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Influenza clinical trials

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NCT ID: NCT02307851 Completed - Influenza Clinical Trials

Quadrivalent Influenza VLP Vaccine Dose Ranging Study in Young Adults

Start date: November 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the immune response of three dose levels of the Quadrivalent VLP vaccine in healthy young (18-49) adults. The study is broken down into four treatment groups. Each group will enroll 100 subjects, for a total of 400 subjects. Groups A-C will receive one of three dose levels of the Quadrivalent VLP vaccine, and Group D will receive a commercially available trivalent influenza vaccine (TIV). The study will also evaluate the safety and tolerability of the Quadrivalent VLP vaccine formulations.

NCT ID: NCT02302924 Completed - Influenza Clinical Trials

Evaluation of Psychometric Testing Properties of Severity Symptom Grading Scale of Influenza Infection: Flu-PRO Stage III

FluPRO3
Start date: September 2014
Phase:
Study type: Observational

There is no standardized method for evaluating the symptoms of influenza. A standardized instrument for measuring influenza symptoms, with appropriate scientifically derived content and construct validity would have value for public health in terms of use as a validated outcome measure in interventions to treat or prevent influenza. The instrument also could serve as part of an overall measure of severity of illness in influenza. Previous efforts in participant reported outcomes (PRO) for influenza (i.e. Flu-PRO Stage I and Stage II) focused on the elicitation and evaluation of items for inclusion in the instrument. The overarching objective of this protocol - Flu-PRO Stage III - is to conduct instrument validation to evaluate item properties and, if need be, reduce the number of items, and quantitatively validate the performance of the final measure.

NCT ID: NCT02293863 Completed - Influenza Clinical Trials

A Study of MHAA4549A in Combination With Oseltamivir Versus Oseltamivir in Participants With Severe Influenza A Infection

Start date: January 14, 2015
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled study that will investigate the safety and clinical activity of a single intravenous (IV) dose of MHAA4549A in adult participants hospitalized with severe influenza A in combination with oseltamivir versus a comparator arm of placebo with oseltamivir.

NCT ID: NCT02293317 Completed - Influenza Clinical Trials

Phase II Study to Assess Safety & Immunogenicity of Multimeric-001 Influenza Vaccine, Followed by TIV

BVX006
Start date: November 2014
Phase: Phase 2
Study type: Interventional

This is a single-site, randomized, double-blind, placebo-controlled study of Multimeric-001 in thirty six (36) volunteers 50-65 years of age. All subjects will receive an intramuscular (IM) injection, in each one of three visits, with a 21±2 days interval between treatments.

NCT ID: NCT02290509 Completed - Influenza Clinical Trials

Safety and Immunogenicity of Flublok Quadrivalent vs IIV4 in Adults 18-49 Years of Age

Start date: October 2014
Phase: Phase 3
Study type: Interventional

Randomized, double-blind trial of safety and immunogenicity of Flublok Quadrivalent versus Inactivated Influenza Vaccine (IIV4) in 1350 healthy, medically stable adults 18-49 years of age. Serum samples for Hemagglutinin Inhibition titers will be determined pre- and 28 days post-vaccination. Subjects will be followed for 6 months after vaccination for serious and/or medically-attended adverse events.

NCT ID: NCT02285998 Completed - Influenza Clinical Trials

Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine in Adults ≥50 Years of Age

Start date: October 2014
Phase: Phase 3
Study type: Interventional

The goal of this study is to establish that Flublok Quadrivalent is non-inferior to fully licensed (traditional approval status) quadrivalent inactivated influenza vaccine (IIV4) in protecting against laboratory-confirmed clinical influenza disease in the ≥50 year age population.

NCT ID: NCT02284594 Completed - Influenza Clinical Trials

Adult Influenza Vaccination Text Message Reminders With Electronic Health Record Alerts

Start date: November 2014
Phase: N/A
Study type: Interventional

Influenza infection leads to on average 3000-49,0000 deaths and 150,000 hospitalizations annually. While vaccination is the cornerstone of preventing influenza infection, vaccination coverage in adults is low. Latino adults have the lowest coverage rates. Text message reminders have been used successfully for improving influenza vaccination for children. This study will assess the use of text messaging to improve influenza vaccination coverage rates in a largely minority, publicly insured adult population. We will also assess if the patient having received a text message makes the patient more likely to accept vaccination when their provider has received in electronic alert regarding need for influenza vaccination in the electronic health record.

NCT ID: NCT02282384 Withdrawn - Influenza Clinical Trials

An RCT of Oseltamivir in Outpatients With CPD: A Pilot Study.

AVT
Start date: October 2014
Phase: Phase 4
Study type: Interventional

The proposed pilot study will provide needed data to establish the feasibility of a conducting a large randomized controlled trial as to the effectiveness of the use of oseltamivir early in the course of influenza in outpatients with chronic pulmonary disease.

NCT ID: NCT02269852 Completed - Influenza Clinical Trials

The Immunogenicity and Safety of 2013-2014 Seasonal Trivalent Influenza Vaccine

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

The purpose of this study is to evaluate the immunogenicity and safety of Northern hemisphere 2013-2014 seasonal trivalent inactivated influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged 18-60 years old, and 60 healthy seniors aged > 60 years.

NCT ID: NCT02269007 Completed - Influenza Clinical Trials

A Phase I Clinical Trial for Inactivated Quadrivalent Influenza Vaccine (Split Virion) in Healthy Adults in China

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

Influenza is an acute respiratory disease caused by influenza viruses. There are three types of the virus including A, B and C. Both type A and type B viruses can cause acute febrile respiratory tract infection, characterized by sudden fever, headache, muscle pain, cough, sore throat, nasal congestion and general malaise. Influenza can periodically cause worldwide pandemic. For nearly a century, the influenza virus had occurred four large variation, causing three world pandemic. Studies have shown that since 1957, most of those new variants of influenza virus started in China, which is recognized by the world to have high incidence of influenza. At present, trivalent influenza vaccines are widely used in China. They only contain two kinds of type A virus antigens and one type B virus antigen. But since 2000, two kinds of type B strains (Victoria and Yamagata) have caused an alternating cycle in different seasons. Gradually, evolved from the original single lineage of influenza B virus B/Yamagata, two distinct antigenic lineages-B/Victoria and B/Yamagata have alternately dominated or caused a mix of popular lineage. These two lineages have little or nearly no cross-protection. Therefore, trivalent influenza vaccines may not cover the popular strains of influenza B virus, whereas quadrivalent influenza vaccines will help to simultaneously prevent two kinds of type A viruses and two kinds of type B virus.