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Influenza, Human clinical trials

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NCT ID: NCT01688297 Completed - Influenza Clinical Trials

Safety Study of an Oral Vaccine to Prevent Seasonal Influenza

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

The purpose of this study was to demonstrate the safety and immunogenicity of an oral vaccine tablet to prevent seasonal influenza. The study was a placebo controlled, double blinded trial at a single site. The study was conducted under two separate protocols. Initially single administrations at two dose levels (low dose and mid dose) of the oral vaccine was tested in a placebo controlled study (37 subjects). And subsequently a single high dose of the oral vaccine was tested in a separate placebo-controlled study (24 subjects).

NCT ID: NCT01687517 Completed - Sarcoidosis Clinical Trials

Efficacy and Safety of Influenza Vaccine During Sarcoidosis

SARCOVAC
Start date: October 2012
Phase: Phase 3
Study type: Interventional

Sarcoidosis is an inflammatory disease of unknown origin that can affect all organs, especially the lungs and mediastinum. Some location of sarcoidosis may require treatment with corticosteroids or immunosuppressors.Although seasonal influenza vaccination can be recommended in sarcoidosis in some subgroups at risk (respiratory failure, pulmonary fibrosis, age over 65, use of immunosuppressive therapy, etc ...), the investigators presently have no data on the efficacy and safety (absence of adverse reactions) of seasonal influenza vaccination in sarcoidosis.Especially it is not known whether the seasonal influenza vaccine provides the same rate and same type of vaccine response in sarcoidosis patients than in the general population. Similarly, it is unclear whether the vaccine response is modified by the severity of the disease and treatment with corticosteroids and immunosuppressors.Based on what is known in systemic lupus and rheumatoid arthritis, which are both inflammatory and autoimmune diseases, the investigators expect at best a 50% vaccine response in patients with sarcoidosis and a 85% vaccination response in healthy controls. The demonstration of a vaccine response could allow reconsidering new vaccine approaches in sarcoidosis.

NCT ID: NCT01683630 Completed - Influenza Clinical Trials

Comparison of Epidemiology and Clinical Outcomes of Influenza A & B Cases in Manitoba, Canada

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

This study compares the epidemiology and clinical outcomes of laboratory confirmed influenza type A to type B following clinical diagnosis of influenza. Multivariate models are used to assess the effects of influenza type on clinical outcomes while accounting for potential confounders.

NCT ID: NCT01682369 Completed - Influenza Clinical Trials

ADITEC FLU STUDY: Understanding the Genetic Basis for Immune Responses

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

Infants and young children do not respond as well as adults to the flu vaccines currently available in the UK. Fluad, is a different type of influenza vaccine that has been available in the European continent for the last decade, and contains an adjuvant known as MF59. This vaccine has been used extensively in adults over 65 years of age. It has been administered to over 4000 children in previous studies, which have shown that it produces an enhanced immune response in children compared with traditional vaccines, and that it is safe in this age group. It is, however, not yet licensed for use in children. The reason for this new study is to gain a better understanding of the how this vaccine is stimulating the immune system, by looking to see which parts of the genetic code are 'switched on' in response to immunisation, and to see how this differs from the response to currently used flu vaccines. To do this the Oxford Vaccine Group will enrol children aged 14 to 26 months to receive either the influenza vaccine with the MF59 adjuvant (ATIV) or one of the influenza vaccines currently available in the UK (Agrippal/ Begripal or TIV). The study will also help to find out whether it is possible to identify patterns of genetic response which can predict responses to immunisation. Being able to do so could potentially enable more rapid development of vaccines against influenza and other diseases in the future. We will also measure how well the immune system responds to the two vaccines and look at any side effects. The study is funded by Aditec is a collaborative research programme that aims to accelerate the development of novel and powerful immunisation technologies for the next generation of human vaccines.

NCT ID: NCT01680679 Completed - Influenza Clinical Trials

Influenza Immunization of Children in India

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

Influenza viruses are significant causes of human illness and death in developed and developing countries. This study will measure the ability of influenza vaccine given to children in India to protect both the children and unimmunized persons around them from influenza. It will also determine whether the best time to immunize in a country like India that has both summer and winter outbreaks of influenza is in the fall, as is done now, or whether immunization should be in the spring to protect against influenza infections in the summer.

NCT ID: NCT01678677 Completed - Clinical trials for Respiratory Disorders

A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Non-typeable Haemophilus Influenzae (NTHi) Investigational Vaccine (GSK2838497A) in Current and Former Smokers

Start date: August 31, 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of 8 different formulations of investigational NTHI vaccine in current and former smokers, 50-70 years of age.

NCT ID: NCT01677715 Completed - Constipation Clinical Trials

Study of Yili Mei Yi Tian Active Lactobacillus Drink to Improve Immunity and Digestive System

Start date: August 2011
Phase: N/A
Study type: Interventional

Study on Evaluating the Promote Effect of Yili Mei Yi Tian Active Lactobacillus Drink on Immunity and Physical Intestinal Canal

NCT ID: NCT01677702 Completed - Common Cold Clinical Trials

Study of Yili Lactoferrin ShuHua Milk in the Improvement of Human Immunization

Start date: March 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether Yili Lactoferrin ShuHua Milk are effective in reducing the occurrence of flu symptoms.

NCT ID: NCT01677676 Completed - Influenza A Clinical Trials

Safety, Tolerability and Immunogenicity of Two Different Formulations of an Influenza A Vaccine (FP-01.1)

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

This study has been designed to evaluate the safety and immunogenicity of two different formulations of FP-01.1 as well as build on the data set from the first in human study FP-01.1_CS_01. It is anticipated that the results of this Phase I study will inform the best formulation of the vaccine to evaluate in efficacy studies.

NCT ID: NCT01676402 Completed - Influenza Clinical Trials

Seasonal Influenza HA DNA With Trivalent Inactivated Vaccine (TIV) Administered ID or IM in Healthy Adults 18-70 Years

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

This is a Phase Ib study in healthy adults (18-70 years) to evaluate the safety, tolerability, and immunogenicity of same season and sequential season vaccination schedules consisting of the 2012/2013 seasonal influenza DNA vaccine (HA DNA) and licensed trivalent influenza vaccine (TIV) administered intradermally (ID) or intramuscularly (IM). The hypothesis is that evaluation of these investigational schedules will inform development of novel influenza vaccine strategies that may offer improved and cross-protective immunity against antigenically diverse influenza strains.