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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00318149
Recruitment Status : Completed
First Posted : April 26, 2006
Results First Posted : August 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Fluarix Biological: Fluarix-AS25 Biological: Fluarix-AS50 Biological: Fluarix-AS01B Biological: Fluarix-AS01E Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 425 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Demonstrate the Non-inferiority in Term of Cellular Mediated Immune Response of GSK Biologicals' Influenza Candidate Vaccines Containing Various Adjuvants Administered in Elderly Population (Aged 65 Years &Amp; Older) vs Fluarix™ (Known as Alpha-Rix™ in Belgium) Administered in Adults (18-40 Years)
Actual Study Start Date : October 10, 2005
Actual Primary Completion Date : May 14, 2006
Actual Study Completion Date : May 14, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: 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.
Biological: Fluarix
1 dose administered intramuscularly in the deltoid region of the non-dominant arm
Other Name: GlaxoSmithKline Biologicals` licensed influenza vaccine

Experimental: 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.
Biological: Fluarix
1 dose administered intramuscularly in the deltoid region of the non-dominant arm
Other Name: GlaxoSmithKline Biologicals` licensed influenza vaccine

Experimental: 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.
Biological: Fluarix-AS25
1 dose administered intramuscularly into the deltoid region of the non-dominant arm
Other Name: Fluarix vaccine adjuvanted with AS25

Experimental: 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.
Biological: Fluarix-AS50
1 dose administered intramuscularly into the deltoid region of the non-dominant arm
Other Name: Fluarix vaccine adjuvanted with AS25

Experimental: 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.
Biological: Fluarix-AS01B
1 dose administered intramuscularly into the deltoid region of the non-dominant arm
Other Name: Fluarix vaccine adjuvanted with AS01B

Experimental: 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.
Biological: Fluarix-AS01E
1 dose administered intramuscularly into the deltoid region of the non-dominant arm
Other Name: Fluarix vaccine adjuvanted with AS01E




Primary Outcome Measures :
  1. Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T-cells Expressing at Least 2 Markers [ Time Frame: At Day 21 ]
    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.


Secondary Outcome Measures :
  1. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease [ Time Frame: At Day 0 and at Day 21 ]

    Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).

    Seropositivity was defined as a serum HI titer greater than or equal to (≥) 1:10.


  2. Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease [ Time Frame: At Day 90 and Day 180 ]

    Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).

    Seropositivity was defined as a serum HI titer of ≥ 1:10.


  3. Number of Seroconverted Subjects Against 3 Strains of Influenza Disease [ Time Frame: At Day 21 ]
    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).

  4. Number of Seroconverted Subjects Against 3 Strains of Influenza Disease [ Time Frame: At Day 90 and Day 180 ]
    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).

  5. Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease [ Time Frame: At Day 21 ]
    The seroconversion factor (SCF) was defined as the fold change in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to pre-vaccination time point. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).

  6. Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease [ Time Frame: At Day 90 and Day 180 ]
    The seroconversion factor (SCF) was defined as the fold change in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to pre-vaccination time point. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).

  7. Number of Seroprotected Subjects Against 3 Strains of Influenza Disease [ Time Frame: At Day 0 and at Day 21 ]
    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).

  8. Number of Seroprotected Subjects Against 3 Strains of Influenza Disease [ Time Frame: At Day 90 and Day 180 ]
    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).

  9. Number of Subjects With Any and Grade 3 Solicited Local Symptoms. [ Time Frame: During the 7-day (Days 0-6) follow-up period after vaccination ]
    Assessed solicited local symptoms were haematoma, pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevented normal everyday activity. Grade 3 haematoma/redness/swelling = haematoma/redness/swelling spreading beyond 50 millimeters (mm).

  10. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. [ Time Frame: During the 7-day (Days 0-6) follow-up period after vaccination ]
    Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, joint pain, muscle aches and shivering. Any = occurrence of any general symptom regardless of intensity grade and relationship to vaccination. Grade 3 = symptoms that prevented normal activity. Grade 3 fever = fever >39°C. Related = general symptom assessed by the investigator as causally related to the study vaccination.

  11. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). [ Time Frame: During the 21-day (Days 0-20) follow-up period after vaccination ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 =event that prevented normal everyday activity. Related = event assessed by the investigator as causally related to the study vaccination.

  12. Number of Subjects With Serious Adverse Events (SAEs). [ Time Frame: During the entire study period (Day 0 - Day 180) ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00318149


Locations
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Belgium
GSK Investigational Site
Gent, Belgium, 9000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 104886
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 104886
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 104886
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 104886
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 104886
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 104886
For additional information about this study please refer to the GSK Clinical Study Register

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00318149    
Other Study ID Numbers: 104886
First Posted: April 26, 2006    Key Record Dates
Results First Posted: August 8, 2018
Last Update Posted: August 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs