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Influenza, Human clinical trials

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NCT ID: NCT03160118 Completed - Clinical trials for Prevention of Influenza

Study of Biomarkers of Immune Activation Associated With Symptoms and Immune Responses After Influenza Vaccination in Adults

Start date: March 27, 2017
Phase: Phase 4
Study type: Interventional

This clinical fase IV study, using the administration of a single dose of a quadrivalent, inactivated, split influenza virus vaccine as biological intervention will mirror a study conducted at Imperial College, London, UK that will use a challenge with live virus as intervention. Comparison of the clinical observations and laboratory measurements generated in both studies will inform us about the similarities and differences in innate and adaptive immune responses elicited by both types of exposure to influenza virus antigen(s).

NCT ID: NCT03158038 Completed - Healthy Clinical Trials

Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2017-2018 Season

FluMist
Start date: May 30, 2017
Phase: Phase 4
Study type: Interventional

This prospective annual release study is designed to evaluate the safety of 1 new influenza virus vaccine strain to be included in FluMist Quadrivalent for the 2017-2018 influenza season.

NCT ID: NCT03154515 Completed - Influenza, Human Clinical Trials

Efficacy and Safety Study of Ingavirin® 90 mg Once Daily to Treat Influenza and Other Acute Viral Infections in Adults

Start date: January 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether Ingavirin® 90 mg once daily is effective and safe for the treatment of influenza and other laboratory confirmed acute respiratory viral infections in the course of standard therapy in patients 18-60 years old.

NCT ID: NCT03150537 Completed - Needle Phobia Clinical Trials

Comparison of Routine IM Influenza Immunization and Administration by Jet-injector (Med-Jet H4™) in Healthy Young Adults

Med-Jet H4™
Start date: May 12, 2017
Phase: Phase 4
Study type: Interventional

80 subjects (healthy adults) will be randomized to receive the seasonal flu vaccine either by needle & syringe or by the MIT needle-free injector (Med-Jet MIT H4™ & Disposable Cartridge). The study will be conducted after the normal flu season has passed (ie: March-April). Half of those randomized to standard vaccination (n=20) will receive vaccine drawn from a multi-dose vial while the other half (n=20) will receive vaccine drawn from a single use vial. The same vaccine as the multi-dose vial will be delivered to the other half of the subjects (n=40) using the MIT injector. How long it takes to prepare and deliver the vaccines will be assessed (a time-motion study). Subject acceptance before and after injection will be assessed as well as local and systemic side effects. Standard serologic measures of immune response to flu vaccination (ie: antibodies) will determine whether the Med-Jet H4 injector induces the same kind of immune response as needle & syringe delivery.

NCT ID: NCT03144518 Completed - Clinical trials for Vaccination; Infection

Mood and Influenza Vaccine Response: A Feasibility Trial

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

This study is a 2-arm, parallel, randomised controlled feasibility trial of a brief video intervention designed to induce positive affect (mood) in older adults in primary care settings prior to the receipt of influenza vaccination. Participants will be randomised into two conditions: experimental and active control. In the experimental condition, participants will view the approximately 15 minute long intervention video immediately prior to vaccination. In the active control condition, participants will view a matched video that is designed to be mood neutral. Pre-and-post positive affect levels will be assessed by self-report questionnaires. Immune response to the intervention and vaccination responses will be assessed in saliva and serum samples respectively. The objectives of the study are to assess the impact of the intervention on mood, immune function, and antibody response to influenza vaccination in older adults. This feasibility trial will also allow data collection on exploring recruitment, attrition, intervention engagement, and practicality of collecting clinical data available through electronic records to inform the design of a future definitive trial.

NCT ID: NCT03139565 Completed - Influenza Clinical Trials

High Dose vs. Standard Influenza Vaccine in Adult SOT

Start date: October 2016
Phase: Phase 3
Study type: Interventional

The study will test whether a high dose influenza vaccination results in improved immunogenicity in adult SOT recipients as compared to standard vaccine. This will be a single center prospective observer-blind randomized controlled trial conducted at the Toronto General Hospital Multi-Organ Transplant Unit, University Health Network, Toronto, Ontario, Canada.

NCT ID: NCT03137667 Completed - Clinical trials for School-located Influenza Vaccination

School-located Influenza Vaccination Clinics for Adolescents

SKIPP RCT2
Start date: November 30, 2015
Phase: N/A
Study type: Interventional

A cluster-randomized trial (clustering by school) was conducted in Monroe County, NY. Twenty middle and high schools were paired based on several characteristics and randomized within pairs to receiving a school-based influenza vaccination clinic or not (control).

NCT ID: NCT03133936 Completed - Influenza, Human Clinical Trials

Evaluation of the Effects of Age, Prior Exposure, and Previous Vaccination on Response to the Flu Vaccine

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

The purpose of this study is to evaluate the immune response in recipients of the vaccine. After participants receive the vaccine, samples of blood will be obtained at several intervals afterwards. These blood samples will be used to measure the immune response to the vaccine. Everyone in this study will receive a single dose of flu vaccine, and have blood samples drawn to measure the immune response over the next 90 days. The investigators will also ask participants to report any flu like illnesses during the flu season, and if participants develop a fever or cough, to come in to be tested for flu. This will allow the investigators to compare the vaccine response between people who got the flu and those who did not.

NCT ID: NCT03121339 Completed - Clinical trials for Seasonal Influenza Preventative Vaccine Pharmacodynamics

Pharmacodynamic Open-Label Trial With VXA-A1.1 Oral H1 Vaccine in Healthy Adults

Start date: March 31, 2017
Phase: Phase 1
Study type: Interventional

This is a phase 1 open-label pharmacodynamics study in healthy adults. The purpose of the study is to determine if the tablet formulation size of VXA-A1.1, an adjuvanted adenoviral based influenza vaccine, has an impact on delivery location. The secondary objective is to evaluate delivery with fasting versus fed status.

NCT ID: NCT03104790 Completed - 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

Flushed
Start date: October 2, 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).