Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to estimate rates of morbidity and mortality and to examine predictors of severity among participants with 2009 H1N1 infection. In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses. The current version of the protocol (released in August 2013) further broadens the scope of this observational study. With the recognition that novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health importance, the objectives of this protocol have been expanded.

NCT01056185

Conditions

1. Influenza
2. Novel Respiratory Virus-1 Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV)
3. Novel Respiratory Virus-2 Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)

MeSH:Virus Diseases Influenza, Human Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome

Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to describe participants seeking medical care in geographically diverse locations with 2009 H1N1 infection and their clinical course over a 14-day period following enrollment. In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses. This version of the protocol further broadens the scope of this observational study. With the recognition that novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health importance, the objectives of this protocol have been expanded

NCT01056354

Conditions

1. Influenza and Other Novel Respiratory Viruses

MeSH:Influenza, Human

The study will be conducted using nasopharyngeal swab specimens collected prospectively from individuals suspected of having the signs and symptoms of an acute respiratory tract infection caused by a respiratory virus. A series of standard viral culture tests validated for routine use in the clinical laboratory, and/or a series of PCR-based Laboratory Developed Tests (PCR-LDT) validated by a central reference laboratory will be used to verify the performance of the investigational artus Influenza A/B RT-PCR test and the QIAGEN ResPlex II Advanced Panel test. From each specimen five (5) aliquots will be prepared: (a) one aliquot will be tested in real-time using the assigned viral culture reference methods; (b) one aliquot will be used to extract nucleic acid in real-time for investigational testing; (c) one aliquot of the specimen will be stored at --70C for subsequent shipment to the reference laboratory for PCR-LDT testing, (d) one aliquot will be archived at -70C for subsequent follow-up by the reference laboratory (e.g., bi-directional sequencing of positive specimens), and (e) any remaining specimen will be stored for the Fresh vs. Frozen Study. The extracted nucleic acid generated from the second aliquot (i.e., "b" above) will be split and subjected to testing by both the artus Influenza A/B RT-PCR test and the ResPlex II Advanced Panel test.

NCT01302418

Conditions

1. QIAGEN ResPlex II Advanced Panel
2. Influenza A
3. Respiratory Syncytial Virus Infections
4. Infection Due to Human Parainfluenza Virus 1
5. Parainfluenza Type 2
6. Parainfluenza Type 3
7. Parainfluenza Type 4
8. Human Metapneumovirus A/B
9. Rhinovirus
10. Coxsackie Virus/Echovirus
11. Adenovirus Types B/C/E
12. Coronavirus Subtypes 229E
13. Coronavirus Subtype NL63
14. Coronavirus Subtype OC43
15. Coronavirus Subtype HKU1
16. Human Bocavirus
17. Artus Influenza A/B RT-PCR Test
18. Influenza B

Interventions

1. Device: artus Influenza A/B RT-PCR Test

MeSH:Infection Communicable Diseases Virus Diseases Influenza, Human Coronavirus Infections Adenoviridae Infections Respiratory Syncytial Virus Infections Paramyxoviridae Infections Coxsackievirus Infections

Currently, there is no treatment for children less than one year of age with influenza related lower respiratory tract infection that is either considered standard or registered in any country. This dismal scenario exists even though influenza related LRTI is a significant illness causing morbidity and mortality, especially in children less than 6 months of age. Avian influenza has been reported rarely in children less than one. There are no data in Vietnam and very few data in Thailand on the burden of influenza in children less than one. This young age group suffers high mortality. Oseltamivir may be beneficial in such children. This is basis of this trial.

NCT01546935

Conditions

1. Influenza

Interventions

1. Drug: Oseltamivir

MeSH:Infection Respiratory Tract Infections Influenza, Human

HPO:Respiratory tract infection

This study aims to quantify the inpatient and ER visits burden of laboratory-confirmed influenza, and compare the clinical features, severity, complications, risk factors and socioeconomic impact of influenza in children presenting with acute respiratory illness (ARI) and/or isolated fever, with or without laboratory-confirmed influenza.

