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CompletedNCT00540228Updated Jun 14, 2019Results posted

Study to Evaluate an Influenza Vaccine Candidate

A Phase 2 interventional study of Influenza Vaccine GSK1247446A - 4 different formulations and Fluarix™ in Influenza, sponsored by GlaxoSmithKline. Completed at 15 sites in 3 countries. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-14.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
1,006
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Influenza

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Keywords

  • Influenza
  • Influenza Vaccine
03

In context

Influenza, Human

2,264 studies on the registry are indexed under Influenza, Human; 173 are open to participants now.

This study's enrollment of 1,006 is above the median of 240 across 1,894 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

Browse GlaxoSmithKline studies →

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

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
1,006 participants (actual)

Study arms

  • Experimental
    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.

    Biological: Influenza Vaccine GSK1247446A - 4 different formulations

  • Experimental
    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.

    Biological: Influenza Vaccine GSK1247446A - 4 different formulations

  • Experimental
    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.

    Biological: Influenza Vaccine GSK1247446A - 4 different formulations

  • Experimental
    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.

    Biological: Influenza Vaccine GSK1247446A - 4 different formulations

  • Active comparator
    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.

    Biological: Fluarix™

Interventions

  • BiologicalInfluenza Vaccine GSK1247446A - 4 different formulations

    Single dose, Intramuscular injection

  • BiologicalFluarix™

    Single dose, Intramuscular injection

06

What researchers measure

Primary outcomes

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

    Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). The seropositivity cut-off assay was 1:10. The results for Day 0 and Day 21 are the primary efficacy variables.

    Time frame: At Days 0, 21 and 180

Secondary outcomes

  1. Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.

    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 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).

    Time frame: At Days 21 and 180

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

    The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).

    Time frame: At Days 21 and 180

  3. Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.

    A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).

    Time frame: At Days 0, 21 and 180

  4. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.

    Titers are presented as geometric mean titers (GMTs). The 4 influenza strains assessed were A/Wisconsin (WISC), B/Malaysia (MALA), A/Brisbane (BRIS) and B/Florida (FLOR). The seropositivity cut-off assay was 1:28.

    Time frame: At Days 0 and 21

  5. Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.

    The mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).

    Time frame: At Days 0, 21 and 180

  6. Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.

    The mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).

    Time frame: At Days 0, 21 and 180

  7. Number of Subjects With Any and Grade 3 Solicited Local Symptoms.

    Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site.

    Time frame: During the 7-day (Days 0-6) post vaccination period

  8. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.

    Assessed solicited general symptoms were arthralgia, fatigue, fever \[oral temperature above (\>) 38.0 degrees Celsius (°C)\], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.

    Time frame: During the 7-day (Days 0-6) post vaccination period

  9. Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs).

    MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination

    Time frame: From Day 0 to Day 180

  10. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (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 = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.

    Time frame: During the 21-day (Days 0-20) post vaccination period

  11. Number of Subjects With Serious Adverse Events (SAEs).

    Serious adverse events (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.

    Time frame: From Day 0 to Day 180

07

Results

Posted Apr 30, 2013

Participant flow

Participant flow — Overall Study
MilestoneGSK1247446A 1 GroupGSK1247446A 2 GroupGSK1247446A 3 GroupGSK1247446A 4 GroupFluarix Group
Started200198204202202
Completed197197204202202
Not completed31000
Withdrew: Adverse event20000
Withdrew: Lost to follow-up11000

Outcome measures

PrimaryTiters for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.

Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). The seropositivity cut-off assay was 1:10. The results for Day 0 and Day 21 are the primary efficacy variables.

