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CompletedNCT00765076Updated Jul 31, 2018Results posted

Clinical Study of the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in People Aged 65 Years or Older

A Phase 3 interventional study of GSK Biologicals' influenza vaccine GSK2186877A and GSK Biologicals' Fluarix in Influenza, sponsored by GlaxoSmithKline. Completed at 4 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-31.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
192
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This clinical trial aims to study the immunogenicity of GSK Biologicals' influenza vaccine GSK2186877A in people aged 65 years or older.

Read the detailed description

The amendment to the protocol posting: minor change in one inclusion criterion and in one secondary outcome measure.

02

Conditions studied

  • Influenza

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Keywords

  • Vaccine
  • Elderly
  • Influenza
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 192 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

All subjects must satisfy the following criteria at study entry:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.
  • Written informed consent obtained from the subject.
  • Free of an acute aggravation of the health status as established by medical history and clinical examination before entering into the study.

Elderly adults:

  • A man or woman 65 year of age or older at the time of the first vaccination.

Young adults:

  • Man or woman between the ages of 18 and 40 years, inclusive.
  • If the subject is female, she must be of non-childbearing potential or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after vaccination.

Exclusion criteria

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.
  • Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to Visit 4 after vaccination and of an influenza vaccine other than the study vaccines up to Visit 4.
  • Vaccination against influenza since February 2008 with a seasonal influenza vaccine.
  • Previous vaccination in the last three years with an investigational adjuvanted vaccine candidate seasonal or pandemic influenza vaccine.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of hypersensivity to a previous dose of influenza vaccine.
  • History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg or chicken protein.
  • Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation or pre-existing laboratory screening tests.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study.
  • Any medical conditions in which intramuscular injections are contraindicated.
  • Pregnant or lactating female.
  • Female of childbearing age planning to become pregnant or planning to discontinue contraceptive precautions.
  • Any medical condition that in the opinion of the investigator precludes the collection of blood volumes as required by the protocol.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
192 participants (actual)

Study arms

  • Experimental
    New generation influenza vaccine GSK2186877A Group

    Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0

    Biological: GSK Biologicals' influenza vaccine GSK2186877A

  • Active comparator
    Fluarix elderly Group

    Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0

    Biological: GSK Biologicals' Fluarix

  • Active comparator
    Fluarix young Group

    Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0

    Biological: GSK Biologicals' Fluarix

Interventions

  • BiologicalGSK Biologicals' influenza vaccine GSK2186877A

    One intramuscular injection at Day 0

  • BiologicalGSK Biologicals' Fluarix

    One intramuscular injection at Day 0

06

What researchers measure

Primary outcomes

  1. The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains Which Are Producing at Least Two Different Markers

    The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α), interferon-gamma (IFN-γ)

    Time frame: Day 21

Secondary outcomes

  1. The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers

    The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.

    Time frame: At Day 0, 21, 42 and 180

  2. The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker

    The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.

    Time frame: At Day 0, 21, 42 and 180

  3. Haemagglutinin Inhibition (HI) Antibody Titers

    Antibody titers were expressed as Geometric mean titers (GMTs) calculated after invitro stimulation with separate vaccine strains.

    Time frame: At Day 0, 21, 42 and 180

  4. The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains.

    Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10

    Time frame: At Day 0, 21, 42 and 180

  5. The Number of Subjects Seroconverted to HI Antibodies

    Seroconversion was defined as the number of vaccinees who had either a prevaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.

    Time frame: At Day 21, 42 and 180

  6. HI Antibody Seroconversion Factors

    Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.

    Time frame: At Day 21, 42 and 180

  7. The Number of Subjects Seroprotected to HI Antibodies

    A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.

    Time frame: At Day 0, 21, 42 and 180

  8. Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)

    Grade 3 ecchymosis, redness and swelling was \>100mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activity.

    Time frame: Day 0 -6

  9. Duration of Solicited Local AEs

    Duration was defined as the number of days with any grade of local symptoms.

