Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| C5251002 | Other Identifier | Alias Study Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to learn about the safety, pharmacokinetics and antiviral activity of the study medicine (RV299) for the potential treatment of respiratory syncytial virus (RSV). RSV is a highly contagious virus that can lead to serious lung infections in patients with reduced ability to fight infection. Most vulnerable populations include babies, the elderly and patients that have received a bone marrow transplant.
This study is seeking healthy participants who are:
Healthy adult male and female participants aged between 18 to 55 years, with a total body weight ≥50 kg and body mass index (BMI) ≥18 kg/m2 and ≤35kg/m2 and who have been screened to be sero-suitable for infection with the RSV-A Memphis 37b virus challenge virus.
A total of 80 participants is planned: 40 participants on RV299 and 40 participants on placebo.
The study is divided into 3 phases:
Screening phase: from Day -90 to Day-3 pre-human viral challenge (HVC).
Inpatient phase: Participants will be resident in the quarantine unit for approximately 15 days (from Day -2 to Day 12).
Outpatient phase: Day 28 (±3 days)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | spray-dried dispersion (SDD) for Oral Suspension |
|
| Placebo | Placebo Comparator | spray-dried dispersion (SDD) for Oral Suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RV299 | Drug | Oral Suspension |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) for RSV-A Memphis 37b Viral Load Determined by Quantitative Real Time Reverse Transcription Polymerase Chain Reaction (qRT-PCR) | Area under the curve (AUC) for RSV viral load measured in nasal washes by qRT-PCR in participants inoculated with RSV-A Memphis 37b, from initial administration of IMP up to the morning of Day 12 (Quarantine discharge) was presented in this outcome measure. | From initial administration of IMP up to the morning of quarantine discharge (up to Day 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Viral Load of RSV Determined by qRT-PCR | Peak viral load of RSV as defined by the maximum viral load determined by qRT-PCR measurements in nasal samples starting from initial administration of IMP up to planned discharge from quarantine was reported in this outcome measure. | From initial administration of IMP up to planned discharge from quarantine (Up to Day 12) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | London | United Kingdom |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
Not provided
A total of 82 healthy participants were enrolled in the study and received Respiratory Syncytial Virus (RSV) - A Memphis 37b virus inoculation (challenge agent) intranasally on Day 0. Three participants withdrew from study (2 withdrew consent and 1 not randomized because of influenza infection) before randomization and a total of 79 participants were randomized in the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | RV299 | Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5. |
| FG001 | Placebo | Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population consisted of all randomized participants who received challenge virus and at least one dose of investigational medicinal product (IMP).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | RV299 | Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Curve (AUC) for RSV-A Memphis 37b Viral Load Determined by Quantitative Real Time Reverse Transcription Polymerase Chain Reaction (qRT-PCR) | Area under the curve (AUC) for RSV viral load measured in nasal washes by qRT-PCR in participants inoculated with RSV-A Memphis 37b, from initial administration of IMP up to the morning of Day 12 (Quarantine discharge) was presented in this outcome measure. | Intent-to-Treat Infected (ITT-I) Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection. | Posted | Mean | Standard Deviation | Hours*log10 copies per milliliter | From initial administration of IMP up to the morning of quarantine discharge (up to Day 12) |
|
From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RV299 | Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA version 25.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 31, 2022 | Nov 30, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 20, 2022 | Nov 30, 2023 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
matching placebo |
|
| Time to Confirmed Negative Test by qRT-PCR Measurement Starting From Initial Administration of Investigational Medicinal Product (IMP) to First Confirmed Undetectable Assessment After Peak Measure | The time from the first administration of IMP to the first confirmed negative qRT-PCR test after the peak qRT-PCR measurement was calculated as: Date and time of first confirmed negative test after peak qRT-PCR measurement minus Date and time of first IMP administration. A negative test was defined as two consecutive 'Not Detected' results in the qRT-PCR test. The peak qRT-PCR was defined as the highest viral load value obtained by a participant after their first administration of IMP. Participants without a confirmed undetectable assessment after their peak, were censored at their last detected qRT-PCR assessment. | From first administration of IMP to the first confirmed negative qRT-PCR test or censoring date (up to Day 12) |