Time frame:
At Days 0, 21 and 180
Reported as:
Geometric mean · titers
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
titersGSK1247446A 1 GroupGSK1247446A 2 GroupGSK1247446A 3 GroupGSK1247446A 4 GroupFluarix Group
SOLO, Day 0 [N=187;189;190;192;185]13.0 (10.9 to 15.5)12.3 (10.2 to 14.8)12.9 (10.6 to 15.8)14.9 (12.3 to 18.2)15.1 (12.5 to 18.2)
SOLO, Day 21 [N=187;189;190;192;185]203.2 (171.7 to 240.3)155.8 (128.2 to 189.4)164.9 (137.6 to 197.8)151.1 (124.7 to 183.1)191.0 (158.5 to 230.2)
SOLO, Day 180 [N=189;190;192;192;187]81.3 (68.3 to 96.8)71.1 (58.8 to 86.1)76.3 (63.2 to 92.0)80.7 (66.7 to 97.5)97.6 (82.5 to 115.5)
WISC, Day 0 [N=187;189;190;192;185]29.4 (23.8 to 36.4)30.0 (24.3 to 37.2)29.9 (24.5 to 36.5)27.2 (22.6 to 32.8)37.4 (30.2 to 46.4)
WISC, Day 21 [N=187;189;190;192;185]380.1 (321.3 to 449.8)326.4 (275.6 to 386.7)319.9 (270.0 to 379.1)273.9 (232.0 to 323.3)335.3 (286.2 to 392.7)
WISC, Day 180 [N=189;190;192;192;187]174.3 (145.6 to 208.8)149.5 (125.3 to 178.3)164.0 (138.0 to 195.0)133.0 (112.5 to 157.3)176.2 (151.7 to 204.6)
MALA, Day 0 [N=187;189;190;192;185]25.8 (21.3 to 31.3)27.3 (22.6 to 32.9)22.6 (18.8 to 27.1)23.2 (19.5 to 27.8)27.0 (22.2 to 32.7)
MALA, Day 21 [N=187;189;190;192;185]225.8 (195.3 to 261.1)246.1 (210.9 to 287.2)195.5 (165.1 to 231.4)171.2 (144.2 to 203.2)217.8 (184.3 to 257.4)
MALA, Day 180 [N=189;190;192;192;187]106.6 (91.7 to 124.0)119.6 (103.7 to 138.0)97.2 (83.2 to 113.5)95.7 (82.1 to 111.7)108.8 (93.1 to 127.0)
SecondaryNumber of Seroconverted Subjects Against 3 Strains of Influenza Disease.

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 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).

Time frame:
At Days 21 and 180
Reported as:
Number · subjects
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
subjectsGSK1247446A 1 GroupGSK1247446A 2 GroupGSK1247446A 3 GroupGSK1247446A 4 GroupFluarix Group
SOLO, Day 21 [N=187;189;190;192;185]154141133119131
SOLO, Day 180 [N=189;190;192;192;187]117108102102110
WISC, Day 21 [N=187;189;190;192;185]150147142142118
WISC, Day 180 [N=189;190;192;192;187]11297112106100
MALA, Day 21 [N=187;189;190;192;185]136127128127125
MALA, Day 180 [N=189;190;192;192;187]99999810288
SecondarySeroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).

Time frame:
At Days 21 and 180
Reported as:
Geometric mean · fold increase
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
fold increaseGSK1247446A 1 GroupGSK1247446A 2 GroupGSK1247446A 3 GroupGSK1247446A 4 GroupFluarix Group
SOLO, Day 21 [N=187;189;190;192;185]15.6 (12.7 to 19.2)12.7 (10.2 to 15.8)12.8 (10.1 to 16.1)10.1 (8.0 to 12.8)12.7 (9.9 to 16.2)
SOLO, Day 180 [N=189;190;192;192;187]6.4 (5.3 to 7.7)5.9 (4.8 to 7.2)5.9 (4.8 to 7.2)5.4 (4.4 to 6.7)6.5 (5.2 to 8.0)
WISC, Day 21 [N=187;189;190;192;185]12.9 (10.5 to 16.0)10.9 (8.9 to 13.3)10.7 (8.6 to 13.2)10.1 (10.1 to 12.3)9.0 (7.2 to 11.2)
WISC, Day 180 [N=189;190;192;192;187]6.0 (5.0 to 7.2)5.0 (4.2 to 6.1)5.4 (4.5 to 6.6)4.9 (4.1 to 5.9)4.7 (3.9 to 5.8)
MALA, Day 21 [N=187;189;190;192;185]8.7 (7.2 to 10.6)9.0 (7.3 to 11.2)8.7 (7.0 to 10.8)7.4 (6.1 to 8.9)8.1 (6.6 to 9.9)
MALA, Day 180 [N=189;190;192;192;187]4.2 (3.5 to 4.9)4.4 (3.6 to 5.3)4.4 (3.6 to 5.3)4.1 (3.5 to 4.8)4.0 (3.3 to 4.8)
SecondaryNumber of Seroprotected Subjects Against 3 Strains of Influenza Disease.

