| Primary | Number of Participants With Any Solicited Influenza Symptoms From Day 1 Through Day 10 | Solicited influenza symptoms included cough, nasal congestion, sore throat, aches and pains, fatigue (tiredness), headache, chills/sweats (feeling feverish). | As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen. | Posted | | Count of Participants | | Participants | | Day 1 (post-dose) through Day 10 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Oseltamivir 75 mg | Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5. | | OG001 | MEDI8852 750 mg + Oseltamivir 75 mg | Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. | | OG002 | MEDI8852 3000 mg + Oseltamivir 75 mg | Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. | | OG003 | MEDI8852 3000 mg | Participants received a single IV infusion of MEDI8852 3000 mg on Day 1. |
| | Units | Counts |
|---|
| Participants | - OG00032
- OG00131
- OG00231
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| Any symptom | - OG00032
- OG00131
- OG00231
- OG003
|
|
| |
| Primary | Number of Participants With Any Solicited Influenza Symptoms From Day 10 Through Day 13 | Solicited influenza symptoms included cough, nasal congestion, sore throat, aches and pains, fatigue (tiredness), headache, chills/sweats (feeling feverish). | As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen. | Posted | | Count of Participants | | Participants | | Day 10 through Day 13 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Oseltamivir 75 mg | Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5. | | OG001 | MEDI8852 750 mg + Oseltamivir 75 mg | Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. | | OG002 | MEDI8852 3000 mg + Oseltamivir 75 mg | Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. | | OG003 |
|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent events were between administration of study drug and Day 28 that were absent before treatment or that worsened relative to pre-treatment state. | As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen. | Posted | | Count of Participants | | Participants | | Day 1 (post-dose) through Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Oseltamivir 75 mg | Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5. | | OG001 | MEDI8852 750 mg + Oseltamivir 75 mg | Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. | | OG002 | MEDI8852 3000 mg + Oseltamivir 75 mg | Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. |
|
| Primary | Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) | A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between administration of study drug and Day 101 that were absent before treatment or that worsened relative to pre-treatment state. | As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen. | Posted | | Count of Participants | | Participants | | Day 1 (post-dose) through Day 101 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Oseltamivir 75 mg | Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5. | | OG001 | MEDI8852 750 mg + Oseltamivir 75 mg | Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. | | OG002 | MEDI8852 3000 mg + Oseltamivir 75 mg | |
|
| Primary | Number of Participants With Treatment Emergent Adverse Events of Special Interest (TEAESIs) | An AE is any untoward medical occurrence attributed to study drug in a participant who received study drug. An AESI was one of scientific and medical interest specific to understanding of the study drug and may have required close monitoring and rapid communication by the investigator to the sponsor. Treatment-emergent events were between administration of study drug and Day 101 that were absent before treatment or that worsened relative to pre treatment state. | As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen. | Posted | | Count of Participants | | Participants | | Day 1 (post-dose) through Day 101 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Oseltamivir 75 mg | Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5. | | OG001 | MEDI8852 750 mg + Oseltamivir 75 mg | Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. | | OG002 | MEDI8852 3000 mg + Oseltamivir 75 mg | |
|
| Secondary | Percentage of Participants With Influenza Viral Shedding as Measured by Quantitative Reverse Transcription-Polymerase Chain Reaction (qRT-PCR) | Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure influenza viral shedding from the nasopharyngeal swabs. Percentage of participants who shed influenza virus are reported. | Per-protocol (PP) population included all randomized participants who received any portion of their protocol-specified treatment regimen with valid assay results from nasopharyngeal specimens obtained at any post-dosing time point. Participants without confirmed influenza A at baseline were excluded from the PP population. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Baseline (Day 1) and Days 3, 5, 7, 9, 11, and 13 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Oseltamivir 75 mg | Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5. | | OG001 | MEDI8852 750 mg + Oseltamivir 75 mg | Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. | | OG002 | MEDI8852 3000 mg + Oseltamivir 75 mg |
|