| Time to Confirmed Negative Test by qRT-PCR Measurement Starting From Peak qRT-PCR After Initial Administration of IMP to First Confirmed Undetectable Assessment After Peak Measure | The time from the peak qRT-PCR measurement after administration of IMP to the first confirmed negative qRT-PCR test was calculated as (Date and time of first confirmed negative test after peak qRT-PCR measurement minus Date and time of peak qRT-PCR measurement). A negative test was defined as two consecutive 'Not Detected' results in the qRT-PCR test. The peak qRT-PCR was defined as the highest viral load value obtained by a participant after their first administration of IMP. Participants without a confirmed undetectable assessment after their peak, were censored at their last detected qRT-PCR assessment. | From peak qRT-PCR measurement to the first confirmed negative qRT-PCR test or censoring date (up to Day 12) |
| Time to Peak qRT-PCR Starting From Initial Administration of IMP | The time to the peak qRT-PCR measurement starting from the initial administration of IMP was calculated as: Date and time of peak qRT-PCR measurement minus Date and time of first IMP administration. The peak qRT-PCR was defined as the highest viral load value obtained by a participant after their first administration of IMP. | From first administration of IMP to peak qRT-PCR measurement (up to Day 12) |
| Area Under the Viral Load-Time Curve (VL-AUC) for RSV-A Memphis 37b Determined by Viral Culture | Area under the viral load-time curve (VL-AUC) of RSV challenge virus as determined by viral culture on nasal samples, starting at initial administration of IMP up to planned discharge from quarantine was reported in this outcome measure. | From initial administration of IMP up to planned discharge from quarantine (up to Day 12) |
| Peak Viral Load of RSV Determined by Viral Culture | Peak viral load of RSV as defined by the maximum viral load determined by viral culture measurements in nasal samples starting from initial administration of IMP up to planned discharge from quarantine was reported in this outcome measure. | From initial administration of IMP up to planned discharge from quarantine (up to Day 12) |
| Time to Confirmed Negative Test by Viral Culture Measurement Starting From at Initial Administration of IMP to First Confirmed Undetectable Assessment After Peak Measure | Time to confirmed negative test by viral culture measurements in nasal samples from initial administration of IMP up to first confirmed negative viral culture measurement after the peak viral culture measurement was calculated as: Date and time of first confirmed negative test after peak viral culture measurement minus Date and time of first IMP administration. A negative test was defined as two consecutive 'Not Detected' results in the viral culture test. The peak viral culture measurement was defined as the highest viral load value obtained by a participant after their first administration of IMP. Participants who did not have a confirmed undetectable assessment after their peak viral culture measurement after first administration of IMP were censored at their last detectable assessment. | From initial administration of IMP up to first confirmed undetectable assessment or censoring date (up to Day 12) |
| Time to Confirmed Negative Test by Viral Culture Measurement Starting From Peak Viral Culture After Initial Administration of IMP to First Confirmed Undetectable Assessment After Peak Measure | The time from the peak viral culture measurement after administration of IMP to the first confirmed negative viral culture measurement was calculated in days as: Date of and time first confirmed negative test minus Date and time of peak qRT-PCR measurement. A negative test was defined as two consecutive 'Not Detected' results in the viral culture test. The peak viral culture measurement was defined as the highest viral load value obtained by a participant after their first administration of IMP. Participants who did not have a confirmed undetectable assessment after their peak viral culture measurement after first administration of IMP were censored at their last detectable assessment. | From peak qRT-PCR measurement to first confirmed undetectable assessment or censoring date (up to Day 12) |
| Area Under the Curve Over Time of Total Clinical Symptoms as Measured From 10 Symptoms Within the Graded Symptom Scoring System | Area under the Curve over Time of Total Clinical Symptoms (TSS-AUC) as measured from 10 symptoms within Graded Symptom Scoring System Collected 3 Times Daily Starting at Initial Administration up to Planned Discharge from Quarantine. TSS (from 10 items of the 13-item symptom diary card) was used to calculate the AUC, from the assessment nearest to the time of the first administration of IMP until Day 12. Following types of symptoms were recorded on symptom diary cards: Upper Respiratory Tract (URT): runny nose, stuffy nose, sore throat, sneezing, earache; Lower Respiratory Tract (LRT): cough, shortness of breath; Systemic: headache, malaise, muscle/joint ache/stiffness. Each symptom was recorded on a grading scale of 0 to 3 (or 0 to 4 for the Shortness of Breath symptom), higher scores = greater severity of symptoms. Total symptom score was calculated as sum of the 10 observed symptom grade values and ranged from 0 to 31, where higher scores indicated more severe symptoms. | From initial administration of IMP (before or after administration) up to planned discharge from quarantine (up to Day 12) |
