Trial Outcomes & Findings for Influenza Resistance Information Study (NCT NCT00884117)
NCT ID: NCT00884117
Last Updated: 2016-10-19
Results Overview
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.)
Recruitment status
COMPLETED
Target enrollment
4561 participants
Primary outcome timeframe
Baseline (Day 1) and post-Baseline (Days 3, 6, 10)
Results posted on
2016-10-19
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
|
Overall Study
STARTED
|
4561
|
|
Overall Study
COMPLETED
|
4312
|
|
Overall Study
NOT COMPLETED
|
249
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Withdrawal by Subject
|
89
|
|
Overall Study
Death
|
3
|
|
Overall Study
Lost to Follow-up
|
143
|
|
Overall Study
Other
|
12
|
Baseline Characteristics
Influenza Resistance Information Study
Baseline characteristics by cohort
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=4553 Participants
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.
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|---|---|
|
Age, Continuous
|
19.5 years
STANDARD_DEVIATION 19.24 • n=99 Participants
|
|
Sex: Female, Male
Female
|
2331 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2222 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and post-Baseline (Days 3, 6, 10)Population: 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.
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.)
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=3725 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
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|---|---|---|---|---|---|---|
|
Number of Participants With Genotypic Resistance
Baseline, H3N2 (n=1432)
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Genotypic Resistance
Baseline, Influenza B (n=1006)
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Genotypic Resistance
Baseline, H1N1 Seasonal (n=47)
|
44 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Genotypic Resistance
Baseline, H1N1pdm09 (n=1240)
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Genotypic Resistance
Baseline, All Types/Subtypes (n=3725)
|
47 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Genotypic Resistance
Post-Baseline, H1N1 Seasonal (n=47)
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Genotypic Resistance
Post-Baseline, H1N1pdm09 (n=1240)
|
39 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Genotypic Resistance
Post-Baseline, H3N2 (n=1432)
|
18 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Genotypic Resistance
Post-Baseline, Influenza B (n=1006)
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Genotypic Resistance
Post-Baseline, All Types/Subtypes (n=3725)
|
57 participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) during Study Years 1, 2, 3, 4, 5, 6, 7Population: 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.
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.
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=20 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
n=473 Participants
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
n=438 Participants
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
n=931 Participants
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
n=713 Participants
Otherwise healthy/non-immunocompromised adults 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. 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.
|
Participants Treated With Oseltamivir
n=1644 Participants
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.
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|---|---|---|---|---|---|---|
|
Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections
Year 2, H3N2 (n=0,0,0,0,22,22)
|
NA percentage of participants
No participants were included in the analysis.
|
NA percentage of participants
No participants were included in the analysis.
|
NA percentage of participants
No participants were included in the analysis.
|
NA percentage of participants
No participants were included in the analysis.
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections
Year 3, H1N1pdm09 (n=0,58,30,88,148,236)
|
NA percentage of participants
No participants were included in the analysis.
|
20.7 percentage of participants
|
3.3 percentage of participants
|
14.8 percentage of participants
|
1.4 percentage of participants
|
6.4 percentage of participants
|
|
Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections
Year 4, H1N1pdm09 (n=0,6,6,12,16,28)
|
NA percentage of participants
No participants were included in the analysis.
|
16.7 percentage of participants
|
0 percentage of participants
|
8.3 percentage of participants
|
0 percentage of participants
|
3.6 percentage of participants
|
|
Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections
Year 4, H3N2 (n=0,19,17,36,67,103)
|
NA percentage of participants
No participants were included in the analysis.
|
10.5 percentage of participants
|
11.8 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
3.9 percentage of participants
|
|
Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections
Year 5, H3N2 (n=0,82,80,162,187,349)
|
NA percentage of participants
No participants were included in the analysis.
|
8.5 percentage of participants
|
1.3 percentage of participants
|
4.9 percentage of participants
|
1.1 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections
Year 6, H1N1pdm09 (n=11,33,25,69,0,69)
|
36.4 percentage of participants
|
6.1 percentage of participants
|
4.0 percentage of participants
|
10.1 percentage of participants
|
NA percentage of participants
No participants were included in the analysis.