    Time frame: Day 0 -6

  10. Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs

    Any fever was defined as oral temperature ≥ 38.0 degree centigrade (°C), grade 3 fever was defined as oral temperature ≥ 39.0°C. For other symptoms grade 3 was defined as general symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.

    Time frame: Day 0 -6

  11. Duration of Solicited General AEs

    Duration was defined as number of days with any grade of general symptoms.

    Time frame: Day 0 -6

  12. Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs

    Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom, regardless of intensity or relation to vaccination, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination.

    Time frame: Day 0-20

  13. Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs)

    For each solicited and unsolicited AE the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination.

    Time frame: Day 0-179

  14. Number of Subjects Reporting Any AEs of Specific Interest (AESI)

    AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination.

    Time frame: Day 0-364

  15. Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)

    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination and related was event assessed by investigator as causally related to the study vaccination.

    Time frame: Day 0-364

07

Results

Posted Apr 5, 2012

Participant flow

Participant flow — Overall Study
MilestoneNew Generation Influenza Vaccine GSK2186877A GroupFluarix Elderly GroupFluarix Young Group
Started697350
Completed687349
Not completed101
Withdrew: Adverse event100
Withdrew: Withdrawal by subject001

Outcome measures

PrimaryThe Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains Which Are Producing at Least Two Different Markers

The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α), interferon-gamma (IFN-γ)

Time frame:
Day 21
Reported as:
Geometric mean · cells per million CD4+ Tcells
The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains Which Are Producing at Least Two Different Markers
cells per million CD4+ TcellsNew Generation Influenza Vaccine GSK2186877A GroupFluarix Elderly GroupFluarix Young Group
The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains Which Are Producing at Least Two Different Markers3371.11 ± 3602.152108.10 ± 1728.38—
SecondaryThe GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers

The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.

Time frame:
At Day 0, 21, 42 and 180
Reported as:
Geometric mean · cells per million CD4+ Tcells
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers
cells per million CD4+ TcellsNew Generation Influenza Vaccine GSK2186877A GroupFluarix Elderly GroupFluarix Young Group
pooled vaccine strain Day 01269.34 ± 1032.601309.30 ± 2098.972026.14 ± 1004.93
pooled vaccine strain Day 213371.11 ± 3602.152108.10 ± 1728.383228.91 ± 1714.91
pooled vaccine strain Day 422657.07 ± 1903.381540.08 ± 1138.942669.41 ± 1391.70
pooled vaccine strain Day 1802105.66 ± 1232.801484.11 ± 1024.532746.76 ± 1232.90
A/Brisbane vaccine strain Day 0402.28 ± 421.64340.57 ± 352.55793.58 ± 452.84
A/Brisbane vaccine strain Day 211062.79 ± 1049.87462.34 ± 712.32982.18 ± 727.70
A/Brisbane vaccine strain Day 42822.07 ± 667.91392.04 ± 498.81874.34 ± 544.91
A/Brisbane vaccine strain Day 180669.67 ± 579.75463.94 ± 458.04973.29 ± 555.34
A/Uruguay vaccine strain Day 0342.58 ± 340.83274.47 ± 282.29437.07 ± 410.66
A/Uruguay vaccine strain Day 21930.98 ± 1262.81497.49 ± 479.98667.38 ± 465.08
A/Uruguay vaccine strain Day 42678.88 ± 669.99331.62 ± 365.40473.17 ± 500.92
A/Uruguay vaccine strain Day 180640.97 ± 567.70331.02 ± 324.69654.30 ± 503.69
B/Brisbane vaccine strain Day 0672.58 ± 615.67504.36 ± 588.821183.48 ± 582.67
B/Brisbane vaccine strain Day 211755.55 ± 1961.871149.98 ± 1032.361861.66 ± 884.81
B/Brisbane vaccine strain Day 421325.35 ± 1094.01807.46 ± 639.011572.47 ± 719.96
B/Brisbane vaccine strain Day 1801034.78 ± 725.84778.13 ± 630.321640.71 ± 897.14
SecondaryThe GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker

The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.

