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Influenza clinical trials

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NCT ID: NCT02979730 Not yet recruiting - Influenza Clinical Trials

Impact of Rapid Flu Testing in BMC ED

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

The purpose of the study is to compare Emergency Department patients who undergo influenza testing using an FDA-approved point-of-care device (Cobas Liat Influenza A/B assay) located in the ED, to patients whose samples are sent to the BMC central laboratory. Patients who agree to participate will have their samples randomly assigned to be tested on either at the core lab, or on the POC device. The current turnaround time for samples sent to the laboratory is approximately two hours; investigators expect that the point of care device can reduce this time. Investigators will determine if the time to disposition and the administration of antibiotics is different in the group undergoing POC influenza testing compared to those undergoing laboratory-based influenza testing

NCT ID: NCT02979626 Not yet recruiting - Influenza Clinical Trials

Evaluation of Moderate to Severe Influenza Outcomes in Children

M2SFlu
Start date: December 2016
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether a moderate-severe endpoints (including high fever, lower respiratory tract disease, acute otitis media, or serious extra-pulmonary complications are predictive of hospitalization, intensive care admission, antibiotic use and other complications in children under 8 years of age.

NCT ID: NCT02972957 Not yet recruiting - Influenza Clinical Trials

A Study of Intranasal Live Attenuated Influenza Vaccine Immunogenicity and Associations With the Nasopharyngeal Microbiome Among Children in the Gambia

NASIMMUNE
Start date: January 2017
Phase: Phase 4
Study type: Interventional

The live attenuated influenza vaccine (LAIV) is made up of weakened influenza viruses given into the nose and in early studies was shown to be better than the standard influenza vaccine at preventing infections in children. However, more recently, it has performed less well and it may also work less well in Sub-Saharan Africa. Not only do the investigators not know why this is, but the investigators also do not fully understand why LAIV produces stronger nasal antibody responses in some individuals but not others. Usually harmless bacteria that are present in participants noses can influence how our immune system works and variations in these may explain differences in how LAIV works. The project will recruit children given LAIV in the Gambia to gain further understanding of these issues. The investigators will measure a variety of responses to LAIV, including genes that can change their expression early after vaccination and use advanced computational techniques to identify new relationships between these genes and other LAIV responses. The investigators will also see whether nasal bacterial profiles in children who respond to LAIV are different from those who do not. In addition, the investigators will alter these bacteria in a subset of children with antibiotics and see whether this affects both nasal gene expression and later responses to LAIV.

NCT ID: NCT02964065 Recruiting - Influenza Clinical Trials

A Trial on the Efficacy, Safety and Immunogenicity of Live-Attenuated Influenza Vaccine (LAIV)

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

This study is a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅲ Trial to evaluate the efficacy, safety and immunogenicity of a single dose of Live-Attenuated influenza Vaccine(LAIV) among healthy children and adolescents aged 3-17 years.

NCT ID: NCT02962908 Recruiting - Influenza Clinical Trials

A Randomised, Double-blind, Placebo-controlled Phase IIb Trial to Test FLU-v Vaccine

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

FLU-v is a vaccine that aims to protect against a wide range of flu viruses. The purpose of this study is to measure the immune responses induced by FLU-v vaccine. This study will look at how safe FLU-v is when administered and how successful it is in preventing flu or reducing the severity of the flu symptoms. The study requires 222 healthy volunteers 18-60 years old. Participation in the study will take a maximum of 7 months and consists of 5 visits. During visit 1, subjects will be examined by a doctor to make sure they are eligible to enter the study. A 15ml blood sample (a tablespoon) will be taken to check general health followed by a general physical exam. Medical history and some personal information will be collected. Subjects that have received the traditional flu vaccine in the past 6 months, and those females who are pregnant or breastfeeding will not be allowed in the study. Subjects of childbearing age must agree to use effective contraceptive methods. At visit 2, subjects will be randomly allocated to one of the four treatment groups summarised below: - Treatment 1: FLU-v (test vaccine) at the start of the study (Day 0) and then again 21 days later - Treatment 2: FLU-v (test vaccine) with an additional substance added [known as Montanide ISA 51] which improves the effect of the test vaccine. Injection will be given on Day 0 and then Placebo (no test vaccine) alone 21 days later - Treatment 3: Placebo (no test vaccine) injection on Day 0 and then 21 days later - Treatment 4: Placebo (no test vaccine) with an additional substance added [known as Montanide ISA 51] on Day 0 and then Placebo (no test vaccine) alone 21 days later Treatment will be injected under the skin in the upper arm on day 0 (visit 2) and 21 days later (visit 3). Blood samples will be taken before treatment (day 0), and on days 42 (visit 4) and 180 (visit 5) to the immune responses induced by the vaccine. Subjects will be asked to complete a diary card to write down any side effects that they may experience after vaccination. Subjects will also be asked to complete another diary card to document any flu-like symptoms experienced between December 2016 and March 2017, this time is officially considered as the flu season. During this period, if the subject experiences flu-like symptoms, a collection of a nose and tonsil swab will be arranged by the study site to confirm whether they have the flu or not.

NCT ID: NCT02955030 Recruiting - Influenza Clinical Trials

Evaluation of the Safety and Immunogenicity of a Sublingual Influenza Vaccine NSV0001 in Healthy Male Volunteers

Start date: October 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of a sublingual administration of NSV0001 in healthy male volunteers.

NCT ID: NCT02954354 Not yet recruiting - Influenza Clinical Trials

A Study of S-033188 Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza

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

The primary objective of this study is to evaluate the efficacy of a single, oral dose of S-033188 compared with placebo by measuring the time to alleviation of symptoms in patients with uncomplicated influenza virus infection.

NCT ID: NCT02949011 Not yet recruiting - Influenza Clinical Trials

Study of S-033188 Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications

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

The primary objective of this study is to evaluate the efficacy of a single, oral dose of S-033188 compared with placebo by measuring the time to improvement of influenza symptoms in patients with influenza presenting within 48 hours of symptom onset.

NCT ID: NCT02935192 Not yet recruiting - Influenza Clinical Trials

Phase 3 Trial of Serbian Seasonal Influenza Vaccine

Torlak-300
Start date: November 2016
Phase: Phase 3
Study type: Interventional

A Phase 3, double-blind, randomized, placebo-controlled trial of a seasonal, trivalent, split, inactivated influenza vaccine produced by Torlak.

NCT ID: NCT02933723 Recruiting - Influenza Clinical Trials

Immunogenicity of Influenza Vaccine in Long Term Care

Start date: October 2016
Phase: Phase 4
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.