| Primary | Area Under the Viral Load-Time Curve (VL-AUC) of Respiratory Syncytial Virus (RSV) by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) | 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. | 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. | Posted | | Median | Inter-Quartile Range | log10 copies*hour per millilitre (h/mL) | | From Day 2 to Day 12 | | | | ID | Title | Description |
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| OG000 | Ad26.RSV.preF (1*10^11 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). | | OG001 | 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). |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0000(0.0 to 268.8)
- OG001236(20.3 to 605.8)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Wilcoxon Rank Sum test | | 0.012 | | | | | | | | | | | | | | Superiority | | |
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| Secondary | Peak Viral Load of RSV-A Memphis 37b | 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. | 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. | Posted | | Median | Inter-Quartile Range | log10 copies per mL | | From Day 2 to Day 12 | | | | ID | Title | Description |
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| OG000 | Ad26.RSV.preF (1*10^11 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). | | OG001 | 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). |
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| Secondary | Viral Load by Quantitative RT-PCR Assay on Day 6 and 7 | 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. | 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. | Posted | | Mean | Standard Error | log10 copies per mL | | Day 6 (0 hour and 12 hours) and Day 7 (0 hour and 12 hours) | | | | ID | Title | Description |
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| OG000 | Ad26.RSV.preF (1*10^11 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). | | OG001 | 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). |
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| Secondary | VL-AUC of RSV by Quantitative Culture of RSV (Plaque Assay) on Day 6 and 7 | 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. | 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 OM at specified timepoints. | Posted | | Mean | Standard Error | log10 pfu*h/mL | | Day 6 (0 hour and 12 hours) and Day 7 (0 hour and 12 hours) | | | | ID | Title | Description |
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| OG000 | Ad26.RSV.preF (1*10^11 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). | | OG001 | 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). |
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| Secondary | Percentage of Participants With Symptomatic RSV Infections | 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. | 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. | Posted | | Number | | Percentage of participants | | From Day 2 to Day 12 | | | | ID | Title | Description |
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| OG000 | Ad26.RSV.preF (1*10^11 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). | | OG001 | Placebo | |
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| Secondary | Total Clinical Symptoms Score at Day 6 and 7 | 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). | 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. | Posted | | Mean | Standard Error | Units on a scale | | Day 6 and 7: morning, afternoon and evening | | | | ID | Title | Description |
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| OG000 | Ad26.RSV.preF (1*10^11 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). | | OG001 | 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). |
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| Secondary | Weight of Mucus Secretions Over Time | 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. | 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 OM at specified timepoints. | Posted | | Mean | Standard Error | Grams | | Day 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 | | | | ID | Title | Description |
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| OG000 | Ad26.RSV.preF (1*10^11 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). | | OG001 | 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). |
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| Secondary | Number of Tissues Used Over Time | 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. | 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. | Posted | | Mean | Standard Error | Tissues | | Day 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 | | | | ID | Title | Description |
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| OG000 | Ad26.RSV.preF (1*10^11 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). | | OG001 | 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). |
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| Secondary | Percentage of Participants With Unsolicited Adverse Events (AEs) | 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. | 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. | Posted | | Number | | Percentage of participants | | Up to 28 days post-vaccination and up to 28 days post-challenge | | | | ID | Title | Description |
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| OG000 | Ad26.RSV.preF (1*10^11 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). | | OG001 | 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). |
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| Secondary | Percentage of Participants With Serious Adverse Events (SAEs) | 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. | 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. | Posted | | Number | | Percentage of participants | | Up to 6 months post-vaccination and up to 6 months post-challenge | | | | ID | Title | Description |
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| OG000 | Ad26.RSV.preF (1*10^11 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). | | OG001 | 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). |
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| Secondary | Percentage of Participants With Solicited Local and Systemic AEs | Solicited local AEs: erythema, swelling/induration, and pain/tenderness. Solicited systemic AEs: fatigue, headache, myalgia, arthralgia, chills, nausea and fever. | 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. | Posted | | Number | | Percentage of participants | | 7 days post-vaccination (Day -21) | | | | ID | Title | Description |
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| OG000 | Ad26.RSV.preF (1*10^11 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). | | OG001 | 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). |
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| Secondary | Percentage of Participants With Vital Signs Abnormalities | 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). | 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. | Posted | | Number | | Percentage of participants | | Up to Day 28 post-challenge | | | | ID | Title | Description |
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| OG000 | Ad26.RSV.preF (1*10^11 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). | | OG001 | 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). |
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| Secondary | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | 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). | 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. | Posted | | Number | | Percentage of participants | | Up to Day 12 post challenge | | | | ID | Title | Description |
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| OG000 | Ad26.RSV.preF (1*10^11 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). | | OG001 | 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). |
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| Secondary | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | 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). | 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. | Posted | | Number | | Percentage of participants | | Up to Day 28 post-challenge | | | | ID | Title | Description |
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| OG000 | Ad26.RSV.preF (1*10^11 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). | | OG001 | 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). |
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