| Area Under the Curve Over Time of Total Clinical Symptoms Change From Baseline (TSS-AUC-CFB) as Measured From 10 Symptoms Within the Graded Symptom Scoring System | Area under the curve over time of total clinical symptoms change from baseline (TSS-AUC-CFB) as measured from 10 symptoms within the graded symptom scoring system collected 3 times daily starting at initial administration of IMP up to planned discharge from quarantine (Day 12, am). The following types of symptoms were recorded: Upper Respiratory Tract (URT): runny nose, stuffy nose, sore throat, sneezing, earache; Lower Respiratory Tract (LRT): cough, shortness of breath; Systemic: headache, malaise, muscle/joint ache/stiffness. Each symptom was recorded on a grading scale of 0 to 3 (or 0 to 4 for the Shortness of Breath symptom), where higher scores indicated greater severity of symptoms. TSS was calculated as sum of the 10 observed symptom grade values and ranged from 0 to 31, where higher scores indicated more severe symptoms. The AUC calculation was based on the available non-missing calculated total symptom scores between the start and end of the defined AUC time. | Baseline (assessment nearest to the time of the first administration of IMP) up to Day 12 |
| Overall Peak Total Clinical Symptoms (TSS) Score | Peak total clinical symptoms (TSS) as measured from 10 symptoms within the graded symptom scoring system collected 3 times daily starting from initial administration of IMP up to planned discharge from quarantine. The following types of symptoms were recorded: Upper Respiratory Tract (URT): runny nose, stuffy nose, sore throat, sneezing, earache; Lower Respiratory Tract (LRT): cough, shortness of breath; Systemic: headache, malaise, muscle/joint ache/stiffness. Each symptom was recorded on a grading scale of 0 to 3 (or 0 to 4 for the Shortness of Breath symptom), where higher scores indicated greater severity of symptoms. The total symptom score was calculated as sum of the 10 observed symptom grade values and ranged from 0 to 31, where higher scores indicated more severe symptoms. The overall peak score was defined as the highest scoring symptom diary card observed from the first administration of IMP until quarantine discharge. | From initial administration of IMP (before or after administration) up to planned discharge from quarantine (up to Day 12) |
| Individual Maximum Daily Peak Symptom Score | Individual maximum daily sum of symptom score from initial administration of IMP up to planned discharge from quarantine. The following types of symptoms were recorded: Upper Respiratory Tract (URT): runny nose, stuffy nose, sore throat, sneezing, earache; Lower Respiratory Tract (LRT): cough, shortness of breath; Systemic: headache, malaise, muscle/joint ache/stiffness. Each symptom was recorded on a grading scale of 0 to 3 (or 0 to 4 for the Shortness of Breath symptom), where higher scores indicated greater severity of symptoms. The total symptom score was calculated as sum of the 10 observed symptom grade values and ranged from 0 to 31, where higher scores indicated more severe symptoms. The highest total symptom score recorded on each day, across the three assessments was reported in this outcome measure. The peak daily score was defined as the highest scoring symptom diary card observed on each day from the first administration of IMP until quarantine discharge. | Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 and Day 9 (days relative to first administration of IMP) |
| Time to Symptom Resolution Starting at Initial Administration of IMP to 24 Hours Symptom Free | Symptom resolution was defined as a participant scoring 0 for the total symptom score for a 24-hour period (e.g., a minimum of three consecutive symptom diary cards, each with a score of 0) after their peak symptom score. The time from the assessment at the time of the first administration of IMP until symptom resolution was calculated as: Date and time of symptom resolution minus Date and time of assessment at IMP administration. If the peak symptom score occurred on more than one day then the first occurrence was selected. Participants who did not record 24 hours symptom free after their highest total symptom score during the quarantine period were censored at their last assessment. | From first administration of IMP until time of symptom resolution or censoring date (up to Day 12) |
| Time to Symptom Resolution Starting at Peak Symptoms After Initial Administration to 24 Hours Symptom Free | Symptom resolution was defined as a participant scoring 0 for the total symptom score for a 24-hour period (e.g., a minimum of three consecutive symptom diary cards, each with a score of 0) after their peak symptom score. The time from the highest total symptom score following administration of IMP until symptom resolution was calculated as: Date and time of symptom resolution minus Date and time of highest total symptom score. If the peak symptom score occurred on more than one day then the first occurrence was selected. Participants who did not record 24 hours symptom free after their highest total symptom score during the quarantine period were censored at their last assessment. | From time of highest total symptom score until time of symptom resolution or censoring date (up to Day 12) |
| Time to Peak Symptom Score From Initial Administration of IMP | Time to peak as measured from 10 symptoms within the graded daily symptom scoring system starting from initial administration of IMP to the time of peak daily symptom score. If the peak symptom score occurred on more than one day then the first occurrence was selected. Participants were censored at their last assessment if they did not record any symptoms during the quarantine period. | From first dose of IMP until time of highest total symptom score or censoring date (Up to Day 12) |
