Influenza A H3N2Phase 2NCT03315104

Exploring Safety & Clinical Benefit of Anti-Influenza Immunoglobulin Intravenous in Hospitalized Adults With Influenza A

A Phase 2 study testing FLU-IGIV in people with Influenza A H3N2 and Influenza A H1N1, run by Emergent BioSolutions at 55 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Influenza A H3N2, Influenza A H1N1
What is being tested?: FLU-IGIV
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 65 participants
Where: 55 sitesin 4 countries
Study dates: 17 Nov 2017to 17 Jun 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of voluntary informed consent in writing by patient, or legally authorized representative.
Age ≥ 18 years of age.
Locally determined positive influenza A infection (Rapid Antigen (Ag) Test or PCR) from a specimen obtained within 2 days prior to randomization.
Onset of symptoms ≤ 6 days before randomization, defined as when the patient first experienced at least one respiratory symptom or fever.
Hospitalized (or in observation unit) with influenza, with anticipated hospitalization for more than 24 hours and will be/already are receiving antiviral SOC.
Experiencing ≥ 1 respiratory symptom (ex. cough, sore throat, nasal congestion) and ≥ 1 constitutional symptom (ex. headache, myalgia, feverishness or fatigue).

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For women of child-bearing potential: willingness to abstain from sexual intercourse or use at least 1 form of hormonal or barrier contraception through Day 60 of the study.
Willingness to have blood and respiratory samples obtained and stored.
National Early Warning Score (NEW score) ≥ 3 at screening.

Who cannot join

Use of any investigational product within the past 30 days prior to screening.
History of hypersensitivity to blood or plasma products (as judged by the site investigator).
History of allergy to latex or rubber.
Known medical history of IgA deficiency.
Pregnancy or lactation.
Medical conditions for which receipt of a 500 mL volume of intravenous fluid may be dangerous to the patient (e.g. decompensated congestive heart failure), based on investigator's medical opinion with careful consideration of lab results.

Show all 13Show fewer

Liver function: liver function test (LFT) > 2.5 times upper limit of normal (ULN).
Renal Function: glomerular filtration rate (GFR) < 60 mL/min/1.73 m2 (age and sex adjusted).
A pre-existing condition or use of a medication that, in the opinion of the site investigator, may place the individual at a substantially increased risk of thrombosis (e.g. cryoglobulinemia, severe refractory hypertriglyceridemia, or clinically significant monoclonal gammopathy).
An opinion of the investigator that it would be unwise to allow participation of the patient in the study (the reason for exclusion of the patient must be documented).
Receiving extracorporeal membrane oxygenation (ECMO).
Anticipated life expectancy of < 90 days.
Confirmed bacterial pneumonia or any concurrent respiratory viral infection that is not influenza A (ex. respiratory syncytial virus (RSV) infection).

Trial locations and contacts

55 sites in 4 countries.

Country

City, postcode or hospital

55 sites in 4 countries

United States42 sites

Northside Hospital
Atlanta, Georgia, 30342
Atlanta Institute for Medical Research Inc.
Atlanta, Georgia, 30350
Augusta University
Augusta, Georgia, 30912
John Hopkins Hospital
Baltimore, Maryland, 21287
St Luke's University Health Network
Bethlehem, Pennsylvania, 18015
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of North Carolina
Chapel Hill, North Carolina, 27599
Northwestern University
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
UT Southwestern Medical Center
Dallas, Texas, 75390
Baylor University Medical Center
Dallas, Texas, 77030
Premier Health Miami Valley Hospital
Dayton, Ohio, 45409
Denver public Health
Denver, Colorado, 80212
Wayne State University/Detroit Receiving Hospital
Detroit, Michigan, 48201
Wayne State University/Sinai Grace Hospital
Detroit, Michigan, 48202
Pulmonlx LLC Pulmonary & Critical Care Medicine
Greensboro, North Carolina, 27403
Baylor College of Medicine
Houston, Texas, 77030
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
University of Kansas medical Center
Kansas City, Kansas, 66160
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205
Yale University School of Medicine
New Haven, Connecticut, 06519
Christiana Care Health Systems
Newark, Delaware, 19718
University of Oklahoma
Oklahoma City, Oklahoma, 73104
University of Nebraska Medical Center
Omaha, Nebraska, 985400
University of California, Irvine Emergency Medicine
Orange, California, 92868
Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Regional Health
Rapid City, South Dakota, 57701
Carilion Medical Center
Roanoke, Virginia, 24014
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah HealthCare
Salt Lake City, Utah, 84108
UT Health San Antonio
San Antonio, Texas, 78229
HonorHealth
Scottsdale, Arizona, 85258
Providence-Providence Park Hospital, Southfield
Southfield, Michigan, 48075
Washington University
St Louis, Missouri, 63110
MultiCare Institute for Research & Innovation
Tacoma, Washington, 98405
Montefiore Medical Center
The Bronx, New York, 10467
Reading Hospital
West Reading, Pennsylvania, 19611
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01605

