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A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants

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: NCT00412737
Recruitment Status : Completed
First Posted : December 18, 2006
Results First Posted : September 9, 2009
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Influenza
Interventions Drug: Oseltamivir
Drug: Placebo
Enrollment 477
Recruitment Details Out of total 477 participants who were randomized to receive study treatments, 2 participants were not included in the study population due to lack of efficacy data. Thus, results are reported only for 475 participants.
Pre-assignment Details One participant was randomized to placebo group but received oseltamivir for the first 9 weeks of the study. This participant was included in the placebo group in the Intention-to-treat (ITT) analysis population, but in the oseltamivir group in the safety analysis population.
Arm/Group Title Placebo Oseltamivir
Hide Arm/Group Description Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks. Oseltamivir 30 milligram (mg) to 75 mg capsule or suspension orally once daily for 12 weeks.
Period Title: Overall Study
Started 237 238
Completed 221 232
Not Completed 16 6
Reason Not Completed
Death             1             0
Adverse Event             3             2
Refused Treatment             6             2
Failure to Return             6             2
Arm/Group Title Placebo Oseltamivir Total
Hide Arm/Group Description Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks. Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 237 238 475
Hide Baseline Analysis Population Description
The safety population included all participants who received at least 1 dose of study drug and had at least 1 post baseline safety assessment. Participants were analyzed as per actual treatment received.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 237 participants 238 participants 475 participants
48.9  (15.67) 49.4  (15.47) 49.2  (15.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 237 participants 238 participants 475 participants
Female
86
  36.3%
74
  31.1%
160
  33.7%
Male
151
  63.7%
164
  68.9%
315
  66.3%
1.Primary Outcome
Title Number of Participants With Laboratory-Confirmed Clinical Influenza, ITT Population
Hide Description Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than [>] 37.2 degrees Celsius [°C]) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum hemagglutination inhibition (HAI) titers measured from baseline to any point during the study.
Time Frame From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. Participants were analyzed as per initial randomization.
Arm/Group Title Placebo Oseltamivir
Hide Arm/Group Description:
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
Overall Number of Participants Analyzed 238 237
Measure Type: Number
Unit of Measure: participants
7 5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Oseltamivir
Comments The null hypothesis tested was that there was no difference between the proportions of participants who met the primary endpoint in the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.772
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk Reduction
Estimated Value 0.283
Confidence Interval (2-Sided) 95%
-2.3 to 4.1
Estimation Comments Relative Risk Reduction = (1.0 - Relative Risk).
2.Secondary Outcome
Title Number of Participants With Laboratory Confirmed Clinical Influenza, Per Protocol (PP) Population
Hide Description Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.
Time Frame From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol (PP) population was defined as the subset of the ITT population who did not have any major protocol violations which would impact the assessment of efficacy.
Arm/Group Title Placebo Oseltamivir
Hide Arm/Group Description:
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
Overall Number of Participants Analyzed 208 220
Measure Type: Number
Unit of Measure: participants
6 4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Oseltamivir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.534
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk Reduction
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
-2.1 to 4.5
Estimation Comments Relative Risk Reduction = (1.0 - Relative Risk).
3.Secondary Outcome
Title Number of Participants With Laboratory Confirmed Clinical Influenza, Intent-to-treat Virus Negative at Baseline (ITTNAB) Population
Hide Description Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.
Time Frame From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITTNAB population was defined as the subset of the ITT population who were culture negative at baseline.
Arm/Group Title Placebo Oseltamivir
Hide Arm/Group Description:
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
Overall Number of Participants Analyzed 231 232
Measure Type: Number
Unit of Measure: participants
7 4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Oseltamivir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.381
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk Reduction
Estimated Value 0.431
Confidence Interval (2-Sided) 95%
-1.7 to 4.6
Estimation Comments Relative Risk Reduction = (1.0 - Relative Risk).
4.Secondary Outcome
Title Number of Participants With Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Confirmed Clinical Influenza, ITT Population
Hide Description RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.
Time Frame From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo Oseltamivir
Hide Arm/Group Description:
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
Overall Number of Participants Analyzed 238 237
Measure Type: Number
Unit of Measure: participants
7 2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Oseltamivir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk Reduction
Estimated Value 0.713
Confidence Interval (2-Sided) 95%
-0.6 to 5.2
Estimation Comments Relative Risk Reduction = (1.0 - Relative Risk).
5.Secondary Outcome
Title Number of Participants With RT-PCR Confirmed Clinical Influenza, ITTNAB Population
Hide Description RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.
Time Frame From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITTNAB population.
Arm/Group Title Placebo Oseltamivir
Hide Arm/Group Description:
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
Overall Number of Participants Analyzed 231 232
Measure Type: Number
Unit of Measure: participants
7 1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Oseltamivir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.858
Confidence Interval (2-Sided) 95%
0.1 to 5.7
Estimation Comments Relative Risk Reduction = (1.0 - Relative Risk).
6.Secondary Outcome
Title Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITT Population
Hide Description RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.
Time Frame From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo Oseltamivir
Hide Arm/Group Description:
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
Overall Number of Participants Analyzed 238 237
Measure Type: Number
Unit of Measure: participants
8 5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Oseltamivir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk Reduction
Estimated Value 0.372
Confidence Interval (2-Sided) 95%
-1.9 to 4.6
Estimation Comments Relative Risk Reduction = (1.0 - Relative Risk).
7.Secondary Outcome
Title Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITTNAB Population
Hide Description RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.
Time Frame From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITTNAB population.
Arm/Group Title Placebo Oseltamivir
Hide Arm/Group Description:
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
Overall Number of Participants Analyzed 231 232
Measure Type: Number
Unit of Measure: participants
8 4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Oseltamivir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk Reduction
Estimated Value 0.502
Confidence Interval (2-Sided) 95%
-1.4 to 5.1
Estimation Comments Relative Risk Reduction = (1.0 - Relative Risk).
Time Frame From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Adverse Event Reporting Description Safety population.
 
Arm/Group Title Placebo Oseltamivir
Hide Arm/Group Description Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks. Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
All-Cause Mortality
Placebo Oseltamivir
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Oseltamivir
Affected / at Risk (%) Affected / at Risk (%)
Total   23/237 (9.70%)   18/238 (7.56%) 
Blood and lymphatic system disorders     
Febrile neutropenia * 1  1/237 (0.42%)  0/238 (0.00%) 
Cardiac disorders     
Angina pectoris * 1  1/237 (0.42%)  0/238 (0.00%) 
Atrial flutter * 1  0/237 (0.00%)  1/238 (0.42%) 
Pericardial effusion * 1  1/237 (0.42%)  0/238 (0.00%) 
Eye disorders     
Abnormal sensation in eye * 1  0/237 (0.00%)  1/238 (0.42%) 
Gastrointestinal disorders     
Upper gastrointestinal haemorrhage * 1  1/237 (0.42%)  1/238 (0.42%) 
Abdominal pain * 1  1/237 (0.42%)  0/238 (0.00%) 
General disorders     
Drug interaction * 1  0/237 (0.00%)  1/238 (0.42%) 
Pyrexia * 1  1/237 (0.42%)  0/238 (0.00%) 
Hepatobiliary disorders     
Cholangitis * 1  1/237 (0.42%)  0/238 (0.00%) 
Cholecystitis * 1  0/237 (0.00%)  1/238 (0.42%) 
Immune system disorders     
Acute graft versus host disease * 1  1/237 (0.42%)  0/238 (0.00%) 
Transplant rejection * 1  1/237 (0.42%)  0/238 (0.00%) 
Infections and infestations     
Gastroenteritis * 1  1/237 (0.42%)  4/238 (1.68%) 
Pneumonia * 1  3/237 (1.27%)  1/238 (0.42%) 
Pyelonephritis acute * 1  1/237 (0.42%)  1/238 (0.42%) 
Abdominal wall abscess * 1  0/237 (0.00%)  1/238 (0.42%) 
Bronchitis * 1  1/237 (0.42%)  0/238 (0.00%) 
Gastroenteritis viral * 1  1/237 (0.42%)  0/238 (0.00%) 
Influenza * 1  1/237 (0.42%)  0/238 (0.00%) 
Upper respiratory tract infection * 1  1/237 (0.42%)  0/238 (0.00%) 
Urinary tract infection * 1  1/237 (0.42%)  0/238 (0.00%) 
Injury, poisoning and procedural complications     
Pelvic fracture * 1  1/237 (0.42%)  0/238 (0.00%) 
Spinal compression fracture * 1  1/237 (0.42%)  0/238 (0.00%) 
Investigations     
Weight decreased * 1  0/237 (0.00%)  1/238 (0.42%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/237 (0.42%)  0/238 (0.00%) 
Gouty arthritis * 1  1/237 (0.42%)  0/238 (0.00%) 
Polyarthritis * 1  1/237 (0.42%)  0/238 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia recurrent * 1  1/237 (0.42%)  0/238 (0.00%) 
Metastatic neoplasm * 1  1/237 (0.42%)  0/238 (0.00%) 
Oesophageal adenocarcinoma * 1  0/237 (0.00%)  1/238 (0.42%) 
Nervous system disorders     
Amnesia * 1  0/237 (0.00%)  1/238 (0.42%) 
Syncope * 1  0/237 (0.00%)  1/238 (0.42%) 
Thalamus haemorrhage * 1  0/237 (0.00%)  1/238 (0.42%) 
Psychiatric disorders     
Depression * 1  1/237 (0.42%)  0/238 (0.00%) 
Renal and urinary disorders     
Renal impairment * 1  0/237 (0.00%)  2/238 (0.84%) 
Nephropathy * 1  1/237 (0.42%)  0/238 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Bronchitis chronic * 1  1/237 (0.42%)  0/238 (0.00%) 
Pleural effusion * 1  1/237 (0.42%)  0/238 (0.00%) 
Pulmonary embolism * 1  1/237 (0.42%)  0/238 (0.00%) 
Skin and subcutaneous tissue disorders     
Angioedema * 1  1/237 (0.42%)  0/238 (0.00%) 
Vascular disorders     
Deep vein thrombosis * 1  0/237 (0.00%)  1/238 (0.42%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Oseltamivir
Affected / at Risk (%) Affected / at Risk (%)
Total   40/237 (16.88%)   42/238 (17.65%) 
Gastrointestinal disorders     
Diarrhoea * 1  18/237 (7.59%)  15/238 (6.30%) 
Nausea * 1  9/237 (3.80%)  13/238 (5.46%) 
General disorders     
Fatigue * 1  7/237 (2.95%)  12/238 (5.04%) 
Nervous system disorders     
Headache * 1  12/237 (5.06%)  11/238 (4.62%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
There were no overall limitations and caveats.
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-LaRoche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00412737    
Other Study ID Numbers: NV20235
First Submitted: December 15, 2006
First Posted: December 18, 2006
Results First Submitted: August 3, 2009
Results First Posted: September 9, 2009
Last Update Posted: June 10, 2016