Time frame:
At Day 0, 21, 42 and 180
Reported as:
Geometric mean · cells per million CD4+ Tcells
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker
cells per million CD4+ TcellsNew Generation Influenza Vaccine GSK2186877A GroupFluarix Elderly GroupFluarix Young Group
pooled strain[CD4-CD40L] D 01104.24 ± 987.151211.72 ± 1086.881879.85 ± 963.74
pooled strain[CD4-CD40L] D 212817.50 ± 3166.071935.66 ± 1597.562929.86 ± 1644.61
pooled strain[CD4-CD40L] D 422447.37 ± 1766.851425.02 ± 1082.352436.43 ± 1365.81
pooled strain[CD4-CD40L] D 1802036.70 ± 1170.141416.78 ± 973.632619.74 ± 1167.44
pooled strain[CD4- IFN-γ] D 0832.47 ± 798.10835.22 ± 1598.811403.57 ± 777.81
pooled strain[CD4- IFN-γ] D 212305.58 ± 2712.791341.17 ± 1195.012258.27 ± 1307.01
pooled strain[CD4- IFN-γ] D 421775.61 ± 1464.84997.25 ± 818.081849.44 ± 1124.86
pooled strain[CD4- IFN-γ] D 1801495.36 ± 1031.141019.64 ± 790.422102.93 ± 1074.53
pooled strain[CD4-IL-2] D 01085.32 ± 930.221119.34 ± 1002.461717.41 ± 852.57
pooled strain[CD4-IL-2] D 212534.86 ± 3188.651779.41 ± 1595.662690.36 ± 1583.12
pooled strain[CD4-IL-2] D422205.91 ± 1754.741310.05 ± 1062.082199.18 ± 1251.48
pooled strain[CD4-IL-2] D 1801837.60 ± 1093.261285.14 ± 955.762302.51 ± 1042.85
pooled strain[CD4-TNF-α] D 0874.43 ± 812.98928.86 ± 1924.681425.50 ± 768.88
pooled strain[CD4-TNF-α] D 212114.47 ± 2448.221284.20 ± 1080.261999.07 ± 1010.68
pooled strain[CD4-TNF-α] D 421741.65 ± 1350.731012.42 ± 805.861752.99 ± 933.90
pooled strain[CD4-TNF-α] D 1801413.29 ± 865.271015.29 ± 830.381821.04 ± 880.59
A/Brisbane strain[CD4-CD40L] D 0387.76 ± 400.63320.29 ± 338.91750.57 ± 435.67
A/Brisbane strain[CD4-CD40L] D 21980.10 ± 937.63462.64 ± 676.17919.30 ± 679.26
A/Brisbane strain[CD4-CD40L] D 42771.49 ± 616.20365.94 ± 474.72818.54 ± 522.72
A/Brisbane strain[CD4-CD40L] D 180653.13 ± 547.36466.55 ± 429.28922.06 ± 511.19
A/Uruguay strain[CD4-CD40L] D 0308.73 ± 316.94227.76 ± 266.35384.02 ± 397.54
A/Uruguay strain[CD4-CD40L] D 21805.56 ± 1066.84451.52 ± 459.24602.51 ± 431.82
A/Uruguay strain[CD4-CD40L] D 42592.88 ± 579.07286.06 ± 333.05417.15 ± 468.52
A/Uruguay strain[CD4-CD40L] D 180609.34 ± 524.50298.70 ± 295.58584.68 ± 446.49
B/Brisbane strain[CD4-CD40L] D 0647.94 ± 581.98515.89 ± 566.111129.44 ± 573.40
B/Brisbane strain[CD4-CD40L] D 211607.98 ± 1806.431077.12 ± 990.771737.45 ± 842.62
B/Brisbane strain[CD4-CD40L] D 421246.10 ± 1033.85763.04 ± 606.041472.48 ± 725.44
B/Brisbane strain[CD4-CD40L] D 1801011.39 ± 682.07757.17 ± 611.011570.98 ± 843.76
A/Brisbane strain[CD4- IFN-γ] D 0279.24 ± 337.13258.94 ± 258.55563.26 ± 323.39
A/Brisbane strain[CD4- IFN-γ] D 21725.55 ± 752.84344.39 ± 447.19680.40 ± 543.42
