A Phase 2 interventional study of FLU-IGIV and Placebo for FLU-IGIV in Influenza A H3N2 and Influenza A H1N1, sponsored by Emergent BioSolutions. Completed at 55 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Emergent BioSolutions · Phase 2, Interventional, and Treatment
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Among 966 studies in Influenza, Human with a site in United States — 60 open to participants now, 85 under way, 7 of them phase 3. Influenza, Human · United States.
Among the 966 studies in Influenza, Human with a site in United States, this one is the 630th largest by enrollment of the 843 interventional ones that give a count, is one of 40 that started in 2017, is one of 161 in phase 2, and was the 633rd registered.
2,358 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
Browse Influenza, Human studies →60 of the 966 studies in Influenza, Human with a site in United States are open now. Recruiting first, the newest first:
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18–55 · Healthy volunteers
ModernaTX, Inc. · Sites in United States
Ages 65+ · Healthy volunteers
ModernaTX, Inc. · Sites in United States
Ages 9–17 · Healthy volunteers
National Institute on Deafness and Other Communication Disorders (NIDCD) · Sites in United States
Ages 18–99 · Healthy volunteers
David Moss · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 121 Influenza, Human studies recruiting now, 66 (55%) set no upper age limit and 45 (37%) stop at 75 or younger; 33 take children under 18; 67 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
966 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 249 · Phase 2 244 · Phase 3 127 · Phase 4 147
First in 1997; this study’s year is marked. 40 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 65 is below the median of 227 across 1,957 interventional studies indexed under Influenza, Human.
Median enrollment 270 across the 843 interventional studies, 261 across the 122 observational. Of the 841 that completed or were terminated, 433 (51%) have results posted.
This tab as a report to print or save as PDF → With an account.
435 of 966 have an industry lead sponsor. The 10 most frequent:
Emergent BioSolutions is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.
Emergent BioSolutions has 3 studies filed under Influenza, Human — fewer than ten, so there is no comparison to draw.
41 of the studies in Influenza, Human with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07496450Phase 3ModernaTX, Inc.A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults | 2027-01-28 |
| NCT06094010Phase 3Hoffmann-La RocheA Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts | 2027-05-11 |
| NCT07159763Phase 3Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06) | 2027-07-02 |
| NCT07851246Phase 3GlaxoSmithKlineA Study to Evaluate the Immune Response and Safety of a Vaccine Against Influenza in Adults 18-64 Years of Age | 2027-07-09 |
| NCT05624450Phase 3AstraZenecaEfficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen | 2027-11-04 |
Add all 41 to your calendar (.ics) → With an account.
Among the 966 studies in Influenza, Human with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
2,358 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
This study's enrollment of 65 is below the median of 227 across 1,957 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Emergent BioSolutions is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.
Compared within Influenza, Human, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Orthomyxoviridae Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: FLU-IGIV
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.
Biological: FLU-IGIV
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.
Other: Placebo for FLU-IGIV
Single dose, sterile liquid formulation for IV administration.
Also known as: Anti-influenza immunoglobulin intravenous (Human), NP-025
Single dose, normal saline solution for IV administration.
Frequency Counts and Percentage of Subjects With Adverse Events
Frequency counts and percentage of subjects with Adverse Events by severity
Time frame: 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.
Time frame: 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.
Time frame: 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 \[Vz\].
Time frame: Measured through Day 8 post-dose
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.
Time frame: At Day 8 post-dose
This study included patients hospitalized with serious illness with laboratory-confirmed influenza A infection. Total 75 subjects were screened with 10 screen failures. Out of 65 randomized subjects, 60 received study treatment and 53 completed the study.
| Milestone | FLU-IGIV High Dose (450 mL) | FLU-IGIV Low Dose (225 mL) | Placebo (500 mL Normal Saline) |
|---|---|---|---|
| Started | 21 | 20 | 24 |
| Dosed (safety population) | 19 | 19 | 22 |
| Completed | 18 | 16 | 19 |
| Not completed | 3 | 4 | 5 |
Frequency counts and percentage of subjects with Adverse Events by severity
| Participants | FLU-IGIV High Dose (450 mL) | FLU-IGIV Low Dose (225 mL) | Placebo (500 mL Normal Saline) |
|---|---|---|---|
| Mild | 6 | 6 | 1 |
| Moderate | 3 | 5 | 6 |
| Severe | 1 | 1 | 4 |
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.
| titer*hours/mL | FLU-IGIV High Dose (450 mL) | FLU-IGIV Low Dose (225 mL) | Placebo (500 mL Normal Saline) |
|---|---|---|---|
| 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 |
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.
| titer | FLU-IGIV High Dose (450 mL) | FLU-IGIV Low Dose (225 mL) | Placebo (500 mL Normal Saline) |
|---|---|---|---|
| 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 |
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 \[Vz\].
| hours | FLU-IGIV High Dose (450 mL) | FLU-IGIV Low Dose (225 mL) | Placebo (500 mL Normal Saline) |
|---|---|---|---|
| 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 |
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.
