CLINICAL TRIAL

Treatment for Influenza, Human

Waitlist Available · 18+ · All Sexes · Houston, TX

This study is evaluating whether a vaccine may help prevent infection from the H7N9 virus.

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About the trial for Influenza, Human

Treatment Groups

This trial involves 7 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Control Group 1
FLU-Q-PAN H7N9 Formulation 2
BIOLOGICAL
+
AS03A
BIOLOGICAL
Control Group 2
FLU-Q-PAN H7N9 Formulation 2
BIOLOGICAL
+
AS03B
BIOLOGICAL
Control Group 3
AS03B
BIOLOGICAL
+
FLU-Q-PAN H7N9 Formulation 1
BIOLOGICAL
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Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
has a negative pregnancy test on the day of vaccination,
Healthy participants as established by medical history and clinical examination before entering into the study.
A male or female ≥ 18 years of age at the time of first vaccination.
Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards and COVID-19 assessment card, return for follow-up visits, or return the diary cards and COVID-19 assessment card in a timely manner using the pre stamped envelope received at the site).
Female participants of non-childbearing potential may be enrolled in the study. Non childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion hysterectomy, bilateral ovariectomy or post-menopause.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: At Day 22 (post-dose 1/pre-vaccination) and Day 43 (post-dose 2/pre-vaccination)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: At Day 22 (post-dose 1/pre-vaccination) and Day 43 (post-dose 2/pre-vaccination).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 8 primary outcomes and 8 secondary outcomes in patients with Influenza, Human. Measurement will happen over the course of At Day 22.

Percentage of seroconverted participants for HI antibodies against vaccine homologous H7N9
AT DAY 22
Seroconversion rate is defined as the percentage of participants with a post-vaccination antibody titer ≥ 40 1/DIL in the serum of participants seronegative before vaccination (i.e. titer < assay cut-off at Day 1). For seropositive participants (i.e. titer ≥ assay cut-off at Day 1), seroconversion requires a 4-fold rise in postvaccination HI antibody titer (but at least a titer of 40 1/DIL). Note: The cut-off value for antibody titer is defined by the laboratory before the analysis.
Percentage of seroconverted participants for anti-HI antibodies against vaccine homologous H7N9
AT DAY 43
CBER criteria for seroconversion rate (SCR) for 18 to 64 years of age is shown if LL of the 99.17% CI for the SCR meets or exceeds 40%, and for ≥ 65 years of age, if the LL of the 99.17% CI for the SCR meets or exceeds 30%. Seroconversion is defined as a post-vaccination antibody titer ≥ 40 1/DIL in the serum of participants seronegative before vaccination (i.e. titer < assay cut-off at Day 1). For seropositive participants (i.e. titer ≥ assay cut-off at Day 1), seroconversion requires a 4-fold rise in postvaccination HI antibody titer (but at least a titer of 40 1/DIL). The percentage of participants is calculated with Clopper-Pearson exact two-sided 99.17% CIs. Note: The cut-off value for antibody titer is defined by the laboratory before the analysis.
Percentage of seroprotected participants for anti-hemagglutination inhibition (HI) antibodies against vaccine homologous H7N9
AT DAY 43
Center for Biologics Evaluation and Research (CBER) criteria for seroprotection rate (SPR) for 18 to 64 years of age is shown if the Lower Limit (LL) of the 99.17% confidence interval (CI) for the SPR meets or exceeds 70%, and for ≥ 65 years of age, if the LL of the 99.17% CI for the SPR meets or exceeds 60%. SPR being defined as the percentage of participants with an HI antibody titer greater than or equal to (≥) 40 1/dilution (DIL). The percentage of participants is calculated along with Clopper-Pearson exact two-sided 99.17% CIs.
Number of participants with any solicited systemic events
WITHIN THE 7-DAY FOLLOW-UP PERIOD AFTER DOSE 2
Solicited systemic events assessed are fatigue, fever, headache, muscle ache all over body, joint pain, shivering, sweating and gastrointestinal symptoms (Nausea, vomiting, diarrhea and abdominal pain). Any = occurrence of symptom regardless of intensity grade. Fever was defined as temperature equal or greater than (≥) 38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).
Number of participants with any solicited administered site events
WITHIN THE 7-DAY FOLLOW-UP PERIOD AFTER DOSE 2
Solicited administered site events assessed are pain, redness and swelling. Any Pain = occurrence of symptom regardless of intensity grade. Any Redness or any Swelling symptom = any symptom having a surface diameter greater than (>) 20 millimeters (mm).
Number of participants with any and related serious adverse events (SAEs)
FROM DAY 1 UP TO MONTH 13
A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant. Should also be considered abnormal pregnancy outcomes (e.g. spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy) or other situations where medical or scientific judgement should be exercised in deciding whether reporting is appropriate.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of influenza, human?