|
10.1 percentage of participants
|
|
Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections
Year 6, H3N2 (n=1,45,27,73,0,73)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
NA percentage of participants
No participants were included in the analysis.
|
0 percentage of participants
|
|
Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections
Year 7, H3N2 (n=8,94,115,217,0,217)
|
0 percentage of participants
|
1.1 percentage of participants
|
0.9 percentage of participants
|
0.9 percentage of participants
|
NA percentage of participants
No participants were included in the analysis.
|
0.9 percentage of participants
|
|
Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections
Year 1, H3N2 (n=0,1,1,2,2,4)
|
NA percentage of participants
No participants were included in the analysis.
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections
Year 2, H1N1pdm09 (n=0,54,81,135,108,243)
|
NA percentage of participants
No participants were included in the analysis.
|
1.9 percentage of participants
|
0 percentage of participants
|
0.7 percentage of participants
|
0.9 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections
Year 3, H3N2 (n=0,37,43,80,122,202)
|
NA percentage of participants
No participants were included in the analysis.
|
2.7 percentage of participants
|
0 percentage of participants
|
1.3 percentage of participants
|
0.8 percentage of participants
|
1.0 percentage of participants
|
|
Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections
Year 5, H1N1pdm09 (n=0,29,8,37,41,78)
|
NA percentage of participants
No participants were included in the analysis.
|
20.7 percentage of participants
|
12.5 percentage of participants
|
18.9 percentage of participants
|
4.9 percentage of participants
|
11.5 percentage of participants
|
|
Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections
Year 7, H1N1pdm09 (n=0,15,5,20,0,20)
|
NA percentage of participants
No participants were included in the analysis.
|
33.3 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
NA percentage of participants
No participants were included in the analysis.
|
25.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1)Population: 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.
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=961 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir
H1N1pdm09
|
323 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir
Influenza B
|
207 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir
Total
|
961 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir
H1N1 Seasonal
|
12 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir
H3N2
|
419 participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 3Population: 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.
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=912 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir
Total (n=912)
|
781 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir
H1N1 Seasonal (n=11)
|
10 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir
H3N2 (n=398)
|
341 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir
H1N1pdm09 (n=308)
|
258 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir
Influenza B (n=195)
|
172 participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 6Population: 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.
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=889 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir
Total (n=889)
|
317 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir
H1N1 Seasonal (n=9)
|
4 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir
H3N2 (n=382)
|
144 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir
H1N1pdm09 (n=308)
|
110 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir
Influenza B (n=190)
|
59 participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10Population: 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.
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=833 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir
Total (n=833)
|
88 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir
H3N2 (n=362)
|
44 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir
H1N1pdm09 (n=283)
|
33 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir
Influenza B (n=188)
|
11 participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1)Population: 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.
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=1283 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir
Total
|
1283 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir
H3N2
|
583 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir
H1N1pdm09
|
371 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir
Influenza B
|
329 participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 3Population: 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.
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=1238 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir
Total (n=1238)
|
1050 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir
H3N2 (n=562)
|
453 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir
H1N1pdm09 (n=358)
|
315 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir
Influenza B (n=318)
|
282 participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 6Population: 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.
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=1250 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir
Total (n=1250)
|
628 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir
H3N2 (n=567)
|
271 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir
H1N1pdm09 (n=362)
|
181 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir
Influenza B (n=321)
|
176 participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10Population: 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.
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=1228 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir
Total (n=1228)
|
197 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir
H3N2 (n=560)
|
73 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir
H1N1pdm09 (n=351)
|
64 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir
Influenza B (n=317)
|
60 participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)Population: ALCIP Population. The "Number of Participants Analyzed" reflects the number of participants who provided sufficient post-Baseline data.
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.
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=637 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
n=644 Participants
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
n=949 Participants
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
|
|---|---|---|---|---|---|---|
|
Time to Non-Detection of Viral RNA
|
9.7 days
Interval 9.3 to 9.9
|
8.2 days
Interval 8.0 to 9.1
|
7.9 days
Interval 7.6 to 8.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)Population: ALCIP Population. The "Number of Participants Analyzed" reflects the number of participants with H3N2 infection who provided sufficient post-Baseline data.
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.
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=295 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
n=287 Participants
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
n=419 Participants
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
|
|---|---|---|---|---|---|---|
|
Time to Non-Detection of Viral RNA Among Participants With H3N2 Infections
|
9.5 days
Interval 8.6 to 10.0
|
8.0 days
Interval 7.1 to 8.7
|
8.0 days
Interval 7.7 to 8.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)Population: ALCIP Population. The "Number of Participants Analyzed" reflects the number of participants with H1N1pdm09 infection who provided sufficient post-Baseline data.
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.
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=212 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
n=158 Participants
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
n=323 Participants
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
|
|---|---|---|---|---|---|---|
|
Time to Non-Detection of Viral RNA Among Participants With H1N1pdm09 Infections
|
9.9 days
Interval 9.5 to 10.2
|
8.0 days
Interval 7.0 to 8.9
|
8.0 days
Interval 7.4 to 8.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)Population: ALCIP Population. The "Number of Participants Analyzed" reflects the number of participants with influenza B infection who provided sufficient post-Baseline data.
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.
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=130 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
n=199 Participants
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
n=207 Participants
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
|
|---|---|---|---|---|---|---|
|
Time to Non-Detection of Viral RNA Among Participants With Influenza B Infections
|
9.8 days
Interval 8.1 to 10.1
|
10.0 days
Interval 8.9 to 10.2
|
7.4 days
Interval 6.9 to 7.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 3, 6, 10Population: 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.
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).
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=959 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
|
|---|---|---|---|---|---|---|
|
Viral Load Among Adults Treated With Oseltamivir
Day 3, Total (n=781)
|
4.2 log10 vp/mL
Standard Deviation 1.17
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Adults Treated With Oseltamivir
Day 1, Total (n=959)
|
5.8 log10 vp/mL
Standard Deviation 1.18
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Adults Treated With Oseltamivir
Day 1, H1N1 Seasonal (n=12)
|
5.7 log10 vp/mL
Standard Deviation 1.22
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Adults Treated With Oseltamivir
Day 1, H3N2 (n=417)
|
5.8 log10 vp/mL
Standard Deviation 1.23
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Adults Treated With Oseltamivir
Day 1, H1N1pdm09 (n=323)
|
5.7 log10 vp/mL
Standard Deviation 1.15
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Adults Treated With Oseltamivir
Day 1, Influenza B (n=207)
|
5.9 log10 vp/mL
Standard Deviation 1.09
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Adults Treated With Oseltamivir
Day 3, H1N1 Seasonal (n=10)
|
4.2 log10 vp/mL
Standard Deviation 1.34
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Adults Treated With Oseltamivir
Day 3, H3N2 (n=341)
|
3.9 log10 vp/mL
Standard Deviation 1.15
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Adults Treated With Oseltamivir
Day 3, H1N1pdm09 (n=258)
|
4.1 log10 vp/mL
Standard Deviation 1.07
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Adults Treated With Oseltamivir
Day 3, Influenza B (n=172)
|
4.7 log10 vp/mL
Standard Deviation 1.19
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Adults Treated With Oseltamivir
Day 6, Total (n=317)
|
3.3 log10 vp/mL
Standard Deviation 1.05
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Adults Treated With Oseltamivir
Day 6, H1N1 Seasonal (n=4)
|
4.1 log10 vp/mL
Standard Deviation 0.48
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Adults Treated With Oseltamivir
Day 6, H3N2 (n=144)
|
3.2 log10 vp/mL
Standard Deviation 1.06
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Adults Treated With Oseltamivir
Day 6, H1N1pdm09 (n=110)
|
3.1 log10 vp/mL
Standard Deviation 0.93
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Adults Treated With Oseltamivir
Day 6, Influenza B (n=59)
|
3.9 log10 vp/mL
Standard Deviation 1.04
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Adults Treated With Oseltamivir
Day 10, Total (n=88)
|
3.0 log10 vp/mL
Standard Deviation 0.88
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Adults Treated With Oseltamivir
Day 10, H3N2 (n=44)
|
2.9 log10 vp/mL
Standard Deviation 0.87
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Adults Treated With Oseltamivir
Day 10, H1N1pdm09 (n=33)
|
2.8 log10 vp/mL
Standard Deviation 0.79
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Adults Treated With Oseltamivir
Day 10, Influenza B (n=11)
|
3.7 log10 vp/mL
Standard Deviation 0.84
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 3, 6, 10Population: 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.