| Participants | FLU-IGIV High Dose (450 mL) | FLU-IGIV Low Dose (225 mL) | Placebo (500 mL Normal Saline) |
|---|---|---|---|
| 1-Death | 0 | 0 | 0 |
| 2-Hospitalization in the ICU | 1 | 0 | 0 |
| 3-Non-ICU hospitalization, requiring supp O2 | 0 | 2 | 4 |
| 4-Non-ICU hospitalization, not requiring supp O2 | 0 | 0 | 0 |
| 5-No longer hospitalized, no normal activities | 7 | 7 | 9 |
| 6-No longer hospitalized, normal activities | 11 | 8 | 8 |
Collected over From start of infusion on Day 1 through Day 60 (2 months).. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FLU-IGIV High Dose (450 mL) | 0/19 (0%) | 1/19 (5.3%) | 5/19 (26.3%) |
| FLU-IGIV Low Dose (225 mL) | 0/19 (0%) | 2/19 (10.5%) | 6/19 (31.6%) |
| Placebo (Normal Saline) | 0/22 (0%) | 5/22 (22.7%) | 8/22 (36.4%) |
| Event | FLU-IGIV High Dose (450 mL) | FLU-IGIV Low Dose (225 mL) | Placebo (Normal Saline) |
|---|---|---|---|
| CellulitisInfections and infestations | 0/19 | 1/19 | 0/22 |
| Acute Kidney InjuryRenal and urinary disorders | 1/19 | 0/19 | 1/22 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/19 | 1/19 | 1/22 |
| StridorRespiratory, thoracic and mediastinal disorders | 1/19 | 0/19 | 0/22 |
| ShockVascular disorders | 1/19 | 0/19 | 0/22 |
| Acute respiratory distress syndromeRespiratory, thoracic and mediastinal disorders | 1/19 | 0/19 | 0/22 |
| Cardiac FailureCardiac disorders | 0/19 | 0/19 | 1/22 |
| Supraventricular tachycardiaCardiac disorders | 0/19 | 0/19 | 1/22 |
| UrosepsisInfections and infestations | 0/19 | 0/19 | 1/22 |
| DehydrationMetabolism and nutrition disorders | 0/19 | 0/19 | 1/22 |
| Event | FLU-IGIV High Dose (450 mL) | FLU-IGIV Low Dose (225 mL) | Placebo (Normal Saline) |
|---|---|---|---|
| ConstipationGastrointestinal disorders | 1/19 | 0/19 | 3/22 |
| HypoglycaemiaMetabolism and nutrition disorders | 2/19 | 0/19 | 0/22 |
| Transaminases increasedInvestigations | 2/19 | 1/19 | 0/22 |
| HeadacheNervous system disorders | 0/19 | 2/19 | 1/22 |
| Oral candidiasisInfections and infestations | 0/19 | 0/19 | 2/22 |
| Fluid overloadMetabolism and nutrition disorders | 1/19 | 1/19 | 1/22 |
| HypomagnesaemiaMetabolism and nutrition disorders | 1/19 | 1/19 | 1/22 |
| HyperglycaemiaMetabolism and nutrition disorders | 1/19 | 1/19 | 0/22 |
| NauseaGastrointestinal disorders | 0/19 | 1/19 | 1/22 |
| White blood cell count increasedInvestigations | 0/19 | 1/19 | 1/22 |
The ITT population includes all randomized subjects regardless of study medication (FLU-IGIV or placebo) dosing, influenza type or Protocol Deviations. Subjects are analyzed according to the treatment to which they were randomized. The ITT population is the primary analysis population for clinical benefit endpoints. Not all subjects had Day 8 data.
| Age, Continuous(years) | FLU-IGIV High Dose (450 mL) | FLU-IGIV Low Dose (225 mL) | Placebo (500 mL Normal Saline) | Total |
|---|---|---|---|---|
| Mean | 48.4 ± 16.2 | 49.1 ± 14.2 | 59.5 ± 14.1 | 52.7 ± 15.5 |
| Age, Customized(Participants) | FLU-IGIV High Dose (450 mL) | FLU-IGIV Low Dose (225 mL) | Placebo (500 mL Normal Saline) | Total |
|---|---|---|---|---|
| 18-54 | 13 | 11 | 8 | 32 |
| 55 and over | 8 | 9 | 16 | 33 |
| Sex: Female, Male(Participants) | FLU-IGIV High Dose (450 mL) | FLU-IGIV Low Dose (225 mL) | Placebo (500 mL Normal Saline) | Total |
|---|---|---|---|---|
| Female | 12 | 10 | 12 | 34 |
| Male | 9 | 10 | 12 | 31 |
| Ethnicity (NIH/OMB)(Participants) | FLU-IGIV High Dose (450 mL) | FLU-IGIV Low Dose (225 mL) | Placebo (500 mL Normal Saline) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 3 | 4 | 3 | 10 |
| Not Hispanic or Latino | 18 | 16 | 21 | 55 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | FLU-IGIV High Dose (450 mL) | FLU-IGIV Low Dose (225 mL) | Placebo (500 mL Normal Saline) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 9 | 9 | 14 | 32 |
| White | 12 | 11 | 10 | 33 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | FLU-IGIV High Dose (450 mL) | FLU-IGIV Low Dose (225 mL) | Placebo (500 mL Normal Saline) | Total |
|---|---|---|---|---|
| North America | 20 | 20 | 22 | 62 |
| Spain | 1 | 0 | 2 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Post results and upload the supporting information.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Within 1 year after the study's Primary Completion Date (Last Subject Last Visit).
Ran from Nov 2017 to primary completion in Jun 2019, 19 months.
Results were first posted in Oct 2020, 1 year 3 months after primary completion.
Of 86 industry-sponsored phase 2 interventional studies under Influenza, Human, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's 19 months is above that.
Counting every sponsor, half of 122 studies reached it within 10 months; a quarter within 5 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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