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

NCT ID: NCT00318149

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 425 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-10
• Study Completion Date: 2006-05-14

Brief 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

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Fluarix 18-40 Y Group

Subjects (aged 18-40 years \[Y\]) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Fluarix

Intervention Type: BIOLOGICAL

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

Fluarix ≥65 Y Group

Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Fluarix

Intervention Type: BIOLOGICAL

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

Fluarix-AS25 Group

Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Fluarix-AS25

Intervention Type: BIOLOGICAL

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

Fluarix-AS50 Group

Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Fluarix-AS50

Intervention Type: BIOLOGICAL

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

Fluarix- AS01B Group

Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Fluarix-AS01B

Intervention Type: BIOLOGICAL

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

Fluarix- AS01E Group

Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Fluarix-AS01E

Intervention Type: BIOLOGICAL

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

Interventions

Fluarix

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

Intervention Type: BIOLOGICAL

Fluarix-AS25

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

Intervention Type: BIOLOGICAL

Fluarix-AS50

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

Intervention Type: BIOLOGICAL

Fluarix-AS01B

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

Intervention Type: BIOLOGICAL

Fluarix-AS01E

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

Intervention Type: BIOLOGICAL

Other Intervention Names

GlaxoSmithKline Biologicals' licensed influenza vaccine; Fluarix vaccine adjuvanted with AS25; Fluarix vaccine adjuvanted with AS25; Fluarix vaccine adjuvanted with AS01B; Fluarix vaccine adjuvanted with AS01E

Eligibility Criteria

Inclusion Criteria

• A male or female aged between 18 and 40 years or aged 65 years or older at the time of the vaccination.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the 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 six months prior to the administration of the study vaccine.
• History of confirmed influenza infection since a year from the date of previous vaccination.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
• History of hypersensitivity to vaccines.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.

• Minimum Eligible Age: 18 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

Ghent, , Belgium

Countries

Belgium

Study Documents

Document Type: Study Protocol

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

Document Type: Informed Consent Form

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: Individual Participant Data Set

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

View Document

Document Type: Dataset Specification

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

View Document

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

104886

Identifier Type: -

Identifier Source: org_study_id