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).

Time frame:
At Days 0, 21 and 180
Reported as:
Number · subjects
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
subjectsGSK1247446A 1 GroupGSK1247446A 2 GroupGSK1247446A 3 GroupGSK1247446A 4 GroupFluarix Group
SOLO, Day 0 [N=187;189;190;192;185]4546435250
SOLO, Day 21 [N=187;189;190;192;185]177170169166172
SOLO, Day 180 [N=189;190;192;192;187]157144144151159
WISC, Day 0 [N=187;189;190;192;185]9090969195
WISC, Day 21 [N=187;189;190;192;185]183186185184183
WISC, Day 180 [N=189;190;192;192;187]175175175173183
MALA, Day 0 [N=187;189;190;192;185]8088818688
MALA, Day 21 [N=187;189;190;192;185]183186180180178
MALA, Day 180 [N=189;190;192;192;187]174177167171169
SecondaryTiters for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.

Titers are presented as geometric mean titers (GMTs). The 4 influenza strains assessed were A/Wisconsin (WISC), B/Malaysia (MALA), A/Brisbane (BRIS) and B/Florida (FLOR). The seropositivity cut-off assay was 1:28.

Time frame:
At Days 0 and 21
Reported as:
Geometric mean · titers
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
titersGSK1247446A 1 GroupGSK1247446A 2 GroupGSK1247446A 3 GroupGSK1247446A 4 GroupFluarix Group
WISC, Day 0 [N=43;47;44;43;42]134.3 (94.6 to 190.8)136.3 (101.4 to 183.1)160.8 (111.0 to 232.9)148.0 (107.0 to 204.5)212.5 (138.2 to 326.6)
WISC, Day 21 [N=47;48;44;47;42]1193.7 (876.6 to 1625.5)859.6 (637.8 to 1158.5)1027.9 (760.3 to 1389.8)842.3 (641.9 to 1105.2)864.0 (654.2 to 1140.9)
MALA, Day 0 [N=46;48;44;44;42]34.1 (25.7 to 45.1)36.5 (25.9 to 51.3)33.3 (24.4 to 45.4)27.7 (21.1 to 36.2)49.7 (35.2 to 70.0)
MALA, Day 21 [N=44;48;43;42;42]162.5 (117.6 to 224.5)161.5 (128.6 to 202.9)141.0 (103.8 to 191.3)130.5 (98.7 to 172.7)166.0 (111.2 to 247.7)
BRIS, Day 0 [N=47;48;44;47;41]494.2 (389.0 to 627.7)365.9 (298.3 to 449.0)392.5 (319.1 to 482.8)445.7 (369.2 to 538.0)466.8 (355.2 to 613.5)
BRIS, Day 21 [N=47;48;44;47;42]1151.5 (901.8 to 1470.4)847.5 (668.0 to 1075.3)884.2 (673.2 to 1161.2)1038.2 (799.3 to 1348.6)867.1 (658.9 to 1141.1)
FLOR, Day 0 [N=45;48;44;47;42]48.9 (35.2 to 67.9)56.9 (38.6 to 83.9)51.0 (35.2 to 73.9)46.8 (32.7 to 66.9)76.7 (51.1 to 115.3)
FLOR, Day 21 [N=43;48;43;43;42]94.3 (68.8 to 129.3)113.6 (79.7 to 162.0)92.1 (60.6 to 139.9)82.7 (57.9 to 118.2)131.1 (93.3 to 184.2)
SecondaryGeometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.

The mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).

