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Influenza clinical trials

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NCT ID: NCT00455169 Completed - Influenza Clinical Trials

Influenza Vaccine in Premature Infants

Start date: October 2007
Phase: Phase 4
Study type: Observational

Background. Influenza is increasingly recognized as causing severe respiratory illness in children. High-risk infants, like former premature infants, and particularly those with lung disease, have influenza hospitalization rates about five times higher than healthy children. Influenza vaccine does not protect young children against influenza as well as it does healthy adults. A small study that measured antibodies (proteins that protect against infection) to influenza suggested that premature infants get even less protection from influenza vaccine than full-term infants. More information about influenza vaccine in premature infants is needed. The overall goals of this project are to collect information about the how well the influenza vaccine induces antibody production, and to develop the collaborative network of centers necessary for a larger trial of influenza vaccine in premature infants. Objective and Hypotheses. The objective of this study is to measure the amount of protective antibody produced by influenza vaccine in premature (less than 30 weeks' [about 7 months] gestation at birth), extremely-low-birth-weight (1000 grams [2¼ pounds] or less at birth) infants. Influenza vaccine needs to be given yearly. We will assess premature infants during their first series of influenza vaccines. We hypothesize that the levels of antibody will be lower in premature infants receiving their first series of influenza vaccine than in full-term infants. Design. We will measure the immune response in premature and full term infants. During the 2007-2008 influenza season, a total of 92 subjects, divided among 2 groups (premature infants 6-17 months old receiving their first influenza vaccine series and full-term infants 6-17 months old receiving their first influenza vaccine series) will be recruited at a consortium of five centers (the University of Rochester, the University of Texas Southwestern Medical Center, Wake Forest University, the University of Miami and the State University of New York at Buffalo), receive 2 doses of influenza vaccine, and have antibody and immune cell responses to each vaccine component measured 4-6 weeks after the second dose of vaccine. Potential Impact. If this study and future investigations suggested ways to improve premature infants influenza vaccine responses, they could lead to changes in recommendations for the number or timing of vaccine doses or of the type of vaccine used in this high-risk group.

NCT ID: NCT00453999 Completed - Influenza Clinical Trials

Evaluation of Efficacy and Safety of Peramivir in Adults With Acute Serious or Potentially Life-threatening Influenza

Start date: July 2007
Phase: Phase 2
Study type: Interventional

This study has been designed as a randomized, double-blind, controlled, study to evaluate the efficacy and safety of two once daily intravenous peramivir regimens (200 mg and 400 mg) versus oral oseltamivir phosphate (75 mg twice daily) in hospitalized subjects with acute serious or potentially life threatening influenza. Study treatments will be provided for up to 5 consecutive days.

NCT ID: NCT00449670 Completed - Influenza Clinical Trials

Assess Consistency of Immunogenicity of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults

Start date: March 24, 2007
Phase: Phase 3
Study type: Interventional

The present study is designed to assess the lot-to-lot consistency of the immunogenicity of a GlaxoSmithKline Biologicals' pandemic influenza candidate vaccine (GSK1562902A) in adults aged between 18 and 60 years.

NCT ID: NCT00448773 Completed - Influenza Clinical Trials

REDucing Influenza Among University Students, University of California at Berkeley

REDI-US
Start date: February 2007
Phase: Phase 4
Study type: Interventional

We will be testing the hypothesis whether online education for UC Berkeley students on respiratory hygiene, cough etiquette, hand hygiene/awareness, as well as face mask use (while ill) will reduce the acquisition and transmission of influenza-like illness. The study will be conducted during the flu seasons 2006-7 and 2007-8.

NCT ID: NCT00446628 Completed - Influenza Clinical Trials

Project to Investigate Ways to Reduce the Spread of Influenza in Schools and Households With Children

PIPP
Start date: January 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to understand the spread of influenza (flu) in schools and households with elementary (K-5) school children, and develop ways to reduce the flu using non-pharmaceutical means.

NCT ID: NCT00442975 Completed - Influenza Clinical Trials

Response of Older Adults to Influenza Vaccination With Regard to Cytomegalovirus (CMV) Status

CMVflu
Start date: March 2007
Phase: Phase 4
Study type: Interventional

The study is being undertaken to evaluate responses to seasonal influenza vaccine in older adults with respect to their CMV status. CMV is cytomegalovirus and is an organism that infects many people, but does not usually cause disease in the individual unless they are immunocompromised i.e. their immune system is not working well such as in the case of HIV infection. CMV is believed to have infected up to 80% of individuals in the age group we will be looking at in our study and we are interested in whether this infection affects their responses to vaccination.

NCT ID: NCT00440362 Completed - Influenza Clinical Trials

A Phase 1/2 Clinical Trial of an Alphavirus Replicon Vaccine for Influenza

Start date: April 2007
Phase: Phase 1/Phase 2
Study type: Interventional

AVX502, an alphavirus replicon vaccine expressing an influenza HA protein, is a candidate vaccine against influenza. The objectives of this Phase 1 study are to test the safety of the vaccine and the immune response to the vaccine in healthy volunteers 18-40 years of age. Volunteers will be assigned by randomization to receive either the vaccine or an inactive substance (placebo) by injections in each arm on one or two occasions over 2 months. The study will last 4 months and will have a total of 8 visits.

NCT ID: NCT00439335 Completed - Influenza Clinical Trials

Higher Dose Intradermal H5 Vaccine

Start date: March 2007
Phase: Phase 1/Phase 2
Study type: Interventional

This study will compare the influenza A/H5N1 virus vaccine given by injection in the muscle versus injection in the skin in healthy adults. The study will look at the safety of the injections, how the body reacts, and what the body's immune response does when the vaccine is given in the muscle versus in the skin. The study will look at 226 healthy volunteers, ages 18-49 years old. Study procedures will include getting 2 doses of vaccine 28 days apart, physical exams, follow-up clinic visits to check the places on the body where each vaccine was given, and blood sample collections. Volunteers will complete a memory aid by writing down temperatures and health changes for 7 days after each vaccination. Volunteers will be involved in the study for up to 241 days.

NCT ID: NCT00436124 Terminated - Influenza Clinical Trials

A Study of Tamiflu (Oseltamivir) Treatment in Laboratory-Confirmed Influenza.

Start date: January 2007
Phase: Phase 4
Study type: Interventional

This study will evaluate the efficacy and safety of Tamiflu in patients with clinically-diagnosed influenza occurring during an influenza outbreak within the community. Patients will be randomized to receive Tamiflu 75mg bid orally plus support therapy (NSAIDs and antibiotics) or support therapy alone. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

NCT ID: NCT00436046 Completed - Influenza Clinical Trials

Interferon as a Mucosal Adjuvant for Influenza Vaccine Given Intranasally

Start date: March 2007
Phase: Phase 1
Study type: Interventional

Influenza is a virus infection that causes sickness from the nose to the lungs. It is thought that type 1 interferon (a protein that helps the immune system fight viruses) will make flu vaccines more effective. This study will determine if type 1 interferon added to a specific flu vaccine will help the immune system of healthy adults fight off infection better than vaccine alone. Ninety volunteers, ages 18-40, will participate in this study. They will attend 3 study visits and have a final follow-up study visit, email, or phone call about six months after the vaccination. Volunteers will receive a single dose of study vaccine sprayed into the nose. Study procedures including blood samples and nasal washes (the inside of the nose is washed out) will be collected to evaluate immune system responses.