Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in People 18 Years Old or Above

NCT00476307 | Completed Phase 3

• 1 other identifier: 110221
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® containing the influenza strains recommended for the 2007-2008 season.

Conditions

Influenza

Keywords

Flu vaccine

Outcome Measures

Primary Outcomes (1)

• Immune response 21 days post vaccination

Secondary Outcomes (1)

• Safety: solicited local and general symptoms, unsolicited symptoms, serious adverse events

Interventions

Fluarix™/Influsplit SSW® 2007/2008 BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

• Healthy male or female aged 18 years or above;
• Non-childbearing or using adequate contraception;
• Written informed consent obtained from the subject.

You may not qualify if:

• Subjects must not:
• Participate in a trial or using non-registered product;
• Use immunosuppressants, blood products, or another influenza vaccine during study;
• Have virologically confirmed influenza within 1 year;
• Have allergic or acute disease;
• Have unstabilized serious chronic disease;
• Be a lactating female.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Dresden, Saxony, 01099, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01307, 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

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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2007
• First Posted: May 22, 2007
• Study Start: June 1, 2007
• Study Completion: July 1, 2007
• Last Updated: November 4, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

DE (3)