Other trials in United States

Canada6 sites

Foothills Medical Centre
Calgary, Alberta, T2N 2T9
CISSS BSL/Hopital Regional de Rimouski
Rimouski, Quebec, G5L 5T1
Ciusss McQ
Trois-Rivières, Quebec, G8Z 3R9
Health Sciences Center
Winnipeg, Manitoba, R3A 1R9
St. Boniface Hospital
Winnipeg, Manitoba, R3A 1R9
Grace Hospital
Winnipeg, Manitoba, R3J 3M7

Other trials in Canada

Spain5 sites

Hospital Clinic of Barcelona
Barcelona, 08036
Hospital del Mar
Barcelona, 08036
Hospital Universitari Mutua Terrassa
Barcelona, 08225
Reina Sofia University Hospital
Córdoba, 14004
Hospital Universitari de Tarragona Joan XXIII
Tarragona, 43007

Other trials in Spain

Puerto Rico2 sites

Mayaguez Medical Center
Mayagüez, 00680
San Cristobal Hospital
Ponce, 00780

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Dose Ranging Study Evaluating Safety, Pharmacokinetics and Clinical Benefit of FLU-IGIV in Hospitalized Patients With Serious Influenza A Infection

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).

Conditions: Influenza A H3N2, Influenza A H1N1
Being tested: FLU-IGIV, Placebo for FLU-IGIV
Keywords: influenza A, hospitalized, H1N1, H3N2, human flu, respiratory tract infection, serious illness, flu
Medical subject headings: Orthomyxoviridae Infections, Influenza, Human, Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FLU-IGIVBiological
Also called Anti-influenza immunoglobulin intravenous (Human), NP-025
Single dose, sterile liquid formulation for IV administration.
Placebo for FLU-IGIVOther
Single dose, normal saline solution for IV administration.

Study groups in NCT03315104
Study group	Role	What they receive
FLU-IGIV High Dose	Experimental	Participants will receive a single infusion of high dose of FLU-IGIV, administered over approximately 3 hours on Day 1. Participants will also receive standard of care (SOC) antiviral treatment for flu. Administered intravenously at a dose of 450 mL of 65 g/mL FLU-IGIV diluted to 500 mL with normal saline. Participants also received standard of care (SOC) antiviral treatment for flu. FLU-IGIV: Single dose, sterile liquid formulation for IV administration. Receives: Biological: FLU-IGIV
FLU-IGIV Low Dose	Experimental	Participants will receive a single infusion of low dose of FLU-IGIV, administered over approximately 3 hours on Day 1. Participants will also receive SOC antiviral treatment for flu. Administered intravenously at a dose of 225 mL of 65 g/mL FLU-IGIV diluted to 500 mL with normal saline. Participants also received standard of care (SOC) antiviral treatment for flu. FLU-IGIV: Single dose, sterile liquid formulation for IV administration. Receives: Biological: FLU-IGIV
FLU-IGIV Placebo	Placebo comparator	Participants will receive a single infusion of placebo for FLU-IGIV, administered over approximately 3 hours on Day 1. Participants will also receive SOC antiviral treatment for flu. Administered IV as 500 mL of normal saline. Participants also received standard of care (SOC) antiviral treatment for flu. Placebo for FLU-IGIV: Single dose, normal saline solution for IV administration. Receives: Other: Placebo for FLU-IGIV