| Total Weight of Mucus Produced Starting at Initial Administration of IMP up to Planned Discharge From Quarantine | Total weight of nasal mucus was calculated as the sum of mucus weights taken from the assessment at the time of the first administration of IMP (prior to or after dosing, depending on whether dosed in the morning or evening) to morning of Day 12 (Quarantine discharge). | From first administration of IMP up to planned discharge from quarantine (up to Day 12) |
| Total Number of Tissues Used by Participants Starting At Initial Administration of IMP up to Planned Discharge From Quarantine | Total number of tissues was counted from the assessment at the time of the first dose of IMP (prior to or after dosing, depending on whether dosed in the morning or evening) to morning of Day 12 (Quarantine discharge). | From first administration of IMP up to planned discharge from quarantine (up to Day 12) |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An adverse event was defined as any untoward medical occurrence in clinical study participants administered a pharmaceutical product. An AE did not necessarily have a causal relationship with the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or important medical event. | From first dose of IMP until end of follow-up visit (up to Day 28) |
| Number of Participants With AEs Related to Viral Challenge | An Adverse Event was defined as any untoward medical occurrence in clinical study participants administered a pharmaceutical product. An AE did not necessarily have a causal relationship with the study intervention. Number of participants with AEs possibly, probably or definitely related to viral challenge agents were reported by preferred terms in this outcome measure. | From viral challenge on Day 0 up to end of follow-up (Day 28) |
| Number of Participants With Concomitant Medications | Number of participants with concomitant medications were reported in this outcome measure. | From viral challenge on Day 0 up to end of follow-up (Day 28) |
| Time to Maximum Plasma Concentration (Tmax) for RV299 | Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96-hours post-dose 1 and dose 10 |
| Terminal Half-Life (t1/2) for RV299 | Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96 hours post-dose 1 and dose 10 |
| Maximum Observed Plasma Concentration for RV299 | Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96 hours post-dose 1 and dose 10 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to the End of the Dosing Interval for RV299 | Area under the plasma concentration-time curve from time zero to the end of the dosing interval for RV299 where dosing interval=12 hours. | Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12 hours post-dose 1 and dose 10 |
| Area Under the Plasma Concentration-Time Curve Over the Last 24 Hours Dosing Interval for RV299 | Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24 hours post-dose 1 and dose 10 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity for RV299 on Day 1 | Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96 hours post-dose 1 |
| Placebo |
Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Placebo | Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5. |
|
|
|
| Secondary | Peak Viral Load of RSV Determined by qRT-PCR | Peak viral load of RSV as defined by the maximum viral load determined by qRT-PCR measurements in nasal samples starting from initial administration of IMP up to planned discharge from quarantine was reported in this outcome measure. | ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection. | Posted | Mean | Standard Deviation | Log10 copies per milliliter | From initial administration of IMP up to planned discharge from quarantine (Up to Day 12) |
|
|
|
|
| Secondary | Time to Confirmed Negative Test by qRT-PCR Measurement Starting From Initial Administration of Investigational Medicinal Product (IMP) to First Confirmed Undetectable Assessment After Peak Measure | The time from the first administration of IMP to the first confirmed negative qRT-PCR test after the peak qRT-PCR measurement was calculated as: Date and time of first confirmed negative test after peak qRT-PCR measurement minus Date and time of first IMP administration. A negative test was defined as two consecutive 'Not Detected' results in the qRT-PCR test. The peak qRT-PCR was defined as the highest viral load value obtained by a participant after their first administration of IMP. Participants without a confirmed undetectable assessment after their peak, were censored at their last detected qRT-PCR assessment. | ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection. | Posted | Median | Inter-Quartile Range | Days | From first administration of IMP to the first confirmed negative qRT-PCR test or censoring date (up to Day 12) |
|
|
|
|
| Secondary | Time to Confirmed Negative Test by qRT-PCR Measurement Starting From Peak qRT-PCR After Initial Administration of IMP to First Confirmed Undetectable Assessment After Peak Measure | The time from the peak qRT-PCR measurement after administration of IMP to the first confirmed negative qRT-PCR test was calculated as (Date and time of first confirmed negative test after peak qRT-PCR measurement minus Date and time of peak qRT-PCR measurement). A negative test was defined as two consecutive 'Not Detected' results in the qRT-PCR test. The peak qRT-PCR was defined as the highest viral load value obtained by a participant after their first administration of IMP. Participants without a confirmed undetectable assessment after their peak, were censored at their last detected qRT-PCR assessment. | ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection. | Posted | Median | Inter-Quartile Range | Days | From peak qRT-PCR measurement to the first confirmed negative qRT-PCR test or censoring date (up to Day 12) |