A/Brisbane strain[CD4- IFN-γ] D 42572.87 ± 520.31326.66 ± 322.73623.21 ± 409.74
A/Brisbane strain[CD4- IFN-γ] D 180586.26 ± 474.54363.03 ± 361.43773.40 ± 486.08
A/Uruguay strain[CD4- IFN-γ] D 0214.92 ± 245.84164.78 ± 199.00283.81 ± 267.71
A/Uruguay strain[CD4- IFN-γ] D 21641.94 ± 944.37314.63 ± 311.72403.00 ± 355.57
A/Uruguay strain[CD4- IFN-γ] D 42458.72 ± 501.32246.18 ± 227.80331.47 ± 356.93
A/Uruguay strain[CD4- IFN-γ] D 180426.59 ± 418.38228.06 ± 215.33451.90 ± 400.61
B/Brisbane strain[CD4- IFN-γ] D 0342.59 ± 532.27319.38 ± 507.10824.76 ± 496.44
B/Brisbane strain[CD4- IFN-γ] D 211219.72 ± 1581.26721.43 ± 849.491361.31 ± 712.84
B/Brisbane strain[CD4- IFN-γ] D 42903.71 ± 918.49517.83 ± 501.511095.12 ± 676.34
B/Brisbane strain[CD4- IFN-γ] D 180697.03 ± 635.80510.37 ± 539.791253.33 ± 862.51
A/Brisbane strain[CD4-IL2] D 0346.00 ± 369.76319.16 ± 331.16677.11 ± 397.23
A/Brisbane strain[CD4-IL2] D 21872.32 ± 897.70427.26 ± 664.07816.95 ± 655.93
A/Brisbane strain[CD4-IL2] D 42696.36 ± 598.29393.67 ± 460.81720.28 ± 468.43
A/Brisbane strain[CD4-IL2] D 180570.30 ± 503.83387.63 ± 429.61817.80 ± 470.25
A/Uruguay strain[CD4-IL2] D 0278.66 ± 306.46240.26 ± 261.18369.77 ± 322.49
A/Uruguay strain[CD4-IL2] D 21680.16 ± 1060.47391.84 ± 425.96510.88 ± 385.11
A/Uruguay strain[CD4-IL2] D 42534.07 ± 579.96295.90 ± 322.75438.09 ± 401.87
A/Uruguay strain[CD4-IL2] D 180526.12 ± 483.57299.67 ± 274.20514.55 ± 404.73
B/Brisbane strain[CD4-IL2] D 0587.16 ± 566.46451.89 ± 549.601019.08 ± 512.69
B/Brisbane strain[CD4-IL2] D 211496.41 ± 1826.011004.17 ± 966.201592.61 ± 810.35
B/Brisbane strain[CD4-IL2] D 421144.72 ± 1021.68724.10 ± 593.131322.64 ± 664.52
B/Brisbane strain[CD4-IL2] D 180933.06 ± 660.87704.18 ± 602.501439.92 ± 753.90
A/Brisbane strain[CD4-TNF-α] D 0262.44 ± 349.53247.22 ± 274.83536.34 ± 369.21
A/Brisbane strain[CD4-TNF-α] D 21621.35 ± 746.04289.38 ± 376.07497.77 ± 499.72
A/Brisbane strain[CD4-TNF-α] D 42500.13 ± 518.12238.28 ± 329.62564.91 ± 395.51
A/Brisbane strain[CD4-TNF-α] D 180462.60 ± 402.23308.96 ± 347.12616.75 ± 383.70
A/Uruguay strain[CD4-TNF-α] D 0223.83 ± 292.61191.52 ± 234.42284.69 ± 317.94
A/Uruguay strain[CD4-TNF-α] D 21600.99 ± 932.13320.59 ± 308.63411.24 ± 333.50
A/Uruguay strain[CD4-TNF-α] D 42452.35 ± 515.50211.12 ± 267.39333.52 ± 375.97
A/Uruguay strain[CD4-TNF-α] D 180370.86 ± 415.54230.70 ± 241.03477.18 ± 355.92
B/Brisbane strain[CD4-TNF-α] D 0414.10 ± 472.20305.51 ± 516.15773.44 ± 420.89
B/Brisbane strain[CD4-TNF-α] D 21967.79 ± 1226.62639.74 ± 663.661057.83 ± 507.15
B/Brisbane strain[CD4-TNF-α] D 42775.92 ± 756.63413.38 ± 490.41953.30 ± 491.50
B/Brisbane strain[CD4-TNF-α] D 180642.05 ± 520.83475.44 ± 511.571051.51 ± 664.61
SecondaryHaemagglutinin Inhibition (HI) Antibody Titers