NCT01592799

Conditions

1. Influenza

Interventions

1. Procedure: Throat swab and/or nasopharyngeal swab
2. Other: Data collection

MeSH:Influenza, Human Emergencies

This study will evaluate the safety, pharmacokinetics and efficacy of baloxavir marboxil in healthy pediatric participants from birth to <1 year with influenza like symptoms

NCT03653364

Conditions

1. Influenza

Interventions

1. Drug: Baloxavir Marboxil

MeSH:Influenza, Human

Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screening. Their households are enrolled within 24 hours of randomization if at least 2 household contacts (HHC) have not received influenza vaccine within 6 months of screening and if all HHC screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs, obtained from both IP and HHC up to 9 (+/-1) days post IP randomization, and through the assessment of symptoms.

NCT03969212

Conditions

1. Influenza

Interventions

1. Drug: Baloxavir Marboxil
2. Drug: Placebo

MeSH:Influenza, Human

The aim of the study is to identify what sender/signal combinations are most persuasive in encouraging low socioeconomic males living in the U.S. to take-up seasonal flu vaccination. The investigators plan to recruit male subjects and randomly assign them to four persuasion treatments: three of which vary dimensions of the sender of a medical recommendation (racial concordance, gender concordance, and authority treatments) and one which varies the signal (standard vs. empathetic). Specifically, the investigators will show subjects videos of either Black or white actors/actresses providing scripted information on the flu vaccination. The investigators will randomize the race of the sender and if the subject is Black, also randomize the authority of the sender, with the actor portraying either a doctor or a layperson. Conditional on project funding, subjects assigned to a concordant sender will have the gender of the sender randomized. In addition, the investigators will vary the script used in the experiment between one that acknowledges past injustices (indicated as an empathetic script hereafter) and one that does not (indicated as a standard script hereafter). The investigators will provide subjects a free flu shot coupon and elicit the price at which subjects would be willing to give up this coupon for a cash reward. Lastly, in light of the relevance of vaccination take-up in combating COVID-19 pandemic, the investigators will assess demand for information about a COVID-19 vaccine, with subjects invited to receive results of a safety and efficacy review from a trusted or standard source. The design requires collection of baseline and endline surveys combined with administrative data from pharmacies about coupon redemption. The primary outcomes of interest are posterior beliefs about seasonal flu vaccination, demand and willingness-to-pay (WTP) for a free flu shot coupon, redemption of the coupon, and demand for information about a COVID-19 vaccine.

NCT04160975

Conditions

1. Flu, Human
2. Influenza, Human
3. Covid19

Interventions

1. Behavioral: Video about safety and effectiveness of adult seasonal flu vaccination
2. Behavioral: Message directing subjects to information on COVID-19 vaccine safety and efficacy

MeSH:Influenza, Human

Multicapillary Ion mobility spectrometry of nasal air aspirates shall be investigated as screening tool for the detection of Influenza and SARS-CoV-2- infection.

NCT04282135

Conditions

1. Influenza

Interventions

1. Diagnostic Test: MCC IMS

MeSH:Influenza, Human

This is a Phase IIb study consisting of two cohorts to evaluate efficacy, safety and pharmacokinetics of DAS181 in IFV infection. An approximate total of 280 subjects will be enrolled into this study.

NCT04298060

Conditions

1. Influenza Infection
2. SAD-RV Infection and COVID-19

Interventions

1. Drug: DAS181
2. Drug: Placebo

MeSH:Infection Communicable Diseases Influenza, Human

This project aims to use artificial intelligence (image discrimination) algorithms, specifically convolutional neural networks (CNNs) for scanning chest radiographs in the emergency department (triage) in patients with suspected respiratory symptoms (fever, cough, myalgia) of coronavirus infection COVID 19. The objective is to create and validate a software solution that discriminates on the basis of the chest x-ray between Covid-19 pneumonitis and influenza

NCT04313946

Conditions

1. COVID-19
2. Pneumonia, Viral
3. Influenza With Pneumonia
4. Flu Symptom
5. Flu Like Illness
6. Pneumonia, Interstitial
7. Pneumonia, Ventilator-Associated
8. Pneumonia Atypical

Interventions

1. Diagnostic Test: Scanning Chest X-rays and performing AI algorithms on images

MeSH:Pneumonia, Ventilator-Associated Influenza, Human Pneumonia, Viral Pneumonia Lung Diseases, Interstitial

HPO:Interstitial pneumonitis Interstitial pulmonary abnormality Pneumonia

Some authors have proposed the use of the flu vaccine to reduce the severity of COVID-19 cases, while some have proposed the use of ACE Inhibitors (ACEI) or Angiotensin Receptor blockers (ARB), since this virus shares hemagglutinin as a transmission mechanism and acts on the ACE2 enzyme during infection. The aim is to evaluate whether the admitted patients who are previously vaccinated or those who were already receiving treatment show a better evolution.

