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Trial record 55 of 118 for:    oseltamivir

Influenza Resistance Information Study (IRIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00884117
Recruitment Status : Completed
First Posted : April 20, 2009
Results First Posted : July 19, 2016
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Influenza
Intervention Drug: Oseltamivir
Enrollment 4561
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Participants Infected With Influenza
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 4561
Completed 4312 [1]
Not Completed 249
Reason Not Completed
Adverse Event             2
Withdrawal by Subject             89
Death             3
Lost to Follow-up             143
Not Specified             12
[1]
Defined as Day 6 visit for those enrolled before Amendment D; thereafter defined as Day 10 visit.
Arm/Group Title Otherwise Healthy Participants Infected With Influenza
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 4553
Hide Baseline Analysis Population Description
All Enrolled Healthy Participants (AEHP) Population: All otherwise healthy participants who entered the study. Due to the imbalance between healthy (n=4553) and immunocompromised participants (n=8), results from immunocompromised participants were not included in any analyses, and data obtained from healthy participants were the focus of the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4553 participants
19.5  (19.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4553 participants
Female
2331
  51.2%
Male
2222
  48.8%
1.Primary Outcome
Title Number of Participants With Genotypic Resistance
Hide Description 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.)
Time Frame Baseline (Day 1) and post-Baseline (Days 3, 6, 10)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Otherwise Healthy Participants Infected With Influenza
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 3725
Measure Type: Number
Unit of Measure: participants
Baseline, H1N1 Seasonal (n=47) 44
Baseline, H1N1pdm09 (n=1240) 1
Baseline, H3N2 (n=1432) 0
Baseline, Influenza B (n=1006) 2
Baseline, All Types/Subtypes (n=3725) 47
Post-Baseline, H1N1 Seasonal (n=47) 0
Post-Baseline, H1N1pdm09 (n=1240) 39
Post-Baseline, H3N2 (n=1432) 18
Post-Baseline, Influenza B (n=1006) 0
Post-Baseline, All Types/Subtypes (n=3725) 57
2.Primary Outcome
Title Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections
Hide Description 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.
Time Frame From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) during Study Years 1, 2, 3, 4, 5, 6, 7
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Children <1 Year of Age Treated With Oseltamivir Children 1 to 5 Years of Age Treated With Oseltamivir Children 6 to 12 Years of Age Treated With Oseltamivir Children Treated With Oseltamivir Adults Treated With Oseltamivir Participants Treated With Oseltamivir
Hide Arm/Group Description:
Otherwise healthy/non-immunocompromised children less than (<) 1 year of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 6 and 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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 20 473 438 931 713 1644
Measure Type: Number
Unit of Measure: percentage of participants
Year 1, H3N2 (n=0,1,1,2,2,4) NA [1]  0 0 0 0 0
Year 2, H1N1pdm09 (n=0,54,81,135,108,243) NA [1]  1.9 0 0.7 0.9 0.8
Year 2, H3N2 (n=0,0,0,0,22,22) NA [1]  NA [1]  NA [1]  NA [1]  0 0
Year 3, H1N1pdm09 (n=0,58,30,88,148,236) NA [1]  20.7 3.3 14.8 1.4 6.4
Year 3, H3N2 (n=0,37,43,80,122,202) NA [1]  2.7 0 1.3 0.8 1.0
Year 4, H1N1pdm09 (n=0,6,6,12,16,28) NA [1]  16.7 0 8.3 0 3.6
Year 4, H3N2 (n=0,19,17,36,67,103) NA [1]  10.5 11.8 11.1 0 3.9
Year 5, H1N1pdm09 (n=0,29,8,37,41,78) NA [1]  20.7 12.5 18.9 4.9 11.5
Year 5, H3N2 (n=0,82,80,162,187,349) NA [1]  8.5 1.3 4.9 1.1 2.9
Year 6, H1N1pdm09 (n=11,33,25,69,0,69) 36.4 6.1 4.0 10.1 NA [1]  10.1
Year 6, H3N2 (n=1,45,27,73,0,73) 0 0 0 0 NA [1]  0
Year 7, H1N1pdm09 (n=0,15,5,20,0,20) NA [1]  33.3 0 25.0 NA [1]  25.0
Year 7, H3N2 (n=8,94,115,217,0,217) 0 1.1 0.9 0.9 NA [1]  0.9
[1]
No participants were included in the analysis.