|
|
|
|
| Secondary | Time to Peak qRT-PCR Starting From Initial Administration of IMP | The time to the peak qRT-PCR measurement starting from the initial administration of IMP was calculated as: Date and time of peak qRT-PCR measurement minus Date and time of first IMP administration. The peak qRT-PCR was defined as the highest viral load value obtained by a participant after their first administration of IMP. | ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection. | Posted | Median | Inter-Quartile Range | Days | From first administration of IMP to peak qRT-PCR measurement (up to Day 12) |
|
|
|
|
| Secondary | Area Under the Viral Load-Time Curve (VL-AUC) for RSV-A Memphis 37b Determined by Viral Culture | Area under the viral load-time curve (VL-AUC) of RSV challenge virus as determined by viral culture on nasal samples, starting at initial administration of IMP up to planned discharge from quarantine was reported in this outcome measure. | ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection. | Posted | Mean | Standard Deviation | Hours*log10 plaque forming units/mL | From initial administration of IMP up to planned discharge from quarantine (up to Day 12) |
|
|
|
|
| Secondary | Peak Viral Load of RSV Determined by Viral Culture | Peak viral load of RSV as defined by the maximum viral load determined by viral culture measurements in nasal samples starting from initial administration of IMP up to planned discharge from quarantine was reported in this outcome measure. | ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection. | Posted | Mean | Standard Deviation | Log10 plaque forming units/mL | From initial administration of IMP up to planned discharge from quarantine (up to Day 12) |
|
|
|
|
| Secondary | Time to Confirmed Negative Test by Viral Culture Measurement Starting From at Initial Administration of IMP to First Confirmed Undetectable Assessment After Peak Measure | Time to confirmed negative test by viral culture measurements in nasal samples from initial administration of IMP up to first confirmed negative viral culture measurement after the peak viral culture measurement was calculated as: Date and time of first confirmed negative test after peak viral culture measurement minus Date and time of first IMP administration. A negative test was defined as two consecutive 'Not Detected' results in the viral culture test. The peak viral culture measurement was defined as the highest viral load value obtained by a participant after their first administration of IMP. Participants who did not have a confirmed undetectable assessment after their peak viral culture measurement after first administration of IMP were censored at their last detectable assessment. | ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection. | Posted | Median | Inter-Quartile Range | Days | From initial administration of IMP up to first confirmed undetectable assessment or censoring date (up to Day 12) |
|
|
|
|
| Secondary | Time to Confirmed Negative Test by Viral Culture Measurement Starting From Peak Viral Culture After Initial Administration of IMP to First Confirmed Undetectable Assessment After Peak Measure | The time from the peak viral culture measurement after administration of IMP to the first confirmed negative viral culture measurement was calculated in days as: Date of and time first confirmed negative test minus Date and time of peak qRT-PCR measurement. A negative test was defined as two consecutive 'Not Detected' results in the viral culture test. The peak viral culture measurement was defined as the highest viral load value obtained by a participant after their first administration of IMP. Participants who did not have a confirmed undetectable assessment after their peak viral culture measurement after first administration of IMP were censored at their last detectable assessment. | ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection. | Posted | Median | Inter-Quartile Range | Days | From peak qRT-PCR measurement to first confirmed undetectable assessment or censoring date (up to Day 12) |
|
|
|
|
| Secondary | Area Under the Curve Over Time of Total Clinical Symptoms as Measured From 10 Symptoms Within the Graded Symptom Scoring System | Area under the Curve over Time of Total Clinical Symptoms (TSS-AUC) as measured from 10 symptoms within Graded Symptom Scoring System Collected 3 Times Daily Starting at Initial Administration up to Planned Discharge from Quarantine. TSS (from 10 items of the 13-item symptom diary card) was used to calculate the AUC, from the assessment nearest to the time of the first administration of IMP until Day 12. Following types of symptoms were recorded on symptom diary cards: Upper Respiratory Tract (URT): runny nose, stuffy nose, sore throat, sneezing, earache; Lower Respiratory Tract (LRT): cough, shortness of breath; Systemic: headache, malaise, muscle/joint ache/stiffness. Each symptom was recorded on a grading scale of 0 to 3 (or 0 to 4 for the Shortness of Breath symptom), higher scores = greater severity of symptoms. Total symptom score was calculated as sum of the 10 observed symptom grade values and ranged from 0 to 31, where higher scores indicated more severe symptoms. | ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection. | Posted | Mean | Standard Deviation | Hours*score | From initial administration of IMP (before or after administration) up to planned discharge from quarantine (up to Day 12) |
