Study to Evaluate the Immunogenicity and the Safety of an Adjuvanted Influenza Vaccine Candidate

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-02

Study Completion Date

2006-11-17

Brief Summary

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The purpose of this study is to evaluate the immunogenicity and the safety of the candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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GSK1247446A Group

Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Group Type EXPERIMENTAL

GSK1247446A Group

Intervention Type BIOLOGICAL

Low dose influenza vaccine adjuvanted with AS03 compared

Fluarix Group

Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Group Type ACTIVE_COMPARATOR

Fluarix™

Intervention Type BIOLOGICAL

GlaxoSmithKline (GSK) Biologicals' inactivated influenza split vaccine.

Interventions

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GSK1247446A Group

Low dose influenza vaccine adjuvanted with AS03 compared

Intervention Type BIOLOGICAL

Fluarix™

GlaxoSmithKline (GSK) Biologicals' inactivated influenza split vaccine.

Intervention Type BIOLOGICAL

Other Intervention Names

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Low dose adjuvanted influenza vaccine

Eligibility Criteria

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Inclusion Criteria

* Subjects who the investigator believes that they can and wil comply with the requirements of the protocol should be enrolled in the study.
* A male or female 60 years or older at the time of the first vaccination.
* Free of obvious health problems

Exclusion Criteria

* Use of non-registered products
* Administration of immune-modifying drugs.
* Administration of vaccine 30 days before enrolment in study.
* Immunosuppressive or immunodeficient condition.
* Hypersensitivity to a previous dose of influenza vaccine
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
* History of confirmed influenza infection within the last 12 Months.
* Acute disease at the time of enrolment/vaccination.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Ghent, , Belgium

Site Status

Countries

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Belgium

Study Documents

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