3.Secondary Outcome
Title Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir
Hide Description [Not Specified]
Time Frame Baseline (Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Adults Treated With Oseltamivir
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 961
Measure Type: Number
Unit of Measure: participants
Total 961
H1N1 Seasonal 12
H3N2 419
H1N1pdm09 323
Influenza B 207
4.Secondary Outcome
Title Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir
Hide Description [Not Specified]
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Adults Treated With Oseltamivir
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 912
Measure Type: Number
Unit of Measure: participants
Total (n=912) 781
H1N1 Seasonal (n=11) 10
H3N2 (n=398) 341
H1N1pdm09 (n=308) 258
Influenza B (n=195) 172
5.Secondary Outcome
Title Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir
Hide Description [Not Specified]
Time Frame Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Adults Treated With Oseltamivir
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 889
Measure Type: Number
Unit of Measure: participants
Total (n=889) 317
H1N1 Seasonal (n=9) 4
H3N2 (n=382) 144
H1N1pdm09 (n=308) 110
Influenza B (n=190) 59
6.Secondary Outcome
Title Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir
Hide Description [Not Specified]
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Adults Treated With Oseltamivir
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 833
Measure Type: Number
Unit of Measure: participants
Total (n=833) 88
H3N2 (n=362) 44
H1N1pdm09 (n=283) 33
Influenza B (n=188) 11
7.Secondary Outcome
Title Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir
Hide Description [Not Specified]
Time Frame Baseline (Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Children Treated With Oseltamivir
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1283
Measure Type: Number
Unit of Measure: participants
Total 1283
H3N2 583
H1N1pdm09 371
Influenza B 329
8.Secondary Outcome
Title Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir
Hide Description [Not Specified]
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Children Treated With Oseltamivir
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1238
Measure Type: Number
Unit of Measure: participants
Total (n=1238) 1050
H3N2 (n=562) 453
H1N1pdm09 (n=358) 315
Influenza B (n=318) 282
9.Secondary Outcome
Title Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir
Hide Description [Not Specified]
Time Frame Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Children Treated With Oseltamivir
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1250
Measure Type: Number
Unit of Measure: participants
Total (n=1250) 628
H3N2 (n=567) 271
H1N1pdm09 (n=362) 181
Influenza B (n=321) 176
10.Secondary Outcome
Title Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir
Hide Description [Not Specified]
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Children Treated With Oseltamivir
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1228
Measure Type: Number
Unit of Measure: participants
Total (n=1228) 197
H3N2 (n=560) 73
H1N1pdm09 (n=351) 64
Influenza B (n=317) 60
11.Secondary Outcome
Title Time to Non-Detection of Viral RNA
Hide Description 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.
Time Frame From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
Hide Outcome Measure Data
Hide Analysis Population Description
ALCIP Population. The “Number of Participants Analyzed” reflects the number of participants who provided sufficient post-Baseline data.
Arm/Group Title Children ≤5 Years of Age Treated With Oseltamivir Children 6 to 12 Years of Age Treated With Oseltamivir Adults Treated With Oseltamivir
Hide Arm/Group Description:
Otherwise healthy/non-immunocompromised children ≤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.
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.
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.
Overall Number of Participants Analyzed 637 644 949
Median (95% Confidence Interval)
Unit of Measure: days
9.7
(9.3 to 9.9)
8.2
(8.0 to 9.1)
7.9
(7.6 to 8.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Children ≤5 Years of Age Treated With Oseltamivir, Children 6 to 12 Years of Age Treated With Oseltamivir, Adults Treated With Oseltamivir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Children ≤5 Years of Age Treated With Oseltamivir, Children 6 to 12 Years of Age Treated With Oseltamivir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Pairwise Wilcoxon
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Children ≤5 Years of Age Treated With Oseltamivir, Adults Treated With Oseltamivir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Pairwise Wilcoxon
Comments [Not Specified]
12.Secondary Outcome
Title Time to Non-Detection of Viral RNA Among Participants With H3N2 Infections
Hide Description 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.
Time Frame From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
Hide Outcome Measure Data
Hide Analysis Population Description
ALCIP Population. The “Number of Participants Analyzed” reflects the number of participants with H3N2 infection who provided sufficient post-Baseline data.
