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Influenza clinical trials

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NCT ID: NCT01631110 Completed - Influenza Clinical Trials

Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains

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

The study is to assess whether the influenza vaccine Inflexal V for season 2012/2013 fulfills the EMA requirements for re-registration of influenza vaccines.

NCT ID: NCT01631071 Completed - Influenza Clinical Trials

Re-licensing Study to Assess Virosomal Influenza Vaccine Formulated With WHO Recommended Influenza Strains

Start date: July 2012
Phase: N/A
Study type: Interventional

The study is to assess whether the virosomal influenza vaccine for season 2012/2013 fulfills the EMA requirements for re-registration of influenza vaccines.

NCT ID: NCT01626820 Completed - Influenza Clinical Trials

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Fluviral® (2012/2013 Season) in Adults

Start date: July 19, 2012
Phase: Phase 3
Study type: Interventional

This study is designed to test the immunogenicity in terms of Hemagglutination Inhibition (HI) antibodies against each of the three vaccine influenza strains and reactogenicity and safety of Fluviral® containing the influenza strains recommended for the 2012-2013 season.

NCT ID: NCT01625689 Completed - Influenza Clinical Trials

Safety and Immunogenicity of a Single Dose of Intranasal Seasonal Trivalent Live-Attenuated Influenza Vaccine

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

In this Phase II randomized controlled clinical trial, generally healthy male and female children from 24 through 59 months of age will be enrolled in Kamalapur (Dhaka), Bangladesh. The study is expected to continue for at least 6 months following vaccination. The experimental intervention is Serum Institute of India Ltd's Trivalent, Seasonal Live Attenuated Influenza Vaccine (SIIL LAIV). The study vaccine has been formulated according to WHO recommendations for the 2011-2012 Northern Hemisphere influenza season. The SIIL LAIV is administered in a 0.5 ml intranasal dose (one spray of 0.25 ml per nostril) via a reusable sprayer device and a single-use nozzle that produces a fine mist that is primarily deposited in the nose and nasopharynx. The comparator vaccine will be an inactive placebo identical in appearance to the active vaccine. The primary study hypothesis is that LAIV is safe and well tolerated by children aged 24 through 59 months in Bangladesh. A secondary hypothesis is that LAIV is immunogenic among children receiving study vaccine as compared to children receiving placebo.

NCT ID: NCT01623518 Completed - Influenza Clinical Trials

A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine ChAdOx1-NP+M1

Start date: June 2012
Phase: Phase 1
Study type: Interventional

This is a first in man dose escalation study, to assess the safety and immunogenicity of the candidate influenza vaccine ChAdOx1-NP+M1. All volunteers recruited will be healthy adults aged 18-50. Volunteers will be enrolled and doses will be escalated according to a "3+3" study plan. Up to 24 volunteers will be vaccinated. Following one dose of the vaccine, volunteers will be followed up to assess the side effect profile of the vaccine and to take blood tests. A series of immunology assays will be performed to determine how potent the vaccine is at inducing an immune response.

NCT ID: NCT01622491 Unknown status - Influenza Clinical Trials

Effectiveness of H1N1 Influenza Vaccines in Manitoba, Canada

Start date: June 2012
Phase: N/A
Study type: Observational

Excellent immune responses following 1 or 2 doses of the GSK monovalent AS03-adjuvanted pandemic H1N1 (pH1N1) vaccines (e.g., Arepanrix®) have been documented in several trials. Observational studies have found that these vaccines were effective in preventing laboratory confirmed influenza infections. However, it remains unclear whether vaccination during the pandemic was associated with reductions in more clinically meaningful outcomes, such as hospitalizations, severe illness, complications, and death. The investigators propose to evaluate the effectiveness of the GSK adjuvanted and non-adjuvanted pH1N1 vaccines used in Manitoba in preventing hospitalization and severe illness (defined as illness necessitating admission to intensive care or associated with major complications) due to influenza or pneumonia by means of a case-control study using data from Manitoba Health (MH) administrative databases and the database of the Cadham Provincial Laboratory. The primary outcome will be hospitalization with laboratory-confirmed influenza or pneumonia. A secondary outcome will be hospitalization with influenza or pneumonia. The investigators will also assess the effectiveness of the above vaccines for different age groups and among high-risk populations, e.g., immunocompromised individuals.

NCT ID: NCT01617239 Completed - Influenza Clinical Trials

Clinical Study for Safety and Immunogenicity Study of Influenza Vaccine

Start date: June 2012
Phase: Phase 1
Study type: Interventional

The goal of the study is to assess the safety and immune response after vaccination with different doses and vaccination schedules of virosomal influenza vaccine.

NCT ID: NCT01612000 Completed - Influenza Clinical Trials

Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults

PSC25
Start date: May 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an un-adjuvanted rHA formulation.

NCT ID: NCT01610245 Completed - Influenza Clinical Trials

Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza

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

This study is a global multicenter randomized factorial double-blind, placebo-controlled trial designed to evaluate (i) efficacy and safety of nitazoxanide 600 mg administered orally twice daily for five days compared to a placebo in the treatment of acute uncomplicated influenza and (ii) efficacy and safety of combination therapy with nitazoxanide 600 mg plus Oseltamivir 75 mg co-administered orally twice daily for five days compared to nitazoxanide monotherapy (600 mg b.i.d. for 5 days) and Oseltamivir monotherapy (75 mg b.i.d. for 5 days) in the treatment of acute uncomplicated influenza.

NCT ID: NCT01609998 Completed - Influenza Clinical Trials

Seasonal Influenza DNA Vaccine & Seasonal Influenza Trivalent Inactivated Vaccine (TIV) in Children & Adolescents

Start date: June 2012
Phase: Phase 1
Study type: Interventional

This is a Phase I, dose escalation study in healthy adolescents and children (6-17 years) to evaluate the safety, tolerability, and immunogenicity of a prime-boost regimen of the 2012/2013 seasonal influenza DNA vaccine (HA DNA) followed by licensed 2012/2013 TIV vaccine. The comparator groups will receive licensed 2012/2013 TIV as prime and boost. The hypothesis is that the 2012/2013 HA DNA prime-TIV boost regimen will be safe and result in a broader and more durable immune response than is observed in age-matched comparator TIV-TIV groups.