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Trial record 13 of 13 for:    "Viral Infectious Disease" | "Amantadine"

Prophylactic Efficacy of Relenza Against Influenza A and B

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: NCT01156701
Recruitment Status : Completed
First Posted : July 5, 2010
Results First Posted : March 4, 2011
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Observational
Study Design Observational Model: Family-Based;   Time Perspective: Retrospective
Conditions Pulmonary Disease, Chronic Obstructive
Bronchospasm
Influenza, Human
Asthma
Respiratory Disease
Exacerbation of COPD
Bronchitis
Otitis Maedia
Pneumonia
Sinusitis
Interventions Drug: Receiving a prescription of Relenza for prophylaxis
Other: No prophylaxis with Relenza
Enrollment 171705
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1: Prophylaxis With Untreated Index Cohort 2: Prophylaxis With Treated Index Cohort 3: Untreated With Untreated Index Cohort 4: Untreated With Treated Index
Hide Arm/Group Description Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir) Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir) Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir) Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
Period Title: Overall Study
Started 257 1007 163716 6725
Completed 257 1007 163716 6725
Not Completed 0 0 0 0
Arm/Group Title All Patients Included in the Analysis
Hide Arm/Group Description All patients at least 5 years old enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009
Overall Number of Baseline Participants 171705
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 171705 participants
5-14 years 47670
15-44 years 85640
45-64 years 37119
>=65 years 1276
[1]
Measure Description: Number of participants in the indicated age category
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 171705 participants
Female
84162
  49.0%
Male
87543
  51.0%
1.Primary Outcome
Title Number of Patients With Influenza
Hide Description The frequency of influenza among the four cohorts was measured.
Time Frame 2006-2009
Hide Outcome Measure Data
Hide Analysis Population Description
The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).
Arm/Group Title Cohort 1: Prophylaxis With Untreated Index Cohort 2: Prophylaxis With Treated Index Cohort 3: Untreated With Untreated Index Cohort 4: Untreated With Treated Index
Hide Arm/Group Description:
Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
Overall Number of Participants Analyzed 257 1007 16371 6725
Measure Type: Number
Unit of Measure: patients
Influenza 3 10 2539 93
No Influenza 254 997 161177 6632
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1: Prophylaxis With Untreated Index, Cohort 3: Untreated With Untreated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-1.42 to 1.12
Estimation Comments Direct effect of Zanamivir prophylaxis on influenza risk
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 2: Prophylaxis With Treated Index, Cohort 3: Untreated With Untreated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.38
Confidence Interval (2-Sided) 95%
-0.93 to 0.17
Estimation Comments Total effect of zanamivir prophylaxis
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort 2: Prophylaxis With Treated Index, Cohort 4: Untreated With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.75 to 0.47
Estimation Comments Direct effect of zanamivir prophylaxis when index is treated
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cohort 1: Prophylaxis With Untreated Index, Cohort 2: Prophylaxis With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.23
Confidence Interval (2-Sided) 95%
-1.15 to 1.62
Estimation Comments Risk in cohort 1 minus risk in cohort 2
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Cohort 3: Untreated With Untreated Index, Cohort 4: Untreated With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.51 to 0.03
Estimation Comments Protective effect of zanamivir on susceptible risk
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Cohort 1: Prophylaxis With Untreated Index, Cohort 3: Untreated With Untreated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.99 to 1.01
Estimation Comments Direct effect of Zanamivir prophylaxis on influenza risk
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Cohort 2: Prophylaxis With Treated Index, Cohort 3: Untreated With Untreated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.99 to 1.00
Estimation Comments Total effect of zanamivir prophylaxis
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Cohort 2: Prophylaxis With Treated Index, Cohort 4: Untreated With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.99 to 1.00
Estimation Comments Direct effect of zanamivir prophylaxis when index is treated
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Cohort 1: Prophylaxis With Untreated Index, Cohort 2: Prophylaxis With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.99 to 1.02
Estimation Comments Risk in cohort 1 minus risk in cohort 2
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Cohort 3: Untreated With Untreated Index, Cohort 4: Untreated With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.99 to 1.00
Estimation Comments Protective effect of zanamivir on susceptible risk
2.Secondary Outcome
Title Number of Patients With Asthma
Hide Description The frequency of asthma among the four cohorts was measured.
Time Frame 2006-2009
Hide Outcome Measure Data
Hide Analysis Population Description
The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).
