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Influenza, Human clinical trials

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NCT ID: NCT03345043 Completed - Influenza Clinical Trials

Safety, Tolerability, and Immunogenicity of VAL-339851 in Healthy Adult Subjects

Start date: May 11, 2016
Phase: Phase 1
Study type: Interventional

This clinical study will assess the safety, tolerability and immunogenicity of VAL-339851 in healthy subjects.

NCT ID: NCT03344029 Completed - Influenza Clinical Trials

Immunogenicity and Safety of the Shenzhen Trivalent Inactivated Influenza Vaccine Versus a Trivalent Influenza Vaccine Comparator in Chinese Subjects 18 to 59 Years

Start date: November 3, 2017
Phase: Phase 4
Study type: Interventional

This was a blind-observer, monocenter, randomized, comparative, Phase IV study designed to evaluate the immunogenicity and safety of the Sanofi Pasteur Shenzhen Trivalent Influenza Vaccine (SP Shz TIV) versus the Trivalent Influenza Vaccine manufactured by Hualan Biological Engineering Inc (Hualan TIV) comparator in healthy Chinese participants aged 18 to 59 years.

NCT ID: NCT03336619 Completed - Influenza Clinical Trials

A Phase III, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Uncomplicated Influenza

Start date: January 17, 2018
Phase: Phase 3
Study type: Interventional

Trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of uncomplicated influenza.

NCT ID: NCT03332992 Completed - Influenza, Human Clinical Trials

Comparative Tests of Flu Vaccination Phone Messages

Start date: November 11, 2017
Phase: N/A
Study type: Interventional

This project is a partnership between Emmi Solutions, a private company that delivers health promotion messages to employees of client organizations, and the University of Michigan and affiliated academic investigators. In particular, Emmi sends out pre-recorded and interactive telephone calls on behalf of their healthcare clients to promote influenza vaccination each Fall. The collaboration will design various scripts (based on established risk communication, behavior change, and behavioral economic principles) to be pre-recorded and sent out on these calls on a randomized basis (with approval by client organizations), with the number of arms to vary based on the size of each client's participant list (to ensure sufficient statistical power within each client's sample). Emmi will deliver the calls and track individual responses to questions posed during the call. Emmi will then provide a de-identified dataset to the academic research team for analysis to determine whether any scripts provided greater or lesser effects to people's their motivations to get a flu vaccination.

NCT ID: NCT03330899 Completed - Influenza Clinical Trials

Safety and Immunogencity of H7N9 Influenza Antigen With 2 Adjuvant Formulations in Healthy Adults in Brazil

Start date: September 24, 2018
Phase: Phase 1
Study type: Interventional

The overall aim of this study is to evaluate the safety, immunogenicity and dose sparing effects of H7N9 influenza antigen formulated with 2 different adjuvants .

NCT ID: NCT03328325 Completed - Influenza Clinical Trials

Age and Response to Flu Vaccines

Start date: December 14, 2017
Phase: Phase 4
Study type: Interventional

The study will be designed as a prospective surveillance of the immune response to seasonal influenza vaccination in 240 healthy children and adults ages 9 and over. Study duration will be 5 years, with a participant duration of 6 months. Subjects will receive a quadrivalent inactivated influenza vaccine, at a dose of not less than 15 ug of hemagglutinin (HA), by intramuscular injection in open label fashion on day 0. Blood draws will occur at baseline, day 7, 28 and 90. The primary objective of this study is to evaluate the relationship between first influenza A virus exposure (inferred by age), vaccine history, and baseline serum antibody response to seasonal influenza vaccine in healthy adults and children.

NCT ID: NCT03321968 Completed - Influenza Clinical Trials

Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults

Start date: September 29, 2017
Phase: Phase 3
Study type: Interventional

This Phase 3 study is intended to assess the clinical lot-to-lot consistency in manufacturing by evaluating and comparing the immunogenicity of three consecutively manufactured lots of the Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine, during the 2016-2017 influenza season, in healthy adults 18-49 years of age. A single dose of one of three consecutive lots of Quadrivalent VLP Influenza Vaccine (30 µg/strain) will be administered to 1,200 participants.

NCT ID: NCT03318315 Completed - Influenza Clinical Trials

Co-Administration of AS03 Adjuvanted A/H7N9 IIV With IIV4

Start date: February 20, 2018
Phase: Phase 2
Study type: Interventional

This is a randomized, un-blinded, Phase II study in males and non-pregnant females, who are in good health, 19 to 64 years of age. This study is designed to assess the safety, reactogenicity, and immunogenicity of a pre-pandemic AS03 (GSK) adjuvanted 2017 monovalent inactivated influenza A/H7N9 vaccine, when two doses are administered 21 days apart either sequentially or simultaneously (within 15 minutes) with licensed seasonal influenza vaccine. Subjects will be randomized into one of three treatment groups. The study will enroll approximately 150 individuals who have no history of influenza A/H7N9 infection or prior receipt of an influenza virus H7 subtype vaccine. Study duration is approximately 16 months with subject participation duration of approximately 13 months. The primary objectives of this study are: 1) to assess the safety and reactogenicity following sequential or simultaneous IM administration of 2 doses of AS03-adjuvanted 2017 H7N9 IIV and one dose of seasonal influenza vaccine (IIV4); 2) to assess the serum HAI and Neut antibody responses against A/H7N9 at approximately 21 days following receipt of two doses of AS03-adjuvanted 2017 H7N9 IIV administered IM approximately 21 days apart; 3) to assess the serum HAI and Neut antibody responses against the seasonal influenza strains at approximately 21 days following receipt of IIV4.

NCT ID: NCT03315104 Completed - Influenza A H1N1 Clinical Trials

Exploring Safety & Clinical Benefit of Anti-Influenza Immunoglobulin Intravenous in Hospitalized Adults With Influenza A

Start date: November 17, 2017
Phase: Phase 2
Study type: Interventional

Influenza, or the flu, is an infectious respiratory disease that can range in severity from mild to severe to even death. This study aims to evaluate a treatment for people who are hospitalized with the flu. The study is looking to see if antibodies collected from people who have recovered from the seasonal flu or who have had the seasonal flu shot can be used safely as a study drug to treat hospitalized patients with severe flu infections. Also, this study will help to find the right dose for this study drug for treatment of severe flu in hospitalized patients. Overall, this study will evaluate if the hospitalized patients receiving standard of care along with the study drug get better more quickly than those treated with standard of care and placebo. The study drug that contains antibodies against the flu is called anti-influenza immunoglobulin intravenous (FLU-IGIV).

NCT ID: NCT03314662 Completed - Influenza, Human Clinical Trials

Phase 3 Safety and Immunogenicity Study of aQIV in Elderly Adults

Start date: October 17, 2017
Phase: Phase 3
Study type: Interventional

This phase 3 study is a randomized, double-blinded, comparator controlled, parallel-group, multicenter study of aQIV versus the US-licensed 2017-2018 adjuvanted trivalent influenza vaccine (aTIV-1, Fluad), and versus an adjuvanted trivalent influenza vaccine (aTIV-2), containing the alternate B strain.