| Secondary | Quantitation of Influenza Viral Shedding as Measured by qRT-PCR | qRT-PCR was used to measure influenza viral shedding from the nasopharyngeal swabs. | PP population included all randomized participants who received any portion of their protocol-specified treatment regimen with valid assay results from nasopharyngeal specimens obtained at any post-dosing time point. Participants without confirmed influenza A at baseline were excluded from the PP population. | Posted | | Mean | Standard Deviation | Log10 (viral copies/mL) | | Baseline (Day 1) and Days 3, 5, 7, 9, 11, and 13 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Oseltamivir 75 mg | Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5. | | OG001 | MEDI8852 750 mg + Oseltamivir 75 mg | Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. | | OG002 | MEDI8852 3000 mg + Oseltamivir 75 mg | Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. |
|
| Secondary | Number of Days of Influenza Viral Shedding as Measured by qRT-PCR | Number of days of viral shedding for participants who shed influenza virus is reported. qRT-PCR was used to measure influenza viral shedding from the nasopharyngeal swabs. | PP population. Participants without confirmed influenza A at baseline were excluded from the PP population. Participants with shedding data available for Day 1 to Day 7 and Day 9 to Day 13 were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | Days | | From Baseline (Day 1) to Day 7; and Day 9 to Day 13 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Oseltamivir 75 mg | Participants received a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5. | | OG001 | MEDI8852 750 mg + Oseltamivir 75 mg | Participants received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. | | OG002 | MEDI8852 3000 mg + Oseltamivir 75 mg | Participants received a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. |
|
| Secondary | Percentage of Participants With Amino Acid Changes in MEDI8852 Binding Site | Genotypic analysis was performed to identify all amino acid changes in MEDI8852 binding site between each baseline (Day1) sample and the participant's corresponding last sample sequenced. Percentage of participants with changes in the amino acid corresponding to MEDI8852 binding site is reported. Due to the fact that the percentage of participants with amino acid changes in MEDI8852 binding site was zero across all participant samples analyzed, no additional per arm analyses were performed. | PP population. Participants without confirmed influenza A at baseline were excluded from the PP population. Participants with confirmed Influenza A positive and Influenza A concentrations greater than the lower limit of quantification (LLOQ) were analyzed. | Posted | | Number | | Percentage of Participants | | From Baseline (Day 1) to Day 13 | | | | ID | Title | Description |
|---|
| OG000 | All MEDI8852 Participants | Participants who received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5; or a single IV infusion of MEDI8852 3,000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5; or a single IV infusion of MEDI8852 3000 mg on Day 1. |
| |
| Secondary | Number of Participants With Viral Susceptibility to MEDI8852 as Determined by a Cell Based Microneutralization Assay | Viral susceptibility to MEDI8852 was measured by a Madin-Darby canine kidney (MDCK) cell-based microneutralization assay (Virospot) for viruses recovered from baseline samples and viruses recovered from samples following treatment that contain amino acid changes within the MEDI8852 binding site. Participants with detectable levels (50% tissue culture infectious dose [TCID50]) of virus were considered susceptible and were reported. Due to the fact that the number of participants with viral susceptibility to MEDI8852 binding site was zero across all participant samples analyzed, no additional per arm analyses were performed. | PP population. Participants without confirmed influenza A at baseline were excluded from the PP population. Participants with quantifiable Influenza A (greater than LLOQ) and a unique hemagglutinin gene sequence were analyzed. | Posted | | Count of Participants | | Participants | | From Baseline (Day 1) to Day 13 | | | | ID | Title | Description |
|---|
| OG000 | All MEDI8852 Participants | Participants who received a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5; or a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5; or a single IV infusion of MEDI8852 3000 mg on Day 1. |
| |
| Secondary | Percentage of Participants With Virus Containing Known Oseltamivir Resistance-Associated Mutations | Genotypic analysis was performed to identify all amino acid changes in neuraminidase (NA) gene between each baseline (Day1) sample and the participant's corresponding last sample sequenced. Percentage of participants with virus containing known oseltamivir resistance-associated mutations (change in the NA genes) is reported. Due to the fact that the percentage of participants with virus containing known oseltamivir resistance-associated mutation was zero across all participant samples analyzed, no additional per arm analyses were performed. | PP population. Participants without confirmed influenza A at baseline were excluded from the PP population. Participants with confirmed Influenza A positive and Influenza A concentrations greater than the LLOQ were analyzed. | Posted | | Number | | Percentage of Participants | | From Baseline (Day 1) to Day 13 | | | | ID | Title | Description |
|---|
| OG000 | All Oseltamivir Participants | Participants who received a single IV infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5; or a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5; or a single IV infusion of MEDI8852 3,000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. |
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