Arm/Group Title Cohort 1: Prophylaxis With Untreated Index Cohort 2: Prophylaxis With Treated Index Cohort 3: Untreated With Untreated Index Cohort 4: Untreated With Treated Index
Hide Arm/Group Description:
Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
Overall Number of Participants Analyzed 257 1007 16371 6725
Measure Type: Number
Unit of Measure: patients
Asthma 1 5 1488 54
No Asthma 256 1002 162228 6671
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1: Prophylaxis With Untreated Index, Cohort 3: Untreated With Untreated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-1.17 to 0.36
Estimation Comments Direct effect of Zanamivir prophylaxis on asthma risk
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 2: Prophylaxis With Treated Index, Cohort 3: Untreated With Untreated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.38
Confidence Interval (2-Sided) 95%
-0.80 to 0.03
Estimation Comments Total effect of zanamivir prophylaxis
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort 2: Prophylaxis With Treated Index, Cohort 4: Untreated With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.75 to 0.18
Estimation Comments Direct effect of zanamivir prophylaxis when index is treated
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cohort 1: Prophylaxis With Untreated Index, Cohort 2: Prophylaxis With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.89 to 0.85
Estimation Comments Risk in cohort 1 minus risk in cohort 2
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Cohort 3: Untreated With Untreated Index, Cohort 4: Untreated With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-0.31 to 0.11
Estimation Comments Protective effect of zanamivir on susceptible risk
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Cohort 1: Prophylaxis With Untreated Index, Cohort 3: Untreated With Untreated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.99 to 1.00
Estimation Comments Direct effect of Zanamivir prophylaxis on asthma risk
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Cohort 2: Prophylaxis With Treated Index, Cohort 3: Untreated With Untreated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.99 to 1.00
Estimation Comments Total effect of zanamivir prophylaxis
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Cohort 2: Prophylaxis With Treated Index, Cohort 4: Untreated With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.99 to 1.00
Estimation Comments Direct effect of zanamivir prophylaxis when index is treated
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Cohort 1: Prophylaxis With Untreated Index, Cohort 2: Prophylaxis With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.99 to 1.01
Estimation Comments Risk in cohort 1 minus risk in cohort 2
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Cohort 3: Untreated With Untreated Index, Cohort 4: Untreated With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
1.00 to 1.00
Estimation Comments Protective effect of zanamivir on susceptible risk
3.Secondary Outcome
Title Number of Patients With Pneumonia
Hide Description The frequency of pneumonia among the four cohorts was measured..
Time Frame 2006-2009
Hide Outcome Measure Data
Hide Analysis Population Description
The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).
Arm/Group Title Cohort 1: Prophylaxis With Untreated Index Cohort 2: Prophylaxis With Treated Index Cohort 3: Untreated With Untreated Index Cohort 4: Untreated With Treated Index
Hide Arm/Group Description:
Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
Overall Number of Participants Analyzed 257 1007 16371 6725
Measure Type: Number
Unit of Measure: patients
Pneumonia 2 1 541 16
No Pneumonia 255 1006 163175 6709
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1: Prophylaxis With Untreated Index, Cohort 3: Untreated With Untreated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.46
Confidence Interval (2-Sided) 95%
-0.61 to 1.54
Estimation Comments Direct effect of Zanamivir prophylaxis on pneumonia risk
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 2: Prophylaxis With Treated Index, Cohort 3: Untreated With Untreated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-0.45 to -0.04
Estimation Comments Total effect of zanamivir prophylaxis
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort 2: Prophylaxis With Treated Index, Cohort 4: Untreated With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.39 to 0.09
Estimation Comments Direct effect of zanamivir prophylaxis when index is treated
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cohort 1: Prophylaxis With Untreated Index, Cohort 2: Prophylaxis With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
-0.38 to 1.81
Estimation Comments Risk in cohort 1 minus risk in cohort 2
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Cohort 3: Untreated With Untreated Index, Cohort 4: Untreated With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-0.22 to 0.02
Estimation Comments Protective effect of zanamivir on susceptible risk
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Cohort 1: Prophylaxis With Untreated Index, Cohort 3: Untreated With Untreated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.99 to 1.02
Estimation Comments Direct effect of Zanamivir prophylaxis on pneumonia risk
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Cohort 2: Prophylaxis With Treated Index, Cohort 3: Untreated With Untreated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
1.00 to 1.00
Estimation Comments Total effect of zanamivir prophylaxis
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Cohort 2: Prophylaxis With Treated Index, Cohort 4: Untreated With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
1.00 to 1.00
Estimation Comments Direct effect of zanamivir prophylaxis when index is treated
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Cohort 1: Prophylaxis With Untreated Index, Cohort 2: Prophylaxis With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
1.00 to 1.02
Estimation Comments Risk in cohort 1 minus risk in cohort 2
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Cohort 3: Untreated With Untreated Index, Cohort 4: Untreated With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
1.00 to 1.00
Estimation Comments Protective effect of zanamivir on susceptible risk
4.Secondary Outcome
Title Number of Patients With Bronchitis
Hide Description The frequency of bronchitis among the four cohorts was measured.