Antibody titers were expressed as Geometric mean titers (GMTs) calculated after invitro stimulation with separate vaccine strains.

Time frame:
At Day 0, 21, 42 and 180
Reported as:
Geometric mean · titer
Haemagglutinin Inhibition (HI) Antibody Titers
titerNew Generation Influenza Vaccine GSK2186877A GroupFluarix Elderly GroupFluarix Young Group
A/Brisbane strain at Day 016.5 (12.7 to 21.5)14.3 (10.9 to 18.7)20.5 (13.0 to 32.3)
A/Brisbane strain at Day 21105.1 (80.3 to 137.6)67.2 (49.6 to 91.2)220.8 (163.3 to 298.7)
A/Brisbane strain at Day 4282.3 (64.5 to 105.0)56.8 (42.0 to 77.0)181.4 (133.5 to 246.6)
A/Brisbane strain at Day 18038.4 (30.3 to 48.7)32.1 (24.0 to 42.8)90.3 (60.7 to 134.2)
A/Uruguay strain at Day 021.4 (15.0 to 30.4)17.5 (13.2 to 23.3)16.4 (11.0 to 24.5)
A/Uruguay strain at Day 21330.9 (239.8 to 456.7)164.2 (113.3 to 238.0)179.0 (115.1 to 278.4)
A/Uruguay strain at Day 42254.8 (182.1 to 356.5)110.1 (77.4 to 156.6)130.3 (86.6 to 196.1)
A/Uruguay strain at Day 180117.0 (83.0 to 164.9)59.9 (41.8 to 85.9)74.4 (47.6 to 116.2)
B/Brisbane strain at Day 092.0 (66.2 to 127.8)97.0 (72.9 to 129.2)169.0 (108.2 to 263.9)
B/Brisbane strain at Day 21699.9 (538.4 to 909.8)502.6 (388.6 to 650.0)1229.4 (972.8 to 1553.8)
B/Brisbane strain at Day 42487.2 (372.2 to 637.8)393.9 (310.3 to 500)971.6 (778.0 to 1213.3)
B/Brisbane strain at Day 180254.5 (195.3 to 331.6)238.4 (188.4 to 301.6)677.2 (513.7 to 892.7)
SecondaryThe Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains.

Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10

Time frame:
At Day 0, 21, 42 and 180
Reported as:
Count of participants · Participants
The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains.
ParticipantsNew Generation Influenza Vaccine GSK2186877A GroupFluarix Elderly GroupFluarix Young Group
A/Brisbane strain at Day 0434025
A/Brisbane strain at Day 21616243
A/Brisbane strain at Day 42606244
A/Brisbane strain at Day 180575740
A/Uruguay strain at Day 0414524
A/Uruguay strain at Day 21626341
A/Uruguay strain at Day 42606242
A/Uruguay strain at Day 180615939
B/Brisbane strain at Day 0596542
B/Brisbane strain at Day 21626643
B/Brisbane strain at Day 42616544
B/Brisbane strain at Day 180626643
SecondaryThe Number of Subjects Seroconverted to HI Antibodies

Seroconversion was defined as the number of vaccinees who had either a prevaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.

Time frame:
At Day 21, 42 and 180
Reported as:
Count of participants · Participants
The Number of Subjects Seroconverted to HI Antibodies
ParticipantsNew Generation Influenza Vaccine GSK2186877A GroupFluarix Elderly GroupFluarix Young Group
A/Brisbane strain at Day 21363229
A/Brisbane strain at Day 42332529
A/Brisbane strain at Day 180161623
A/Uruguay strain at Day 21525033
A/Uruguay strain at Day 42484430
A/Uruguay strain at Day 180362820
B/Brisbane strain at Day 21443829
B/Brisbane strain at Day 42383525
B/Brisbane strain at Day 180222220
SecondaryHI Antibody Seroconversion Factors

Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.

Time frame:
At Day 21, 42 and 180
Reported as:
Geometric mean · fold increase
HI Antibody Seroconversion Factors
fold increaseNew Generation Influenza Vaccine GSK2186877A GroupFluarix Elderly GroupFluarix Young Group
A/Brisbane strain at Day 216.4 (4.5 to 9.0)4.7 (3.4 to 6.6)10.6 (6.3 to 17.9)
A/Brisbane strain at Day 425.1 (3.7 to 7.0)3.9 (2.8 to 5.4)8.9 (5.3 to 14.7)
A/Brisbane strain at Day 1802.3 (1.8 to 3.0)2.2 (1.7 to 3.0)4.6 (2.9 to 7.2)
A/Uruguay strain at Day 2115.5 (10.8 to 22.2)9.4 (6.6 to 13.2)11.3 (7.2 to 17.8)
A/Uruguay strain at Day 4212.2 (8.5 to 17.4)6.4 (4.7 to 8.6)7.9 (5.3 to 11.9)
A/Uruguay strain at Day 1805.5 (4.1 to 7.3)3.4 (2.5 to 4.6)4.5 (3.0 to 6.9)
B/Brisbane strain at Day 217.6 (5.6 to 10.3)5.2 (3.8 to 7.1)7.4 (4.7 to 11.6)
B/Brisbane strain at Day 425.4 (4.0 to 7.2)4.1 (3.1 to 5.4)5.8 (3.7 to 8.9)
B/Brisbane strain at Day 1802.8 (2.2 to 3.4)2.5 (1.9 to 3.1)4.0 (2.8 to 5.8)
SecondaryThe Number of Subjects Seroprotected to HI Antibodies

A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.

Time frame:
At Day 0, 21, 42 and 180
Reported as:
Count of participants · Participants
The Number of Subjects Seroprotected to HI Antibodies
ParticipantsNew Generation Influenza Vaccine GSK2186877A GroupFluarix Elderly GroupFluarix Young Group
A/Brisbane strain at Day 0201618
A/Brisbane strain at Day 21575342
A/Brisbane strain at Day 42564742
A/Brisbane strain at Day 180393436
A/Uruguay strain at Day 0262416
A/Uruguay strain at Day 21615739
A/Uruguay strain at Day 42595339
A/Uruguay strain at Day 180534833
B/Brisbane strain at Day 0515739
B/Brisbane strain at Day 21626543
B/Brisbane strain at Day 42616444
B/Brisbane strain at Day 180606542
SecondaryNumber of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)

Grade 3 ecchymosis, redness and swelling was \>100mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activity.

