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Influenza clinical trials

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NCT ID: NCT01982331 Completed - Influenza Clinical Trials

Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/CALIFORNIA/66/395 (H2N2) Influenza Vaccine

Start date: October 2013
Phase: Phase 1
Study type: Interventional

This is a phase I study to evaluate the safety of a vaccine to protect against influenza viruses of the H2N2 subtype. A total of 40 adults will be enrolled and receive two doses of vaccine or placebo one month apart.

NCT ID: NCT01974895 Completed - Influenza Clinical Trials

Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age

Start date: October 23, 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the immunogenicity and safety of the new influenza vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's Fluzone® (TIV) in children 6 to 35 months of age.

NCT ID: NCT01971255 Completed - Influenza Clinical Trials

Evaluation of Anti-Hemagglutinin (Anti-HA) Antibodies as Protection From the Flu in Healthy People

Start date: September 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - Researchers want to know if a certain type of antibody in the blood affects whether people get influenza (the flu). They will study 2 different groups with different levels of anti-HA antibodies and expose them to the flu virus. They will study how the flu develops in a healthy person. This may lead to future studies to develop new vaccines and treatments for the flu. Objective: - To study how people can be protected from flu infection. Eligibility: - Healthy volunteers 18 to 50 years of age. Design: - Participants will be screened through the use of a medical history, physical exam, and laboratory tests. - Groups of 7 participants will stay in an isolation unit in a hospital for at least 9 days with no visitors. - Participants will be screened again upon admission. They will also have: - ECG: soft electrodes will be stuck to the skin. A machine will record the heart s electrical signals. - Echocardiogram: a small probe will be held to the chest to take pictures of the heart. - Lung tests: participants will blow into a machine. - They will also have nasal fluid collected. This will be done either with a swab or with a tube of water washing out the nose. This will be done once every day. - The flu virus will be sprayed into the participant s nose. This will be done only once. - Participants will complete a questionnaire on day 1 and twice a day after that for 14 days. - A medical team will watch participants 24 hours a day. They will go home after 2 days of negative flu tests. - Participants will have 4 follow-up visits over 8 weeks.

NCT ID: NCT01967784 Completed - Influenza Clinical Trials

Study of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Children and Adolescents in Taiwan

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

The aim of the study is to describe the immunogenicity and safety of the new formulation of Quadrivalent Influenza Vaccine (QIV) for the 2013-2014 season in the Northern Hemisphere (NH) in subjects aged 9 to 17 years in Taiwan Primary Objective: - To describe the immunogenicity of the QIV (split-virion, inactivated) NH seasonal formulation Secondary Objective: - To describe the safety of the QIV (split-virion, inactivated) NH seasonal formulation

NCT ID: NCT01961960 Completed - Influenza Clinical Trials

A Study to Evaluate Intramuscular ASP7374

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

The purpose of this study is to evaluate safety and immunogenicity of intramuscular ASP7374 in adults ≥61 years of age.

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.