NCT00386113

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
5 days until next milestone

Study Start

First participant enrolled

October 16, 2006

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2006

Completed
Last Updated

February 26, 2018

Status Verified

February 1, 2018

Enrollment Period

29 days

First QC Date

October 9, 2006

Last Update Submit

February 22, 2018

Conditions

Influenza

Keywords

Influenzaimproved vaccineelderly

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Fluarix and adjuvanted influenza vaccineBIOLOGICAL

Eligibility Criteria

Age67 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • The subjects must be healthy elderly \>/= 67 years and previously vaccinated with 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 immunemodifying 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, or if subjects have acute or chronic clinically significant disease or an immunosuppressive/deficient condition, or have contra-indications to influenza vaccination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

fluarix

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory 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 16, 2006

Primary Completion

November 14, 2006

Study Completion

November 14, 2006

Last Updated

February 26, 2018

Record last verified: 2018-02

Locations

BE(1)