Time Frame 2006-2009
Hide Outcome Measure Data
Hide Analysis Population Description
The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).
Arm/Group Title Cohort 1: Prophylaxis With Untreated Index Cohort 2: Prophylaxis With Treated Index Cohort 3: Untreated With Untreated Index Cohort 4: Untreated With Treated Index
Hide Arm/Group Description:
Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
Overall Number of Participants Analyzed 257 1007 16371 6725
Measure Type: Number
Unit of Measure: patients
Bronchitis 8 15 2572 96
No Bronchitis 249 992 161144 6629
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1: Prophylaxis With Untreated Index, Cohort 3: Untreated With Untreated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 1.28
Confidence Interval (2-Sided) 95%
-0.83 to 3.40
Estimation Comments Direct effect of Zanamivir prophylaxis on bronchitis risk
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 2: Prophylaxis With Treated Index, Cohort 3: Untreated With Untreated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.98 to 0.47
Estimation Comments Total effect of zanamivir prophylaxis
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort 2: Prophylaxis With Treated Index, Cohort 4: Untreated With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.85 to 0.67
Estimation Comments Direct effect of zanamivir prophylaxis when index is treated
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cohort 1: Prophylaxis With Untreated Index, Cohort 2: Prophylaxis With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 1.53
Confidence Interval (2-Sided) 95%
-0.70 to 3.76
Estimation Comments Risk in cohort 1 minus risk in cohort 2
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Cohort 3: Untreated With Untreated Index, Cohort 4: Untreated With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.16
Confidence Interval (2-Sided) 95%
-0.44 to 0.12
Estimation Comments Protective effect of zanamivir on susceptible risk
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Cohort 1: Prophylaxis With Untreated Index, Cohort 3: Untreated With Untreated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.99 to 1.03
Estimation Comments Direct effect of Zanamivir prophylaxis on bronchitis risk
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Cohort 2: Prophylaxis With Treated Index, Cohort 3: Untreated With Untreated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.99 to 1.00
Estimation Comments Total effect of zanamivir prophylaxis
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Cohort 2: Prophylaxis With Treated Index, Cohort 4: Untreated With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.99 to 1.01
Estimation Comments Direct effect of zanamivir prophylaxis when index is treated
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Cohort 1: Prophylaxis With Untreated Index, Cohort 2: Prophylaxis With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.99 to 1.04
Estimation Comments Risk in cohort 1 minus risk in cohort 2
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Cohort 3: Untreated With Untreated Index, Cohort 4: Untreated With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
1.00 to 1.00
Estimation Comments Protective effect of zanamivir on susceptible risk
5.Secondary Outcome
Title Number of Patients With Any Respiratory Diagnosis
Hide Description The frequency of any respiratory diagnosis among the four cohorts was measured.
Time Frame 2006-2009
Hide Outcome Measure Data
Hide Analysis Population Description
The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).
