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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006149-24 | EudraCT Number |
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This study will assist in the early detection of influenza resistant to antivirals and will monitor the clinical outcome of adults and children infected with influenza according to subtype and susceptibility. Participants clinically diagnosed with influenza will undergo a rapid diagnostic test and viral sampling at Baseline and on Days 3, 6, and 10. Participants will be clinically managed according to local guidelines and the decision to treat/not treat will be at the discretion of the Investigator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants Infected with Influenza | Participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness will be enrolled and followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes. Participants may receive treatment including oseltamivir, other treatment/medication, or no treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oseltamivir | Drug | Participants may receive treatment at the discretion of the investigator according to local practice standards, and there is no protocol-specified intervention. However, analyses will be presented separately for participants treated with oseltamivir during the course of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Genotypic Resistance | Samples were analyzed using reverse transcriptase-polymerase chain reaction (RT-PCR). Pre-defined mutations in viral ribonucleic acid (RNA) were noted, the presence of which was defined as genotypic resistance. The number of participants with genotypic resistance at Baseline was reported. The number of participants with genotypic resistance post-Baseline was determined by a collective count of all participants who had a resistance mutation at least once on Days 3, 6, and/or 10. (Hereafter, "H" stands for hemagglutinin and "N" stands for neuraminidase in abbreviations of viral subtype such as H1N1, H1N1pdm09, and H3N2.) | Baseline (Day 1) and post-Baseline (Days 3, 6, 10) |
| Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. The percentage of participants with treatment-emergent resistance was reported by study year for participants with H3N2 or H1N1pdm09 infections. Only data with evaluable participants were reported. | From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) during Study Years 1, 2, 3, 4, 5, 6, 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir | Baseline (Day 1) | |
| Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir | Day 3 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness will be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chicago | Illinois | 60655 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31560055 | Derived | Roosenhoff R, Reed V, Kenwright A, Schutten M, Boucher CA, Monto A, Clinch B, Kumar D, Whitley R, Nguyen-Van-Tam JS, Osterhaus ADME, Fouchier RAM, Fraaij PLA. Viral Kinetics and Resistance Development in Children Treated with Neuraminidase Inhibitors: The Influenza Resistance Information Study (IRIS). Clin Infect Dis. 2020 Aug 22;71(5):1186-1194. doi: 10.1093/cid/ciz939. | |
| 25849228 |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants Infected With Influenza | Participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled. During Years 1 to 5 of the overall study, otherwise healthy/non-immunocompromised adults and children greater than or equal to (≥) 1 year of age were considered as eligible. Following a protocol amendment, inclusion criteria for Years 6 and 7 were changed to only include healthy or immunocompromised children less than or equal to (≤) 12 years of age being treated with an influenza antiviral medication. Participants were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All Enrolled Healthy Participants (AEHP) Population: All otherwise healthy participants who entered the study. Due to the imbalance between healthy (n=4553) and immunocompromised participants (n=8), results from immunocompromised participants were not included in any analyses, and data obtained from healthy participants were the focus of the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Otherwise Healthy Participants Infected With Influenza | Otherwise healthy/non-immunocompromised participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled. During Years 1 to 5 of the overall study, adults and children ≥1 year of age were considered as eligible. Following a protocol amendment, inclusion criteria for Years 6 and 7 were changed to only include children ≤12 years of age being treated with an influenza antiviral medication. Participants were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes. |