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency Counts and Percentage of Subjects With Adverse Events
Frequency counts and percentage of subjects with Adverse Events by severity
Measured: Measured through Day 60
Area Under the Plasma Concentration Curve [AUC] From Time 0 to 48 Hours Post-dose by Hemagglutinin Inhibition Assay
Levels of anti-influenza A antibodies circulating in blood over time. We initially intended to look at this variable through Day 8, however, potential native antibody level changes and sparse sampling confounded results from 0 to 48 hours post-dose from PK samples collected from Baseline Day 1 pre-dose (time 0), Day 1 post-dose, Day 2 and Day 3 (if continued hospitalization), and Day 8. For AUC from time 0 to 48 hours, subjects who did not have a sample collected within +/-10% of 48 hours post-dose had this parameter set to missing, which is why the number of subjects who contributed data for this outcome measure is lower than the overall number of subjects analyzed.
Measured: Measured through 48 Hours post-dose
Maximum Plasma Concentration [Cmax] Reported as a Titer for Hemagglutinin Inhibition Assay
Maximum observed concentration (reported as a titer) of anti-influenza A antibodies measured from Day 1 pre-dose (time 0) through Day 8 post-dose from PK samples collected from Baseline Day 1 pre-dose (time 0), Day 1 post-dose, Day 2 and Day 3 (if continued hospitalization), and Day 8.
Measured: Measured through Day 8 post-dose
Time Cmax is Observed [Tmax] by Hemagglutinin Inhibition Assay
Time that anti-influenza A antibodies are at maximum concentration from Day 1 pre-dose (time 0) through Day 8 post-dose from PK samples collected from Baseline Day 1 pre-dose (time 0), Day 1 post-dose, Day 2 and Day 3 (if continued hospitalization), and Day 8.
The rate of study drug elimination and dependent parameters were not accurately estimable due to rising or sustained levels of anti-influenza A antibodies, this includes First Order Terminal Elimination Rate Constant [Kel], Plasma Clearance [Cl] and Total Volume of Distribution [Vz].
Measured: Measured through Day 8 post-dose

Secondary outcomes (1)

Ordinal Scale Subject Distribution Reflecting Clinical Status
Score (physician-assessed): 1=death; 2=hospitalization in the intensive care unit (ICU); 3=non-ICU hospitalization requiring supplemental oxygen; 4=non-ICU hospitalization not requiring supplemental oxygen; 5=no longer hospitalized but unable to resume normal activities; 6=no longer hospitalized with full resumption of normal activities. A higher score reflects improved clinical status. Not all ITT subjects had ordinal scale data available at Day 8 post-dose which explains why the overall number of participants analyzed is not consistent with the overall number of subjects included at baseline. For subjects who were discharged with unknown ordinal score the more conservative of two relevant discharged categories was imputed.
Measured: At Day 8 post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Nov 201717 Jun 2019

First posted19 Oct 2017
Study start17 Nov 2017
Primary completion17 Jun 2019
Study completion17 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Influenza A H3N2Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Staggered enrollment for the first 9 subjects, then parallel low and high dose treatment with a placebo group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03315104
Sponsor's protocol ID: IA-001
Status last verified: Mar 2024
First submitted: 6 Oct 2017
Last updated: 18 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Post results and upload the supporting information.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 4
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Influenza
RecruitingPhase 1
Establishing a Controlled Human Infection Model for Influenza H3N2 as a Foundation for Pandemic Preparedness
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Recruiting
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All Influenza A H3N2 trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled Dose Ranging Study Evaluating Safety, Pharmacokinetics and Clinical Benefit of FLU-IGIV in Hospitalized Patients With Serious Influenza A Infection
ClinicalTrials.gov ID: NCT03315104
Acronym / sponsor ID: IA-001
Conditions: Influenza A H3N2, Influenza A H1N1
Keywords: influenza A, hospitalized, H1N1, H3N2, human flu, respiratory tract infection, serious illness, flu
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Emergent BioSolutionsIndustry (pharma, biotech, devices)
Study start: 17 Nov 2017 (actual)
Primary completion: 17 Jun 2019 (actual)
Study completion: 17 Jun 2019 (actual)
First posted: 19 Oct 2017 (actual)
Results: Posted 5 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: Staggered enrollment for the first 9 subjects, then parallel low and high dose treatment with a placebo group