Arm/Group Title Children ≤5 Years of Age Treated With Oseltamivir Children 6 to 12 Years of Age Treated With Oseltamivir Adults Treated With Oseltamivir
Hide Arm/Group Description:
Otherwise healthy/non-immunocompromised children ≤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.
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.
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.
Overall Number of Participants Analyzed 295 287 419
Median (95% Confidence Interval)
Unit of Measure: days
9.5
(8.6 to 10.0)
8.0
(7.1 to 8.7)
8.0
(7.7 to 8.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Children ≤5 Years of Age Treated With Oseltamivir, Children 6 to 12 Years of Age Treated With Oseltamivir, Adults Treated With Oseltamivir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Children ≤5 Years of Age Treated With Oseltamivir, Children 6 to 12 Years of Age Treated With Oseltamivir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Pairwise Wilcoxon
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Children 6 to 12 Years of Age Treated With Oseltamivir, Adults Treated With Oseltamivir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Pairwise Wilcoxon
Comments [Not Specified]
13.Secondary Outcome
Title Time to Non-Detection of Viral RNA Among Participants With H1N1pdm09 Infections
Hide Description 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.
Time Frame From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
Hide Outcome Measure Data
Hide Analysis Population Description
ALCIP Population. The “Number of Participants Analyzed” reflects the number of participants with H1N1pdm09 infection who provided sufficient post-Baseline data.
Arm/Group Title Children ≤5 Years of Age Treated With Oseltamivir Children 6 to 12 Years of Age Treated With Oseltamivir Adults Treated With Oseltamivir
Hide Arm/Group Description:
Otherwise healthy/non-immunocompromised children ≤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.
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.
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.
Overall Number of Participants Analyzed 212 158 323
Median (95% Confidence Interval)
Unit of Measure: days
9.9
(9.5 to 10.2)
8.0
(7.0 to 8.9)
8.0
(7.4 to 8.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Children ≤5 Years of Age Treated With Oseltamivir, Children 6 to 12 Years of Age Treated With Oseltamivir, Adults Treated With Oseltamivir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Children ≤5 Years of Age Treated With Oseltamivir, Children 6 to 12 Years of Age Treated With Oseltamivir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Pairwise Wilcoxon
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Children ≤5 Years of Age Treated With Oseltamivir, Adults Treated With Oseltamivir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Pairwise Wilcoxon
Comments [Not Specified]
14.Secondary Outcome
Title Time to Non-Detection of Viral RNA Among Participants With Influenza B Infections
Hide Description 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.
Time Frame From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
Hide Outcome Measure Data
Hide Analysis Population Description
ALCIP Population. The “Number of Participants Analyzed” reflects the number of participants with influenza B infection who provided sufficient post-Baseline data.
Arm/Group Title Children ≤5 Years of Age Treated With Oseltamivir Children 6 to 12 Years of Age Treated With Oseltamivir Adults Treated With Oseltamivir
Hide Arm/Group Description:
Otherwise healthy/non-immunocompromised children ≤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.
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.
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.
Overall Number of Participants Analyzed 130 199 207
Median (95% Confidence Interval)
Unit of Measure: days
9.8
(8.1 to 10.1)
10.0
(8.9 to 10.2)
7.4
(6.9 to 7.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Children ≤5 Years of Age Treated With Oseltamivir, Children 6 to 12 Years of Age Treated With Oseltamivir, Adults Treated With Oseltamivir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Children ≤5 Years of Age Treated With Oseltamivir, Adults Treated With Oseltamivir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Pairwise Wilcoxon
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Children 6 to 12 Years of Age Treated With Oseltamivir, Adults Treated With Oseltamivir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Pairwise Wilcoxon
Comments [Not Specified]
15.Secondary Outcome
Title Viral Load Among Adults Treated With Oseltamivir
Hide Description 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).