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.
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=1283 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
|
|---|---|---|---|---|---|---|
|
Viral Load Among Children Treated With Oseltamivir
Day 6, H3N2 (n=271)
|
3.6 log10 vp/mL
Standard Deviation 1.19
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Children Treated With Oseltamivir
Day 6, H1N1pdm09 (n=181)
|
3.7 log10 vp/mL
Standard Deviation 1.21
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Children Treated With Oseltamivir
Day 1, Total (n=1283)
|
5.8 log10 vp/mL
Standard Deviation 1.15
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Children Treated With Oseltamivir
Day 1, H3N2 (n=583)
|
5.6 log10 vp/mL
Standard Deviation 1.22
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Children Treated With Oseltamivir
Day 1, H1N1pdm09 (n=371)
|
5.7 log10 vp/mL
Standard Deviation 1.13
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Children Treated With Oseltamivir
Day 1, Influenza B (n=329)
|
6.1 log10 vp/mL
Standard Deviation 0.98
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Children Treated With Oseltamivir
Day 3, Total (n=1050)
|
4.5 log10 vp/mL
Standard Deviation 1.25
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Children Treated With Oseltamivir
Day 3, H3N2 (n=453)
|
4.1 log10 vp/mL
Standard Deviation 1.16
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Children Treated With Oseltamivir
Day 3, H1N1pdm09 (n=315)
|
4.3 log10 vp/mL
Standard Deviation 1.12
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Children Treated With Oseltamivir
Day 3, Influenza B (n=282)
|
5.2 log10 vp/mL
Standard Deviation 1.19
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Children Treated With Oseltamivir
Day 6, Total (n=628)
|
3.8 log10 vp/mL
Standard Deviation 1.18
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Children Treated With Oseltamivir
Day 6, Influenza B (n=176)
|
4.1 log10 vp/mL
Standard Deviation 1.08
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Children Treated With Oseltamivir
Day 10, Total (n=197)
|
3.3 log10 vp/mL
Standard Deviation 0.99
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Children Treated With Oseltamivir
Day 10, H3N2 (n=73)
|
3.1 log10 vp/mL
Standard Deviation 1.01
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Children Treated With Oseltamivir
Day 10, H1N1pdm09 (n=64)
|
3.1 log10 vp/mL
Standard Deviation 0.84
|
—
|
—
|
—
|
—
|
—
|
|
Viral Load Among Children Treated With Oseltamivir
Day 10, Influenza B (n=60)
|
3.6 log10 vp/mL
Standard Deviation 1.04
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 6Population: 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.
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.
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=1730 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Symptom Resolution on Day 6 Comparing Resistant and Susceptible Viruses
Total (n=1730)
|
61.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Symptom Resolution on Day 6 Comparing Resistant and Susceptible Viruses
Resistant (n=59)
|
55.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Symptom Resolution on Day 6 Comparing Resistant and Susceptible Viruses
Susceptible (n=1671)
|
61.4 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 3, 6, 10Population: 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.
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.