Arm	Type	Receives
FLU-IGIV High Dose	Experimental	Biological: FLU-IGIVParticipants will receive a single infusion of high dose of FLU-IGIV, administered over approximately 3 hours on Day 1. Participants will also receive standard of care (SOC) antiviral treatment for flu. Administered intravenously at a dose of 450 mL of 65 g/mL FLU-IGIV diluted to 500 mL with normal saline. Participants also received standard of care (SOC) antiviral treatment for flu. FLU-IGIV: Single dose, sterile liquid formulation for IV administration.
FLU-IGIV Low Dose	Experimental	Biological: FLU-IGIVParticipants will receive a single infusion of low dose of FLU-IGIV, administered over approximately 3 hours on Day 1. Participants will also receive SOC antiviral treatment for flu. Administered intravenously at a dose of 225 mL of 65 g/mL FLU-IGIV diluted to 500 mL with normal saline. Participants also received standard of care (SOC) antiviral treatment for flu. FLU-IGIV: Single dose, sterile liquid formulation for IV administration.
FLU-IGIV Placebo	Placebo comparator	Other: Placebo for FLU-IGIVParticipants will receive a single infusion of placebo for FLU-IGIV, administered over approximately 3 hours on Day 1. Participants will also receive SOC antiviral treatment for flu. Administered IV as 500 mL of normal saline. Participants also received standard of care (SOC) antiviral treatment for flu. Placebo for FLU-IGIV: Single dose, normal saline solution for IV administration.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Provision of voluntary informed consent in writing by patient, or legally authorized representative.
Age ≥ 18 years of age.
Locally determined positive influenza A infection (Rapid Antigen (Ag) Test or PCR) from a specimen obtained within 2 days prior to randomization.
Onset of symptoms ≤ 6 days before randomization, defined as when the patient first experienced at least one respiratory symptom or fever.
Hospitalized (or in observation unit) with influenza, with anticipated hospitalization for more than 24 hours and will be/already are receiving antiviral SOC.

Key exclusion criteria (13 listed)

Use of any investigational product within the past 30 days prior to screening.
History of hypersensitivity to blood or plasma products (as judged by the site investigator).
History of allergy to latex or rubber.
Known medical history of IgA deficiency.
Pregnancy or lactation.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FLU-IGIVAlso: Anti-influenza immunoglobulin intravenous (Human), NP-025Single dose, sterile liquid formulation for IV administration.	Biological	FLU-IGIV High Dose, FLU-IGIV Low Dose
Placebo for FLU-IGIVSingle dose, normal saline solution for IV administration.	Other	FLU-IGIV Placebo

Primary outcome

Frequency Counts and Percentage of Subjects With Adverse Events
Time frame: Measured through Day 60
Frequency counts and percentage of subjects with Adverse Events by severity
Area Under the Plasma Concentration Curve [AUC] From Time 0 to 48 Hours Post-dose by Hemagglutinin Inhibition Assay
Time frame: Measured through 48 Hours post-dose
Levels of anti-influenza A antibodies circulating in blood over time. We initially intended to look at this variable through Day 8, however, potential native antibody level changes and sparse sampling confounded results from 0 to 48 hours post-dose from PK samples collected from Baseline Day 1 pre-dose (time 0), Day 1 post-dose, Day 2 and Day 3 (if continued hospitalization), and Day 8. For AUC from time 0 to 48 hours, subjects who did not have a sample collected within +/-10% of 48 hours post-dose had this parameter set to missing, which is why the number of subjects who contributed data for this outcome measure is lower than the overall number of subjects analyzed.
Maximum Plasma Concentration [Cmax] Reported as a Titer for Hemagglutinin Inhibition Assay
Time frame: Measured through Day 8 post-dose
Maximum observed concentration (reported as a titer) of anti-influenza A antibodies measured from Day 1 pre-dose (time 0) through Day 8 post-dose from PK samples collected from Baseline Day 1 pre-dose (time 0), Day 1 post-dose, Day 2 and Day 3 (if continued hospitalization), and Day 8.
Time Cmax is Observed [Tmax] by Hemagglutinin Inhibition Assay
Time frame: Measured through Day 8 post-dose
Time that anti-influenza A antibodies are at maximum concentration from Day 1 pre-dose (time 0) through Day 8 post-dose from PK samples collected from Baseline Day 1 pre-dose (time 0), Day 1 post-dose, Day 2 and Day 3 (if continued hospitalization), and Day 8. The rate of study drug elimination and dependent parameters were not accurately estimable due to rising or sustained levels of anti-influenza A antibodies, this includes First Order Terminal Elimination Rate Constant [Kel], Plasma Clearance [Cl] and Total Volume of Distribution [Vz].