Time Frame Days 1, 3, 6, 10
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Adults Treated With Oseltamivir
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 959
Mean (Standard Deviation)
Unit of Measure: log10 vp/mL
Day 1, Total (n=959) 5.8  (1.18)
Day 1, H1N1 Seasonal (n=12) 5.7  (1.22)
Day 1, H3N2 (n=417) 5.8  (1.23)
Day 1, H1N1pdm09 (n=323) 5.7  (1.15)
Day 1, Influenza B (n=207) 5.9  (1.09)
Day 3, Total (n=781) 4.2  (1.17)
Day 3, H1N1 Seasonal (n=10) 4.2  (1.34)
Day 3, H3N2 (n=341) 3.9  (1.15)
Day 3, H1N1pdm09 (n=258) 4.1  (1.07)
Day 3, Influenza B (n=172) 4.7  (1.19)
Day 6, Total (n=317) 3.3  (1.05)
Day 6, H1N1 Seasonal (n=4) 4.1  (0.48)
Day 6, H3N2 (n=144) 3.2  (1.06)
Day 6, H1N1pdm09 (n=110) 3.1  (0.93)
Day 6, Influenza B (n=59) 3.9  (1.04)
Day 10, Total (n=88) 3.0  (0.88)
Day 10, H3N2 (n=44) 2.9  (0.87)
Day 10, H1N1pdm09 (n=33) 2.8  (0.79)
Day 10, Influenza B (n=11) 3.7  (0.84)
16.Secondary Outcome
Title Viral Load Among Children Treated With Oseltamivir
Hide Description 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.
Time Frame Days 1, 3, 6, 10
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Children Treated With Oseltamivir
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1283
Mean (Standard Deviation)
Unit of Measure: log10 vp/mL
Day 1, Total (n=1283) 5.8  (1.15)
Day 1, H3N2 (n=583) 5.6  (1.22)
Day 1, H1N1pdm09 (n=371) 5.7  (1.13)
Day 1, Influenza B (n=329) 6.1  (0.98)
Day 3, Total (n=1050) 4.5  (1.25)
Day 3, H3N2 (n=453) 4.1  (1.16)
Day 3, H1N1pdm09 (n=315) 4.3  (1.12)
Day 3, Influenza B (n=282) 5.2  (1.19)
Day 6, Total (n=628) 3.8  (1.18)
Day 6, H3N2 (n=271) 3.6  (1.19)
Day 6, H1N1pdm09 (n=181) 3.7  (1.21)
Day 6, Influenza B (n=176) 4.1  (1.08)
Day 10, Total (n=197) 3.3  (0.99)
Day 10, H3N2 (n=73) 3.1  (1.01)
Day 10, H1N1pdm09 (n=64) 3.1  (0.84)
Day 10, Influenza B (n=60) 3.6  (1.04)
17.Secondary Outcome
Title Percentage of Participants With Symptom Resolution on Day 6 Comparing Resistant and Susceptible Viruses
Hide Description 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.
Time Frame Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants Treated With Oseltamivir
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1730
Measure Type: Number
Unit of Measure: percentage of participants
Total (n=1730) 61.2
Resistant (n=59) 55.9
Susceptible (n=1671) 61.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants Treated With Oseltamivir
Comments Resistant versus Susceptible
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4464
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
18.Secondary Outcome
Title Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses
Hide Description 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.
Time Frame Days 3, 6, 10
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants Treated With Oseltamivir
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1682
Measure Type: Number
Unit of Measure: percentage of participants
Day 3, Total (n=1682) 15.3
Day 3, Resistant (n=59) 0
Day 3, Susceptible (n=1623) 15.8
Day 6, Total (n=1682) 40.5
Day 6, Resistant (n=59) 10.2
Day 6, Susceptible (n=1623) 41.7
Day 10, Total (n=1682) 30.4
Day 10, Resistant (n=59) 59.3
Day 10, Susceptible (n=1623) 29.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants Treated With Oseltamivir
Comments Resistant versus Susceptible
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
19.Secondary Outcome
Title Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load
Hide Description 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.
Time Frame Baseline (Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants Treated With Oseltamivir
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1802
Measure Type: Number
Unit of Measure: percentage of participants
Total, Resistant (n=1802) 3.2
Total, Susceptible (n=1802) 96.8
Viral Load <4.95, Resistant (n=452) 2.0
Viral Load <4.95, Susceptible (n=452) 98.0
Viral Load 4.95 to 5.89, Resistant (n=450) 3.8
Viral Load 4.95 to 5.89, Susceptible (n=450) 96.2
Viral Load 5.89 to 6.61, Resistant (n=457) 3.1
Viral Load 5.89 to 6.61, Susceptible (n=457) 96.9
Viral Load >6.61, Resistant (n=443) 3.8
Viral Load >6.61, Susceptible (n=443) 96.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants Treated With Oseltamivir
Comments Resistant versus Susceptible
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2499
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
20.Secondary Outcome
Title Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir
Hide Description 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.
