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Influenza, Human clinical trials

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NCT ID: NCT01964989 Completed - Influenza Virus Clinical Trials

Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.

Start date: November 2013
Phase: Phase 3
Study type: Interventional

Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to <72 Months of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere influenza season.

NCT ID: NCT01961947 Completed - Influenza Clinical Trials

Study of ASP7374, Cell-culture-derived Influenza Vaccine

Start date: October 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare immunogenicity and safety of ASP7374 (cell-culture derived influenza vaccine) with those of approved egg-derived trivalent inactivated vaccine (TIV) in adults ≥20 and <65 years.

NCT ID: NCT01959945 Completed - Influenza Clinical Trials

Safety, Reactogenicity and Immunogenicity of Flublok Quadrivalent (Recombinant Influenza Vaccine,Seasonal Formulation)

Start date: November 2013
Phase: Phase 3
Study type: Interventional

Flublok was studied previously in children 6 -59 months of age and demonstrated less than satisfactory immunogenicity results, especially in the 6-36 month age group. Thus, the initial introduction of Flublok Quadrivalent Formulation (RIV4) into the pediatric population will evaluate immunogenicity and safety older children and adolescents, aged 6-17. This clinical trial is designed to demonstrate safety and non-inferior immunogenicity of Flublok-Q in pediatric subjects 6-17 years of age as compared to IIV4. Positive results in this study may support further studies in younger children.

NCT ID: NCT01949090 Completed - Influenza Clinical Trials

Immunogenicity and Safety Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals H7N1 Influenza Vaccine Administered to Adults 65 Years of Age and Older

Start date: September 25, 2013
Phase: Phase 2
Study type: Interventional

The purpose of this placebo controlled study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals H7N1 influenza vaccine in subjects 65 years of age and older. The study will evaluate safety related events and antibody immune responses to different formulations of study vaccine.

NCT ID: NCT01947049 Completed - Influenza Clinical Trials

Influenza Diagnosis, Treatment and Surveillance With Xpert Flu

Start date: July 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to: 1. Evaluate the clinical performance of a newly available highly-sensitive rapid influenza test, Xpert Flu. 2. Derive and validate an adult clinical decision guideline to guide clinical testing of influenza patients who meed CDC criteria for antiviral treatment. 3. Evaluate impact of rapid influenza testing for antiviral treatment. 4. Determine cost effectiveness of influenza testing and treatment strategies.

NCT ID: NCT01946438 Completed - Influenza Clinical Trials

Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose Influenza Virus Vaccines in Adults

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

The aim of the study is describe the safety and immunogenicity of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to < 65 years of age, and to describe the safety and immunogenicity of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age. Primary Objective: - To describe the safety of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the safety of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age. Observational objectives: - To describe the immunogenicity of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the immunogenicity of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age. - To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone Quadrivalent, Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group with the historical requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96. - To submit sera from selected subjects to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.

NCT ID: NCT01946425 Completed - Influenza Clinical Trials

Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent Influenza Virus Vaccine

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

The aim of this study is to evaluate the safety and immunogenicity of Fluzone® Quadrivalent vaccine in participants aged 6 months to < 9 years at enrollment, divided into 2 age strata (6 months to < 36 months and 3 years to < 9 years) Primary Objective: - To describe the safety of the 2013-2014 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to < 9 years of age. Observational Objectives: - To describe the immunogenicity of the 2013-2014 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP recommendations, in children 6 months to < 9 years of age. - To submit sera from subjects to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.

NCT ID: NCT01945424 Completed - Pregnancy Clinical Trials

Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry

Start date: August 16, 2013
Phase:
Study type: Observational [Patient Registry]

The Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry will be a prospectively recruited pregnancy surveillance program designed to collect and analyze information on vaccine exposures, pregnancy outcomes, and fetal and offspring outcomes.

NCT ID: NCT01945268 Completed - Heart Failure Clinical Trials

Influenza Vaccine To Prevent Adverse Vascular Events:Pilot

IVVE:Pilot
Start date: April 2015
Phase: Phase 4
Study type: Interventional

A multi-centre, randomized, placebo controlled, trial. Participants at high-risk for vascular events from the network of INTER- CHF will be randomized to inactivated influenza vaccine or placebo and followed prospectively over three influenza seasons. 600 participants will be enrolled prior to influenza season and randomized to either influenza vaccine or saline placebo.

NCT ID: NCT01942824 Completed - Clinical trials for Influenza Vaccination

Adult Influenza Vaccination Text Message Reminders

Start date: September 2013
Phase: N/A
Study type: Interventional

Influenza infection leads to on average 24,0000 deaths and 150,000 hospitalizations annually. While vaccination is the cornerstone of preventing influenza infection, vaccination coverage in adults is low with only 35% vaccinated by end of November. 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.