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Influenza, Human clinical trials

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NCT ID: NCT02635724 Completed - Influenza Clinical Trials

Safety, PK and Effectiveness of IV Peramivir in Elderly and Higher Risk Subjects With Uncomplicated Influenza

Start date: December 2015
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of 600 mg IV peramivir in the treatment of elderly subjects with acute uncomplicated influenza infection and in subjects with acute uncomplicated influenza infection at higher risk for influenza complications. All subjects will receive IV peramivir.

NCT ID: NCT02632578 Completed - Influenza, Human Clinical Trials

Influenza Vaccine in HIV Study

Start date: February 2015
Phase: N/A
Study type: Observational

The aims of this study are: 1. to investigate if HIV infection alters the antibody responses to influenza and 2. to assess the ability of licensed influenza vaccine to induce functional non-neutralising antibodies in HIV-infected and HIV-uninfected subjects.

NCT ID: NCT02624219 Completed - Influenza Clinical Trials

H5N8 Mix and Match With or Without AS03 or MF59 in Healthy Adults

Start date: August 16, 2016
Phase: Phase 1
Study type: Interventional

This is a Phase I randomized, double-blind, controlled trial in 275 males and non-pregnant females, 19 to 64 years old, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of a monovalent inactivated influenza A/H5N8 virus vaccine manufactured by bioCSL administered at different dosages (7.5 or 15 mcg of HA/0.5 mL dose) given with or without AS03 or MF59 adjuvants manufactured by GlaxoSmithKline Biologicals and Novartis Vaccines and Diagnostics, respectively.

NCT ID: NCT02623322 Completed - Influenza A Clinical Trials

A Study of MHAA4549A as Monotherapy for Acute Uncomplicated Seasonal Influenza A in Otherwise Healthy Adults

Start date: October 12, 2016
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo-controlled single dose study in otherwise healthy adults with acute uncomplicated seasonal influenza A to assess the safety and tolerability, efficacy, and pharmacokinetics of MHAA4549A.

NCT ID: NCT02623075 Completed - Influenza Clinical Trials

Influenza Vaccine Responses as a Means of Assessing Immune Competence in Chimeric Kidney/Stem Cell Transplant Recipients

Start date: October 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Influenza infection in solid organ transplant recipients is associated with increased morbidity and mortality compared to non-transplanted controls, due in part to the effects of immunosuppression which is necessary to prevent rejection of the transplanted organ. However, transplant patients are less likely to produce antibodies when vaccinated and when they do, the peak and duration of antibody responses are reduced compared to healthy controls. There are considerable differences in the magnitude of these responses, reflecting variability in individual responses to the influenza vaccine and to the immunosuppression regimen. The investigators hypothesize that chimeric kidney transplant recipients off of immunosuppression will have post vaccine immune responses that are comparable to age and gender matched healthy controls.

NCT ID: NCT02621177 Completed - Influenza, Human Clinical Trials

Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Healthy Children and Adolescents

Start date: November 2013
Phase: Phase 3
Study type: Interventional

This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of the study is to describe the immunogenicity and safety of the trivalent cell culture-derived influenza vaccine compared to the trivalent egg-derived influenza vaccine among subjects.

NCT ID: NCT02621164 Completed - Influenza, Human Clinical Trials

Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents

Start date: September 2014
Phase: Phase 3
Study type: Interventional

This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of the study is to describe the immunogenicity and safety of the quadrivalent cell culture-derived influenza vaccine compared to the trivalent egg-derived influenza vaccine among subjects.

NCT ID: NCT02612922 Completed - Influenza Clinical Trials

Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza

Start date: December 2015
Phase: Phase 3
Study type: Interventional

Trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of acute uncomplicated influenza.

NCT ID: NCT02612909 Completed - Avian Influenza Clinical Trials

A Safety and Immunogenicity Study of IVACFLU-A/H5N1

Start date: March 7, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The study hypothesis was that two 0.5 mL doses of whole virion monovalent A/H5N1 influenza vaccine (IVACFLU-A/H5N1) adjuvanted with alum would be safe and well tolerated in healthy adults, and that at least one of the two doses tested would be immunogenic in 60% or more of the subjects tested.

NCT ID: NCT02609399 Completed - Influenza Clinical Trials

ED Influenza Therapeutic Pilot Study: Oseltamivir vs. Peramivir

Start date: November 1, 2015
Phase: Phase 4
Study type: Interventional

This pilot study is designed to demonstrate the feasibility of utilizing Emergency Departments (EDs) as a primary site for subject enrollment in clinical trials evaluating influenza therapeutics, and to provide pilot data for future clinical trial design and planning. Primary Objective: To prospectively enroll high-risk subjects with laboratory-confirmed influenza into a randomized, open label study of oral versus IV influenza therapeutic to include symptom evaluation and outcome assessments. Secondary Objective 1: To identify influenza positive patients utilizing a previously established triage-based assessment and rapid testing algorithm for suspected influenza infection. Secondary Objective 2: To retrospectively evaluate all potentially eligible patients for potential enrollment biases. Secondary Objective 3: To create a repository of residual nasopharyngeal samples collected from ED patients with suspected influenza illness.