF (1x10^11 vp) n=31 participants at risk Participants received a single intramuscular injection of 1\*10\^11 vp (viral particles) of Ad26.RSV.preF on Day -28.	Post-dose: Placebo n=32 participants at risk Participants received a single intramuscular injection of matching placebo on Day -28.	Post-challenge: Challenge After Ad26.RSV.preF n=27 participants at risk Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving single intramuscular doses of 1x1011 vp of Ad26.RSV.preF on Day -28.	Post-challenge: Challenge After Placebo n=26 participants at risk Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving single intramuscular doses of placebo on Day -28.
Reproductive system and breast disorders Ovarian Cyst	0.00% 0/31 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/32 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	3.7% 1/27 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/26 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.

Other adverse events

Other adverse events
Measure	Post-dose: Ad26.RSV.preF (1x10^11 vp) n=31 participants at risk Participants received a single intramuscular injection of 1\*10\^11 vp (viral particles) of Ad26.RSV.preF on Day -28.	Post-dose: Placebo n=32 participants at risk Participants received a single intramuscular injection of matching placebo on Day -28.	Post-challenge: Challenge After Ad26.RSV.preF n=27 participants at risk Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving single intramuscular doses of 1x1011 vp of Ad26.RSV.preF on Day -28.	Post-challenge: Challenge After Placebo n=26 participants at risk Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving single intramuscular doses of placebo on Day -28.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/31 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/32 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	22.2% 6/27 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	3.8% 1/26 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
Gastrointestinal disorders Nausea	0.00% 0/31 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/32 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/27 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	7.7% 2/26 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
Infections and infestations Pharyngitis	0.00% 0/31 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/32 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	11.1% 3/27 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	15.4% 4/26 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
Injury, poisoning and procedural complications Sunburn	0.00% 0/31 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	6.2% 2/32 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/27 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/26 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
Investigations Alanine Aminotransferase Increased	6.5% 2/31 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/32 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	25.9% 7/27 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	11.5% 3/26 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
Investigations Aspartate Aminotransferase Increased	6.5% 2/31 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	3.1% 1/32 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	7.4% 2/27 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	7.7% 2/26 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
Investigations Troponin T Increased	0.00% 0/31 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/32 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/27 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	7.7% 2/26 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
Nervous system disorders Headache	3.2% 1/31 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	12.5% 4/32 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	7.4% 2/27 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	7.7% 2/26 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/31 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/32 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/27 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	11.5% 3/26 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	3.2% 1/31 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	3.1% 1/32 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/27 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	7.7% 2/26 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/31 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/32 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	3.7% 1/27 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	15.4% 4/26 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
Skin and subcutaneous tissue disorders Dry Skin	3.2% 1/31 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	3.1% 1/32 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	11.1% 3/27 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.	7.7% 2/26 • Up to 6 months post-vaccination and up to 6 months post-challenge The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.

Additional Information

Medical Leader

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation.
Publication restrictions are in place

Restriction type: OTHER