| 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 | Number of Participants With Genotypic Resistance | Samples were analyzed using reverse transcriptase-polymerase chain reaction (RT-PCR). Pre-defined mutations in viral ribonucleic acid (RNA) were noted, the presence of which was defined as genotypic resistance. The number of participants with genotypic resistance at Baseline was reported. The number of participants with genotypic resistance post-Baseline was determined by a collective count of all participants who had a resistance mutation at least once on Days 3, 6, and/or 10. (Hereafter, "H" stands for hemagglutinin and "N" stands for neuraminidase in abbreviations of viral subtype such as H1N1, H1N1pdm09, and H3N2.) | All Laboratory-Confirmed Influenza Participants (ALCIP) Population: All with confirmed influenza by positive RT-PCR at Baseline. The "Number of Participants Analyzed" reflects the total of participants who provided evaluable data for their viral RNA subtype. The number who provided data for each viral RNA subtype in each timeframe (n) is shown. | Posted | Number | participants | Baseline (Day 1) and post-Baseline (Days 3, 6, 10) |
|
From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants Treated With Oseltamivir | Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
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This was a non-randomized, observational study and many comparisons were not powered to detect a true statistically significant difference between groups. Inferential analyses should be interpreted with caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
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|
|
| Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir | Day 6 |
| Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir | Day 10 |
| Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir | Baseline (Day 1) |
| Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir | Day 3 |
| Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir | Day 6 |
| Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir | Day 10 |
| Time to Non-Detection of Viral RNA | Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days. | From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) |
| Time to Non-Detection of Viral RNA Among Participants With H3N2 Infections | Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days. | From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) |
| Time to Non-Detection of Viral RNA Among Participants With H1N1pdm09 Infections | Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days. | From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) |
| Time to Non-Detection of Viral RNA Among Participants With Influenza B Infections | Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days. | From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) |
| Viral Load Among Adults Treated With Oseltamivir | Viral load was determined for those with detectable virus above the lower limit of quantification (LLQ) of 1.82 for influenza A viruses and 1.99 for influenza B viruses. The viral load from each sample was averaged among all participants and expressed in log10 of the number of viral particles per milliliter (log10 vp/mL). | Days 1, 3, 6, 10 |
| Viral Load Among Children Treated With Oseltamivir | Viral load was determined for those with detectable virus above the LLQ of 1.82 for influenza A viruses and 1.99 for influenza B viruses. The viral load from each sample was averaged among all participants and expressed in log10 vp/mL. | Days 1, 3, 6, 10 |
| Percentage of Participants With Symptom Resolution on Day 6 Comparing Resistant and Susceptible Viruses | Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as 50% inhibitory concentration (IC50) more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The percentage of participants with mild or absent symptoms on Day 6 was reported and stratified by resistant and susceptible viruses. | Day 6 |
| Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses | Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as IC50 more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The percentage of participants by earliest post-Baseline test day on which viral RNA was not detected was reported and stratified by resistant and susceptible viruses. | Days 3, 6, 10 |
| Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load | Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as IC50 more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The mean viral load from each sample was expressed in log10 vp/mL and stratified by resistant and susceptible viruses. | Baseline (Day 1) |
| Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir | Symptoms were assessed on Days 1, 6, and 10. The Investigator rated seven symptoms of fever, sore throat, nasal congestion, cough, aches/pains, headache, and fatigue on a scale of 0 (absent/no problem) to 3 (severe/major problem). The global score was calculated as a sum of all individual symptom scores. Global scores may range from 0 to 21, with higher scores indicating worse or more pronounced symptoms. | Days 1, 6, 10 |
| Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir | Symptoms were assessed on Days 1, 6, and 10. The Investigator rated seven symptoms of fever, sore throat, nasal congestion, cough, aches/pains, headache, and energy/tiredness on a scale of 0 (absent/no problem) to 3 (severe/major problem). The global score was calculated as a sum of all individual symptom scores. Global scores may range from 0 to 21, with higher scores indicating worse or more pronounced symptoms. | Days 1, 6, 10 |
| Body Temperature Among Adults Treated With Oseltamivir | Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. Body temperature at each visit was averaged among all participants and expressed in degrees Celsius. | Days 1, 10 |
| Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir | Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. The change in body temperature between visits was averaged among all participants and expressed in degrees Celsius. | Baseline (Day 1) to Day 10 |
| Body Temperature Among Children Treated With Oseltamivir | Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. Body temperature at each visit was averaged among all participants and expressed in degrees Celsius. | Days 1, 10 |
| Change From Baseline in Body Temperature Among Children Treated With Oseltamivir | Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. The change in body temperature between visits was averaged among all participants and expressed in degrees Celsius. | Baseline (Day 1) to Day 10 |
| Westmead |
| New South Wales |
| 2145 |
| Australia |
| Bron | 69677 | France |
| Berlin | 14052 | Germany |
| Shatin | Hong Kong |
| Rotterdam | 3000 CA | Netherlands |
| Sandnes | 4313 | Norway |
| Krakow | 31-159 | Poland |
| Derived |
| Fraaij PL, Schutten M, Javouhey E, Burleigh L, Outlaw R, Kumar D, Boucher CA. Viral shedding and susceptibility to oseltamivir in hospitalized immunocompromised patients with influenza in the Influenza Resistance Information Study (IRIS). Antivir Ther. 2015;20(6):633-42. doi: 10.3851/IMP2957. Epub 2015 Apr 7. |
| Lost to Follow-up |
|
| Other |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 | Otherwise Healthy Participants Infected With Influenza | Otherwise healthy/non-immunocompromised participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled. During Years 1 to 5 of the overall study, adults and children ≥1 year of age were considered as eligible. Following a protocol amendment, inclusion criteria for Years 6 and 7 were changed to only include children ≤12 years of age being treated with an influenza antiviral medication. Participants were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes. |
|
|
| Primary | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. The percentage of participants with treatment-emergent resistance was reported by study year for participants with H3N2 or H1N1pdm09 infections. Only data with evaluable participants were reported. | ALCIP Population. The "Number of Participants Analyzed" reflects combined H3N2 or H1N1pdm09-infected participants across all study years who provided an analyzable post-Baseline sample for their viral RNA subtype. The number of participants who provided evaluable data for each viral RNA subtype in the specified timeframe (n) is shown in the table. | Posted | Number | percentage of participants | From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) during Study Years 1, 2, 3, 4, 5, 6, 7 |
|
|
|
| Secondary | Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir | ALCIP Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Baseline visit. | Posted | Number | participants | Baseline (Day 1) |
|
|
|
| Secondary | Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir | ALCIP Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 3 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 3 visit (n) is shown in the table. | Posted | Number | participants | Day 3 |
|
|
|
| Secondary | Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir | ALCIP Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 6 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 6 visit (n) is shown in the table. | Posted | Number | participants | Day 6 |
|
|
|
| Secondary | Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir | ALCIP Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 10 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 10 visit (n) is shown in the table. | Posted | Number | participants | Day 10 |