NCT04367883

Conditions

1. COVID19
2. Influenza Vaccination
3. ACE Inhibitors
4. ARB

Interventions

1. Drug: ACE inhibitor
2. Drug: ARB

MeSH:Influenza, Human

The primary objectives of the study are: - To describe the safety profile of the different formulations in all participants - To describe the hemagglutinin inhibition (HAI) and seroneutralization (SN) antibody responses against hemagglutinin (H1, H3, B/Victoria, and B/Yamagata) antigens present in the control vaccine in all groups at all timepoints. The secondary objectives are: - To describe antigenic coverage in each group by assessing the HAI and SN antibody responses against a panel of H3 antigens (not present in any of the vaccine formulations). - To describe SN antibody responses in each group against each of the H3 antigens. - To compare H3 HAI and SN antibody responses for the groups with quadrivalent recombinant influenza vaccine (RIV) formulations with H3 antigens to those of the quadrivalent RIV control group. - To compare the HAI and SN antibody responses for the groups with quadrivalent RIV formulation with adjuvant to the group without adjuvant.

NCT04451954

Conditions

1. Influenza

Interventions

1. Biological: Quadrivalent RIV with H3 strain 1
2. Biological: Quadrivalent RIV with H3 strain 1 and adjuvant
3. Biological: Quadrivalent RIV with H3 strain 2
4. Biological: Quadrivalent RIV with H3 strain 2 and adjuvant
5. Biological: Quadrivalent RIV with 2018-2019 NH H3 strain
6. Biological: Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant

MeSH:Influenza, Human

The investigators decided to conduct a longitudinal study that compares the pulmonary tomographic patterns found in patients with viral pneumonia (i.e. influenza H1N1 and SARS-CoV-2) at a regional hospital. The primary aim of this study is to compare the radiological patterns found in patients with COVID-19 and influenza H1N1. The secondary aims of this study will assess the association between the radiological CT pattern and the need for invasive mechanical ventilation and mortality within the first 28 days of intensive care unit admission.

NCT04497311

Conditions

1. SARS-CoV-2
2. Covid19
3. H1N1 Influenza
4. Computed Tomography

Interventions

1. Diagnostic Test: Thoraxic computed tomography

MeSH:Influenza, Human

The investigators decided to conduct a longitudinal study that compares the pulmonary tomographic patterns found in patients with viral pneumonia (i.e. influenza H1N1 and SARS-CoV-2) at a regional hospital. The primary aim of this study is to evaluate the association between the radiological CT pattern and the need for invasive mechanical ventilation. A secondary aim is to assess the mortality within the first 28 days of intensive care unit admission.