Signs and symptoms of influenza may vary depending on the age and underlying disease of the person. Therefore, it's important to pay attention as the disease progresses. The most common signs in adults are fever, muscular pains, difficulty swallowing, and sore throat. In children it's usually cough, weakness, and breathing problems. Symptoms in the elderly may include weakness, shortness of breath, and difficulty walking. In adults, influenza is most common during the late winter and early spring, and in children it's most common between September and November. It's also most common in the young and the very young. A [CDC influenza] (https://www.cdc.gov/influenza/virus/virus.

Anonymous Patient Answer

How many people get influenza, human a year in the United States?

Each year influenza, human causes about 185,000 hospitalizations and about 2750 deaths in the United States. Most Americans have had influenza epidemics during their lifetime.

Anonymous Patient Answer

What are common treatments for influenza, human?

For many individuals with the flu, it is common to take acetaminophen, Tylenol, or other nonsteroidal anti-inflammatory drugs (NSAIDs) for pain relief. This finding supports the need for a bigger study of the relationship between acetaminophen, NSAIDs, and flu, especially in view of the widespread use of NSAIDs.

Anonymous Patient Answer

Can influenza, human be cured?

The effects of current influenza vaccination interventions on incidence of human influenza have not changed over the last 20 years; in all periods there has been insufficient evidence of either benefit or harm of influenza vaccination.

Anonymous Patient Answer

What causes influenza, human?

Influenza A/09/H1N1 is transmitted from person to person, and may have a zoonotic source. Human influenza viruses generally circulate worldwide and are an important cause of influenza epidemics and interpandemic pandemics. Most human cases of the 2009/09 epidemic were caused by viruses of the influenza A subtype H1N1. Influenza B is uncommonly isolated from humans. Influenza does not cause human disease. Influenza is transmitted primarily by airborne droplets or secretions from infected individuals, direct contact, contaminated surfaces, and close droplet-to-droplet contact such as sharing pillows, kissing, or sharing a common handkerchief.

Anonymous Patient Answer

What is influenza, human?

The influenza viruses are a group of small, enveloped, viruses that infect humans and other vertebrates. In humans, it causes an illness with variable clinical manifestations that may result in either mild or severe infection. Infections with influenza viruses may be seasonal or may be acquired periodically without a prior infection. Influenza is an acute febrile respiratory tract disease characterized by the presence of a runny nose, cough, sore throat, and muscle pains. Influenza may also spread to other people without symptoms in the absence of an infected individual. Influenza A and B are the only viruses that are typically responsible for causing illness in humans and may be spread through airborne or direct contact.

Anonymous Patient Answer

Has treatment proven to be more effective than a placebo?

For patients with mild-to-moderate [influenza](https://www.withpower.com/clinical-trials/influenza)-like symptoms, most guideline-based antivirals are as effective as a placebo. The recommendation for antiviral therapy for patients with serious complications from influenza should be reevaluated. Until the risk-benefit ratio of antivirals is clearly established, clinicians should monitor patients carefully with influenza, not take a recommendation to treat for flu as an indication to treat with antivirals, and consider alternative treatments, including lifestyle, for their flu-like symptoms.

Anonymous Patient Answer

Does treatment improve quality of life for those with influenza, human?

The overall QOL of people with influenza is comparable to that for people in the general population. The treatment of influenza for a moderate disease course has little effects on QOL as measured by the AQWB and the QOL domains (pain, fatigue, appetite, cognitive functions, respiratory and itching symptoms). However, the improvement of mood, the recovery rate after treatment and the improvement of cough duration are related to the improvement of the overall AQWB score.

Anonymous Patient Answer

What are the latest developments in treatment for therapeutic use?

Our understanding of the pathogenesis of viral respiratory infections is improving. The current literature should help identify the optimum approach to treating patients with viral infections.

Anonymous Patient Answer

How does treatment work?

There is evidence that treatment for [influenza](https://www.withpower.com/clinical-trials/influenza) affects health in children as it does in adults. We will need to see how treatment for the winter flu interacts with treatment for disease flare-ups.

Anonymous Patient Answer

What is the latest research for influenza, human?

This is the first comprehensive article about the most recent vaccine updates. Current research on flu and human is limited but growing in scope. Further knowledge might prove useful in preventing complications or mitigating their consequences.

Anonymous Patient Answer

What does treatment usually treat?

Influenza and human coronavirus infections pose a challenge to public health in Singapore and elsewhere. The current clinical management may be insufficient to control these infections. A vaccine for influenza was developed and approved by regulatory authorities in 2013. The vaccine coverage was found to be very low amongst seasonal flu patients when compared to the population-wide coverage in Singapore in winter months. Therefore, mass vaccination against influenza is crucial in Singapore, as it will likely benefit the Singaporean health care services and save the healthcare expenses.

Anonymous Patient Answer
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