Time frame:
Day 0 -6
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
ParticipantsNew Generation Influenza Vaccine GSK2186877A GroupFluarix Elderly GroupFluarix Young Group
Any ecchymosis210
Grade 3 ecchymosis000
Any pain431535
Grade 3 pain000
Any redness500
Grade 3 redness000
Any swelling810
Grade 3 swelling000
SecondaryDuration of Solicited Local AEs

Duration was defined as the number of days with any grade of local symptoms.

Time frame:
Day 0 -6
Reported as:
Median · Days
Duration of Solicited Local AEs
DaysNew Generation Influenza Vaccine GSK2186877A GroupFluarix Elderly GroupFluarix Young Group
Ecchymosis3.5 (3.0 to 4.0)5.0 (5.0 to 5.0)—
Pain2.0 (1.0 to 6.0)1.0 (1.0 to 3.0)2.0 (1.0 to 4.0)
Redness2.0 (1.0 to 5.0)——
Swelling4.0 (1.0 to 6.0)5.0 (5.0 to 5.0)—
SecondaryNumber of Subjects Reporting Any, Grade 3 and Related Solicited General AEs

Any fever was defined as oral temperature ≥ 38.0 degree centigrade (°C), grade 3 fever was defined as oral temperature ≥ 39.0°C. For other symptoms grade 3 was defined as general symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.

Time frame:
Day 0 -6
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
ParticipantsNew Generation Influenza Vaccine GSK2186877A GroupFluarix Elderly GroupFluarix Young Group
Any arthralgia1434
Grade 3 arthralgia000
Related arthralgia1213
Any fatigue221221
Grade 3 fatigue000
Related fatigue21811
Any gastrointestinal symptoms646
Grade 3 gastrointestinal symptoms000
Related gastrointestinal symptoms514
Any headache22714
Grade 3 headache000
Related headache1727
Any myalgia17811
Grade 3 myalgia000
Related myalgia1679
Any shivering1102
Grade 3 shivering001
Related shivering801
Any fever200
Grade 3 fever100
Related fever200
SecondaryDuration of Solicited General AEs

Duration was defined as number of days with any grade of general symptoms.

Time frame:
Day 0 -6
Reported as:
Median · Days
Duration of Solicited General AEs
DaysNew Generation Influenza Vaccine GSK2186877A GroupFluarix Elderly GroupFluarix Young Group
Arthralgia2.0 (1.0 to 6.0)2.0 (1.0 to 3.0)1.5 (1.0 to 6.0)
Fatigue2.0 (1.0 to 7.0)2.5 (1.0 to 7.0)2.0 (1.0 to 7.0)
Gastrointestinal symptoms1.0 (1.0 to 3.0)2.0 (1.0 to 3.0)1.0 (1.0 to 2.0)
Headache1.0 (1.0 to 5.0)2.0 (1.0 to 4.0)1.5 (1.0 to 4.0)
Myalgia2.0 (1.0 to 6.0)1.5 (1.0 to 3.0)1.0 (1.0 to 2.0)
Shivering1.0 (1.0 to 7.0)—2.5 (2.0 to 3.0)
Fever2.0 (1.0 to 3.0)——
SecondaryNumber of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs

Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom, regardless of intensity or relation to vaccination, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination.

Time frame:
Day 0-20
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
ParticipantsNew Generation Influenza Vaccine GSK2186877A GroupFluarix Elderly GroupFluarix Young Group
Any AE(s)132115
Grade 3 AE(s)221
Related AE(s)321
SecondaryNumber of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs)

For each solicited and unsolicited AE the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination.

Time frame:
Day 0-179
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs)
ParticipantsNew Generation Influenza Vaccine GSK2186877A GroupFluarix Elderly GroupFluarix Young Group
Any MAE(s)242113
Grade 3 MAE(s)493
Related MAE(s)000
SecondaryNumber of Subjects Reporting Any AEs of Specific Interest (AESI)

AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination.