|
|
|
| Secondary | Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir | ALCIP Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Baseline visit. | Posted | Number | participants | Baseline (Day 1) |
|
|
|
| Secondary | Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir | ALCIP Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 3 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 3 visit (n) is shown in the table. | Posted | Number | participants | Day 3 |
|
|
|
| Secondary | Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir | ALCIP Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 6 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 6 visit (n) is shown in the table. | Posted | Number | participants | Day 6 |
|
|
|
| Secondary | Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir | ALCIP Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 10 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 10 visit (n) is shown in the table. | Posted | Number | participants | Day 10 |
|
|
|
| Secondary | Time to Non-Detection of Viral RNA | Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days. | ALCIP Population. The "Number of Participants Analyzed" reflects the number of participants who provided sufficient post-Baseline data. | Posted | Median | 95% Confidence Interval | days | From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) |
|
|
|
|
| Secondary | Time to Non-Detection of Viral RNA Among Participants With H3N2 Infections | Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days. | ALCIP Population. The "Number of Participants Analyzed" reflects the number of participants with H3N2 infection who provided sufficient post-Baseline data. | Posted | Median | 95% Confidence Interval | days | From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) |
|
|
|
|
| Secondary | Time to Non-Detection of Viral RNA Among Participants With H1N1pdm09 Infections | Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days. | ALCIP Population. The "Number of Participants Analyzed" reflects the number of participants with H1N1pdm09 infection who provided sufficient post-Baseline data. | Posted | Median | 95% Confidence Interval | days | From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) |
|
|
|
|
| Secondary | Time to Non-Detection of Viral RNA Among Participants With Influenza B Infections | Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days. | ALCIP Population. The "Number of Participants Analyzed" reflects the number of participants with influenza B infection who provided sufficient post-Baseline data. | Posted | Median | 95% Confidence Interval | days | From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) |
|
|
|
|
| Secondary | Viral Load Among Adults Treated With Oseltamivir | Viral load was determined for those with detectable virus above the lower limit of quantification (LLQ) of 1.82 for influenza A viruses and 1.99 for influenza B viruses. The viral load from each sample was averaged among all participants and expressed in log10 of the number of viral particles per milliliter (log10 vp/mL). | ALCIP Population. The "Number of Participants Analyzed" reflects the highest total number of participants who provided evaluable data for their viral RNA subtype at any visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table. | Posted | Mean | Standard Deviation | log10 vp/mL | Days 1, 3, 6, 10 |
|
|
|
| Secondary | Viral Load Among Children Treated With Oseltamivir | Viral load was determined for those with detectable virus above the LLQ of 1.82 for influenza A viruses and 1.99 for influenza B viruses. The viral load from each sample was averaged among all participants and expressed in log10 vp/mL. | ALCIP Population. The "Number of Participants Analyzed" reflects the highest total number of participants who provided evaluable data for their viral RNA subtype at any visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table. | Posted | Mean | Standard Deviation | log10 vp/mL | Days 1, 3, 6, 10 |
|
|
|
| Secondary | Percentage of Participants With Symptom Resolution on Day 6 Comparing Resistant and Susceptible Viruses | Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as 50% inhibitory concentration (IC50) more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The percentage of participants with mild or absent symptoms on Day 6 was reported and stratified by resistant and susceptible viruses. | ALCIP Population. The "Number of Participants Analyzed" reflects the total number of participants with wild-type infection status at Baseline who provided evaluable data at the Day 6 visit. The number of participants who provided evaluable data for each resistance status at the Day 6 visit (n) is shown in the table. | Posted | Number | percentage of participants | Day 6 |
