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Influenza, Human clinical trials

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NCT ID: NCT01097941 Withdrawn - 2009 H1N1 Influenza Clinical Trials

Effect of Age and Prior Immunity on Response to H1N1 Vaccines in Children

H1N1Children
Start date: March 2010
Phase: Phase 4
Study type: Interventional

A total of 51 children between the ages of 4 and 9 will be randomized to receive a two dose schedule of either licensed live attenuated A/California/07/09 influenza vaccine (LAIV) or licensed inactivated A/California/07/09 influenza vaccine (IIV) or IIV followed by LAIV separated by 28 days. Children with prior vaccination or natural infection with novel H1N1 influenza will be excluded. Randomization will be stratified by pre-existing HAI titers to the previous winter's seasonal H1N1 A/Brisbane/57/07 reference virus.

NCT ID: NCT01063933 Withdrawn - Influenza Clinical Trials

Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Intravenous Peramivir in Children With Influenza

Start date: n/a
Phase: Phase 1/Phase 2
Study type: Interventional

The purposes of this study are to evaluate the pharmacokinetics (affect the body has on a drug), and pharmacodynamics (affect the drug has on the body) and safety of an experimental intravenous (within a vein) flu medication, peramivir, in children. Participants will include 63 hospitalized children with confirmed flu. Children will be grouped according to age and younger children will not receive drug until safety data from the groups of older children are reviewed. Hospitalized children may receive up to 5 doses of peramivir. Study procedures include: nasal/throat swabs, reporting any experienced side effects, physical examination including assessment of the nervous system, and blood sample collection. Participants will be involved in study related procedures for up to 28 days.

NCT ID: NCT01045564 Withdrawn - Influenza Clinical Trials

Safety and Immunogenicity of Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure

Start date: January 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to characterize the immunogenicity and safety of 3 doses of GSK's avian flu vaccine GSK 1557484A given at different time intervals to adults aged 18 years or greater who are at increased occupational risk of H5N1 exposure.

NCT ID: NCT01037634 Withdrawn - Influenza Clinical Trials

Safety and Efficacy of Oseltamivir in Children Younger Than One Year of Age

Start date: March 2010
Phase: Phase 2
Study type: Interventional

Currently, there is no standard treatment for influenza with related lower respiratory tract infection (LRTI) in children younger than one year of age, even though influenza related LRTI is a potentially fatal illness in these children. This study will test a medicine for influenza in children younger than one year of age to see if it is safe and effective.

NCT ID: NCT01008956 Withdrawn - Influenza Clinical Trials

Safety and Immune Response of One-Dose of Candidate H1N1 Influenza Vaccine GSK2340274A in Adults

Start date: April 2010
Phase: Phase 2
Study type: Interventional

This study is designed to characterize the safety and immunogenicity of a' pandemic influenza (H1N1) candidate vaccine GSK2340274A in adults 18 to 64 years of age.

NCT ID: NCT00989274 Withdrawn - Influenza Clinical Trials

Clinical Trial to Evaluate the Immunogenicity and Safety of the Vaccine Against Influenza A/H1N1

Start date: June 2010
Phase: Phase 2
Study type: Interventional

In agreement with the World Organization of the Health (WHO), during the annual epidemics of influenza they become infected between 10-20 % of the total population, appearing from a feverish disease up to leading to the hospitalization and in some cases to the death. To unpredictable intervals and due to the nature of the virus, this one can acquire new genes of others virus of the influenza that they concern birds or porks, of it it turns out to be a new virus with a completely new subtype of IT (HE,SHE) HAS and NA, and if this one is transmitted efficiently of person-to-person can cause a pandemic. This phenomenon has been the one that has given place to the appearance of a new causative virus of the outbreak of influenza humanizes in Mexico (A/México/2009 (H1N1)), and in agreement to official Mexican numbers(figures), until August 13 there have been brought(reported) a whole of 18,861 cases and 163 deaths. The measure of the most effective control against the influenza constitutes it the vaccine, by what study becomes imperative to possess (to rely on) a vaccine against the new virus To (H1N1) East is relevant, due to the level of response of alert to a level 6 (pandemic) that has passed the World Organization of the Health (WHO).

NCT ID: NCT00966342 Withdrawn - Influenza Clinical Trials

Rapid Evaluation of Seasonal Influenza Vaccine

Start date: August 2009
Phase: Phase 1
Study type: Interventional

This is an invitation to consider taking part in a research study occurring just before the upcoming influenza vaccination program across Canada. The purpose of the study is to closely assess influenza vaccine safety and immune responses, as part of a nationwide, annual surveillance project sponsored by the Public Health Agency of Canada. Such scrutiny is important given the changing nature of flu vaccines from year to year.

NCT ID: NCT00964951 Withdrawn - Influenza Clinical Trials

CSL H1N1 Influenza Vaccine Administered at Different Dose Levels With and Without AS03 Adjuvant in Healthy Adult and Elderly Populations

Start date: n/a
Phase: Phase 2
Study type: Interventional

The purpose of this study is to see how the body reacts to different strengths of the H1N1 flu shot when it is given with or without an "adjuvant." An adjuvant is a substance that may cause the body to produce more antibodies when it is given with a vaccine. This study will also compare how age affects the body's response to the H1N1 flu shot. In this study, 3 strengths of the H1N1 flu shot will be tested combined with an adjuvant. In addition, 2 strengths of the H1N1 flu shot will be tested without adjuvant. Two H1N1 flu shots of the same strength, with or without adjuvant, will be given about 3 weeks apart. Participants will include up to 800 healthy adults, approximately 500 individuals ages 18-64 and 250 individuals greater than or equal to age 65. Study procedures include: physical exam, blood samples, completing a memory aid to record vaccine side effects, medications and daily oral temperature. Participants will be involved in study related procedures for up to 13 months.

NCT ID: NCT00866580 Withdrawn - Influenza Clinical Trials

A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine

Start date: May 2010
Phase: Phase 3
Study type: Interventional

This observer-blind study is designed to evaluate the immune response and safety of pandemic influenza vaccine in the elderly population.

NCT ID: NCT00844155 Withdrawn - Clinical trials for Influenza A Virus Infection

Study of the Relative Oral Bioavailability of the Antiflu Medicine Oseltamivir in the Intensive Care Unit

Start date: March 2009
Phase: N/A
Study type: Interventional

This proposed pharmacokinetic study will test the hypothesis that in critically ill patients with respiratory failure requiring mechanical ventilation such as might be anticipated to be needed to treat patients with severe influenza pneumonia, oseltamivir administered enterally via nasogastric tube, with and without concomitant food or alimentation, will have similar oral bioavailability to that observed in ambulatory adults ill with influenza in whom oseltamivir therapy 75 mg BID is efficacious and well tolerated. Additionally, this experiment will test the hypothesis that increasing the dose (150 mg), with and without concomitant enteral feeding, will show a proportionate increase in bioavailability. Relative oral bioavailability will be assessed from plasma concentration vs. time over 12 hrs and urinary recovery of drug from 0 to 48 hrs after administration.