NCT04499378

Conditions

1. Covid19
2. Influenza A H1N1
3. Intubation Complication
4. Morality
5. Lung Injury, Acute

Interventions

1. Diagnostic Test: Lung CT

MeSH:Influenza, Human Lung Injury Acute Lung Injury

Background: Each Belgian winter season is characterized by a wave of influenza like and respiratory symptoms. Especially, the elderly people are more vulnerable to be infected by influenza, but also RSV. The recent COVID-19 pandemic and eventually a next wave, will increase the prevalence of influenza like and respiratory symptoms. Method: A multicentre non-commercial cohort study will be conducted in nursing home staff and residents during the Winter season 2020-2021. Objectives: Primary objective is the difference in incidence of influenza like and respiratory symptoms between cases (cases have evidence of past infection with SARS-CoV-2, referred to as Covid +) and controls (controls have no evidence of previous infection and are referred to as Covid -). The primary outcome analysis as well as the secondary outcome analyses will use two strata: nursing home staff and nursing home residents. The secondary objectives are the difference in incidence of COVID-19, influenza, RSV infections confirmed by PCR between cases and controls, to define a correlate of protection in the covid + group against re-infection with SARS-CoV-2 based on the study of the pre-existing antibody profile (antigen specificity, antibody type and antibody level) at the time of re-exposure. A multiplex assay will be used to assess the antibody profile. Finally, to study the COVID-19 disease severity (7 point WHO ordinal scale, this includes a.o. hospitalisation, mechanical ventilation need and ICU admission, mortality) based on the presence/absence of pre-existing antibodies and the pre-existing antibody profile. For other respiratory infections we will study the need for hospitalization and mortality.

NCT04527614

Conditions

1. Influenza, Human
2. SARS Virus
3. COVID-19
4. Espiratory Tract Infections

Interventions

1. Diagnostic Test: qRT-PCR and serology

MeSH:Infection Communicable Diseases Respiratory Tract Infections Influenza, Human

HPO:Respiratory tract infection

As part of the fight against COVID-19, the UK government has announced its most comprehensive flu campaign to date (https://www.gov.uk/government/news/most-comprehensive-flu-programme-in-uk-history-will-be-ro lled-out-this-winter). This should not be surpising: every year NHS hospitals experience an overwhelming number of influenza cases, and COVID-19 increases this concern. As in previous years, the flu vaccine is free at the point of care for people 65 and over. New this year is that later in the season the vaccine will be made available free at the point of care for people 50 and over. However, if people refuse to take the vaccine this comprehensive program cannot benefit public health. The degree to which vaccine hesitancy is expressed varies across characteristics of the vaccine considered and the time and place it is offered, and across characteristics of the person's perceptions of complacency, convenience, confidence, calculations, and communal responsibility, i.e. the "5Cs". Information campaigns can be used to influence all 5Cs, and public facing information is often a necessary component of public health campaigns that may also include structural components. Largely, information campaigns can be viewed as a type of educational intervention. Educational interventions may fall short of what is needed to alter people's intentions to vaccinate where they focus on system 1 rational thinking processes and neglect system 2 automatic thinking processes. To be more effective, public health messages must be tailored to align with the "beliefs, attitudes, and motivations" of the very people they intend to influence. Fact-led educational interventions to increase parents' intentions to vaccinate their children are particularly ineffective where more subtle content opposes the recipient's deep-seated values. In a different context, recycling behaviour, previous research demonstrated that messages aligned with people's deep-seated values (i.e. the moral foundations that underlie political ideologies) are more likely to promote desired behavioural intentions than unaligned messages. The present research expands the scope of previous research in two ways. First, rather than investigating parental attitudes towards vaccination, the investigators will look at people's intentions to self-vaccinate. Second, the investigators will explore the effectiveness of messages aligned with the moral foundations that underlie individual's political ideologies on their intentions to be vaccinated.

NCT04546854

Conditions

1. Influenza Vaccine

Interventions

1. Behavioral: Appeals

MeSH:Influenza, Human

The proposed study is designed to investigate if and how pregnant women infected with Coronavirus Disease-19 (COVID-19) infection go on to develop long-term immunity. In December 2019, a group of people in Wuhan, China presented with symptoms of a pneumonia of an unknown cause that led to the discovery of a new coronavirus called COVID-19. COVID-19 has caused a global pandemic with 7,140,000 confirmed cases and 418,000 deaths as of 13th June 2020. In the United Kingdom (UK), there have been 294,000 cases and 41,662 deaths as of 13th June 2020. In humans, this infection primarily involves the upper part of the lungs, but it can also affect other organs. It causes mild symptoms in the majority of people affected but some people can have severe infections, with some even requiring critical care in hospital. During Severe acute respiratory syndrome (SARS), a previous coronavirus epidemic, pregnant women were disproportionately affected with severe illness. Understanding how the immune system responds long-term to this infection may hold the key to developing better vaccines and efficient treatment plans. Specialised immunity develops when individuals are infected by this and other viruses. The investigators of this study propose that, in pregnancy, this specialised immunity may not behave effectively. This may affect their ability to develop long lasting immunity and make them more vulnerable to re-infection. In this study, the investigators aim to recruit patients across 6 groups including COVID-19 newly infected pregnant women, and people with differing illness severity, mild to moderate, severe/critical, no infection (controls), as well as pregnant women with influenza and those receiving influenza vaccine. The study team will compare COVID-19 in pregnancy with non-pregnant infected and with influenza infected and vaccinated pregnant women. The study team will consent patients in all of these groups to provide a series of blood samples at different time points in a 12-month period.