|
|
|
|
| Secondary | Area Under the Curve Over Time of Total Clinical Symptoms Change From Baseline (TSS-AUC-CFB) as Measured From 10 Symptoms Within the Graded Symptom Scoring System | Area under the curve over time of total clinical symptoms change from baseline (TSS-AUC-CFB) as measured from 10 symptoms within the graded symptom scoring system collected 3 times daily starting at initial administration of IMP up to planned discharge from quarantine (Day 12, am). The following types of symptoms were recorded: Upper Respiratory Tract (URT): runny nose, stuffy nose, sore throat, sneezing, earache; Lower Respiratory Tract (LRT): cough, shortness of breath; Systemic: headache, malaise, muscle/joint ache/stiffness. Each symptom was recorded on a grading scale of 0 to 3 (or 0 to 4 for the Shortness of Breath symptom), where higher scores indicated greater severity of symptoms. TSS was calculated as sum of the 10 observed symptom grade values and ranged from 0 to 31, where higher scores indicated more severe symptoms. The AUC calculation was based on the available non-missing calculated total symptom scores between the start and end of the defined AUC time. | ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection. | Posted | Mean | Standard Deviation | Hours*score | Baseline (assessment nearest to the time of the first administration of IMP) up to Day 12 |
|
|
|
|
| Secondary | Overall Peak Total Clinical Symptoms (TSS) Score | Peak total clinical symptoms (TSS) as measured from 10 symptoms within the graded symptom scoring system collected 3 times daily starting from initial administration of IMP up to planned discharge from quarantine. The following types of symptoms were recorded: Upper Respiratory Tract (URT): runny nose, stuffy nose, sore throat, sneezing, earache; Lower Respiratory Tract (LRT): cough, shortness of breath; Systemic: headache, malaise, muscle/joint ache/stiffness. Each symptom was recorded on a grading scale of 0 to 3 (or 0 to 4 for the Shortness of Breath symptom), where higher scores indicated greater severity of symptoms. The total symptom score was calculated as sum of the 10 observed symptom grade values and ranged from 0 to 31, where higher scores indicated more severe symptoms. The overall peak score was defined as the highest scoring symptom diary card observed from the first administration of IMP until quarantine discharge. | ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection. | Posted | Mean | Standard Deviation | Units on a scale | From initial administration of IMP (before or after administration) up to planned discharge from quarantine (up to Day 12) |
|
|
|
|
| Secondary | Individual Maximum Daily Peak Symptom Score | Individual maximum daily sum of symptom score from initial administration of IMP up to planned discharge from quarantine. The following types of symptoms were recorded: Upper Respiratory Tract (URT): runny nose, stuffy nose, sore throat, sneezing, earache; Lower Respiratory Tract (LRT): cough, shortness of breath; Systemic: headache, malaise, muscle/joint ache/stiffness. Each symptom was recorded on a grading scale of 0 to 3 (or 0 to 4 for the Shortness of Breath symptom), where higher scores indicated greater severity of symptoms. The total symptom score was calculated as sum of the 10 observed symptom grade values and ranged from 0 to 31, where higher scores indicated more severe symptoms. The highest total symptom score recorded on each day, across the three assessments was reported in this outcome measure. The peak daily score was defined as the highest scoring symptom diary card observed on each day from the first administration of IMP until quarantine discharge. | ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints. | Posted | Mean | Standard Deviation | Units on a scale | Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 and Day 9 (days relative to first administration of IMP) |
|
|
|
| Secondary | Time to Symptom Resolution Starting at Initial Administration of IMP to 24 Hours Symptom Free | Symptom resolution was defined as a participant scoring 0 for the total symptom score for a 24-hour period (e.g., a minimum of three consecutive symptom diary cards, each with a score of 0) after their peak symptom score. The time from the assessment at the time of the first administration of IMP until symptom resolution was calculated as: Date and time of symptom resolution minus Date and time of assessment at IMP administration. If the peak symptom score occurred on more than one day then the first occurrence was selected. Participants who did not record 24 hours symptom free after their highest total symptom score during the quarantine period were censored at their last assessment. | ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection. Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Median | Inter-Quartile Range | Days | From first administration of IMP until time of symptom resolution or censoring date (up to Day 12) |
|
|
|