1 secondary outcome

Ordinal Scale Subject Distribution Reflecting Clinical Status
Time frame: At Day 8 post-dose

Results and safety

Results posted to the registry on 5 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FLU-IGIV High Dose (450 mL)	21	18
FLU-IGIV Low Dose (225 mL)	20	16
Placebo (500 mL Normal Saline)	24	19

Primary outcome: Frequency Counts and Percentage of Subjects With Adverse Events

Time frame: Measured through Day 60. Count of participants. Unit: Participants

Measure	FLU-IGIV High Dose (450 mL) n = 19	FLU-IGIV Low Dose (225 mL) n = 19	Placebo (500 mL Normal Saline) n = 22
Mild	6	6	1
Moderate	3	5	6
Severe	1	1	4

Population analysed: The safety population includes all subjects who receive any amount of study medication (FLU-IGIV or placebo). In the case of incorrect treatment administration, subjects are analyzed according to the treatment received. The safety population is the primary analysis population for all safety data.

Primary outcome: Area Under the Plasma Concentration Curve [AUC] From Time 0 to 48 Hours Post-dose by Hemagglutinin Inhibition Assay

Time frame: Measured through 48 Hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: titer*hours/mL

Measure	FLU-IGIV High Dose (450 mL) n = 7	FLU-IGIV Low Dose (225 mL) n = 10	Placebo (500 mL Normal Saline) n = 13
H1N1 California	8589.9 (65.2)	4955.4 (87.8)	1973.1 (85.0)
H1N1 Michigan	5266.3 (67.6)	3446.3 (123.2)	1630.2 (106.4)
H3N2 Hong Kong	11729.3 (47.4)	7054.8 (39.1)	3682.5 (126.7)
H3N2 Singapore	6754.0 (34.2)	4431.6 (45.3)	2511.3 (219.6)

Population analysed: The PK population includes all safety subjects who have adequate PK data for analysis that includes Day 1 baseline (pre-infusion) and at least one post-infusion time point. Subjects are analyzed according to the treatment received. See outcome measure description for subject exclusion details.

Primary outcome: Maximum Plasma Concentration [Cmax] Reported as a Titer for Hemagglutinin Inhibition Assay

Time frame: Measured through Day 8 post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: titer

Measure	FLU-IGIV High Dose (450 mL) n = 19	FLU-IGIV Low Dose (225 mL) n = 19	Placebo (500 mL Normal Saline) n = 21
H1N1 California	408.3 (99.8)	152.5 (81.6)	54.7 (135.9)
H1N1 Michigan	371.6 (138.2)	121.7 (114.6)	54.7 (155.8)
H3N2 Hong Kong	309.6 (38.4)	239.8 (97.2)	117.7 (317.2)
H3N2 Singapore	206.7 (35.1)	192.7 (95.2)	86.7 (297.0)

Primary outcome: Time Cmax is Observed [Tmax] by Hemagglutinin Inhibition Assay

Time frame: Measured through Day 8 post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: hours

Measure	FLU-IGIV High Dose (450 mL) n = 19	FLU-IGIV Low Dose (225 mL) n = 19	Placebo (500 mL Normal Saline) n = 21
H1N1 California	24.4 (660.7)	17.4 (358.8)	108.7 (64.3)
H1N1 Michigan	40.3 (522.5)	13.9 (423.6)	120.3 (58.4)
H3N2 Hong Kong	4.8 (127.1)	14.6 (298.4)	76.8 (119.9)
H3N2 Singapore	6.0 (146.0)	23.0 (328.2)	64.8 (171.4)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From start of infusion on Day 1 through Day 60 (2 months).. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FLU-IGIV High Dose (450 mL)	1 of 19 (5.3%)	5 of 19 (26.3%)	0 of 19
FLU-IGIV Low Dose (225 mL)	2 of 19 (10.5%)	6 of 19 (31.6%)	0 of 19
Placebo (Normal Saline)	5 of 22 (22.7%)	8 of 22 (36.4%)	0 of 22

Limitations and caveats (from the sponsor): This phase 2 study was not powered to show efficacy. The target enrollment of 75 subjects randomized was not met (65 randomized and 60 dosed); the study was completed after the second northern hemisphere influenza season.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Post results and upload the supporting information.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christine Hall study director

Emergent BioSolutions Inc

55 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FLU-IGIV in people with Influenza A H3N2 and Influenza A H1N1, run by Emergent BioSolutions at 55 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, Canada, Spain, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency Counts and Percentage of Subjects With Adverse Events (time frame: Measured through Day 60). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03315104.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.