Time frame:
At Days 0, 21 and 180
Reported as:
Mean · cells
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
cellsGSK1247446A 1 GroupGSK1247446A 2 GroupGSK1247446A 3 GroupGSK1247446A 4 GroupFluarix Group
All Doubles, Day 0 [N=45;47;43;47;39]2106.16 ± 1274.902043.17 ± 894.182252.44 ± 1726.882103.66 ± 1370.891976.23 ± 1051.16
All Doubles, Day 21 [N=45;45;40;45;39]3857.76 ± 2195.473366.93 ± 1693.403103.30 ± 1549.212827.84 ± 1561.602489.15 ± 1468.71
All Doubles, Day 180 [N=46;42;42;43;41]2628.96 ± 1353.462249.88 ± 1325.731963.38 ± 1245.212153.12 ± 1473.451952.02 ± 1240.63
CD40L, Day 0 [N=45;47;43;47;39]1914.96 ± 1241.381863.96 ± 830.552045.86 ± 1638.111954.13 ± 1290.771827.67 ± 1033.38
CD40L, Day 21 [N=45;45;40;45;39]3337.89 ± 1982.592947.20 ± 1487.132624.30 ± 1316.602472.98 ± 1378.172223.74 ± 1398.63
CD40L, Day 180 [N=46;42;42;43;41]2108.04 ± 1190.421758.95 ± 1093.801581.31 ± 1184.991731.00 ± 1331.051560.76 ± 1009.77
IFN-γ, Day 0 [N=45;47;43;47;39]1379.33 ± 987.071377.13 ± 741.311510.84 ± 1349.581342.57 ± 1040.631260.97 ± 809.24
IFN-γ, Day 21 [N=45;45;40;45;39]2525.91 ± 1615.782233.24 ± 1371.052056.40 ± 1205.901824.69 ± 1265.291565.79 ± 1064.31
IFN-γ, Day 180 [N=46;42;42;43;41]1792.74 ± 1075.761546.55 ± 1055.941335.62 ± 970.491440.09 ± 1199.841299.95 ± 894.25
IL2, Day 0 [N=45;47;43;47;39]1684.24 ± 983.481657.28 ± 744.171796.33 ± 1354.891732.91 ± 1140.541572.69 ± 812.49
IL2, Day 21 [N=45;45;40;45;39]3020.09 ± 1741.782634.64 ± 1415.242343.15 ± 1199.202256.02 ± 1251.581933.10 ± 1153.35
IL2, Day 180 [N=46;42;42;43;41]2121.67 ± 1088.481816.26 ± 1116.551571.19 ± 987.961797.79 ± 1228.491581.73 ± 1028.49
TNF-α, Day 0 [N=45;47;43;47;39]1606.64 ± 1087.171522.70 ± 747.671712.42 ± 1355.231548.00 ± 1094.031421.82 ± 781.48
TNF-α, Day 21 [N=45;45;40;45;39]2767.02 ± 1598.412337.38 ± 1068.822109.45 ± 1075.511990.60 ± 1157.581639.31 ± 975.93
TNF-α, Day 180 [N=46;42;42;43;41]1980.39 ± 1078.921654.90 ± 944.901454.40 ± 898.011627.67 ± 1155.631392.05 ± 933.32
SecondaryGeometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.

The mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).

Time frame:
At Days 0, 21 and 180
Reported as:
Mean · cells
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
cellsGSK1247446A 1 GroupGSK1247446A 2 GroupGSK1247446A 3 GroupGSK1247446A 4 GroupFluarix Group
All Doubles, Day 0 [N=44;46;43;45;39]50.02 ± 113.85109.63 ± 405.0917.33 ± 33.1264.47 ± 181.3248.38 ± 82.57
All Doubles, Day 21 [N=44;43;40;42;38]47.18 ± 106.5550.09 ± 101.5538.53 ± 67.21109.86 ± 282.0455.11 ± 126.17
All Doubles, Day 180 [N=44;40;42;41;41]44.32 ± 99.11126.13 ± 323.6836.31 ± 95.0697.27 ± 258.5330.98 ± 62.35
CD40L, Day 0 [N=44;46;43;45;39]3.64 ± 12.375.91 ± 15.922.63 ± 8.0616.27 ± 56.567.05 ± 20.43
CD40L, Day 21 [N=44;43;40;42;38]8.82 ± 28.3810.09 ± 21.586.45 ± 16.0350.83 ± 193.0037.55 ± 117.41
CD40L, Day 180 [N=44;40;42;41;41]9.45 ± 35.5915.88 ± 61.592.86 ± 8.481.68 ± 4.372.27 ± 5.83
IFN-γ, Day 0 [N=44;46;43;45;39]29.50 ± 53.2796.91 ± 375.6114.42 ± 32.9244.80 ± 137.5917.31 ± 38.50
IFN-γ, Day 21 [N=44;43;40;42;38]24.86 ± 61.1848.07 ± 106.6525.65 ± 49.9864.98 ± 178.6332.11 ± 104.54
IFN-γ, Day 180 [N=44;40;42;41;41]38.18 ± 50.84110.75 ± 303.9120.62 ± 47.5679.85 ± 239.3619.80 ± 37.25
IL2, Day 0 [N=44;46;43;45;39]35.59 ± 91.4975.41 ± 309.228.81 ± 16.6546.22 ± 130.4643.59 ± 81.53
IL2, Day 21 [N=44;46;43;45;39]36.98 ± 85.0521.51 ± 42.4731.28 ± 59.8987.86 ± 244.8450.84 ± 116.74
IL2, Day 180 [N=44;40;42;41;41]27.36 ± 87.5974.03 ± 183.5924.50 ± 82.6257.15 ± 136.7328.73 ± 55.08
TNF-α, Day 0 [N=44;46;43;45;39]42.98 ± 109.79102.72 ± 391.9615.42 ± 28.6054.73 ± 156.4146.18 ± 91.78
TNF-α, Day 21 [N=44;43;40;42;38]37.93 ± 109.4644.16 ± 99.1731.55 ± 59.5290.48 ± 239.4737.82 ± 110.79
TNF-α, Day 180 [N=44;40;42;41;41]34.70 ± 86.94111.10 ± 299.6733.60 ± 80.5079.54 ± 208.1325.63 ± 56.06
SecondaryNumber of Subjects With Any and Grade 3 Solicited Local Symptoms.

Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site.

Time frame:
During the 7-day (Days 0-6) post vaccination period
Reported as:
Number · subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
subjectsGSK1247446A 1 GroupGSK1247446A 2 GroupGSK1247446A 3 GroupGSK1247446A 4 GroupFluarix Group
Any Ecchymosis1198147
Grade 3 Ecchymosis10011
Any Pain182175167151121
Grade 3 Pain55311
Any Redness7566536449
Grade 3 Redness174322
Any Swelling6954494827
Grade 3 Swelling114532
SecondaryNumber of Subjects With Any, Grade 3 and Related Solicited General Symptoms.

Assessed solicited general symptoms were arthralgia, fatigue, fever \[oral temperature above (\>) 38.0 degrees Celsius (°C)\], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.

Time frame:
During the 7-day (Days 0-6) post vaccination period
Reported as:
Number · subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
subjectsGSK1247446A 1 GroupGSK1247446A 2 GroupGSK1247446A 3 GroupGSK1247446A 4 GroupFluarix Group
Any Arthralgia6451383925
Grade 3 Arthralgia44201
Related Arthralgia5249323120
Any Fatigue10390867847
Grade 3 Fatigue54222
Related Fatigue8183726234
Fever >38°C2716863
Fever ≥ 39°C20000
Related Fever2313863
Any Headache9077686651
Grade 3 Headache72431
Related Headache7261494936
Any Myalgia10285747049
Grade 3 Myalgia66402
Related Myalgia8177595740
Any Nausea2528121311
Grade 3 Nausea12300
Related Nausea192210116
Any Shivering7453403412
Grade 3 Shivering45112
Related Shivering645031298
SecondaryNumber of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs).

MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination

Time frame:
From Day 0 to Day 180
Reported as:
Number · subjects
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs).
subjectsGSK1247446A 1 GroupGSK1247446A 2 GroupGSK1247446A 3 GroupGSK1247446A 4 GroupFluarix Group
Subjects with any MSCs7056536445
Subjects with grade 3 and related MSCs22001
Subjects with related MSCs52001
SecondaryNumber of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (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 = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.

Time frame:
During the 21-day (Days 0-20) post vaccination period
Reported as:
Number · subjects
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
subjectsGSK1247446A 1 GroupGSK1247446A 2 GroupGSK1247446A 3 GroupGSK1247446A 4 GroupFluarix Group
Subjects with any AE(s)8591708280
Subjects with grade 3 AE(s)4103105
Subjects with related AE(s)3741251914
SecondaryNumber of Subjects With Serious Adverse Events (SAEs).

Serious adverse events (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.

