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Influenza, Human clinical trials

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NCT ID: NCT00956046 Completed - Influenza Clinical Trials

A Study of Swine-origin A/H1N1 Influenza Vaccines in Healthy Europeans Children Aged 6 to 35 Months

Start date: September 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration. Primary objectives: - To describe the immune response to vaccines 21 days after each vaccination in all participants. - To describe the antibody persistence eight months after the first vaccine administration using hemagglutination inhibition (HAI) method in a subset of participants who received two half-doses of either formulation 1 or 2. - To describe the immune response against the A/H1N1 strain using the HAI method 21 days after last vaccination with the 2010-2011 NH seasonal Trivalent Influenza Vaccine (TIV) administered 13 months after the first vaccination in a subset of subjects who received two half-doses of either t either formulation 1 or 2 of the A/H1N1 influenza vaccines as primary series. - To describe the safety profile of each vaccine in all participants.

NCT ID: NCT00954798 Completed - Influenza Clinical Trials

A Study of Swine-origin A/H1N1 Influenza Vaccines in Healthy European Adults and the Elderly

Start date: August 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration. Primary objectives: - To describe the immune response to study vaccine 21 days after each vaccination. - To describe the antibody persistence 8 months after the first vaccine administration using hemagglutination inhibition (HAI) method in a randomized subset of adult subjects who received two injections. - To describe the immune response against the A/H1N1 strain using HAI method 21 days after a vaccination with the 2010-2011 Northern Hemisphere (NH) seasonal trivalent influenza vaccine (TIV) administered 13 months after the first vaccination in a subset subjects who received the A/H1N1 influenza vaccine and in subjects naïve to the swine origin A/H1N1 strain. - To describe the safety profiles of study vaccines in all participants.

NCT ID: NCT00953524 Completed - Influenza Clinical Trials

A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly

Start date: August 2009
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine. Primary Objectives: - To describe the immunogenicity of the candidate vaccines after each injection. - To describe the safety of the candidate vaccines after each injection.

NCT ID: NCT00952419 Completed - Influenza Clinical Trials

A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years

Start date: August 2009
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in toddlers and children. Primary Objectives: - To describe the immunogenicity of the candidate vaccines after each injection. - To describe the safety of the candidate vaccines after each injection.

NCT ID: NCT00952276 Completed - Influenza Clinical Trials

A Study of Different Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly

Start date: October 2009
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in adults and the elderly. Primary Objectives: - To describe the immunogenicity of the candidate vaccines after a single injection. - To describe the safety of the candidate vaccines after a single injection.

NCT ID: NCT00951041 Completed - Influenza Clinical Trials

Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults

Start date: August 11, 2009
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety and immunogenicity of GSK Biologicals' influenza vaccine GSK2340272A.

NCT ID: NCT00950456 Completed - Influenza Clinical Trials

Observational Study to Assess Safety of H1N1 Pandemic Influenza Vaccine

Start date: November 2009
Phase: N/A
Study type: Observational

The purpose of this observational study, which will be initiated as soon as the licensed H1N1 Pandemic Influenza Vaccine is used in a mass vaccination campaign, is to estimate the incidence of any medically-attended adverse events in all vaccinated subjects.

NCT ID: NCT00949533 Completed - Influenza Clinical Trials

A Study on Emergence of Resistance With Tamiflu (Oseltamivir) in Patients With Seasonal Influenza

Start date: July 2009
Phase: Phase 4
Study type: Interventional

This open-label randomized 2arm study will determine the emergence of viral resistance in patients with seasonal influenza A infection treated with Tamiflu. Eligible patients </=5 years of age will be randomized to receive Tamiflu at either standard dose (30-75mg orally bid) or double dose (60-150mg orally bid) for 5 days. Target sample size is >100.

NCT ID: NCT00947687 Completed - Healthy Clinical Trials

Safety and Efficacy Study of Inhaled PUR003 on a Controlled Influenza Virus Challenge in Healthy Adult Subjects

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

The objectives of the study are to demonstrate the effectiveness, safety and tolerability of multiple daily doses of inhaled PUR003, in comparison with placebo, in healthy adults experimentally inoculated with Influenza A/Wisconsin/67/2005 (H3N2) virus.

NCT ID: NCT00946179 Completed - Influenza Clinical Trials

Study of Influenza Vaccine (Split Virion, Inactivated) Northern Hemisphere 2009-2010 Formulation

Start date: May 2009
Phase: Phase 2
Study type: Interventional

This study is in support of the annual application for the variation of the vaccine strains for a marketing authorization. Objectives: - To evaluate the compliance, in terms of immunogenicity, of the influenza vaccine (split virion, inactivated) Northern Hemisphere (NH) 2009-2010 formulation in two adult groups, aged 18 to 60 years and aged 61 years or older. - To describe the safety of the influenza vaccine (split virion, inactivated) NH 2009-2010 formulation in both adult groups.