Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose 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

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-03

Study Completion Date

2006-11-30

Brief Summary

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The purpose of this study is to evaluate the immunogenicity and the safety of candidate vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years

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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 Formulation 1 Group

Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Group Type EXPERIMENTAL

GSK1247446A

Intervention Type BIOLOGICAL

Low-dose GlaxoSmithKline Biologicals' GSK1247446A influenza vaccine

GSK1247446A Formulation 2 Group

Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Group Type EXPERIMENTAL

GSK1247446A

Intervention Type BIOLOGICAL

Low-dose GlaxoSmithKline Biologicals' GSK1247446A influenza vaccine

Fluarix Group

Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Group Type ACTIVE_COMPARATOR

Fluarix™

Intervention Type BIOLOGICAL

GlaxoSmithKline Biologicals' licensed influenza vaccine

Interventions

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Fluarix™

GlaxoSmithKline Biologicals' licensed influenza vaccine

Intervention Type BIOLOGICAL

GSK1247446A

Low-dose GlaxoSmithKline Biologicals' GSK1247446A influenza vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* A male or female aged 18-59 years 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
* Previous vaccination against influenza in 2006
* Acute or chronic 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

18 Years

Maximum Eligible Age

59 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

Wilrijk, , Belgium

Site Status

Countries

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Belgium

Study Documents

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