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Influenza, Human clinical trials

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NCT ID: NCT01196975 Completed - Influenza Clinical Trials

A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults

Start date: October 1, 2010
Phase: Phase 3
Study type: Interventional

This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in adults compared to two other influenza vaccines. This study will also evaluate the lot-to-lot consistency of three vaccine lots.

NCT ID: NCT01196026 Completed - Influenza Clinical Trials

Immunogenicity and Safety Study of Fluarix™ Vaccine in Children Who Have Previously Been Vaccinated With Pandemrix™

Start date: September 15, 2010
Phase: Phase 4
Study type: Interventional

This study is designed to assess the immunogenicity, reactogenicity and safety following vaccination with GSK Biologicals' Fluarix vaccine in children who have previously been vaccinated with two doses of Pandemrix at the age of 6 months-9 years.

NCT ID: NCT01195038 Completed - Influenza Clinical Trials

Immunogenicity and Safety Study of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Primed Adults

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

The study is designed to assess the immunogenicity and safety of one booster vaccination with 45 μg of a recombinant H5N1 influenza (A/Indonesia/05/2005) HA vaccine in healthy young adults, previously primed with a two-vaccination of 3 different doses of a recombinant H5N1 influenza (A/Vietnam/1203/2004) HA vaccine in a priming study (JPIP501-01a, NCT00980447).

NCT ID: NCT01192737 Completed - Pregnancy Clinical Trials

"COhort Study on A/H1N1 FLU During PREGnancy"

COFLUPREG
Start date: October 2009
Phase: N/A
Study type: Observational

The purpose of this study is to measure the incidence of A/H1N1 Influenza infection in the mother and her child and to identify the determinants in pregnant women during pandemic period in three public maternities in Paris, France.

NCT ID: NCT01191853 Completed - Healthy Volunteers Clinical Trials

Cellular and Molecular Characterization of the Immune Response in Healthy NIH Employees atBaseline, and After Immunization With the H1N1 or Seasonal Influenza Vaccines

Start date: September 18, 2009
Phase:
Study type: Observational

Background: - Seasonal influenza is a major health problem whose impact is typically reduced by vaccination. The H1N1 (swine flu) influenza virus is an emerging pathogen that has the potential to cause devastating illness and even death in the coming months. Currently, there are limited data on the cellular and molecular immune responses in adult recipients of either the seasonal or the H1N1 influenza vaccines. Objectives: - To obtain blood and nasal wash samples and perform laboratory studies to characterize the immune response in healthy adult volunteers at baseline and after immunization with the seasonal or H1N1 influenza vaccines. Eligibility: - Adult employees at least 18 years of age of the NIH Clinical Center who are deemed healthy by a brief medical history and physical examination and routine blood testing. Design: - Before the start of the influenza season, volunteers will receive either the seasonal influenza vaccine or the H1N1 vaccine when it becomes available. If the H1N1 vaccine is available at the start of the season, volunteers will receive both the seasonal vaccine and the H1N1 vaccine. - Blood will be drawn over an 8-week period. Volunteers must not eat anything for 8 hours prior to the blood draw. The sequence of the blood draws is as follows: 2 weeks before vaccination; right before vaccination; and 1, 7, 14, 28, and 60 days after vaccination. - Two to four nasal washings will be collected by a nurse before volunteers receive the vaccination(s) and 28 days after the vaccination. - Prevaccine and postvaccine blood and nasal wash samples will be compared to determine volunteers immune responses. - Research samples will be stored indefinitely and will be used strictly for laboratory experiments.

NCT ID: NCT01190215 Completed - Influenza Clinical Trials

Immunogenicity and Safety Study of FluarixTM Vaccine in Children Who Have Previously Been Vaccinated With PandemrixTM

Start date: October 4, 2010
Phase: Phase 4
Study type: Interventional

This study is designed to assess the immunogenicity, reactogenicity and safety following vaccination with GSK Biologicals' FluarixTM vaccine in children who have previously been vaccinated with one dose of PandemrixTM at the age of 10-17 years.

NCT ID: NCT01189123 Completed - Clinical trials for Immunity to Influenza Vaccine

Cell Mediated Immunity in Older Adults

CMI
Start date: August 2010
Phase: N/A
Study type: Interventional

This study is to study the immune response to the flu vaccine in people 65 years old and older. Only adults 65 years old and older and who are getting their flu vaccine are being asked to join in this study. The investigators plan to enroll approximately 100 people in this study in the 2010-2011 flu season. Vanderbilt is working with the Centers for Disease Control and Prevention on this study. There will be 5 study visits. Up to 4 tablespoons of blood from a vein will be obtained prior to the flu shot. Return visits will be 1, 2, and 4 weeks later,with up to 4 tablespoons of blood drawn again. Patients will be randomized to receive either the standard dose or the high dose flu vaccine. Both flu vaccines are FDA-approved.

NCT ID: NCT01182870 Completed - Influenza Clinical Trials

Vitamin D and the Influenza Epidemic

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

Subjects included in ongoing vitamin d intervention trials were asked by questionnaire if they were ill with influenza during the winter season 2009/2010 to see if vitamin d supplementation prevented flu like disease.

NCT ID: NCT01181336 Completed - Influenza Clinical Trials

Phase 1b Influenza Vaccine Study in Healthy Subjects

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

The purpose of this study is to see whether a single vaccination (injection) with the investigational influenza vaccine is safe in healthy subjects. The study is also designed to evaluate four different dose formulations of the vaccine to see which gives the best immune response.

NCT ID: NCT01181323 Completed - Influenza Clinical Trials

Post-Partum Immunization With Live Attenuated Influenza Vaccine (LAIV) or Trivalent Influenza Vaccine (TIV) in Post-Partum Breast Feeding Women

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

The purpose of this research study is to learn more about the safety of 2 licensed flu vaccines, nasal spray and flu vaccine shot, in mothers and their infants, when given to women who are breastfeeding and to compare the immune response (body's defense against foreign substances) of breastfeeding mothers, who receive intranasal flu vaccine, with breastfeeding mothers receiving the flu vaccine shot. Healthy women (240 volunteers, 28-120 days post delivery) who plan to breastfeed through 28 days post vaccination and who have not received influenza vaccine for the influenza season for which they are being enrolled, will be assigned by chance to 1 of the 2 vaccines in the following manner: flu vaccine nasal spray and a placebo (inactive substance) shot or a flu vaccine shot and a placebo nasal spray. Study procedures include: nasal swabs, blood samples, and completion of memory aids. Participants will be involved in this United States based study for about 6 months.