Study to Evaluate the Safety and Immunogenicity of Fluarix™ 2006/2007 in Adults Aged 18 Years or Above

NCT00345904 | Completed Phase 3

• 1 other identifier: 107507
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

Vaccination is currently the most effective mean of controlling influenza and preventing its complications and mortality in persons at risk. Because of the variable nature of influenza viruses, the composition of influenza vaccines changes almost every year, to target the 3 main circulating strains. Each year the influenza vaccine formulation may thus be different and clinical studies are mandated to ensure that the immunogenicity and safety of the vaccine formulated from the three annual circulating strains are similar to what was observed during the previous years. This study is designed to test the immunogenicity and reactogenicity of the Fluarix™ vaccine containing the influenza strains recommended for the 2006-2007 season.

Conditions

Influenza

Keywords

influenza, vaccine; prophylaxis of influenza

Outcome Measures

Primary Outcomes (1)

• to evaluate the humoral immune response in terms of anti-Haemmagglutinin antibodies 21 days post-vaccination

Secondary Outcomes (1)

• To evaluate the safety and reactogenicity of the vaccine in term of solicited local and general adverse events, unsolicited adverse events and serious adverse events

Interventions

Fluarix BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A male or female aged 18 years or above at the time of the vaccination;
• Healthy subjects or with well-controlled chronic diseases;
• If the subject is female, she must be of non-childbearing potential

You may not qualify if:

• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
• Administration of an influenza vaccine within 6 months preceding the study start.
• Administration of an influenza vaccine other than the study vaccine during the entire study
• Clinically or virologically confirmed influenza infection within 6 months preceding the study start
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Acute disease at the time of enrolment.
• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Not stabilized or clinically serious chronic underlying disease
• Lactating female.
• History of chronic alcohol consumption and/or drug abuse.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
• Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Dresden, Saxony, 01097, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01099, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01277, Germany

Location

GSK Investigational Site

Freital, Saxony, 01705, Germany

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Influenza, Human

Interventions

fluarix

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2006
• First Posted: June 29, 2006
• Study Start: July 1, 2006
• Study Completion: August 1, 2006
• Last Updated: September 28, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (4)