|
|
|
|
| Secondary | Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses | Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as IC50 more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The percentage of participants by earliest post-Baseline test day on which viral RNA was not detected was reported and stratified by resistant and susceptible viruses. | ALCIP Population. The "Number of Participants Analyzed" reflects the total number of participants with wild-type infection status at Baseline who provided evaluable data at the specified visit. The number of participants who provided evaluable data for each resistance status at the specified visit (n) is shown in the table. | Posted | Number | percentage of participants | Days 3, 6, 10 |
|
|
|
|
| Secondary | Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load | Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as IC50 more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The mean viral load from each sample was expressed in log10 vp/mL and stratified by resistant and susceptible viruses. | ALCIP Population. The "Number of Participants Analyzed" reflects the total number of participants with wild-type infection status at Baseline who provided evaluable data. The number of participants who provided evaluable data for each resistance status at Baseline (n) is shown in the table. | Posted | Number | percentage of participants | Baseline (Day 1) |
|
|
|
|
| Secondary | Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir | Symptoms were assessed on Days 1, 6, and 10. The Investigator rated seven symptoms of fever, sore throat, nasal congestion, cough, aches/pains, headache, and fatigue on a scale of 0 (absent/no problem) to 3 (severe/major problem). The global score was calculated as a sum of all individual symptom scores. Global scores may range from 0 to 21, with higher scores indicating worse or more pronounced symptoms. | ALCIP Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table. | Posted | Mean | Standard Deviation | units on a scale | Days 1, 6, 10 |
|
|
|
| Secondary | Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir | Symptoms were assessed on Days 1, 6, and 10. The Investigator rated seven symptoms of fever, sore throat, nasal congestion, cough, aches/pains, headache, and energy/tiredness on a scale of 0 (absent/no problem) to 3 (severe/major problem). The global score was calculated as a sum of all individual symptom scores. Global scores may range from 0 to 21, with higher scores indicating worse or more pronounced symptoms. | ALCIP Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table. | Posted | Mean | Standard Deviation | units on a scale | Days 1, 6, 10 |
|
|
|
| Secondary | Body Temperature Among Adults Treated With Oseltamivir | Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. Body temperature at each visit was averaged among all participants and expressed in degrees Celsius. | ALCIP Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table. | Posted | Mean | Standard Deviation | degrees Celsius | Days 1, 10 |
|
|
|
| Secondary | Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir | Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. The change in body temperature between visits was averaged among all participants and expressed in degrees Celsius. | ALCIP Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for their viral RNA subtype at Baseline and Day 10. The number of participants who provided evaluable data for each viral RNA subtype at Baseline and Day 10 (n) is shown in the table. | Posted | Mean | Standard Deviation | degrees Celsius | Baseline (Day 1) to Day 10 |
|
|
|
| Secondary | Body Temperature Among Children Treated With Oseltamivir | Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. Body temperature at each visit was averaged among all participants and expressed in degrees Celsius. | ALCIP Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table. | Posted | Mean | Standard Deviation | degrees Celsius | Days 1, 10 |
|
|
|
| Secondary | Change From Baseline in Body Temperature Among Children Treated With Oseltamivir | Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. The change in body temperature between visits was averaged among all participants and expressed in degrees Celsius. | ALCIP Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for their viral RNA subtype at Baseline and Day 10. The number of participants who provided evaluable data for each viral RNA subtype at Baseline and Day 10 (n) is shown in the table. | Posted | Mean | Standard Deviation | degrees Celsius | Baseline (Day 1) to Day 10 |
|
|
|
| 24 |
| 2,578 |
| 0 |
| 2,578 |