Time Frame Days 1, 6, 10
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Adults Treated With Oseltamivir
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 961
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 1, Total (n=960) 12.3  (5.03)
Day 1, H1N1 Seasonal (n=12) 11.4  (6.02)
Day 1, H3N2 (n=419) 11.2  (5.41)
Day 1, H1N1pdm09 (n=323) 13.2  (4.28)
Day 1, Influenza B (n=206) 13.4  (4.76)
Day 6, Total (n=890) 3.7  (3.27)
Day 6, H1N1 Seasonal (n=9) 2.8  (2.91)
Day 6, H3N2 (n=383) 3.4  (3.03)
Day 6, H1N1pdm09 (n=307) 3.8  (3.28)
Day 6, Influenza B (n=191) 4.1  (3.66)
Day 10, Total (n=827) 2.0  (2.51)
Day 10, H3N2 (n=357) 2.1  (2.6)
Day 10, H1N1pdm09 (n=281) 1.9  (2.36)
Day 10, Influenza B (n=189) 2.1  (2.57)
21.Secondary Outcome
Title Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir
Hide Description 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.
Time Frame Days 1, 6, 10
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Children Treated With Oseltamivir
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1283
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 1, Total (n=1283) 12.4  (3.92)
Day 1, H3N2 (n=583) 12.3  (3.77)
Day 1, H1N1pdm09 (n=371) 11.9  (4.02)
Day 1, Influenza B (n=329) 13.0  (3.98)
Day 6, Total (n=1252) 3.3  (2.83)
Day 6, H3N2 (n=567) 3.2  (2.57)
Day 6, H1N1pdm09 (n=364) 3.2  (2.60)
Day 6, Influenza B (n=321) 3.5  (3.44)
Day 10, Total (n=1228) 1.3  (1.59)
Day 10, H3N2 (n=562) 1.3  (1.59)
Day 10, H1N1pdm09 (n=350) 1.4  (1.54)
Day 10, Influenza B (n=316) 1.3  (1.63)
22.Secondary Outcome
Title Body Temperature Among Adults Treated With Oseltamivir
Hide Description 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.
Time Frame Days 1, 10
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Adults Treated With Oseltamivir
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 960
Mean (Standard Deviation)
Unit of Measure: degrees Celsius
Day 1, Total (n=960) 38.0  (0.91)
Day 1, H1N1 Seasonal (n=12) 37.8  (1.10)
Day 1, H3N2 (n=418) 37.8  (0.89)
Day 1, H1N1pdm09 (n=323) 38.2  (0.88)
Day 1, Influenza B (n=207) 38.0  (0.90)
Day 10, Total (n=827) 36.6  (0.40)
Day 10, H3N2 (n=356) 36.6  (0.40)
Day 10, H1N1pdm09 (n=282) 36.6  (0.38)
Day 10, Influenza B (n=189) 36.6  (0.41)
23.Secondary Outcome
Title Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir
Hide Description 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.
Time Frame Baseline (Day 1) to Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Adults Treated With Oseltamivir
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 826
Mean (Standard Deviation)
Unit of Measure: degrees Celsius
Total (n=826) -1.4  (0.96)
H3N2 (n=355) -1.2  (0.94)
H1N1pdm09 (n=282) -1.7  (0.93)
Influenza B (n=189) -1.4  (0.95)
24.Secondary Outcome
Title Body Temperature Among Children Treated With Oseltamivir
Hide Description 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.
Time Frame Days 1, 10
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Children Treated With Oseltamivir
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1282
Mean (Standard Deviation)
Unit of Measure: degrees Celsius
Day 1, Total (n=1282) 38.3  (0.93)
Day 1, H3N2 (n=583) 38.3  (0.98)
Day 1, H1N1pdm09 (n=370) 38.3  (0.91)
Day 1, Influenza B (n=329) 38.2  (0.87)
Day 10, Total (n=1223) 36.7  (0.38)
Day 10, H3N2 (n=560) 36.6  (0.37)
Day 10, H1N1pdm09 (n=346) 36.7  (0.40)
Day 10, Influenza B (n=317) 36.6  (0.38)
25.Secondary Outcome
Title Change From Baseline in Body Temperature Among Children Treated With Oseltamivir
Hide Description 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.
