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Influenza clinical trials

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NCT ID: NCT03104790 Not yet recruiting - Influenza Clinical Trials

Assessment of Viral Shedding in Children Previously in Receipt of Multiple Doses of Live Attenuated Influenza Vaccine (LAIV) Compared to Influenza Vaccine-naïve Controls

Start date: September 30, 2017
Phase: Phase 4
Study type: Interventional

LAIV shedding studies in children could be an important way to confirm whether impediments to viral replication do indeed explain these observed reductions in vaccine effectiveness(VE), whether prior vaccination has any influence on replication and what future implications (if any) this might have for the UK paediatric LAIV programme. LAIV virus replication in children will be dependent on virological and host factors. The virus factors include replicative fitness of individual strains and the susceptibility to inhibition by other replicating strains (ability to compete). Host factors which may influence this include pre-existing specific immunity as a result of prior infection or previous vaccination (with either LAIV or IIV), and innate immune factors including mucosal immunity. Understanding the relative importance of different factors over two seasons when the strain composition of the A/H1N1pdm09 LAIV virus will change and by comparing previously unvaccinated and highly vaccinated groups (with both LAIV and IIV), can potentially give unique insights into their contribution to the US LAIV observations. With the change of the A/H1N1pdm09 vaccine strain in 2017/18, demonstrating improved performance (in terms of VE, virus shedding and immunogenicity) and what contribution prior vaccination might make will be key evidence for both the UK, but also the US. Information presented at the ACIP in June 2018 from the 2016/17 and 2017/18 seasons will be key to inform US future decisions around use of LAIV. This is a parallel group, non randomised study which will enrol at least 400 children. Both written informed consent from parent/ guardian and written assent from the child will be in place prior to any study procedure. The two groups will be defined by previous influenza vaccination history, with around half the children naïve to any influenza vaccination (LAIV or IIV) and half having had at least three doses of LAIV with or without IIV. All will follow the same schedule of vaccination and oral fluid collection at day 0 (by the nurse in the home or at the GP surgery); nasal swab collection (by the parent at home on days 1,3,6); day 21 oral fluid collection (by nurse or parent at home or at GP surgery).

NCT ID: NCT03101462 Completed - Influenza Clinical Trials

Live Attenuated Influenza Vaccine (LAIV) Versus Trivalent Inactivated Influenza Vaccine in Healthy Adults 18-49 Years

Start date: February 24, 2011
Phase: Phase 4
Study type: Interventional

This randomized, open-label, single-site study at Saint Louis University will enroll approximately 40 subjects who are healthy, 18 to 49 years old. Subjects will be randomized in a 1:1 fashion to receive either licensed trivalent FluMist containing (2010-2011 season appropriate), or licensed inactivated trivalent influenza vaccine (2010-2011 season appropriate) so that approximately 20 subjects will be randomized to receive LAIV, and 20 will receive TIV.

NCT ID: NCT03088904 Recruiting - Healthy Clinical Trials

Genetic and Environmental Factors in the Response to Influenza Vaccination

Start date: September 2014
Phase: Phase 4
Study type: Interventional

The purpose of the study is to investigate and compare the cell responses to influenza vaccination in monozygotic (identical) and dizygotic (fraternal) twins to determine the roles of genetics and environment in the response to flu vaccination.

NCT ID: NCT03076385 Active, not recruiting - Influenza Clinical Trials

Safety, Tolerability, and Immunogenicity of VAL-506440 in Healthy Adult Subjects

Start date: December 2015
Phase: Phase 1
Study type: Interventional

This clinical study will assess the safety, tolerability and immunogenicity of VAL-506440 in healthy adult subjects.

NCT ID: NCT03068949 Recruiting - Influenza Clinical Trials

Comparison of Three Licensed Influenza Vaccines

Start date: October 28, 2015
Phase: Phase 4
Study type: Interventional

This study will evaluate in detail the way that the immune system responds to three different kinds of flu shots that are licensed in the United States.

NCT ID: NCT03061955 Active, not recruiting - Influenza Clinical Trials

Safety and Efficacy of Concurrent Administration of Influenza Vaccine in Patients Undergoing Anti-PD-1 Immunotherapy (Nivolumab, Pembrolizumab)

Start date: October 1, 2016
Phase: N/A
Study type: Observational

The objective of this study is to evaluate the safety and efficacy of concurrent administration of influenza vaccine in patients receiving anti-PD1 immunotherapy (nivolumab or pembrolizumab). This will be a prospective observational study, aiming to assess patient tolerance of treatment, adverse events (incidence, grade, need for hospitalization), incidence of influenza infections, and seroconversion rates.

NCT ID: NCT03058692 Not yet recruiting - Influenza Clinical Trials

Two Doses of Multimeric-001 (M-001) Followed by Two Doses of an Influenza A/H7N9 Vaccine

Start date: n/a
Phase: Phase 2
Study type: Interventional

This is a Phase II randomized, double-blind, placebo-controlled trial in 240 males and non-pregnant females, 18 to 45 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 two priming doses of M-001 followed by boosting with two doses of MF59-adjuvanted or non-adjuvanted monovalent influenza A/H7N9 IIV. The monovalent influenza A/H7N9 IIV was derived from the HA of the influenza A/Shanghai/2/2013 (H7N9) virus. Primary objectives: To assess the safety and reactogenicity of M-001 vaccine following receipt of two doses; To assess the safety and reactogenicity of a monovalent inactivated influenza A/H7N9 vaccine (A/H7N9 IIV; two doses) administered with or without MF59 adjuvant following immunization with two doses of M-001 vaccine or placebo, and to assess the serum hemagglutination inhibition (HAI) antibody responses to the A/H7N9 IIV virus after receipt of the first and second dose of MF59 adjuvanted or non-adjuvanted A/H7N9 IIV when administered to adults following receipt of placebo or two doses of M-001 vaccine.

NCT ID: NCT03028987 Completed - Influenza Clinical Trials

Adaptive Immune Responses and Repertoire in Influenza Vaccination and Infection (SLVP031)

Start date: November 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is provide a better understanding of the adaptive immune response to the licensed flu vaccines. The investigators hope the information learned from this study will help identify and describe important factors of influenza immunity especially of or specific proteins associated with the T-cell immune response.

NCT ID: NCT03028974 Active, not recruiting - Influenza Clinical Trials

Innate and Acquired Immunity to Influenza Infection and Immunization (SLVP029)

Start date: September 2014
Phase: Phase 4
Study type: Interventional

The purpose of the study is to get a better understanding of the natural and adaptive immune response to the flu virus and to compare the immune cell responses to FDA-licensed flu vaccines in nasal mucosal cells and in blood.

NCT ID: NCT03023709 Terminated - Influenza Clinical Trials

Tissue-specific Responses to Influenza Immunization and Their Relation to Blood Biomarkers (SLVP032)

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

The investigators collected blood and lymphoid tissues routinely discarded during surgery from adults after a routine seasonal influenza vaccination to determine how immune memory develops at the actual site of infection, and how immunization may alter this process.