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Influenza clinical trials

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NCT ID: NCT01804946 Completed - Influenza Clinical Trials

Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza

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

The purpose of this study is: - to assess clinical efficiency of Ergoferon for treatment of influenza - to assess safety of Ergoferon for treatment of influenza - to compare efficiency of Ergoferon and Tamiflu for treatment of influenza

NCT ID: NCT01797029 Completed - Influenza Clinical Trials

A Randomized, Controlled Trial on the Efficacy and Safety of Live-Attenuated Influenza Vaccine (LAIV) Among Children in Bangladesh

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

This is a single center, multi-site, double-blind, parallel group, placebo-controlled trial of the clinical efficacy of trivalent Serum Institute of India, Ltd. (SIIL)live-attenuated influenza vaccine (LAIV) vaccine among children aged 24 through 59 months in Bangladesh. Background: 1. Burden: Within Bangladesh, community- based influenza surveillance identified 84.5 cases/1000 children-years among children <5 years, while 10% of clinical pneumonia cases were influenza positive in this age group. 2. Knowledge gap: There has never been a randomized clinical efficacy trial of the SIIL LAIV vaccine conducted among children in a low-income country. 3. Relevance: Another LAIV vaccine (made by MedImmune) has been shown to have high efficacy against laboratory-confirmed influenza among children. The SIIL LAIV has the potential to be an inexpensive intervention to prevent pediatric influenza disease. Primary Hypothesis: In children aged 24 through 59 months in Bangladesh, LAIV is efficacious in reducing rates of symptomatic, laboratory-confirmed influenza (vaccine-matched strains) among children vaccinated with LAIV as compared to children vaccinated with a placebo through the first influenza season following vaccination. Primary Objective: To determine the efficacy of LAIV in reducing rates of symptomatic, laboratory-confirmed influenza virus infection (vaccine-matched strains) among children receiving LAIV as compared to children receiving a placebo through the first influenza season following vaccination (through December 2013). Methods: A total of 1761 children will be enrolled and randomized in a 2:1 ratio of LAIV to placebo beginning in March 2013. After vaccination, all children will be evaluated for reactions with one home visit four days post vaccination. Subsequently, all children will be monitored weekly for safety outcomes and illness signs at weekly field worker home visits through December 2013. An extended surveillance period was added to this study and, for participants consenting to additional follow-up, surveillance will extend through a second season (through September 2014). Participants with illness signs will be referred to the study clinic for evaluation using standardized diagnostic criteria and treatment by a study physician. Children meeting protocol-defined clinical Specimen Collection Criteria will have a nasopharyngeal wash specimen collected. Clinical specimens will be tested by Real time polymerase chain reaction (rRT-PCR) for evidence of influenza virus infection. Primary Outcome measures/variables: Vaccine efficacy will be assessed against symptomatic, laboratory-confirmed influenza for all circulating virus strains.

NCT ID: NCT01793883 Completed - Influenza Clinical Trials

Efficacy and Safety Study of Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Influenza

Igloo
Start date: May 2013
Phase: Phase 2
Study type: Interventional

This Phase 2 protocol is designed to compare two dose levels of laninamivir octanoate versus placebo. The objectives are to obtain safety and efficacy in adults aged 18 to 64 years who present to clinic with symptomatic presumptive influenza A or B infection.

NCT ID: NCT01788514 Completed - Influenza Clinical Trials

Combining Entertainment & Influenza Education for Pediatric Patients

Start date: January 2013
Phase: N/A
Study type: Interventional

The investigators have developed an influenza-vaccination-education-study-program that will involve the use of an animated influenza vaccine-based computer program (videogame) that is designed from the investigator's own initiative. The investigators propose implementing an influenza vaccination educational program in the pediatric satellite office that serves a population that has historical low rates of influenza vaccination.

NCT ID: NCT01788228 Completed - Influenza Clinical Trials

Safety and Tolerability Study of GlaxoSmithKline (GSK)1557484A Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure

Start date: March 22, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of GSK Biologicals' vaccine GSK1557484A against pandemic avian (H5N1) influenza in adults at occupational risk of exposure to the virus.

NCT ID: NCT01779570 Completed - Influenza Clinical Trials

Anti-inflammatory Effects of Macrolide Treatment in Influenza Lower Respiratory Tract Infections

Start date: February 2013
Phase: Phase 4
Study type: Interventional

Influenza lower respiratory tract infection (LRTI) is a major cause of morbidity and mortality worldwide. While viral replication can be suppressed by antiviral treatment, excessive inflammatory responses, which are increasingly recognized to contribute to severe influenza complications, remain unopposed. Macrolides have been used widely to treat community-acquired pneumonia, and shown to exert anti-inflammatory effects in other respiratory diseases, providing clinical benefits. In this randomized, open-label, multicenter study, we aim to investigate the anti-inflammatory effects of macrolide treatment in influenza LRTI. Its impacts on the cytokine response, viral clearance, symptoms and disease resolution will be studied. Such results may lead to the development of new therapeutic approaches against severe influenza infection, and provide better insights into disease pathogenesis.

NCT ID: NCT01774032 Completed - Influenza Clinical Trials

H5N1 Vaccine Study in Japanese Elderly Population Aged 65 Years and Older

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

The purpose of this study is to obtain immunogenicity and safety data of an H5N1 pandemic influenza vaccine in a Japanese elderly population aged 65 years and older.

NCT ID: NCT01773928 Completed - Influenza Clinical Trials

Inactivated Split Virus Seasonal Influenza Vaccine (Vero Cell-Derived)

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

The purpose of this study is to determine if a Vero cell-derived trivalent seasonal influenza vaccine produced by the modified manufacturing process: 1. induces immune responses comparable to that produced by the current manufacturing process 2. has an acceptable safety profile compared to a licensed trivalent seasonal influenza vaccine 3. demonstrates consistency of immune response among three different lots.

NCT ID: NCT01772901 Completed - Pregnancy Clinical Trials

Brief Influenza Vaccine Education to Pregnant Women

Start date: October 2013
Phase: N/A
Study type: Interventional

The investigators will conduct a brief educational intervention to pregnant women who have not yet received the influenza vaccine in this pregnancy to improve the uptake of seasonal influenza vaccine.

NCT ID: NCT01767896 Completed - Influenza Clinical Trials

Phase-3 Study of ASP7374, Cell-culture-derived Influenza Vaccine

Start date: October 2012
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 elderly subjects.