Study to Evaluate an Influenza Vaccine Candidate

NCT ID: NCT00540228

Last Updated: 2019-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1006 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-05
• Study Completion Date: 2008-05-08

Brief Summary

In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 18-64 years.

Detailed Description

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

GSK1247446A 1 Group

Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Influenza Vaccine GSK1247446A - 4 different formulations

Intervention Type: BIOLOGICAL

Single dose, Intramuscular injection

GSK1247446A 2 Group

Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Influenza Vaccine GSK1247446A - 4 different formulations

Intervention Type: BIOLOGICAL

Single dose, Intramuscular injection

GSK1247446A 3 Group

Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Influenza Vaccine GSK1247446A - 4 different formulations

Intervention Type: BIOLOGICAL

Single dose, Intramuscular injection

GSK1247446A 4 Group

Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Influenza Vaccine GSK1247446A - 4 different formulations

Intervention Type: BIOLOGICAL

Single dose, Intramuscular injection

Fluarix Group

Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Group Type: ACTIVE_COMPARATOR

Fluarix™

Intervention Type: BIOLOGICAL

Single dose, Intramuscular injection

Interventions

Influenza Vaccine GSK1247446A - 4 different formulations

Single dose, Intramuscular injection

Intervention Type: BIOLOGICAL

Fluarix™

Single dose, Intramuscular injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Only subjects who the investigator believes that they can and will comply with the requirements of the protocol .
• A male or female between, and including, 18 - 64 years of age at the time of vaccination.
• Written informed consent obtained from the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must have a negative pregnancy test, practice adequate contraception for 30 days prior to vaccination, and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose
• Administration of a vaccine not foreseen by the study protocol from 30 days before vaccination, up to 21 days after vaccination.
• History of hypersensitivity to a previous dose of influenza vaccine.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s)
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Confirmed influenza infection within a year preceding the study start.
• Administration of an influenza vaccine within a year preceding the study start.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
• Pregnant or lactating female.
• Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
• Acute disease at the time of enrolment.
• History of chronic alcohol consumption and/or drug abuse.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.
• Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
• History of administration of experimental/licensed vaccine containing squalene and/or tocopherol within the last 12 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Caen, , France

GSK Investigational Site

Lagord, , France

GSK Investigational Site

Lille, , France

GSK Investigational Site

Paris, , France

GSK Investigational Site

Paris, , France

GSK Investigational Site

Toulouse, , France

GSK Investigational Site

Tübingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Würzburg, Bavaria, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Freiberg, Saxony, Germany

GSK Investigational Site

Schmiedeberg, Saxony, Germany

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

Countries

France; Germany; Spain

Study Documents

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

2007-003776-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

110794

Identifier Type: -

Identifier Source: org_study_id