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Influenza, Human clinical trials

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NCT ID: NCT02955030 Completed - Influenza Clinical Trials

Evaluation of the Safety and Immunogenicity of a Sublingual Influenza Vaccine NSV0001 in Healthy Male Volunteers

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

The purpose of this study is to evaluate the safety and immunogenicity of a sublingual administration of NSV0001 in healthy male volunteers.

NCT ID: NCT02954354 Completed - Influenza Clinical Trials

A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza

CAPSTONE 1
Start date: December 8, 2016
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of a single, oral dose of baloxavir marboxil compared with placebo by measuring the time to alleviation of symptoms in patients with uncomplicated influenza virus infection.

NCT ID: NCT02949011 Completed - Influenza Clinical Trials

Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications

CAPSTONE 2
Start date: January 11, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of a single, oral dose of baloxavir marboxil compared with placebo by measuring the time to improvement of influenza symptoms in patients with influenza presenting within 48 hours of symptom onset.

NCT ID: NCT02935192 Completed - Influenza Clinical Trials

Phase 3 Trial of Serbian Seasonal Influenza Vaccine

Torlak-300
Start date: November 28, 2016
Phase: Phase 3
Study type: Interventional

A Phase 3, double-blind, randomized, placebo-controlled trial of a seasonal, trivalent, split, inactivated influenza vaccine produced by InstituteTorlak.

NCT ID: NCT02924467 Completed - Clinical trials for Reminder System for Influenza Vaccines

Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates in New York State

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

Despite U.S. guidelines for influenza vaccination of all children starting at age 6 months, only about half of children are vaccinated annually, leading to substantial influenza disease in children and spread of disease to adults. A major barrier is that families are not reminded about the need for their children to receive influenza vaccination. The investigators will evaluate the impact of patient reminder/recall performed by state immunization information systems to improve influenza vaccination rates by using three clinical trials in two states. The investigators will assess effectiveness and cost-effectiveness of phone reminder/recall on improving influenza vaccination rates. The investigators will disseminate the state immunization information system-based reminder/recall system to all states for use for seasonal and pandemic influenza vaccinations with the goal of lowering influenza morbidity.

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: NCT02921633 Completed - Influenza, Human Clinical Trials

Childhood Influenza Immunisation in General Practice Invitation Trial

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

This study will investigate whether behaviourally informed changes to the invitation process can improve uptake of childhood influenza vaccine by two and three year olds at primary care.

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: NCT02917304 Completed - Influenza, Human Clinical Trials

A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Subjects Aged 65 Years and Older

Start date: October 10, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate immunological efficacy and safety of GC3110A among healthy adults over 65 years of age.

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.