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Influenza clinical trials

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NCT ID: NCT03300362 Not yet recruiting - Influenza Clinical Trials

Improved Novel VaccIne CombinaTion InflUenza Study

INVICTUS
Start date: October 2017
Phase: Phase 2
Study type: Interventional

A Phase IIb randomised, participant-blinded, placebo-controlled, multi-centre phase IIb efficacy study in 2030 volunteers aged 65 and over. The study will assess the safety and efficacy of the co-administration of a viral vectored vaccine, MVA- NP+M1, and the annual recommended licensed inactivated influenza vaccine (IIV). Within the main cohort 100 participants will be recruited to an immunology sub-cohort.

NCT ID: NCT03300050 Not yet recruiting - Influenza Clinical Trials

Safety and Immunogenicity of a Live-attenuated Universal Flu Vaccine Followed by an Inactivated Universal Flu Vaccine

Start date: October 5, 2017
Phase: Phase 1
Study type: Interventional

The clinical study will evaluate safety and the immune response of a prime- boost regimen with a live attenuated influenza vaccine (LAIV) prime and an inactivated split influenza vaccine (IIV) boost with or without adjuvant.

NCT ID: NCT03293498 Active, not recruiting - Influenza Clinical Trials

Evaluation of the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix M-1 Adjuvant (NanoFlu)

Start date: September 18, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, randomized, observer-blinded, active-controlled trial. Approximately 330 eligible subjects will be enrolled and randomized into 1 of 3 treatment groups as shown in the Trial Design table below. Each group will consist of approximately 110 subjects total, stratified by age, gender, and history of receipt of 2016 - 17 influenza vaccine. On Day 0, subjects in Groups A and B will be administered an IM injection of NanoFlu at one of two dose levels; subjects in Group C will receive the preconfigured comparator (Fluzone HD) at the manufacturer's recommended dose and volume. On Day 21, all Group A and B subjects will be administered a rescue injection with a licensed seasonal influenza vaccine, while all Group C subjects will be administered an injection with sterile saline placebo to maintain trial blind. Trial follow-up for each subject will span approximately 1 year from the Day 0.

NCT ID: NCT03287830 Not yet recruiting - Influenza Clinical Trials

Flu2Text: Text Message Reminders for 2nd Dose of Influenza Vaccine 2017-18

F2T
Start date: September 2017
Phase: N/A
Study type: Interventional

This multi-site study assesses the impact of text message reminders on the receipt of the second dose of influenza vaccine, and takes place in practices from the American Academy of Pediatrics (AAP) Pediatric Research in Office Settings (PROS) network.

NCT ID: NCT03282240 Active, not recruiting - Influenza Clinical Trials

Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US

Start date: September 8, 2017
Phase: Phase 3
Study type: Interventional

This randomized, modified double-blind, active-controlled, multi-center trial will assess the safety and immunogenicity of the high-dose quadrivalent influenza vaccine (QIV-HD) compared to either the licensed or investigational high-dose trivalent influenza vaccine (TIV-HD) in adults.

NCT ID: NCT03274310 Not yet recruiting - Influenza Clinical Trials

FluSAFE: Flu SMS Alerts to Freeze Exposure

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

Influenza infection results in an estimated 31 million outpatient visits, 55,000 to 974,200 hospitalizations, and 3,000 to 49,000 deaths. Membership in household in which someone else has influenza is the major risk factor for contracting influenza. The household secondary attack rate (SAR) is as high as 19% based on laboratory-confirmed influenza and 30% based on symptoms. Non-pharmaceutical preventive measures, including education, may play a role in decreasing transmission, but are only effective if started within 36 hours of symptom onset in index cases. Yet, most interventions are delayed because they are not initiated until care is sought. The investigators have demonstrated in one primarily Latino, urban community sample, that text messaging can be used to rapidly identify community members with influenza-like illness (ILI) early in an illness. This early identification would enable implementation of an educational intervention in the optimal time frame to reduce influenza transmission. Providing education within a text message is a proven successful strategy to influence behavior. Text messaging itself is scalable, low-cost, and can be used in low literacy populations. However, using text-message based surveillance to trigger a real-time text-message behavioral educational intervention to decrease household influenza transmission has not been assessed.

NCT ID: NCT03266237 Completed - Influenza Clinical Trials

The Immune Response to Influenza Vaccinations in Elderly Individuals

Start date: December 2013
Phase: Phase 4
Study type: Interventional

The aim of this study is to characterize the immune profile of frail and healthy aged individuals and investigate their immune responsiveness including the response to influenza vaccine over an 18-month period. The project will include a longitudinal study to define immune signatures and multi-parameter profiles associated with frailty and may lead to the identification of predictive markers of evolution to frailty and Immunosenescence in the elderly.

NCT ID: NCT03248960 Recruiting - Influenza Clinical Trials

Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.

Start date: July 27, 2017
Phase: N/A
Study type: Interventional

The primary purpose of this study is to validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture. The secondary aims are to: Validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR). Evaluate the correct interpretation of the iTreat Flu A+B Test by subjects with influenza-like symptoms. Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the iTreat Flu A+B Test. Evaluate the operators' satisfaction with the ease of use of the ellume.lab Flu A+B Test.

NCT ID: NCT03239665 Not yet recruiting - Influenza Clinical Trials

Vaccination Education Through Pharmacists and Senior Centers (VEPSC)

VEPSC
Start date: October 2017
Phase: N/A
Study type: Interventional

The study consists of two arms (PHARM and PEER) designed to educate participants about three vaccine-preventable diseases (zoster, pneumonia, and influenza) and vaccination. PHARM will consist of a 60-minute presentation about the three vaccine-preventable diseases and their vaccinations delivered by a pharmacist, featuring a didactic lecture and discussion supplemented by video clips of community members discussing their experiences around vaccination, as well as physicians underscoring the importance of vaccination. PEER will consist of a 60-minute small-group session led by a peer educator which includes scripted roleplaying exercises designed to reinforce learnings pertaining to these three vaccine-preventable diseases and their vaccinations. The components of these interventions will be designed to address specific barriers to vaccination identified by literature search and our prior work in the area of community-based vaccine education. Both arms will focus primarily on pneumococcal disease and zoster but will include limited content on influenza because participants are likely to have questions about how the flu and its vaccination differ from pneumococcal diseases and zoster. The study will be implemented in an older, predominantly African-American (AA) population, consistent with our prior work in this area.

NCT ID: NCT03233217 Recruiting - Influenza Clinical Trials

Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Patients ≥65 Years

Start date: September 15, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II, randomized, modified double-blind, multi-center study will assess the safety and immunogenicity of a high-dose quadrivalent influenza vaccine (QIV-HD) in older adults (≥65 years).