Phase 2
N=126
A Phase 2a to Evaluate the Safety of MEDI8852 in Adults With Uncomplicated Influenza
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT02603952 ↗Enrolled (actual)
126
Serious AEs
1.6%
Results posted
Jun 2018
Primary outcome: Primary: Number of Participants With Any Solicited Influenza Symptoms From Day 1 Through Day 10 — 32; 31; 31; 31 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oseltamivir (Drug); MEDI8852 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Solicited Influenza Symptoms From Day 1 Through Day 10 |
32; 31; 31; 31 | — |
| PRIMARY Number of Participants With Any Solicited Influenza Symptoms From Day 10 Through Day 13 |
11; 14; 18; 11 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
9; 11; 15; 12 | — |
| PRIMARY Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) |
1; 0; 1; 0 | — |
| PRIMARY Number of Participants With Treatment Emergent Adverse Events of Special Interest (TEAESIs) |
0; 0; 1; 0 | — |
| SECONDARY Percentage of Participants With Influenza Viral Shedding as Measured by Quantitative Reverse Transcription-Polymerase Chain Reaction (qRT-PCR) |
100; 100; 100; 100; 90; 88.9 | — |
| SECONDARY Quantitation of Influenza Viral Shedding as Measured by qRT-PCR |
6.37; 6.62; 6.92; 6.34; 4.35; 4.75 | — |
| SECONDARY Number of Days of Influenza Viral Shedding as Measured by qRT-PCR |
4.7; 5.8; 4.9; 4.8; 5.4; 6.3 | — |
| SECONDARY Percentage of Participants With Amino Acid Changes in MEDI8852 Binding Site |
— | — |
| SECONDARY Number of Participants With Viral Susceptibility to MEDI8852 as Determined by a Cell Based Microneutralization Assay |
— | — |
| SECONDARY Percentage of Participants With Virus Containing Known Oseltamivir Resistance-Associated Mutations |
— | — |
Summary
The purpose of this study is to evaluate safety and tolerability of a single dose of MEDI8852 when given with oseltamivir, the safety and tolerability of oseltamivir alone, and the safety and tolerability of a single dose of MEDI8852 alone in adult participants with acute, uncomplicated influenza caused by Type A strains.
Eligibility Criteria
Inclusion Criteria
- Age 18 through 65 years at the time of screening.
- Symptomatic presumptive Influenza A infection with onset of symptoms less than or equal to (≤) 5 days prior to MEDI8852 administration and defined as the presence of:
- Fever of greater than or equal to (≥) 38.0 degrees Celsius (100.4 degrees Fahrenheit) at screening AND
- ≥ 1 moderate systemic symptom (headache, malaise, myalgia, sweats and/or chills, or fatigue) AND
- ≥ 1 moderate respiratory symptom (cough, sore throat, or nasal symptoms)
- Influenza A infection confirmed with positive rapid antigen test
- Able to complete the follow-up period through Day 101 as required by protocol (including telephone follow-up for Days 11 to 101)
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for at least 2 days prior to the first dose of investigational product and must agree to continue using such precautions through Day 101 of the study
Exclusion Criteria
- Hospitalized subjects.
- Receipt of influenza antiviral therapy within the preceding 14 days.
- Receipt of immunoglobulin or blood products within 6 months prior to screening.
- Known immunodeficiency due to illness, including human immunodeficiency virus (HIV), or due to drugs, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6 months prior to screening.
- Current clinical evidence of pneumonia.
- Active bacterial infection requiring treatment with oral or parenteral antibiotics.
- History of malignancy other than treated non-melanoma skin cancers or locally-treated cervical cancer in previous 3 years.
- Any planned surgical procedure before completion of Day 101.
Data sourced from ClinicalTrials.gov (NCT02603952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.