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Influenza clinical trials

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NCT ID: NCT04164212 Active, not recruiting - Influenza Clinical Trials

Live Attenuated Influenza Vaccine as a Nasal Model for Influenza Infection

Start date: September 1, 2020
Phase: Phase 4
Study type: Interventional

The purpose of this study is to develop a nasal model for influenza infection using the live attenuated influenza vaccine (LAIV). The investigators will administer LAIV to healthy adult volunteers in order to simulate influenza infection, and obtain nasal specimens to measure influenza virus and inflammatory/immune responses. In a subset of participants, cystic fibrosis transmembrane conductance regulator (CFTR) function will also be evaluated via measurement of nasal potential difference (NPD)

NCT ID: NCT04048369 Active, not recruiting - Influenza Clinical Trials

Impact of Influenza/RSV PCR Point-of-care Testing in the Emergency Medical Service.

Start date: January 17, 2019
Phase: N/A
Study type: Interventional

The purpose of the study is to compare Emergency Department patients who undergo influenza and RSV PCR testing using an FDA-approved point-of-care device (Cepheid Xpert® Xpress Flu/RSV) located in the ED, to patients who undergo influenza and RSV PCR testing at the core laboratory. The principal purpose is to determine if the time spent in the ED is different in the group undergoing POC influenza testing compared to those undergoing laboratory-based influenza testing.

NCT ID: NCT03965195 Active, not recruiting - Influenza Clinical Trials

Recombinant Influenza Vaccination in U.S. Nursing Homes

Start date: July 20, 2019
Phase: Phase 4
Study type: Interventional

Based on recent evidence on the mutation of the A/H3N2 strain in egg-grown vaccine, the investigators will study the quadrivalent recombinant influenza vaccine (RIV4, Flublok) compared to the standard dose quadrivalent vaccine (IV4) in a cohort of long-stay NH residents with a primary endpoint of all-cause hospitalization.

NCT ID: NCT03753347 Active, not recruiting - Influenza Clinical Trials

TITRE III: Influenza B Immunogenicity Investigation

Start date: December 1, 2018
Phase: Phase 4
Study type: Interventional

Each winter, viruses belonging to two kinds of influenza A ("A/H1N1" & "A/H3N2") and two kinds of influenza B ("B/Yamagata" & "B/Victoria") can cause illness. Historically, the yearly influenza vaccine that was recommended in children was designed to protect against both kinds of influenza A but only one kind of influenza B. In a series of trials conducted between 2008-09 and 2010-11 (TITRE I, II, and IIB), the TITRE investigators measured antibody response to influenza B in children who were primed with two doses of trivalent inactivated influenza vaccine (TIV) containing B/Yamagata. Overall, the investigators found that 2 doses of vaccine containing B/Yamagata did not adequately prime children for response to the alternate B/Victoria antigen and that subsequent vaccine doses containing B/Victoria-lineage antigen strongly boosted antibodies to the B/Yamagata antigen that was introduced during first immunization priming, but with lower responses to B/Victoria. For the first time since 2009-10, the recommended B/Victoria component of the seasonal influenza vaccine has been changed, from B/Brisbane/60/2008 to B/Colorado/60/2007 for the coming 2018-19 season. The investigators thus have a unique opportunity to clarify lineage-specific influenza B responses in a well-characterized cohort of children originally primed to Yamagata. The investigators' main interest is to assess whether TITRE I children primed with two doses of B/Yamagata in 2008-09 have since or are now capable of achieving a sufficient antibody response to B/Victoria following a single dose of 2018-19 QIV, ten years after their initial TIV B/Yamagata priming exposure.

NCT ID: NCT03734237 Active, not recruiting - Influenza Clinical Trials

A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD

PAIVED
Start date: November 6, 2018
Phase: Phase 4
Study type: Interventional

A total of 18,000 eligible subjects (or 6,000 subject distributed evenly between the 3 study arms) will be enrolled. Eligible subjects will be randomized in 1:1:1 (cell-culture-based vaccine, the recombinant vaccine, or the egg-based vaccine) over four influenza seasons (2018-2019, 2019-2020, 2020-2021, and 2021-2022).

NCT ID: NCT03598439 Active, not recruiting - Influenza Clinical Trials

Randomized Influenza Vaccine Evaluation of Immune Response

RIVER
Start date: July 30, 2018
Phase: Phase 4
Study type: Interventional

Licensed influenza vaccines are manufactured with a variety of technologies. The majority are split, inactivated vaccines derived from egg-adapted, high growth reassortant viruses. Two US licensed products do not use egg-adapted viruses: Flucelvax (mammalian cell culture) and FluBlok (recombinant). There is increasing evidence that egg propagation induces virus mutations that impair the immune responses to circulating viruses. However, the impact of egg-propagation on clinical vaccine effectiveness is uncertain, and there is no preferential recommendation for any specific influenza vaccine product or technology. A direct comparison of serologic response to egg based and non-egg based vaccines in adults has not been performed. This randomized trial will compare serologic responses to the egg- and non-egg A(H3N2) vaccine component. The study cohort will be followed for two influenza seasons to evaluate sequential vaccination effects on immune response.

NCT ID: NCT02933723 Active, not recruiting - Influenza Clinical Trials

Immunogenicity of Influenza Vaccine in Long Term Care

Start date: October 2016
Phase: N/A
Study type: Interventional

The study is designed to evaluated if adjuvanted vaccine elicits higher T cell and B cell responses than non-adjuvanted standard dose influenza vaccine in nursing home residents.

NCT ID: NCT02860039 Active, not recruiting - Influenza Clinical Trials

High Dose Flu Vaccine in Treating Children Who Have Undergone Donor Stem Cell Transplant

Start date: September 2016
Phase: Phase 2
Study type: Interventional

This phase II randomized trial studies how well high dose flu vaccine works in treating children who have undergone done stem cell transplant. Higher dose flu vaccine may build a better immune response and may provide better protection against the flu than the standard vaccine.

NCT ID: NCT02658409 Active, not recruiting - Influenza Clinical Trials

A Multicenter, Double-blind, Parallel, Non-inferiority, Phase III Study

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

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study.

NCT ID: NCT02563093 Active, not recruiting - Influenza Clinical Trials

Study of Fluzone® Quadrivalent, Fluzone® Intradermal Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines in Adults

Start date: September 2015
Phase: Phase 4
Study type: Interventional

The aim of the study is to evaluate the safety and immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults 18 to < 65 years of age, and of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age. Primary Objective: - To describe the safety of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults 18 to < 65 years of age and the safety of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age. Observational Objectives: - To describe the immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults 18 to < 65 years of age and the immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age. - To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, and Fluzone High-Dose) in the applicable age group with the historical requirements of the CHMP NfG CPMP/BWP/214/96.