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Influenza clinical trials

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NCT ID: NCT02921997 Completed - Influenza Clinical Trials

H7N9 Vaccination With and Without AS03 and Unadjuvanted H3N2v Vaccination: Standard and Systems Biology Analyses

Start date: November 7, 2016
Phase: Phase 2
Study type: Interventional

This is a single center, randomized, partially-blinded, Phase II, small, targeted, prospective study in approximately 30 healthy male and non-pregnant female subjects aged 18 to 49 years old, inclusive, designed to evaluate and compare the immunogenicity between an intramuscular monovalent inactivated influenza A/H7N9 virus vaccine given with and without AS03 adjuvant, and an intramuscular unadjuvanted monovalent inactivated influenza A/H3N2v virus vaccine. The primary objectives are (1) assessing the serum anti-HA hemagglutination-inhibition (HAI) response to influenza A/H7N9 antigen (with and without adjuvant) at Day 57 (approximately one month after the second study vaccination with A/H7N9 vaccine with or without AS03) and influenza A/H3N2v antigen at Day 29 (approximately one month after the study vaccination with A/H3N2v), and (2) identifying differentially expressed genes in human immune cells on Days 2, 4, and 29 (following the first study vaccination with A/H7N9 vaccine with or without AS03) and on Days 30, 32, and 36 (following the second study vaccination with A/H7N9 vaccine with or without AS03), compared to baseline assessments performed prior to each study vaccination (Days -7, 1, and 29).

NCT ID: NCT02918006 Completed - Influenza Clinical Trials

A Phase 2 Influenza A Challenge Study Following Oral Administration of an H1N1 HA Ad-Vector Seasonal Flu Vaccine

Start date: August 31, 2016
Phase: Phase 2
Study type: Interventional

A Phase 2 Randomized, Placebo- and Active-Controlled, Human Influenza A/California/04/2009 (H1N1) Challenge Study Following Administration of an Oral H1N1 Hemagglutinin (HA) Adenoviral-Vector Based Seasonal Influenza Vaccine and dsRNA Adjuvant (VXA-A1.1) to Healthy Adult Volunteers.

NCT ID: NCT02915302 Completed - Influenza Clinical Trials

Safety and Immunogenicity of Fluzone® Quadrivalent Vaccine Administered to Healthy Children

Start date: September 23, 2016
Phase: Phase 4
Study type: Interventional

The aim of the study was to describe the safety and immunogenicity of a 0.5-mL dose (15 μg hemagglutinin [HA] per strain) of Fluzone Quadrivalent vaccine in children 6 to <36 months of age. Primary objective: - To compare the rate of any fever (temperature ≥100.4 degrees Fahrenheit [38.0 degrees Celsius) following a 0.5-mL dose of Fluzone Quadrivalent vaccine to that following a 0.25-mL dose of Fluzone Quadrivalent vaccine during the 7 days after either vaccination (Dose 1 and Dose 2 combined) in participants 6 to < 36 months of age. Secondary objective: - To compare antibody responses induced by a 0.5-mL dose of Fluzone Quadrivalent vaccine to those induced by a 0.25-mL dose of Fluzone Quadrivalent vaccine as assessed by geometric mean titer (GMT) ratios and seroconversion rate differences after the final vaccination in participants 6 to < 36 months of age. Other objectives: - To describe the safety of 2 different dose levels of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in participants 6 to < 36 months of age. - To describe the immunogenicity of 2 different dose levels of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in participants 6 months to < 36 months of age. - To submit available sera from approximately 30 participants to the Center for Biologics Evaluation and Research for further analysis by the World Health Organization, the Centers for Disease Control and Prevention, and the FDA to support formulation recommendations for subsequent influenza vaccines.

NCT ID: NCT02909842 Completed - Influenza Clinical Trials

Effect of Drinking Fermented Milk on Immune Response

Start date: January 1, 2016
Phase: N/A
Study type: Interventional

This blinded randomized controlled trial aims to investigate the effect of drinking fermented milk containing Lactobacillus paracasei (IMULUS) on immune response against influenza.

