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Influenza, Human clinical trials

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NCT ID: NCT01654224 Completed - Influenza Clinical Trials

Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting

Start date: November 2011
Phase: Phase 4
Study type: Interventional

The purpose of the study is to compare the performance of two currently available influenza (flu) vaccines. This study will try and determine if the high dose flu vaccine provides protection that is the same or better than that of regular dose flu vaccine. Both the regular dose and the high dose flu vaccines are approved by the FDA for use in older adults.

NCT ID: NCT01653015 Completed - Influenza Clinical Trials

Live Versus Inactivated Influenza Vaccine Study in Hutterite Children

Start date: November 2012
Phase: Phase 4
Study type: Interventional

There is uncertainty about whether a live attenuated vaccine (LAIV) offers additional benefit over inactivated trivalent influenza vaccine (TIV) in providing indirect benefit to those who are unvaccinated through herd immunity. The goal of this randomized clinical trial is to determine whether immunizing children in Hutterite colonies with LAIV can provide increased community-wide protection over TIV. Children aged 3 to 15 years in Hutterite colonies from Alberta and Saskatchewan will be randomized to one of two regimens: TIV or LAIV. The primary outcome of this study will be laboratory-confirmed influenza as detected by PCR in all participants (i.e vaccine recipients and nonrecipients). Secondary outcomes will include influenza-like illness, hospitalization, pneumonia, death, antibiotic use, absenteeism.

NCT ID: NCT01651494 Completed - Influenza Clinical Trials

Influenza Antiviral DAS-181-F04 in Healthy Adults

Start date: August 12, 2011
Phase: Phase 1
Study type: Interventional

This study will be a double-blind, randomized, placebo-controlled study of a single dose (20mg) of Influenza Antiviral DAS181-F04 for 3 days. The group of nine subjects will be randomly assigned to DAS181 or placebo at 2:1 ratios. Subjects will be admitted to the inpatient clinic at a minimum of the night prior to first dose. The subjects will stay in the inpatient clinic for the duration of dosing and one day after dosing, they will be required to come back for follow-up visits on study days 4, 6, 9, 16 (+/-1 day), 32 (+/-3 days), and 90 (+/-10 days). The safety parameters will include abnormal laboratory values, adverse events and clinical observations.

NCT ID: NCT01651104 Completed - Human Influenza Clinical Trials

Safety and Immunogenicity of a Trivalent Influenza Vaccine When Administered to Elderly Subjects

Start date: July 2012
Phase: Phase 2
Study type: Interventional

To evaluate the safety of a single intramuscular (IM) injection of trivalent adjuvanted influenza study vaccine, formulation 2012/2013, in elderly subjects and the antibody response to each influenza vaccine antigen, as measured by single radial hemolysis (SRH) and hemagglutination inhibition (HI) at approximately 21 days postimmunization in elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.

NCT ID: NCT01649713 Completed - Influenza Clinical Trials

Yearly Licence Tolerability and Immunogenicity Study of Fluval AB Seasonal Influenza Vaccine to be Used in the 2012/2013 Vaccination Season

Start date: August 2012
Phase: Phase 4
Study type: Interventional

This is a yearly licence tolerability and immunogenicity study of Fluval AB suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/strain/0.5mL) in adult and elderly subjects to assess immunogenicity of a single intramuscular injection of Fluval AB suspension for injection, as measured by haemagglutination inhibition (HI) test, and to evaluate safety and tolerability (incidence of adverse events) of a single intramuscular injection of Fluval AB suspension for injection.

NCT ID: NCT01646138 Completed - Influenza Clinical Trials

Influenza A 2009 H1N1 Challenge Study in Healthy Adults

Start date: February 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - A challenge study exposes a person to a disease and allows researchers to study the disease through the body's healing process. An influenza challenge study that looks at different amounts of the flu virus can provide more information on the smallest amount needed to cause an infection. Researchers want to give one dose of the Influenza A H1N1 virus to healthy volunteers to see how the body responds to the virus. Objectives: - To find the smallest dose of Influenza A H1N1 virus that may cause a mild to moderate flu infection in a healthy adult. - To study how the body s immune system responds to the virus. Eligibility: - Healthy volunteers at least 18 years of age. - Participants must be willing to remain in isolation for a minimum of 9 days. Design: - Participants will be admitted to a hospital inpatient isolation unit. They will be screened with a physical exam and medical history. They will also have heart and lung function tests. Blood, urine, and nasal swab/wash samples will be collected. - Participants will receive a single nasal spray of the flu virus. They will stay on the inpatient unit for at least 9 days. - Participants will be monitored for the length of their stay. They will have frequent blood tests and other procedures as needed. - Participants will be allowed to go home once they have had two negative tests for the virus. The tests will be given on two consecutive days....

NCT ID: NCT01644149 Completed - Clinical trials for Influenza Prophylaxis

Clinical Trial Assessing the Immunologic Response to a Influenza Vaccine Delivered Using an Jet Injection Device or a Needle Syringe

Start date: January 2012
Phase: Phase 4
Study type: Interventional

The primary objective of this study was to evaluate if administration of a seasonal flu vaccine using a jet injector device is comparable to traditional needle and syringe delivery for eliciting an immune response. A secondary objective was to compare the safety of the two delivery methods.

NCT ID: NCT01640691 Completed - Pandemic Influenza Clinical Trials

Immunogenicity and Safety of Pandemic Influenza Vaccine in Healthy Adults

Start date: July 10, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The objectives of this single arm study are to evaluate the immune response and safety profiles of two injections of an inactivated whole-virion vaccine containing aluminum hydroxide adjuvant, AdimFlu-W (H5N1), against influenza A (H5N1) in healthy adults.

NCT ID: NCT01640327 Completed - Influenza Clinical Trials

Safety and Immunogenicity of One Dose of Seasonal Trivalent Influenza Virus Vaccine (TIVf, Purified Surface Antigen, Inactivated, Egg Derived) in Adults Aged 18 Years and Above

Start date: July 2012
Phase: Phase 3
Study type: Interventional

This protocol was designed to evaluate the safety, clinical tolerability and immunogenicity of the Trivalent Influenza Virus Vaccine (TIVf, purified surface antigen, inactivated, egg derived), Northern Hemisphere formulation 2012/2013. The principal aim was to provide safety and immunogenicity data, in compliance to current EU Guidelines, with the intent of obtaining marketing approval of the vaccine formulation intended for use prior to the next influenza season in the Northern Hemisphere. The antibody response to each influenza vaccine antigen, was measured by hemagglutination inhibition (HI) and single radial hemolysis (SRH) at approximately 21 days postimmunization in adult and elderly subjects. The safety and immunogenicity of a single intramuscular (IM) injection of the vaccine was evaluated in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines (CPMP/BWP/214/96).

NCT ID: NCT01640314 Completed - Influenza Clinical Trials

Safety and Immunogenicity of a Cell Derived Subunit Trivalent Nonadjuvated Influenza Study Vaccine in Adults Aged 18 Years and Above

Start date: July 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety of a single intramuscular (IM) injection of the cell derived subunit trivalent nonadjuvanted influenza vaccine in adult and elderly subjects and the antibody response to each influenza vaccine antigen, as measured by hemagglutination inhibition (HI) at approximately 21 days postimmunization in adult and elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.