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Influenza, Human clinical trials

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NCT ID: NCT04074928 Completed - Influenza Clinical Trials

Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects

Start date: September 6, 2019
Phase: Phase 3
Study type: Interventional

This phase 3 clinical study is a randomized, observer-blind, comparator-controlled, multicenter study of QIVc versus a US-licensed comparator QIV in children 6 months through 47 months of age. The purpose of this study is to demonstrate that vaccination with QIVc elicits an immune response that is noninferior to that of a US-licensed comparator QIV containing the same virus strains, in children 6 months through 47 months of age.

NCT ID: NCT04044352 Completed - Influenza Clinical Trials

H1N1v Virus Challenge Study in Healthy Subjects

Start date: October 22, 2019
Phase: Phase 1
Study type: Interventional

This is a study of a reverse-engineered, Good Manufacturing Practice (GMP) grade, antiviral-sensitive, influenza A/Bethesda/MM2/H1N1 virus (A/California/04/2009/H1N1-like) infection to assess the effect of pre-existing immunity on clinical and immunological responses. Up to 80 healthy adult subjects will undergo intranasal inoculation with A/Bethesda/MM2/H1N1 virus, and their clinical manifestations, viral shedding and immunological responses will be characterized. The Primary Objective for this study is to evaluate the association of symptomatic Reverse Transcription-Polymerase Chain Reaction (RT-PCR)-positive influenza virus infection post-challenge and pre-existing Hemagglutinin Inhibition Test (HAI) antibody titers.

NCT ID: NCT04043923 Completed - Clinical trials for Influenza -Like Illness

Norketotifen for the Treatment of Uncomplicated Influenza-like Illness

Start date: October 21, 2019
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT04038333 Completed - Influenza, Human Clinical Trials

Financing Strategies of Influenza Vaccination in China

Start date: August 1, 2019
Phase:
Study type: Observational

This trial focuses on influenza vaccination among three recommended groups in China. Data concerning the economic burden of influenza-like illness (ILI), vaccine hesitancy, discrete choice experiment, immunization records and willingness to pay for vaccines will be collected via questionnaires, and the financing strategies of influenza vaccines in China will be further analyzed. Besides, the knowledge, attitude/belief and practice (KAP) of medical staff will also be asked in a supplementary questionnaire.

NCT ID: NCT04033406 Completed - Influenza A Clinical Trials

Study of VIR-2482 in Healthy Volunteers

Start date: August 26, 2019
Phase: Phase 1
Study type: Interventional

This is a phase 1 study in which healthy volunteers will receive VIR-2482 or placebo and will be assessed for safety, pharmacokinetics, and immunogenicity of VIR-2482 in preventing Influenza A illness.

NCT ID: NCT04024228 Completed - Healthy Volunteers Clinical Trials

Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Europeans Adults 60 Years of Age and Older

Start date: October 28, 2019
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate that high-dose quadrivalent influenza vaccine (QIV-HD) induces an immune response that is superior to the responses induced by standard-dose quadrivalent influenza vaccine (QIV-SD) for all 4 virus strains 28 days post-vaccination in participants 60 to 64 years of age and in participants 65 years of age and older. Secondary Objective: - Immunogenicity: To further describe the immune response induced by QIV-HD and QIV-SD in all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD). - Safety: To describe the safety profile of all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD).

NCT ID: NCT04024137 Completed - Influenza A Clinical Trials

Study of ZSP1273 in Patients With Acute Uncomplicated Influenza A

Start date: December 7, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the antiviral effect, as measured by the time to alleviation of influenza symptoms and viral titer in nasopharyngeal secretions in adults with acute uncomplicated influenza A following administration of ZSP1273.

NCT ID: NCT04008823 Completed - Clinical trials for Influenza Virus Infection

Study of Influenza Virus Infection in Children Hospitalized in Spain in Two Consecutive Influenza Seasons

HOSPIGRIP
Start date: October 5, 2017
Phase:
Study type: Observational

This is an epidemiological, retrospective and observational study, by reviewing clinical histories, of children hospitalized for influenza virus infection, their comorbidities and the treatments that have been performed

NCT ID: NCT04001504 Completed - Clinical trials for Acute Coronary Syndrome

Vaccination Against Influenza to Prevent Cardiovascular Events After Acute Coronary Syndromes

VIP-ACS
Start date: July 19, 2019
Phase: Phase 3
Study type: Interventional

Cardiovascular disease has a great burden in the context of public health, as well as the low pharmacological adherence of patients who have chronic non-transmissible diseases. However, the investigators do not have data on the efficacy of vaccination to reduce cardiovascular events in the acute coronary syndromes, and the few studies evaluating the cardioprotective potential of the influenza vaccine were conducted in countries with well defined seasonalities, divergent of Brazil, that presents a constant viral circulation during all months of the year and distinct among its regions. Therefore, study evaluating higher dose vaccination in a period that contemplates the seasonality of the influenza virus in Brazil may bring important findings to different scientific gaps, as well as clarify questions about the possible benefit of doubled vaccination - which does not present contraindications - immediately after a atherothrombotic event. If it shows real benefit, it could also be a future therapeutic tool adjuvant to traditional drug therapy in the prevention of cardiovascular events.

NCT ID: NCT03999554 Completed - Influenza A Clinical Trials

Safety and Immunogenicity of the Bris10 M2SR and Sing2016 M2SR H3N2 Monovalent Influenza Vaccines

Start date: September 3, 2019
Phase: Phase 1
Study type: Interventional

This is a Phase I double-blind, randomized, placebo-controlled study in 250 healthy adults, 18-49 years of age, inclusive, who are in good health and meet all eligibility criteria. The purpose of this dose escalation clinical study is to assess the safety, tolerability/reactogenicity, and immunogenicity of H3N2 M2SR investigational vaccines for prevention of influenza, when delivered at higher dosages or in two doses . Eligible subjects will be screened and randomized to receive two administrations 28 days apart of Sing2016 M2SR at three dose levels (low, medium, high), Bris10 M2SR at one dose level (low), or placebo in a 1:1:1:1:1 ratio. Study duration will be approximately 8 months with subject participation duration approximately 7 months. The primary study objective is to assess the safety and reactogenicity of a monovalent live single replication influenza H3N2 M2SR vaccine.