Arm/Group Title Cohort 1: Prophylaxis With Untreated Index Cohort 2: Prophylaxis With Treated Index Cohort 3: Untreated With Untreated Index Cohort 4: Untreated With Treated Index
Hide Arm/Group Description:
Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
Overall Number of Participants Analyzed 257 1007 16371 6725
Measure Type: Number
Unit of Measure: patients
Respiratory Diagnosis 16 50 10166 420
No Respiratory Diagnosis 241 957 153550 6305
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1: Prophylaxis With Untreated Index, Cohort 3: Untreated With Untreated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-3.08 to 2.79
Estimation Comments Direct effect of Zanamivir prophylaxis on risk of any respiratory diagnosis
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 2: Prophylaxis With Treated Index, Cohort 3: Untreated With Untreated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -1.07
Confidence Interval (2-Sided) 95%
-2.39 to 0.25
Estimation Comments Total effect of zanamivir prophylaxis
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort 2: Prophylaxis With Treated Index, Cohort 4: Untreated With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -1.08
Confidence Interval (2-Sided) 95%
-2.51 to 0.35
Estimation Comments Direct effect of zanamivir prophylaxis when index is treated
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cohort 1: Prophylaxis With Untreated Index, Cohort 2: Prophylaxis With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
-2.29 to 4.14
Estimation Comments Risk in cohort 1 minus risk in cohort 2
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Cohort 3: Untreated With Untreated Index, Cohort 4: Untreated With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.58 to 0.59
Estimation Comments Protective effect of zanamivir on susceptible risk
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Cohort 1: Prophylaxis With Untreated Index, Cohort 3: Untreated With Untreated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.97 to 1.03
Estimation Comments Direct effect of Zanamivir prophylaxis on risk of any respiratory diagnosis
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Cohort 2: Prophylaxis With Treated Index, Cohort 3: Untreated With Untreated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.98 to 1.00
Estimation Comments Total effect of zanamivir prophylaxis
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Cohort 2: Prophylaxis With Treated Index, Cohort 4: Untreated With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.98 to 1.00
Estimation Comments Direct effect of zanamivir prophylaxis when index is treated
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Cohort 1: Prophylaxis With Untreated Index, Cohort 2: Prophylaxis With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.98 to 1.04
Estimation Comments Risk in cohort 1 minus risk in cohort 2
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Cohort 3: Untreated With Untreated Index, Cohort 4: Untreated With Treated Index
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.99 to 1.00
Estimation Comments Protective effect of zanamivir on susceptible risk
6.Other Pre-specified Outcome
Title Number of Patients With Respiratory Outcomes
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).
Arm/Group Title Cohort 1: Prophylaxis With Untreated Index Cohort 2: Prophylaxis With Treated Index Cohort 3: Untreated With Untreated Index Cohort 4: Untreated With Treated Index
Hide Arm/Group Description:
Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
Overall Number of Participants Analyzed 257 1007 16371 6725
Measure Type: Number
Unit of Measure: patients
Influenza 3 10 2539 93
Asthma 1 5 1488 54
Chronic obstructive pulmonary disease (COPD) 0 0 153 3
Exacerbation of COPD 0 0 34 0
Bronchospasm 0 0 110 5
Pneumonia 2 1 541 16
Bronchitis 8 15 2572 96
Sinusitis 1 20 2708 140
Otitis media 2 4 1582 64
Any of the above 16 50 10166 420
7.Other Pre-specified Outcome
Title Number of Participants Experiencing Hospitalization or Death Due to Influenza
Hide Description The frequency of hospitalization and death in the study population was analyzed.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).
Arm/Group Title Cohort 1: Prophylaxis With Untreated Index Cohort 2: Prophylaxis With Treated Index Cohort 3: Untreated With Untreated Index Cohort 4: Untreated With Treated Index
Hide Arm/Group Description:
Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
Overall Number of Participants Analyzed 257 1007 16371 6725
Measure Type: Number
Unit of Measure: patients
Hospitalization 0 6 1063 41
Death 0 0 4 0
Time Frame [Not Specified]
Adverse Event Reporting Description This is a retrospective study of pre-existing medical record and/or health insurance claims data; all data are de-identified, and thus no assessments of Serious or Non-serious Adverse Events are possible.
 
Arm/Group Title Cohort 1: Prophylaxis With Untreated Index Cohort 2: Prophylaxis With Treated Index Cohort 3: Untreated With Untreated Index Cohort 4: Untreated With Treated Index
Hide Arm/Group Description Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir) Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir) Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir) Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
All-Cause Mortality
Cohort 1: Prophylaxis With Untreated Index Cohort 2: Prophylaxis With Treated Index Cohort 3: Untreated With Untreated Index Cohort 4: Untreated With Treated Index
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: Prophylaxis With Untreated Index Cohort 2: Prophylaxis With Treated Index Cohort 3: Untreated With Untreated Index Cohort 4: Untreated With Treated Index
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1: Prophylaxis With Untreated Index Cohort 2: Prophylaxis With Treated Index Cohort 3: Untreated With Untreated Index Cohort 4: Untreated With Treated Index
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications of Results:
Kandace Amend, Vani Vannappagari, Maria Wood-Armany, Rob Gately, John Seeger; Effectiveness of Zanamivir Prophylaxis for Influenza.26th ICPE: International Conference on Pharmacoepidemiology & Therapeutic Risk Management August 19-22, 2010, Brighton, UK
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01156701     History of Changes
Other Study ID Numbers: 113502
WEUSRTP2058
EPI40499
First Submitted: April 22, 2010
First Posted: July 5, 2010
Results First Submitted: January 28, 2011
Results First Posted: March 4, 2011
Last Update Posted: May 30, 2017