| Secondary | Time to Symptom Resolution Starting at Peak Symptoms After Initial Administration to 24 Hours Symptom Free | Symptom resolution was defined as a participant scoring 0 for the total symptom score for a 24-hour period (e.g., a minimum of three consecutive symptom diary cards, each with a score of 0) after their peak symptom score. The time from the highest total symptom score following administration of IMP until symptom resolution was calculated as: Date and time of symptom resolution minus Date and time of highest total symptom score. If the peak symptom score occurred on more than one day then the first occurrence was selected. Participants who did not record 24 hours symptom free after their highest total symptom score during the quarantine period were censored at their last assessment. | ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection. Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Median | Inter-Quartile Range | Days | From time of highest total symptom score until time of symptom resolution or censoring date (up to Day 12) |
|
|
|
| Secondary | Time to Peak Symptom Score From Initial Administration of IMP | Time to peak as measured from 10 symptoms within the graded daily symptom scoring system starting from initial administration of IMP to the time of peak daily symptom score. If the peak symptom score occurred on more than one day then the first occurrence was selected. Participants were censored at their last assessment if they did not record any symptoms during the quarantine period. | ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection. | Posted | Median | Inter-Quartile Range | Days | From first dose of IMP until time of highest total symptom score or censoring date (Up to Day 12) |
|
|
|
| Secondary | Total Weight of Mucus Produced Starting at Initial Administration of IMP up to Planned Discharge From Quarantine | Total weight of nasal mucus was calculated as the sum of mucus weights taken from the assessment at the time of the first administration of IMP (prior to or after dosing, depending on whether dosed in the morning or evening) to morning of Day 12 (Quarantine discharge). | ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection. | Posted | Mean | Standard Deviation | Grams | From first administration of IMP up to planned discharge from quarantine (up to Day 12) |
|
|
|
| Secondary | Total Number of Tissues Used by Participants Starting At Initial Administration of IMP up to Planned Discharge From Quarantine | Total number of tissues was counted from the assessment at the time of the first dose of IMP (prior to or after dosing, depending on whether dosed in the morning or evening) to morning of Day 12 (Quarantine discharge). | ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection. | Posted | Mean | Standard Deviation | Tissues | From first administration of IMP up to planned discharge from quarantine (up to Day 12) |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An adverse event was defined as any untoward medical occurrence in clinical study participants administered a pharmaceutical product. An AE did not necessarily have a causal relationship with the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or important medical event. | Safety analysis population was defined as all randomized participants who received challenge virus and at least 1 dose of IMP. | Posted | Count of Participants | Participants | From first dose of IMP until end of follow-up visit (up to Day 28) |
|
|
|
| Secondary | Number of Participants With AEs Related to Viral Challenge | An Adverse Event was defined as any untoward medical occurrence in clinical study participants administered a pharmaceutical product. An AE did not necessarily have a causal relationship with the study intervention. Number of participants with AEs possibly, probably or definitely related to viral challenge agents were reported by preferred terms in this outcome measure. | Safety analysis population was defined as all randomised participants who received challenge virus and at least 1 dose of IMP. | Posted | Count of Participants | Participants | From viral challenge on Day 0 up to end of follow-up (Day 28) |
|
|
|
| Secondary | Number of Participants With Concomitant Medications | Number of participants with concomitant medications were reported in this outcome measure. | Safety analysis population was defined as all randomized participants who received challenge virus and at least 1 dose of IMP. | Posted | Count of Participants | Participants | From viral challenge on Day 0 up to end of follow-up (Day 28) |
|
|
|
| Secondary | Time to Maximum Plasma Concentration (Tmax) for RV299 | Pharmacokinetic (PK) population consisted of all participants from ITT population (all randomized participants who received challenge virus and at least 1 dose of IMP) with at least one post-dose PK result. | Posted | Median | Full Range | Hours | Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96-hours post-dose 1 and dose 10 |
|
|
|
| Secondary | Terminal Half-Life (t1/2) for RV299 | PK population consisted of all participants from ITT population (all randomized participants who received challenge virus and at least 1 dose of IMP) with at least one post-dose PK result. Here, 'Number Analyzed' signifies participants evaluable for specified timepoints. t1/2 for dose 1 could not be calculated as at least 3 data points were required in terminal elimination phase within same participant; this criteria could not be fulfilled due to insufficient data above limit of quantification. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96 hours post-dose 1 and dose 10 |
|
|
|
| Secondary | Maximum Observed Plasma Concentration for RV299 | PK population consisted of all participants from ITT population (all randomized participants who received challenge virus and at least 1 dose of IMP) with at least one post-dose PK result. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96 hours post-dose 1 and dose 10 |
|
|
|
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to the End of the Dosing Interval for RV299 | Area under the plasma concentration-time curve from time zero to the end of the dosing interval for RV299 where dosing interval=12 hours. | PK population consisted of all participants from ITT population (all randomized participants who received challenge virus and at least 1 dose of IMP) with at least one post-dose PK result Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12 hours post-dose 1 and dose 10 |
|
|
|
| Secondary | Area Under the Plasma Concentration-Time Curve Over the Last 24 Hours Dosing Interval for RV299 | PK population consisted of all participants from ITT population (all randomized participants who received challenge virus and at least 1 dose of IMP) with at least one post-dose PK result. Only participants with evaluable results for this PK parameter were reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24 hours post-dose 1 and dose 10 |
|
|
|
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity for RV299 on Day 1 | PK population consisted of all participants from ITT population (all randomized participants who received challenge virus and at least 1 dose of IMP) with at least one post-dose PK result. AUC(0-infinity) could not be calculated as atleast 3 data points are required in terminal elimination phase within same participant; this criteria could not be fulfilled due to insufficient data above limit of quantification and did not include a characterization of the terminal elimination. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96 hours post-dose 1 |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 12 |
| 39 |
| EG001 | Placebo | Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5. | 0 | 40 | 0 | 40 | 12 | 40 |
| Dizziness | Nervous system disorders | MedDRA version 25.0 | Non-systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA version 25.0 | Non-systematic Assessment |
|
| Anosmia | Nervous system disorders | MedDRA version 25.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA version 25.0 | Non-systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA version 25.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA version 25.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA version 25.0 | Non-systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | MedDRA version 25.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 25.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 25.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 25.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 25.0 | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA version 25.0 | Non-systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA version 25.0 | Non-systematic Assessment |
|
| Electrocardiogram T wave abnormal | Investigations | MedDRA version 25.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA version 25.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Non-systematic Assessment |
|
| Bundle branch block | Cardiac disorders | MedDRA version 25.0 | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA version 25.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Day 1 |
|
|
| Day 2 |
|
|
| Day 3 |
|
|
| Day 4 |
|
|
| Day 5 |
|
|
| Day 6 |
|
|
| Day 7 |
|
|
| Day 8 |
|
|
| Day 9 |
|
|
| Headache (Definitely Related) |
|
| Ageusia (Possibly Related) |
|
| Ageusia (Probably Related) |
|
| Ageusia (Definitely Related) |
|
| Anosmia (Possibly Related) |
|
| Anosmia (Probably Related) |
|
| Anosmia (Definitely Related) |
|
| Syncope (Possibly Related) |
|
| Syncope (Probably Related) |
|
| Syncope (Definitely Related) |
|
| Nausea (Possibly Related) |
|
| Nausea (Probably Related) |
|
| Nausea (Definitely Related) |
|
| Abdominal distension (Possibly Related) |
|
| Abdominal distension (Probably Related) |
|
| Abdominal distension (Definitely Related) |
|
| Diarrhoea (Possibly Related) |
|
| Diarrhoea (Probably Related) |
|
| Diarrhoea (Definitely Related) |
|
| Mouth ulceration (Possibly Related) |
|
| Mouth ulceration (Probably Related) |
|
| Mouth ulceration (Definitely Related) |
|
| Malaise (Possibly Related) |
|
| Malaise (Probably Related) |
|
| Malaise (Definitely Related) |
|
| Chest discomfort (Possibly Related) |
|
| Chest discomfort (Probably Related) |
|
| Chest discomfort (Definitely Related) |
|
| Chills (Possibly Related) |
|
| Chills (Probably Related) |
|
| Chills (Definitely Related) |
|
| Dyspnoea (Possibly Related) |
|
| Dyspnoea (Probably Related) |
|
| Dyspnoea (Definitely Related) |
|
| Cough (Possibly Related) |
|
| Cough (Probably Related) |
|
| Cough (Definitely Related) |
|
| Electrocardiogram T wave abnormal (Possibly Related) |
|
| Electrocardiogram T wave abnormal (Probably Related) |
|
| Electrocardiogram T wave abnormal (Definitely Related) |
|
| Platelet count decreased (Possibly Related) |
|
| Platelet count decreased (Probably Related) |
|
| Platelet count decreased (Definitely Related) |
|
| Tachycardia (Possibly Related) |
|
| Tachycardia (Probably Related) |
|
| Tachycardia (Definitely Related) |
|
| Upper respiratory tract infection (Possibly Related) |
|
| Upper respiratory tract infection (Probably Related) |
|
| Upper respiratory tract infection (Definitely Related) |
|
| Musculoskeletal pain (Possibly Related) |
|
| Musculoskeletal pain (Probably Related) |
|
| Musculoskeletal pain (Definitely Related) |
|
|
|