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

NCT00318149 | Completed Phase 2 Results

• 1 other identifier: 104886
• Study Type: interventional
• Target: 425
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T-cells Expressing at Least 2 Markers

  The frequency was expressed as the geometric mean of influenza-specific CD4 T-cells, expressing at least 2 markers among CD40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ ) upon in vitro stimulation.

  At Day 21

Secondary Outcomes (12)

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease

  At Day 0 and at Day 21

• Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease

  At Day 90 and Day 180

• Number of Seroconverted Subjects Against 3 Strains of Influenza Disease

  At Day 21

• Number of Seroconverted Subjects Against 3 Strains of Influenza Disease

  At Day 90 and Day 180

• Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease

  At Day 21

Study Arms (6)

Fluarix 18-40 Y Group

EXPERIMENTAL

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

Biological: Fluarix

Fluarix ≥65 Y Group

EXPERIMENTAL

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

Biological: Fluarix

Fluarix-AS25 Group

EXPERIMENTAL

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.

Biological: Fluarix-AS25

Fluarix-AS50 Group

EXPERIMENTAL

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.

Biological: Fluarix-AS50

Fluarix- AS01B Group

EXPERIMENTAL

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.

Biological: Fluarix-AS01B

Fluarix- AS01E Group

EXPERIMENTAL

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.

Biological: Fluarix-AS01E

Interventions

Fluarix BIOLOGICAL

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

Also known as: GlaxoSmithKline Biologicals' licensed influenza vaccine

Fluarix 18-40 Y Group; Fluarix ≥65 Y Group

Fluarix-AS25 BIOLOGICAL

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

Also known as: Fluarix vaccine adjuvanted with AS25

Fluarix-AS25 Group

Fluarix-AS50 BIOLOGICAL

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

Also known as: Fluarix vaccine adjuvanted with AS25

Fluarix-AS50 Group

Fluarix-AS01B BIOLOGICAL

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

Also known as: Fluarix vaccine adjuvanted with AS01B

Fluarix- AS01B Group

Fluarix-AS01E BIOLOGICAL

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

Also known as: Fluarix vaccine adjuvanted with AS01E

Fluarix- AS01E Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Ghent, 9000, Belgium

Location

Related Links

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

MeSH Terms

Conditions

Influenza, Human

Interventions

fluarix

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2006
• First Posted: April 26, 2006
• Study Start: October 10, 2005
• Primary Completion: May 14, 2006
• Study Completion: May 14, 2006
• Last Updated: August 8, 2018
• Results First Posted: August 8, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)