Time frame:
Day 0-364
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any AEs of Specific Interest (AESI)
ParticipantsNew Generation Influenza Vaccine GSK2186877A GroupFluarix Elderly GroupFluarix Young Group
Number of Subjects Reporting Any AEs of Specific Interest (AESI)000
SecondaryNumber of Subjects Reporting Any and Related Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination and related was event assessed by investigator as causally related to the study vaccination.

Time frame:
Day 0-364
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
ParticipantsNew Generation Influenza Vaccine GSK2186877A GroupFluarix Elderly GroupFluarix Young Group
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)5111

Adverse events

Collected over Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
New Generation Influenza Vaccine GSK2186877A Group—5/69 (7.2%)53/69 (76.8%)
Fluarix Elderly Group—11/73 (15.1%)27/73 (37%)
Fluarix Young Group—1/50 (2%)43/50 (86%)
Most frequent serious events
Showing 10 of 21
Most frequent serious events
EventNew Generation Influenza Vaccine GSK2186877A GroupFluarix Elderly GroupFluarix Young Group
HypersensitivityImmune system disorders0/690/731/50
Abdominal herniaGastrointestinal disorders1/690/730/50
AnaemiaBlood and lymphatic system disorders1/690/730/50
Atrial flutterCardiac disorders1/690/730/50
MeningiomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/690/730/50
Myocardial infarctionCardiac disorders1/690/730/50
Rectal haemorrhageGastrointestinal disorders1/690/730/50
VertigoEar and labyrinth disorders1/690/730/50
AmnesiaNervous system disorders0/691/730/50
ArrhythmiaCardiac disorders0/691/730/50
Most frequent other events
Most frequent other events
EventNew Generation Influenza Vaccine GSK2186877A GroupFluarix Elderly GroupFluarix Young Group
PainGeneral disorders43/6915/7335/50
FatigueGeneral disorders22/6912/7321/50
HeadacheGeneral disorders22/697/7314/50
MyalgiaGeneral disorders17/698/7311/50
ArthralgiaGeneral disorders14/693/734/50
ShiveringGeneral disorders11/690/732/50
Gastrointestinal symptomsGeneral disorders6/694/736/50
SwellingGeneral disorders8/691/730/50
NasopharyngitisInfections and infestations2/692/734/50
RednessGeneral disorders5/690/730/50

Baseline characteristics

Age, Continuous
Age, Continuous(Years)New Generation Influenza Vaccine GSK2186877A GroupFluarix Elderly GroupFluarix Young GroupTotal
Mean71.5 ± 5.4471.5 ± 5.3226.0 ± 4.9159.7 ± 20.69
Sex: Female, Male
Sex: Female, Male(Participants)New Generation Influenza Vaccine GSK2186877A GroupFluarix Elderly GroupFluarix Young GroupTotal
Female36292792
Male334423100
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Study locations

4 sites
  • GSK Investigational Site
    Houston, Texas 77030, United States
  • GSK Investigational Site
    Barcelona, 08035, Spain
  • GSK Investigational Site
    Madrid, 28046, Spain
  • GSK Investigational Site
    Marid, 28040, Spain
09

References and documents

Publications

  • Couch RB, Bayas JM, Caso C, Mbawuike IN, Lopez CN, Claeys C, El Idrissi M, Herve C, Laupeze B, Oostvogels L, Moris P. Superior antigen-specific CD4+ T-cell response with AS03-adjuvantation of a trivalent influenza vaccine in a randomised trial of adults aged 65 and older. BMC Infect Dis. 2014 Jul 30;14:425. doi: 10.1186/1471-2334-14-425. PubMed 25078387 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00765076
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Oct 2, 2008
Start date
Oct 16, 2008
Primary completion
Dec 4, 2009
Completion
Dec 4, 2009
Results posted
Apr 5, 2012
Last update
Jul 31, 2018

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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