Time Frame Baseline (Day 1) to Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Children Treated With Oseltamivir
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1222
Mean (Standard Deviation)
Unit of Measure: degrees Celsius
Total (n=1222) -1.6  (0.98)
H3N2 (n=560) -1.6  (1.02)
H1N1pdm09 (n=345) -1.5  (0.97)
Influenza B (n=317) -1.6  (0.91)
Time Frame From Baseline (Day 1) to Day 10; assessed on Days 1, 3, 6, 10
Adverse Event Reporting Description AEHP Population.
 
Arm/Group Title Participants Treated With Oseltamivir Participants Not Treated With Oseltamivir
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Participants Treated With Oseltamivir Participants Not Treated With Oseltamivir
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Participants Treated With Oseltamivir Participants Not Treated With Oseltamivir
Affected / at Risk (%) Affected / at Risk (%)
Total   24/2578 (0.93%)   11/1975 (0.56%) 
Cardiac disorders     
Cardiac arrest * 1  1/2578 (0.04%)  0/1975 (0.00%) 
Myocardial infarction * 1  1/2578 (0.04%)  0/1975 (0.00%) 
General disorders     
Non-cardiac chest pain * 1  0/2578 (0.00%)  1/1975 (0.05%) 
Oedema peripheral * 1  1/2578 (0.04%)  0/1975 (0.00%) 
Infections and infestations     
Pneumonia * 1  5/2578 (0.19%)  1/1975 (0.05%) 
Bronchitis * 1  0/2578 (0.00%)  2/1975 (0.10%) 
Bronchiolitis * 1  1/2578 (0.04%)  0/1975 (0.00%) 
Bronchopneumonia * 1  1/2578 (0.04%)  0/1975 (0.00%) 
Cellulitis * 1  1/2578 (0.04%)  0/1975 (0.00%) 
Gastroenteritis * 1  1/2578 (0.04%)  0/1975 (0.00%) 
Gastrointestinal infection * 1  1/2578 (0.04%)  0/1975 (0.00%) 
Pneumonia staphylococcal * 1  1/2578 (0.04%)  0/1975 (0.00%) 
Pyelonephritis * 1  0/2578 (0.00%)  1/1975 (0.05%) 
Respiratory tract infection * 1  0/2578 (0.00%)  1/1975 (0.05%) 
Scarlet fever * 1  1/2578 (0.04%)  0/1975 (0.00%) 
Sepsis * 1  1/2578 (0.04%)  0/1975 (0.00%) 
Sinusitis * 1  0/2578 (0.00%)  1/1975 (0.05%) 
Staphylococcal infection * 1  1/2578 (0.04%)  0/1975 (0.00%) 
Tonsillitis * 1  1/2578 (0.04%)  0/1975 (0.00%) 
Tracheitis * 1  0/2578 (0.00%)  1/1975 (0.05%) 
Injury, poisoning and procedural complications     
Cardiac pacemaker malfunction * 1  0/2578 (0.00%)  1/1975 (0.05%) 
Metabolism and nutrition disorders     
Dehydration * 1  1/2578 (0.04%)  0/1975 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Pregnancy * 1  0/2578 (0.00%)  1/1975 (0.05%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  3/2578 (0.12%)  2/1975 (0.10%) 
Respiratory distress * 1  2/2578 (0.08%)  0/1975 (0.00%) 
Epistaxis * 1  1/2578 (0.04%)  0/1975 (0.00%) 
Pneumothorax * 1  1/2578 (0.04%)  0/1975 (0.00%) 
Respiratory failure * 1  1/2578 (0.04%)  0/1975 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Participants Treated With Oseltamivir Participants Not Treated With Oseltamivir
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2578 (0.00%)   0/1975 (0.00%) 
This was a non-randomized, observational study and many comparisons were not powered to detect a true statistically significant difference between groups. Inferential analyses should be interpreted with caution.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00884117     History of Changes
Other Study ID Numbers: NV20237
2008-006149-24 ( EudraCT Number )
First Submitted: April 15, 2009
First Posted: April 20, 2009
Results First Submitted: June 8, 2016
Results First Posted: July 19, 2016
Last Update Posted: October 19, 2016