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Influenza clinical trials

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NCT ID: NCT00665509 Completed - Influenza Clinical Trials

Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 08/09 Season.

Start date: June 2008
Phase: Phase 3
Study type: Interventional

Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of healthy subjects: subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly).

NCT ID: NCT00664417 Completed - Influenza Clinical Trials

Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine

Start date: April 2008
Phase: Phase 1
Study type: Interventional

Following the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity using adjuvants were initiated. The present study is part of this endeavor. It is primarily a formulation/dose-finding study with a secondary aim at generating safety and immunogenicity data for the final formulation for the development of a pre-pandemic vaccine.

NCT ID: NCT00662272 Completed - Influenza Clinical Trials

Safety and Efficacy Study of Fluzone® Vaccine Combined With Different Doses of JVRS-100 Adjuvant

H-100-001
Start date: June 2008
Phase: Phase 1
Study type: Interventional

This study is designed to assess safety, tolerability and immunogenicity of Fluzone® vaccine with four dose levels of JVRS-100 adjuvant compared to Fluzone® vaccine alone in healthy adults 18-49 years of age.

NCT ID: NCT00657111 Completed - Influenza Clinical Trials

CS-8958 Single Inhaled Dose in Elderly

Start date: April 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the safety and tolerability of an investigational inhaled flu medication, CS-8958. Study participants will include 38 elderly males and females, age 65 and older. Participants will be divided into 1 of 4 possible treatment groups (Groups A, B, C and D) to receive the study drug or placebo (substance containing no medication). Group A will receive 5 mg CS-8958, Group B will receive 10 mg CS-8958, Group C will receive 20 mg CS-8958 and Group D will receive 40mg CS-8958. Safety information will be reviewed prior to administering a higher dose of treatment. Study procedures will include blood and urine samples, ECGs (measure of heart activity), and a 7 day clinic stay. Participants will be involved in study related procedures for up to 6 weeks.

NCT ID: NCT00652743 Completed - Influenza Clinical Trials

Immunogenicity of GSK Biologicals' Pandemic Influenza Vaccine (GSK1562902A) at Different Boosting Vaccination Schedules

Start date: March 23, 2008
Phase: Phase 3
Study type: Interventional

Today, the leading contender for the next influenza pandemic is H5N1, a strain of avian virus found primarily in domestic and wild birds. Experts warn that the next influenza pandemic is imminent and could be severe. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the best formulation and vaccination schedule. The purpose of this study is to assess the immune response of a candidate pandemic vaccine. The protocol posting deals with objectives & outcome measures of the secondary phase of this study. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00449670).

NCT ID: NCT00649883 Completed - Influenza Clinical Trials

Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Two Different Influenza Vaccines in Healthy Children Aged 6 to <60 Months

Start date: January 2008
Phase: Phase 2
Study type: Interventional

This a multicenter phase II trial will evaluate safety and immunogenicity of two 0.25 mL or 0.5 mL doses of investigational influenza vaccine and active control influenza vaccine in healthy children aged 6 to <60 months.

NCT ID: NCT00646152 Completed - Influenza Clinical Trials

Poly-ICLC to Prevent Respiratory Viral Infections A Safety Study

Start date: March 24, 2008
Phase: Phase 1
Study type: Interventional

This study will examine the safety of an experimental medication called Poly-ICLC, developed for preventing or reducing the severity of infections from influenza and other viruses acquired through the nose, mouth and lungs. The study is divided into two parts, in which Poly-ICLC is tested at different dose levels. Healthy people between 18 and 70 years of age who have no chronic medical problems may be eligible for this study. Participants undergo the following procedures: Part I - Up to 7 days before Poly-ICLC administration: Medical history, physical examination and blood tests. - Day 1: Nasal wash and Poly-ICLC administration. A small amount of salt water is placed into the front of the nose and then suctioned out. Poly-ICLC is then squirted into each nostril, one after the other, at a dose of 0.25, 0.5 or 1 mg. A small number of subjects are given a placebo (a solution with no active ingredient.) Subjects are observed in the clinic for 30 minutes after treatment. - Day 2: Subjects receive a second nasal wash and repeat blood tests. They keep a diary card for 1 week, recording any drug side effects. - Day 5: Subjects have repeat blood tests and a review of their diary card. The keep a diary card for another 3 weeks. - Day 12: Subjects are contacted by phone to review their diary card. - Day 28: Subjects are contacted by phone to review their diary card. Part II - Up to 7 days before Poly-ICLC administration: Medical history, physical examination and blood tests. - Day 1: Nasal wash and Poly-ICLC administration. Same as above for Part I participants. - Day 3: Subjects receive a second dose of medication and are observed again for 30 minutes. - Day 4: Subjects receive a second nasal wash and repeat blood tests. They keep a diary card for 1 week, recording any drug side effects. - Day 7: Subjects have repeat blood tests and a review of their diary card. The keep a diary card for another 3 weeks. - Day 14: Subjects are contacted by phone to review their diary card. - Day 28: Subjects are contacted by phone to review their diary card.

NCT ID: NCT00645411 Completed - Influenza Clinical Trials

Pediatric Safety and Immunogenicity Study of Cell-Culture Derived and Egg-based Subunit Influenza Vaccines in Healthy Children and Adolescents

Start date: October 2007
Phase: Phase 2/Phase 3
Study type: Interventional

The present study is the first study designed to evaluate safety, tolerability and immunogenicity of the cell culture-derived influenza vaccine in healthy children and adolescents aged 3 to 17 years. A step-down approach is utilized in which reactogenicity and safety will be assessed in children and adolescents 9 to 17 years of age (Cohort 1) prior to enrolling additional children and adolescents 9 to 17 years of age (Cohort 2) and children 3 to 8 years of age (Cohort 3).

NCT ID: NCT00636662 Completed - Influenza Clinical Trials

FLU A+B Nasal Swab Clinical Study

FLUA+B
Start date: February 2008
Phase:
Study type: Observational

The purpose of this clinical study is to obtain clearance for the nasal swab sample type by demonstrating the performance characteristics of the FLU A+B Test versus standard laboratory culture for Influenza A and B viruses using nasal swab samples.

NCT ID: NCT00633074 Completed - Influenza Clinical Trials

Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations

Start date: March 3, 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.