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Safety Study of Four Candidate Influenza Vaccines to Prevent Influenza Disease in the Elderly Population

NCT00318149 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 425

Last updated 2018-08-08

Study results available
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Summary

As influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy adults, probably as a result of immunosenescence, there is a desire to devise ways to increase the current vaccines efficacy for this target population. Adjuvants are known to boost immune responses, thus representing one way to increase the efficacy of the current GlaxoSmithKline Fluarix™ influenza vaccine in elderly subjects. The purpose of this study is to evaluate the immunogenicity and the reactogenicity of a vaccination with four different adjuvanted GlaxoSmithKline influenza vaccines administered to elderly subjects. For immunogenicity and safety evaluations, healthy adults aged 18 to 40 years old and elderly aged 65 years and older will receive Fluarix™ and form the control groups of this trial.

Conditions

Interventions

BIOLOGICAL

Fluarix

1 dose administered intramuscularly in the deltoid region of the non-dominant arm

BIOLOGICAL

Fluarix-AS25

1 dose administered intramuscularly into the deltoid region of the non-dominant arm

BIOLOGICAL

Fluarix-AS50

1 dose administered intramuscularly into the deltoid region of the non-dominant arm

BIOLOGICAL

Fluarix-AS01B

1 dose administered intramuscularly into the deltoid region of the non-dominant arm

BIOLOGICAL

Fluarix-AS01E

1 dose administered intramuscularly into the deltoid region of the non-dominant arm

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-10-10
Primary Completion
2006-05-14
Completion
2006-05-14

Countries

  • Belgium

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00318149 on ClinicalTrials.gov