Time frame:
From Day 0 to Day 180
Reported as:
Number · subjects
Number of Subjects With Serious Adverse Events (SAEs).
subjectsGSK1247446A 1 GroupGSK1247446A 2 GroupGSK1247446A 3 GroupGSK1247446A 4 GroupFluarix Group
Number of Subjects With Serious Adverse Events (SAEs).73342

Adverse events

Collected over SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
GSK1247446A 1 Group1/200 (0.5%)7/200 (3.5%)182/200 (91%)
GSK1247446A 2 Group0/198 (0%)3/198 (1.5%)175/198 (88.4%)
GSK1247446A 3 Group0/204 (0%)3/204 (1.5%)167/204 (81.9%)
GSK1247446A 4 Group0/202 (0%)4/202 (2%)151/202 (74.8%)
Fluarix Group0/202 (0%)2/202 (1%)121/202 (59.9%)
Most frequent serious events
Showing 10 of 20
Most frequent serious events
EventGSK1247446A 1 GroupGSK1247446A 2 GroupGSK1247446A 3 GroupGSK1247446A 4 GroupFluarix Group
Ectopic pregnancyPregnancy, puerperium and perinatal conditions0/2001/1980/2040/2020/202
Hand fractureInjury, poisoning and procedural complications0/2001/1980/2040/2020/202
HypertensionVascular disorders0/2001/1980/2040/2020/202
Renal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/2001/1980/2040/2020/202
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/2000/1980/2040/2020/202
Cerebrovascular accidentNervous system disorders1/2000/1980/2040/2020/202
Cervical spinal stenosisMusculoskeletal and connective tissue disorders1/2000/1980/2040/2020/202
HypersensitivityImmune system disorders1/2000/1980/2040/2020/202
HypotensionVascular disorders1/2000/1980/2040/2020/202
Optic neuritisNervous system disorders1/2000/1980/2040/2020/202
Most frequent other events
Showing 10 of 13
Most frequent other events
EventGSK1247446A 1 GroupGSK1247446A 2 GroupGSK1247446A 3 GroupGSK1247446A 4 GroupFluarix Group
PainGeneral disorders182/200175/198167/204151/202121/202
FatigueGeneral disorders103/20090/19886/20478/20247/202
MyalgiaGeneral disorders102/20085/19874/20470/20249/202
HeadacheGeneral disorders90/20077/19868/20466/20251/202
RednessGeneral disorders75/20066/19853/20464/20249/202
ShiveringGeneral disorders74/20053/19840/20434/20212/202
SwellingGeneral disorders69/20054/19849/20448/20227/202
ArthralgiaGeneral disorders64/20051/19838/20439/20225/202
NauseaGeneral disorders25/20028/19812/20413/20211/202
Fever >38°CGeneral disorders27/20016/1988/2046/2023/202

Baseline characteristics

Age, Continuous
Age, Continuous(Years)GSK1247446A 1 GroupGSK1247446A 2 GroupGSK1247446A 3 GroupGSK1247446A 4 GroupFluarix GroupTotal
Mean40.5 ± 14.1440.3 ± 13.7939.7 ± 14.3739.7 ± 14.3140.1 ± 14.1140.1 ± 14.14
Sex: Female, Male
Sex: Female, Male(Participants)GSK1247446A 1 GroupGSK1247446A 2 GroupGSK1247446A 3 GroupGSK1247446A 4 GroupFluarix GroupTotal
Female115116115140123609
Male8582896279397
08

Study locations

15 sites
  • GSK Investigational Site
    Caen, 14052, France
  • GSK Investigational Site
    Lagord, 17140, France
  • GSK Investigational Site
    Lille, 59019, France
  • GSK Investigational Site
    Paris, 75679, France
  • GSK Investigational Site
    Paris, 75877, France
  • GSK Investigational Site
    Toulouse, 31300, France
  • GSK Investigational Site
    Tübingen, Baden-Wurttemberg 72074, Germany
  • GSK Investigational Site
    Würzburg, Bavaria 97070, Germany
  • GSK Investigational Site
    Dresden, Saxony 01307, Germany
  • GSK Investigational Site
    Freiberg, Saxony 09599, Germany
  • GSK Investigational Site
    Schmiedeberg, Saxony 01762, Germany
  • GSK Investigational Site
    Barcelona, 08035, Spain
  • GSK Investigational Site
    Barcelona, 08036, Spain
  • GSK Investigational Site
    Madrid, 28035, Spain
  • GSK Investigational Site
    Madrid, 28040, Spain
09

References and documents

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 Jun 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00540228
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Oct 5, 2007
Start date
Oct 5, 2007
Primary completion
May 8, 2008
Completion
May 8, 2008
Results posted
Apr 30, 2013
Last update
Jun 14, 2019

Study contacts

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

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