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=1682 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses
Day 3, Resistant (n=59)
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses
Day 3, Susceptible (n=1623)
|
15.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses
Day 6, Total (n=1682)
|
40.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses
Day 10, Susceptible (n=1623)
|
29.4 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses
Day 3, Total (n=1682)
|
15.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses
Day 6, Resistant (n=59)
|
10.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses
Day 6, Susceptible (n=1623)
|
41.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses
Day 10, Total (n=1682)
|
30.4 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses
Day 10, Resistant (n=59)
|
59.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1)Population: 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.
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.
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=1802 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load
Total, Susceptible (n=1802)
|
96.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load
Viral Load 4.95 to 5.89, Resistant (n=450)
|
3.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load
Viral Load 4.95 to 5.89, Susceptible (n=450)
|
96.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load
Viral Load <4.95, Resistant (n=452)
|
2.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load
Viral Load <4.95, Susceptible (n=452)
|
98.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load
Viral Load 5.89 to 6.61, Resistant (n=457)
|
3.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load
Viral Load 5.89 to 6.61, Susceptible (n=457)
|
96.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load
Viral Load >6.61, Resistant (n=443)
|
3.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load
Viral Load >6.61, Susceptible (n=443)
|
96.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load
Total, Resistant (n=1802)
|
3.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 6, 10Population: 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.
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.
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=961 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
|
|---|---|---|---|---|---|---|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir
Day 1, Total (n=960)
|
12.3 units on a scale
Standard Deviation 5.03
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir
Day 1, H1N1 Seasonal (n=12)
|
11.4 units on a scale
Standard Deviation 6.02
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir
Day 1, H3N2 (n=419)
|
11.2 units on a scale
Standard Deviation 5.41
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir
Day 1, H1N1pdm09 (n=323)
|
13.2 units on a scale
Standard Deviation 4.28
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir
Day 1, Influenza B (n=206)
|
13.4 units on a scale
Standard Deviation 4.76
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir
Day 6, Total (n=890)
|
3.7 units on a scale
Standard Deviation 3.27
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir
Day 10, Total (n=827)
|
2.0 units on a scale
Standard Deviation 2.51
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir
Day 10, H3N2 (n=357)
|
2.1 units on a scale
Standard Deviation 2.6
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir
Day 10, H1N1pdm09 (n=281)
|
1.9 units on a scale
Standard Deviation 2.36
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir
Day 10, Influenza B (n=189)
|
2.1 units on a scale
Standard Deviation 2.57
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir
Day 6, H1N1 Seasonal (n=9)
|
2.8 units on a scale
Standard Deviation 2.91
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir
Day 6, H3N2 (n=383)
|
3.4 units on a scale
Standard Deviation 3.03
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir
Day 6, H1N1pdm09 (n=307)
|
3.8 units on a scale
Standard Deviation 3.28
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir
Day 6, Influenza B (n=191)
|
4.1 units on a scale
Standard Deviation 3.66
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 6, 10Population: 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.
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.
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=1283 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
|
|---|---|---|---|---|---|---|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir
Day 1, Total (n=1283)
|
12.4 units on a scale
Standard Deviation 3.92
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir
Day 1, H3N2 (n=583)
|
12.3 units on a scale
Standard Deviation 3.77
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir
Day 1, H1N1pdm09 (n=371)
|
11.9 units on a scale
Standard Deviation 4.02
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir
Day 1, Influenza B (n=329)
|
13.0 units on a scale
Standard Deviation 3.98
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir
Day 6, Total (n=1252)
|
3.3 units on a scale
Standard Deviation 2.83
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir
Day 6, H3N2 (n=567)
|
3.2 units on a scale
Standard Deviation 2.57
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir
Day 6, H1N1pdm09 (n=364)
|
3.2 units on a scale
Standard Deviation 2.60
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir
Day 6, Influenza B (n=321)
|
3.5 units on a scale
Standard Deviation 3.44
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir
Day 10, Total (n=1228)
|
1.3 units on a scale
Standard Deviation 1.59
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir
Day 10, H3N2 (n=562)
|
1.3 units on a scale
Standard Deviation 1.59
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir
Day 10, H1N1pdm09 (n=350)
|
1.4 units on a scale
Standard Deviation 1.54
|
—
|
—
|
—
|
—
|
—
|
|
Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir
Day 10, Influenza B (n=316)
|
1.3 units on a scale
Standard Deviation 1.63
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 10Population: 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.
