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Influenza clinical trials

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NCT ID: NCT01173211 Completed - Influenza Clinical Trials

2010-2011 Trivalent Influenza Vaccine (TIV) in Pregnant Women

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

The purpose of this study is to see how much antibody (proteins produced by the immune system that help fight infections) the body makes after getting a flu vaccine. Researchers will also look at how the body reacts to the flu vaccine and how it affects the babies of pregnant women. The study will enroll approximately 240 women ages 18-39 years, including 180 pregnant women in their second or third trimester of pregnancy (at least 14 weeks pregnant) and 60 non-pregnant women. Participants will be randomly (by chance) assigned to 1 of 3 vaccine groups. Each participant will receive one shot of a 2010-2011 flu season licensed vaccine. The vaccine will be given as an intramuscular injection (shot in the muscle) in the upper arm. Study procedures include pregnancy testing, blood draws, and memory aids. Patient participation may be up to 8 months. The information from this study will help guide researchers in developing flu vaccines for pregnant women.

NCT ID: NCT01172054 Completed - Influenza Clinical Trials

Comparative Safety and Immunogenicity of VAX128A, VAC128B and VAX128C Novel H1N1 Influenza Vaccine in Healthy Adults

VAX128-01
Start date: July 2010
Phase: Phase 1
Study type: Interventional

This is a multicenter, escalating dose-ranging study to assess the safety, reactogenicity and immunogenicity of 3 different novel H1N1 influenza vaccine constructs delivered i.m. as a single dose vaccination on day 0.

NCT ID: NCT01171157 Terminated - Influenza Clinical Trials

Effectiveness of Flu Vaccination and Burden of Illness Among Community-dwelling Elderly With Influenza Like Illness in Brazil

Start date: May 26, 2009
Phase:
Study type: Observational

The purpose of this research study is to estimate how many elderly people who have symptoms that look like influenza (i.e. an influenza-like illness) actually have the disease and how effective influenza vaccines are in preventing influenza in elderly people. The study will also examine the severity of the disease (e.g. how long are people ill, were there any complications) and how it affects everyday life (e.g. cost, medications, care by family members).

NCT ID: NCT01164553 Completed - Influenza Clinical Trials

Comparison of Flu Vaccine Doses in Children

Start date: October 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the possibility that giving an increased dose of flu vaccine to children 6 through 35 months of age will improve protection against influenza without increasing side effects. Investigators will evaluate the body's response to the vaccine. Male and female participants' ages 6-35 months, who have never received flu vaccine, and those ages 12-35 months, who have been previously vaccinated, will participate in the study for about 7 months. Vaccine naïve study participants will receive two doses of flu vaccine, either the 0.25 mL dose (Group 1) or 0.5 mL dose (Group 2). Previously vaccinated subjects will receive one dose of flu vaccine, either the 0.25 mL dose (Group 1) or 0.5 mL dose (Group 2). Study procedures include physical examination, memory aids, blood sampling and a follow-up phone call about 6 months after the last vaccine dose.

NCT ID: NCT01162122 Completed - Influenza Clinical Trials

Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects

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

The present phase III study aims to evaluate the safety and immunogenicity of MF59-adjuvanted subunit seasonal influenza vaccine and to evaluate the consistency in the manufacturing process of three consecutive lots of MF59-adjuvanted subunit seasonal influenza vaccine with respect to immunogenicity in subjects aged 65 years and older. The active comparator non-adjuvanted seasonal influenza vaccine is approved for use in this age group in the United States and will be used to provide a comparative assessment for immunogenicity and safety.

NCT ID: NCT01161160 Completed - Influenza Clinical Trials

Safety and Immune Response of Candidate H1N1 Influenza Vaccines GSK2340274A and GSK234072A in Children 3 to Less Than 10 Years Old

Start date: July 1, 2010
Phase: Phase 2
Study type: Interventional

This study is designed to characterize the safety and immunogenicity of pandemic influenza (H1N1) candidate vaccines GSK2340274A and GSK234072A in children 3 to less than 10 years old.

NCT ID: NCT01158326 Completed - Influenza Clinical Trials

Evaluation of Efficacy and Safety of Oral Solution Resfenol in Reducing Symptoms of Common Cold And Flu

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

This study aimed to evaluate the efficacy and safety of the oral solution of paracetamol, chlorpheniramine maleate and phenylephrine hydrochloride in reducing symptoms of flu and the common cold. There will be a randomized, double-blind, placebo-controlled trial. Will be included 216 subjects, male or female, aged greater than 12 and less than or equal to 60 years, irrespective of color and / or race with symptoms of recent onset, for more than 6 hours and less than 48 hours length, characterizing Common Cold and / or Influenza. After clinical evaluation and laboratory research subjects will be randomized to receive active drug or placebo, 10 ml oral solution every 6 hours for 48 hours. The follow-up visits will be held on 2 (24 hours after first intervention) and in 3 days (48 hours after first intervention). The outcomes to assess the effectiveness so far consist of the scores of symptoms and to assess the safety of the drug will be accompanied by the emergence of adverse events.

NCT ID: NCT01157702 Completed - Influenza Clinical Trials

Yearly Strain Variation Study, 2010/2011

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

The purpose of the study is to verify the immunogenicity and tolerance of a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2010/2011 season for yearly licensing application.

NCT ID: NCT01153685 Completed - Influenza Clinical Trials

Immunogenicity & Safety Study of Fluviral® (2010 - 2011 Season) in Adults Aged 18 to 60 Years and Over 60 Years

Start date: July 9, 2010
Phase: Phase 3
Study type: Interventional

This study is designed to test the safety and immunogenicity of Fluviral® (2010 - 2011 Season) in adults aged 18 to 60 years and over 60 years.

NCT ID: NCT01150149 Withdrawn - Influenza Clinical Trials

Evaluating Modes of Influenza Transmission Between Humans

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

Most countries of the world, including the USA are making preparations for a possible influenza pandemic. Such an event will constitute a global public health emergency, but it is impossible to predict when this will happen. Up to 80 million people could die worldwide, so as much as possible needs to be done in advance to find ways of how the impact can be reduced. Although the investigators know that medical interventions such as anti-influenza drugs and antibiotics will be important, even in well resourced countries these might be in short supply. Vaccines will also be important but these will not be available until at least 4-5 months after the pandemic has started. This means that other non-pharmaceutical measures could well be important such as social distancing, school closures and the use of face masks. Guidance also needs to be developed so that families can care for each other whilst minimizing the spread of infection. To do these things, the investigators need to know how influenza is transmitted from person-to person. This is poorly understood at present. The investigators also need to know if face masks work before recommendations for public use can be made. The best way to study influenza transmission and the effectiveness of masks is to perform a study using healthy adult volunteers. The investigators will do this by giving some volunteers normal influenza via nasal drops. When they get symptoms the investigators will create an 'experimental household' by getting them to live with other non-infected volunteers for 48 hours, in a specially designed quarantine isolation unit. Some of the non-infected volunteers will be unprotected; others will be selected randomly to wear either face masks or a special plastic 'cloak' so that they do not touch their faces; another group will wear both. The investigators will then measure the rate at which the different groups get 'flu'. From these data the investigators can work out whether it is touching the face or coughing and sneezing that spreads flu most or whether both are important; the investigators can also deduce how well face masks work to prevent spread. The investigators need almost 2000 volunteers for this study, it will take at least 2 years to complete and it will be very costly, however, the results will be of global importance. If the study is successful, the investigators can tell governments around the world whether face masks work to prevent influenza and be clearer about the guidance that should be given to families.