| EG001 | Participants Not Treated With Oseltamivir | Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants not receiving oseltamivir, including no treatment or other antiviral treatment, were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes. | 11 | 1,975 | 0 | 1,975 |
| Bronchitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Pneumonia staphylococcal | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Scarlet fever | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Tracheitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Cardiac pacemaker malfunction | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Year 2, H1N1pdm09 (n=0,54,81,135,108,243) |
|
| Year 2, H3N2 (n=0,0,0,0,22,22) |
|
| Year 3, H1N1pdm09 (n=0,58,30,88,148,236) |
|
| Year 3, H3N2 (n=0,37,43,80,122,202) |
|
| Year 4, H1N1pdm09 (n=0,6,6,12,16,28) |
|
| Year 4, H3N2 (n=0,19,17,36,67,103) |
|
| Year 5, H1N1pdm09 (n=0,29,8,37,41,78) |
|
| Year 5, H3N2 (n=0,82,80,162,187,349) |
|
| Year 6, H1N1pdm09 (n=11,33,25,69,0,69) |
|
| Year 6, H3N2 (n=1,45,27,73,0,73) |
|
| Year 7, H1N1pdm09 (n=0,15,5,20,0,20) |
|
| Year 7, H3N2 (n=8,94,115,217,0,217) |
|
| Title | Measurements |
|---|
|
| H1N1pdm09 |
|
| Influenza B |
|
| Title | Measurements |
|---|---|
|
| H1N1pdm09 (n=308) |
|
| Influenza B (n=195) |
|
| Title | Measurements |
|---|---|
|
| H1N1pdm09 (n=308) |
|
| Influenza B (n=190) |
|
| Title | Measurements |
|---|---|
|
| Influenza B (n=188) |
|
| Title | Measurements |
|---|
|
| Influenza B |
|
| Title | Measurements |
|---|---|
|
| Influenza B (n=318) |
|
| Title | Measurements |
|---|---|
|
| Influenza B (n=321) |
|
| Title | Measurements |
|---|---|
|
| Influenza B (n=317) |
|
| No |
| Superiority or Other |
| Pairwise Wilcoxon | <0.01 | No | Superiority or Other |
| No |
| Superiority or Other |
| Pairwise Wilcoxon | 0.03 | No | Superiority or Other |
| No |
| Superiority or Other |
| Pairwise Wilcoxon | <0.0001 | No | Superiority or Other |
| No |
| Superiority or Other |
| Pairwise Wilcoxon | <0.0001 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Day 1, H1N1pdm09 (n=323) |
|
| Day 1, Influenza B (n=207) |
|
| Day 3, Total (n=781) |
|
| Day 3, H1N1 Seasonal (n=10) |
|
| Day 3, H3N2 (n=341) |
|
| Day 3, H1N1pdm09 (n=258) |
|
| Day 3, Influenza B (n=172) |
|
| Day 6, Total (n=317) |
|
| Day 6, H1N1 Seasonal (n=4) |
|
| Day 6, H3N2 (n=144) |
|
| Day 6, H1N1pdm09 (n=110) |
|
| Day 6, Influenza B (n=59) |
|
| Day 10, Total (n=88) |
|
| Day 10, H3N2 (n=44) |
|
| Day 10, H1N1pdm09 (n=33) |
|
| Day 10, Influenza B (n=11) |
|
| Title | Measurements |
|---|---|
|
| Day 1, Influenza B (n=329) |
|
| Day 3, Total (n=1050) |
|
| Day 3, H3N2 (n=453) |
|
| Day 3, H1N1pdm09 (n=315) |
|
| Day 3, Influenza B (n=282) |
|
| Day 6, Total (n=628) |
|
| Day 6, H3N2 (n=271) |
|
| Day 6, H1N1pdm09 (n=181) |
|
| Day 6, Influenza B (n=176) |
|
| Day 10, Total (n=197) |
|
| Day 10, H3N2 (n=73) |
|
| Day 10, H1N1pdm09 (n=64) |
|
| Day 10, Influenza B (n=60) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Day 6, Total (n=1682) |
|
| Day 6, Resistant (n=59) |
|
| Day 6, Susceptible (n=1623) |
|
| Day 10, Total (n=1682) |
|
| Day 10, Resistant (n=59) |
|
| Day 10, Susceptible (n=1623) |
|
| Title | Measurements |
|---|---|
|
| Viral Load <4.95, Susceptible (n=452) |
|
| Viral Load 4.95 to 5.89, Resistant (n=450) |
|
| Viral Load 4.95 to 5.89, Susceptible (n=450) |
|
| Viral Load 5.89 to 6.61, Resistant (n=457) |
|
| Viral Load 5.89 to 6.61, Susceptible (n=457) |
|
| Viral Load >6.61, Resistant (n=443) |
|
| Viral Load >6.61, Susceptible (n=443) |
|
| Title | Measurements |
|---|---|
|
| Day 1, H1N1pdm09 (n=323) |
|
| Day 1, Influenza B (n=206) |
|
| Day 6, Total (n=890) |
|
| Day 6, H1N1 Seasonal (n=9) |
|
| Day 6, H3N2 (n=383) |
|
| Day 6, H1N1pdm09 (n=307) |
|
| Day 6, Influenza B (n=191) |
|
| Day 10, Total (n=827) |
|
| Day 10, H3N2 (n=357) |
|
| Day 10, H1N1pdm09 (n=281) |
|
| Day 10, Influenza B (n=189) |
|
| Title | Measurements |
|---|---|
|
| Day 1, Influenza B (n=329) |
|
| Day 6, Total (n=1252) |
|
| Day 6, H3N2 (n=567) |
|
| Day 6, H1N1pdm09 (n=364) |
|
| Day 6, Influenza B (n=321) |
|
| Day 10, Total (n=1228) |
|
| Day 10, H3N2 (n=562) |
|
| Day 10, H1N1pdm09 (n=350) |
|
| Day 10, Influenza B (n=316) |
|
| Title | Measurements |
|---|---|
|
| Day 1, H1N1pdm09 (n=323) |
|
| Day 1, Influenza B (n=207) |
|
| Day 10, Total (n=827) |
|
| Day 10, H3N2 (n=356) |
|
| Day 10, H1N1pdm09 (n=282) |
|
| Day 10, Influenza B (n=189) |
|
| Title | Measurements |
|---|---|
|
| Influenza B (n=189) |
|
| Title | Measurements |
|---|---|
|
| Day 1, Influenza B (n=329) |
|
| Day 10, Total (n=1223) |
|
| Day 10, H3N2 (n=560) |
|
| Day 10, H1N1pdm09 (n=346) |
|
| Day 10, Influenza B (n=317) |
|
| Title | Measurements |
|---|---|
|
| Influenza B (n=317) |
|