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.
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=960 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
|
|---|---|---|---|---|---|---|
|
Body Temperature Among Adults Treated With Oseltamivir
Day 1, H3N2 (n=418)
|
37.8 degrees Celsius
Standard Deviation 0.89
|
—
|
—
|
—
|
—
|
—
|
|
Body Temperature Among Adults Treated With Oseltamivir
Day 1, H1N1pdm09 (n=323)
|
38.2 degrees Celsius
Standard Deviation 0.88
|
—
|
—
|
—
|
—
|
—
|
|
Body Temperature Among Adults Treated With Oseltamivir
Day 1, Influenza B (n=207)
|
38.0 degrees Celsius
Standard Deviation 0.90
|
—
|
—
|
—
|
—
|
—
|
|
Body Temperature Among Adults Treated With Oseltamivir
Day 10, Total (n=827)
|
36.6 degrees Celsius
Standard Deviation 0.40
|
—
|
—
|
—
|
—
|
—
|
|
Body Temperature Among Adults Treated With Oseltamivir
Day 10, H3N2 (n=356)
|
36.6 degrees Celsius
Standard Deviation 0.40
|
—
|
—
|
—
|
—
|
—
|
|
Body Temperature Among Adults Treated With Oseltamivir
Day 10, H1N1pdm09 (n=282)
|
36.6 degrees Celsius
Standard Deviation 0.38
|
—
|
—
|
—
|
—
|
—
|
|
Body Temperature Among Adults Treated With Oseltamivir
Day 1, Total (n=960)
|
38.0 degrees Celsius
Standard Deviation 0.91
|
—
|
—
|
—
|
—
|
—
|
|
Body Temperature Among Adults Treated With Oseltamivir
Day 1, H1N1 Seasonal (n=12)
|
37.8 degrees Celsius
Standard Deviation 1.10
|
—
|
—
|
—
|
—
|
—
|
|
Body Temperature Among Adults Treated With Oseltamivir
Day 10, Influenza B (n=189)
|
36.6 degrees Celsius
Standard Deviation 0.41
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 10Population: 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.
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.
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=826 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir
Total (n=826)
|
-1.4 degrees Celsius
Standard Deviation 0.96
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir
H3N2 (n=355)
|
-1.2 degrees Celsius
Standard Deviation 0.94
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir
H1N1pdm09 (n=282)
|
-1.7 degrees Celsius
Standard Deviation 0.93
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir
Influenza B (n=189)
|
-1.4 degrees Celsius
Standard Deviation 0.95
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 10Population: 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.
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.
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=1282 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
|
|---|---|---|---|---|---|---|
|
Body Temperature Among Children Treated With Oseltamivir
Day 1, Total (n=1282)
|
38.3 degrees Celsius
Standard Deviation 0.93
|
—
|
—
|
—
|
—
|
—
|
|
Body Temperature Among Children Treated With Oseltamivir
Day 1, H3N2 (n=583)
|
38.3 degrees Celsius
Standard Deviation 0.98
|
—
|
—
|
—
|
—
|
—
|
|
Body Temperature Among Children Treated With Oseltamivir
Day 1, H1N1pdm09 (n=370)
|
38.3 degrees Celsius
Standard Deviation 0.91
|
—
|
—
|
—
|
—
|
—
|
|
Body Temperature Among Children Treated With Oseltamivir
Day 1, Influenza B (n=329)
|
38.2 degrees Celsius
Standard Deviation 0.87
|
—
|
—
|
—
|
—
|
—
|
|
Body Temperature Among Children Treated With Oseltamivir
Day 10, Total (n=1223)
|
36.7 degrees Celsius
Standard Deviation 0.38
|
—
|
—
|
—
|
—
|
—
|
|
Body Temperature Among Children Treated With Oseltamivir
Day 10, H3N2 (n=560)
|
36.6 degrees Celsius
Standard Deviation 0.37
|
—
|
—
|
—
|
—
|
—
|
|
Body Temperature Among Children Treated With Oseltamivir
Day 10, H1N1pdm09 (n=346)
|
36.7 degrees Celsius
Standard Deviation 0.40
|
—
|
—
|
—
|
—
|
—
|
|
Body Temperature Among Children Treated With Oseltamivir
Day 10, Influenza B (n=317)
|
36.6 degrees Celsius
Standard Deviation 0.38
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 10Population: 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.