NCT ID: NCT02908269 Completed - Influenza Clinical Trials

Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2016-2017 Formulations

Start date: September 15, 2016
Phase: Phase 4
Study type: Interventional

The aim of the study was to describe the safety and immunogenicity of the 2016-2017 formulations of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and in adults 18 to < 65 years or age, and of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥65 years of age. Primary Observational Objectives - To describe the safety of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and adults 18 to < 65 years of age, and the safety of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age. Observational Objectives: - To describe the immunogenicity of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and adults 18 to < 65 years of age, and the immunogenicity of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age. - To submit available sera from approximately 90 participants (30 participants 3 to < 9 years of age and 30 participants 18 to < 65 years of age who receive Fluzone Quadrivalent vaccine, and 30 participants ≥ 65 years of age who receive Fluzone High-Dose vaccine) to 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: NCT02907645 Completed - Influenza Clinical Trials

Influenza Vaccine Randomized Educational Trial: Adult

Start date: October 6, 2016
Phase: N/A
Study type: Interventional

Influenza vaccine is recommended as routine care for all individuals who are at least 6 months of age and older. Recently, questions about vaccine safety and concerns for side effects have increased, contributing to both influenza vaccine hesitancy and refusal. In an effort to educate patients, public health entities and physicians give informational handouts in various forms. However, recent publications have found that pro-vaccine messages can have paradoxical effects on vaccine intentions, therefore further studies on vaccine related public health communication is needed. The purpose of this study is to compare the effectiveness of pro-vaccine messages of local data, pro-vaccine messages of national data, and no educational message on patient's receipt of the influenza vaccine. These results will help to understand the relationship between patient education and the intent to vaccinate and receipt of the influenza vaccine as well as to optimize educational information given to patients regarding the influenza vaccine.

NCT ID: NCT02907580 Completed - Influenza Clinical Trials

Influenza Vaccine Attitudes, Intent, and Receipt: Pediatric

Start date: September 13, 2016
Phase: N/A
Study type: Interventional

Influenza vaccine is recommended as routine care for all individuals who are at least 6 months of age and older. Recently, questions about vaccine safety and concerns for side effects have increased, contributing to both influenza vaccine hesitancy and refusal. In an effort to educate parents and patients, public health entities and physicians give informational handouts in various forms. However, recent publications have found that pro-vaccine messages can have paradoxical effects on vaccine intentions, therefore further studies on vaccine related public health communication is needed. Few, if any, studies have analyzed the relationship between influenza vaccine attitudes and intention with actual vaccine receipt in the pediatric population. These results will help to understand the relationship between parent's vaccine perception and the intent to vaccinate versus the child's receipt of the influenza vaccine, as well as to optimize educational information given to families regarding the influenza vaccine.

NCT ID: NCT02897011 Recruiting - Clinical trials for Rheumatoid Arthritis

2-week dc of MTX and Influenza Vaccination in RA

2 wk MTX
Start date: September 2016
Phase: N/A
Study type: Interventional

To investigate whether a transient discontinuation of methotrexate MTX for 2 weeks improves the vaccination response to a seasonal influenza.

NCT ID: NCT02894840 Completed - Influenza Clinical Trials

Safety and Immunogenicity of GPO Seasonal Trivalent Inactivated Influenza Vaccine in Healthy Thai Adults

Start date: November 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The study is aim to evaluate the safety and immunogenicity of one dose (15 μg HA per strain per dose) of the GPO seasonal trivalent inactivated split virion influenza vaccine (Tri Fluvac) in healthy adults aged 18 to 49 years over 90 days post-injection.

NCT ID: NCT02883426 Terminated - Influenza Clinical Trials

Evaluating the Safety and Immunogenicity of a Live Attenuated Virus Vaccine to Prevent Influenza H3N2v Disease

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

This study will evaluate the safety and immunogenicity of the H3N2v MN 2010/AA ca live attenuated influenza vaccine (H3N2v LAIV) in healthy children and adults, 6 to 26 years old.