This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal prophylaxis of influenza in immunocompromised participants (as represented by transplant recipients). Transplant recipients enrolled when influenza is circulating in the community will be randomized to receive oseltamivir syrup or capsules 30 milligrams (mg) to 75 mg daily (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will be recorded throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
477
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
Number of Participants With Laboratory-Confirmed Clinical Influenza, ITT Population
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)
Number of Participants With Laboratory Confirmed Clinical Influenza, Per Protocol (PP) Population
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)
Number of Participants With Laboratory Confirmed Clinical Influenza, Intent-to-treat Virus Negative at Baseline (ITTNAB) Population
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Stanford, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Hartford, Connecticut, United States
Unnamed facility
Newark, Delaware, United States
Unnamed facility
St. Petersburg, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Augusta, Georgia, United States
Unnamed facility
Chicago, Illinois, United States
...and 68 more locations
Time frame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Number of Participants With Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Confirmed Clinical Influenza, ITT Population
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)
Number of Participants With RT-PCR Confirmed Clinical Influenza, ITTNAB Population
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)
Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITT Population
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)
Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITTNAB Population
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)