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.
Outcome measures
| Measure |
Otherwise Healthy Participants Infected With Influenza
n=1222 Participants
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.
|
Children 1 to 5 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 1 to 5 years of age 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.
|
Children 6 to 12 Years of Age Treated With Oseltamivir
Otherwise healthy/non-immunocompromised children 6 to 12 years of age 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.
|
Children Treated With Oseltamivir
Otherwise healthy/non-immunocompromised 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.
|
Adults Treated With Oseltamivir
Otherwise healthy/non-immunocompromised adults 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. 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.
|
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.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Body Temperature Among Children Treated With Oseltamivir
Total (n=1222)
|
-1.6 degrees Celsius
Standard Deviation 0.98
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Body Temperature Among Children Treated With Oseltamivir
H3N2 (n=560)
|
-1.6 degrees Celsius
Standard Deviation 1.02
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Body Temperature Among Children Treated With Oseltamivir
H1N1pdm09 (n=345)
|
-1.5 degrees Celsius
Standard Deviation 0.97
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Body Temperature Among Children Treated With Oseltamivir
Influenza B (n=317)
|
-1.6 degrees Celsius
Standard Deviation 0.91
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Participants Treated With Oseltamivir
Serious events: 24 serious events
Other events: 0 other events
Deaths: 0 deaths
Participants Not Treated With Oseltamivir
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants Treated With Oseltamivir
n=2578 participants at risk
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.
|
Participants Not Treated With Oseltamivir
n=1975 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.19%
5/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.05%
1/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.10%
2/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Infections and infestations
Bronchiolitis
|
0.04%
1/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.00%
0/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Infections and infestations
Bronchopneumonia
|
0.04%
1/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.00%
0/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Infections and infestations
Cellulitis
|
0.04%
1/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.00%
0/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Infections and infestations
Gastroenteritis
|
0.04%
1/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.00%
0/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Infections and infestations
Gastrointestinal infection
|
0.04%
1/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.00%
0/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.04%
1/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.00%
0/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.05%
1/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.05%
1/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Infections and infestations
Scarlet fever
|
0.04%
1/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.00%
0/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Infections and infestations
Sepsis
|
0.04%
1/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.00%
0/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.05%
1/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Infections and infestations
Staphylococcal infection
|
0.04%
1/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.00%
0/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Infections and infestations
Tonsillitis
|
0.04%
1/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.00%
0/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.05%
1/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.12%
3/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.10%
2/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.08%
2/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.00%
0/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.04%
1/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.00%
0/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.04%
1/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.00%
0/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.04%
1/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.00%
0/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.05%
1/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
General disorders
Oedema peripheral
|
0.04%
1/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.00%
0/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Cardiac disorders
Cardiac arrest
|
0.04%
1/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.00%
0/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Cardiac disorders
Myocardial infarction
|
0.04%
1/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.00%
0/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Injury, poisoning and procedural complications
Cardiac pacemaker malfunction
|
0.00%
0/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.05%
1/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.04%
1/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.00%
0/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/2578 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
0.05%
1/1975 • From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
AEHP Population.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER