Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03315104 · ClinicalTrials.gov registry record · Phase 2
Exploring Safety & Clinical Benefit of Anti-Influenza Immunoglobulin Intravenous in Hospitalized Adults With Influenza A
A Phase 2 study of Influenza A H3N2 and Influenza A H1N1, sponsored by Emergent BioSolutions.
- Completed
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
- 20
- Study locations
NCT03315104: Completed Phase 2 study of Influenza A H3N2 and Influenza A H1N1, sponsored by Emergent BioSolutions.
NCT03315104 is a Phase 2 study of Influenza A H3N2 and Influenza A H1N1 that has completed, run by Emergent BioSolutions. The registered enrollment target is 65 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03315104, a Phase 2 study of Influenza A H3N2 and Influenza A H1N1, has completed, sponsored by Emergent BioSolutions.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
- 20
- Study locations
Study Summary
Influenza, or the flu, is an infectious respiratory disease that can range in severity from mild to severe to even death. This study aims to evaluate a treatment for people who are hospitalized with the flu. The study is looking to see if antibodies collected from people who have recovered from the seasonal flu or who have had the seasonal flu shot can be used safely as a study drug to treat hospitalized patients with severe flu infections. Also, this study will help to find the right dose for this study drug for treatment of severe flu in hospitalized patients. Overall, this study will evaluate if the hospitalized patients receiving standard of care along with the study drug get better more quickly than those treated with standard of care and placebo. The study drug that contains antibodies against the flu is called anti-influenza immunoglobulin intravenous (FLU-IGIV).
Primary Outcome
Frequency counts and percentage of subjects with Adverse Events by severity
Conditions Studied
Interventions
- BIOLOGICAL FLU-IGIV
- OTHER Placebo for FLU-IGIV
Study Locations (20)
Georgia
- Northside Hospital - Atlanta
- Atlanta Institute for Medical Research Inc. - Atlanta
- Augusta University - Augusta
Michigan
- Wayne State University/Detroit Receiving Hospital - Detroit
- Wayne State University/Sinai Grace Hospital - Detroit
- Providence-Providence Park Hospital, Southfield - Southfield
Illinois
- Northwestern University - Chicago
- University of Chicago - Chicago
Massachusetts
- Massachusetts General Hospital - Boston
- University of Massachusetts Memorial Medical Center - Worcester
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- HonorHealth - Scottsdale
Arkansas
- Baptist Health Center for Clinical Research - Little Rock
California
- University of California, Irvine Emergency Medicine - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2017-11-17 |
| Est. Completion | 2019-06-17 |
| Phase | Phase 2 |
What the finished NCT03315104 record still lists
NCT03315104 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower).
The record links to 2 conditions, with Influenza A H3N2 appearing as the primary indexed condition, and to 2 interventions - of which FLU-IGIV is the first listed.
NCT03315104 names 20 study sites across 14 states, led by Georgia, Michigan, Illinois.
Frequently Asked Questions
What is clinical trial NCT03315104 about?
NCT03315104 is a clinical study titled "Exploring Safety & Clinical Benefit of Anti-Influenza Immunoglobulin Intravenous in Hospitalized Adults With Influenza A". Influenza, or the flu, is an infectious respiratory disease that can range in severity from mild to severe to even death. This study aims to evaluate a treatment for people who are hospitalized with the flu. The study is looking to see if antibodies collected from people who have recovered from the ...
What is the current status of trial NCT03315104?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2017-11-17. Estimated completion is 2019-06-17.
What conditions does trial NCT03315104 study?
This clinical trial studies the following conditions: Influenza A H3N2, Influenza A H1N1.
What interventions are being tested in trial NCT03315104?
The interventions under investigation include: FLU-IGIV (BIOLOGICAL), Placebo for FLU-IGIV (OTHER).
Who is sponsoring clinical trial NCT03315104?
This trial is sponsored by Emergent BioSolutions, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03315104 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza A H3N2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03315104's enrollment target sits among peer trials
65 987th of 2000 higher than 1,005 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03366116 · 65 participants · Phase 1
5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in People With Advanced Solid Tumors
- NCT03603730 · 65 participants · NA
Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis
- NCT03796559 · 65 participants · NA
Magseed Enabled Long-Term Localization of Axillary Lymph Nodes
- NCT03993106 · 65 participants · Phase 2
A Study of sEphB4-HSA in Kaposi Sarcoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI