NCT00386113

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

Completed Phase 2 Last updated 26 February 2018

What this trial tests

Phase 2 trial testing Fluarix and adjuvanted influenza vaccine in Influenza in 74 participants. Completed in 14 November 2006.

Timeline

16 October 2006

Primary endpoint
14 November 2006

14 November 2006

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	74
Start date	16 October 2006
Primary completion	14 November 2006
Estimated completion	14 November 2006
Sites	1 location across Belgium

Drugs / interventions tested

• Fluarix and adjuvanted influenza vaccine — full drug profile →

Conditions studied

• Influenza — all drugs for Influenza →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

67 and older, any sex, with Influenza. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.