Study to Evaluate Reactogenicity and Immunogenicity of Revaccination With Adjuvanted Influenza Vaccine in Elderly Adults

NCT00386698 | Completed Phase 2

• 1 other identifier: 104887
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Since influenza vaccines are normally administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profiles of the adjuvanted influenza vaccine need to be re-evaluated after repeated vaccine administration. In this study, subjects enrolled in a previous study will receive a booster dose with the 2006-2007 season's formulations of Fluarix or the adjuvanted vaccine.

Conditions

Influenza

Keywords

Influenza,; improved vaccine,; influenza disease; elderly

Outcome Measures

Primary Outcomes (1)

• Evaluation of the safety and reactogenicity of repeated vaccination with adjuvanted influenza vaccine during the 21 days following administration of the vaccine

Secondary Outcomes (1)

• Evaluation of the humoral immune response and cell-mediated immune response 21 days after revaccination with candidate vaccine

Interventions

Fluarix BIOLOGICAL

adjuvanted influenza vaccine BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

• The subjects must be healthy adults ages 18-40 years or \>/= 65 years previously vaccinated with either Fluarix or the adjuvanted vaccine.

You may not qualify if:

• Subjects will be excluded if they take/have taken chronically high doses of immunosuppressants or other immune modifying drugs within six months before vaccination, or immunoglobulins or blood products within three months before vaccination, or any investigational product within 30 days before vaccination
• Have a history of influenza infection since previous vaccination
• Women who are pregnant
• Subjects who have an acute or chronic clinically significant disease or an immunosuppressive/deficient condition, or have contra-indications to influenza vaccination

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Ghent, 9000, Belgium

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 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2006
• First Posted: October 11, 2006
• Study Start: October 1, 2006
• Study Completion: December 1, 2006
• Last Updated: October 7, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)