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Influenza, Human clinical trials

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NCT ID: NCT01609998 Completed - Influenza Clinical Trials

Seasonal Influenza DNA Vaccine & Seasonal Influenza Trivalent Inactivated Vaccine (TIV) in Children & Adolescents

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

This is a Phase I, dose escalation study in healthy adolescents and children (6-17 years) to evaluate the safety, tolerability, and immunogenicity of a prime-boost regimen of the 2012/2013 seasonal influenza DNA vaccine (HA DNA) followed by licensed 2012/2013 TIV vaccine. The comparator groups will receive licensed 2012/2013 TIV as prime and boost. The hypothesis is that the 2012/2013 HA DNA prime-TIV boost regimen will be safe and result in a broader and more durable immune response than is observed in age-matched comparator TIV-TIV groups.

NCT ID: NCT01599390 Completed - Influenza Clinical Trials

Influenza Burden Assessment in the United States, July1997 - up to April 2009

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

The study will assess the burden of severe influenza outcomes by age, risk status, and influenza subtype, in order to create a profile of the burden of influenza-related morbidity and mortality in United States from July 1997 to April 2009.

NCT ID: NCT01592799 Completed - Influenza Clinical Trials

Study on the Burden of Influenza-related Hospitalizations and Emergency Room (ER) Visits in Children in Spain

Start date: November 23, 2010
Phase: N/A
Study type: Interventional

This study aims to quantify the inpatient and ER visits burden of laboratory-confirmed influenza, and compare the clinical features, severity, complications, risk factors and socioeconomic impact of influenza in children presenting with acute respiratory illness (ARI) and/or isolated fever, with or without laboratory-confirmed influenza.

NCT ID: NCT01591837 Completed - Influenza, Human Clinical Trials

A Study to Assess the Immunogenicity and Safety of CSL's 2012/2013 Formulation of Enzira® Vaccine in Healthy Volunteers

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

This is a study to assess the immune (antibody) response and safety of the 2012/2013 formulation of Enzira® (CSL Influenza vaccine) in healthy adult volunteers aged 18 years or older.

NCT ID: NCT01587131 Completed - Clinical trials for Respiratory Tract Infections

DNA-based Influenza Vaccine in the Elderly

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

The purpose of this study is to determine whether FVH1, a DNA-based influenza vaccine, will be safe and generally well tolerated in healthy elderly adult volunteers and will result in greater immunogenicity when used to prime the immune response to a dose of a trivalent inactivated seasonal vaccine.

NCT ID: NCT01584908 Completed - Influenza Clinical Trials

Adjuvanted Influenza Vaccine Evaluation in Kidney Transplant Recipients

Start date: August 2012
Phase: Phase 4
Study type: Observational

Influenza is an important public health problem. Organ transplant patients are particularly susceptible to severe disease. Also, they shed higher quantities of virus for longer durations, leading to greater contagious potential, thereby potentially serving as nodes of spread in the community. Therefore, improved strategies to prevent influenza in this population is an important public health concern. Standard vaccination is poorly immunogenic post-transplant and new vaccine strategies are needed. Adjuvanted vaccines contain molecules that create a strong local inflammatory response and they attract immune cells to the site of injection, increasing the immunogenicity of the vaccine antigen. Recently seasonal influenza vaccines containing adjuvants have become available in Canada but have only limited information in transplant patients. This randomized trial is designed to assess the immunogenicity of an adjuvanted vaccination strategy compared to a standard vaccine for seasonal influenza in a cohort of adult organ transplant recipients.

NCT ID: NCT01579916 Completed - Influenza Clinical Trials

A Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults

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

This prospective annual release study was designed to assess the safety of a trivalent influenza virus vaccine using two new strains recommended for the 2012-2013 influenza season not previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy adults will receive a single dose of vaccine or placebo and will be followed for 180 days after study vaccination.

NCT ID: NCT01577732 Completed - Tetanus Clinical Trials

Safety of GSK Biologicals' Infanrix-IPV+HibTM Vaccine in Healthy Vietnamese Toddlers

Start date: December 8, 2012
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the safety and reactogenicity of a booster dose of Infanrix-IPV+Hibâ„¢ when administered to healthy Vietnamese toddlers at 12 to 24 months of age who were vaccinated previously against diphtheria, tetanus, and pertussis diseases within their first six months of lives.

NCT ID: NCT01573312 Completed - Influenza Clinical Trials

H5N1 Vaccination With and Without AS03: Systems Biology Analysis

Start date: May 24, 2012
Phase: Phase 1
Study type: Interventional

This is a single center, randomized, double-blinded, controlled, Phase I, small targeted prospective study in healthy male and non-pregnant female subjects, 18 to 49 years old, inclusive, designed to determine the safety, reactogenicity, and immunogenicity of an intramuscular subvirion inactivated monovalent influenza A/H5N1 (HA of A/Indonesia/05/2005) virus vaccine manufactured by Sanofi Pasteur administered at 3.75 mcg per dose given with or without AS03 adjuvant manufactured by GSK. In the study, each subject will receive two doses administered 28 days apart. This study will use a systems biology approach to assess the human early gene and protein signatures expressed at Days 1, 3, 7, and 28 after the first vaccination. The systems data will be integrated with immunogenicity and reactogenicity data to develop a systems model of the human immune response to A/H5N1 vaccine with or without AS03 adjuvant.

NCT ID: NCT01568788 Completed - Human Influenza Clinical Trials

Post-marketing Clinical Observation of an Inactivated Influenza Split Vaccine

Start date: December 2008
Phase: N/A
Study type: Interventional

Phase III clinical trial was carried out in Jintan city, Jiangsu Province, China in May, 2006. Trial results showed that the vaccine had proved safety and immunogenicity. Influenza vaccine of Hualanbio has obtained production permission and marketing authorization in May, 2008. In order to further investigate the safety and immunogenicity of the vaccine in the market, The clinical observation was planned to be conducted in Mianyang city (Yanting County), Sichuan Province, China.