NCT04568044

Conditions

1. COVID-19
2. Pregnancy Related
3. Influenza, Human

Interventions

1. Procedure: Blood sample

MeSH:Influenza, Human

This study uses a prospective cohort design to investigate if the seasonal influenza vaccine is equally effective when given early and late before the proceeding influenza season. All health care workers will be vaccinated for seasonal influenza either 3 months before or 1 month prior to the start of the influenza season. HCWs that consent to take part in the study will have 4 blood samples taken for an antibody check. The initial antibody checks will be done just prior to vaccination as well as 2 weeks after vaccination. Subsequent samples will be taken at the peak of influenza season and at the end of the influenza season. HCWs that develop ILI during the course of the influenza season will be asked to complete a questionnaire and oropharyngeal self-swab. HCWs will also provide exhaled breath samples and wear a mask in order to evaluate novel non-invasive methods for diagnosis of influenza. Influenza positive and negative inpatients identified through the University of Leicester's laboratory system will also be asked to provide breath samples to evaluate this technique for the diagnosis of influenza.

NCT04570904

Conditions

1. Influenza
2. Influenza -Like Illness

Interventions

1. Biological: Influenza vaccination at different time points

MeSH:Influenza, Human

The aims of this vaccine trial are: (1) to measure humoral and selected cellular immune responses to repeated influenza vaccination with Flublok, including these responses' associations with age, birth year, and prior vaccination history; (2) to identify the characteristics of study participants who are vaccinated but still become infected with influenza virus ("vaccine failures") and participants who have poor immune responses to vaccination; and (3) to predict how influenza vaccinations and infections shape immunity.

NCT04576377

Conditions

1. Influenza, Human

Interventions

1. Biological: FluBlok
2. Other: Placebo

MeSH:Influenza, Human

Background: Influenza (flu) is a contagious respiratory illness. It is caused by influenza viruses that infect the nose, throat, and lungs. Some people, such as older people, young children, and people with certain health conditions, are at high risk of serious flu complications. Researchers want to test a vaccine to prevent flu. Objective: To see if the H10 Ferritin vaccine is safe and how the body responds to it. Eligibility: Healthy adults ages 18-70. Design: Participants will be screened with: Medical history Physical exam Blood tests Pregnancy test (if needed). Participants will get 1-2 injections of the study vaccine in the upper arm. They will stay in the clinic for at least 30 minutes after each vaccination. Participants will keep a diary card for 7 days after each vaccination. They will record their temperature and any symptoms. They will measure any skin changes at the injection site. Participants may have nose and throat secretions, and/or oral mucosal samples, collected with a disposable swab. Participants will have blood drawn. Some participants may have apheresis. A needle is placed into a vein in both arms. Blood is removed through a needle in the vein of one arm. The blood is spun in a machine that separates the white blood cells. The rest of the blood is returned to the participant through a needle in the other arm. Before apheresis, participants weight, pulse, and blood pressure will be checked. Their medical history will be taken. Participants will have 8-10 follow-up visits. Participation will last about 10 months.

NCT04579250

Conditions

1. Influenza

Interventions

1. Biological: VRC-FLUNPF0103-00-VP VRC-FLUNPF0103-00-VP (H10ssF-6473)

MeSH:Influenza, Human

This is a Phase 2b, multi-center, double-blind, randomized, placebo-controlled, parallel-group study of NKT versus placebo in otherwise healthy adults presenting with acute uncomplicated ILI due to influenza or other respiratory viruses in a community setting.

NCT04610047

Conditions

1. Influenza
2. Influenza -Like Illness

Interventions

1. Drug: Norketotifen
2. Drug: Placebo

MeSH:Influenza, Human