AzTrials
AzTrials

InfluenzaPhase 2NCT00985088

Safety and Immunogenicity of H1N1 Vaccines in Adults Aged 18 Years and Older

A Phase 2 study testing GSK2340274A and GSK2340273A in people with Influenza, run by GlaxoSmithKline at 14 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to characterize the safety and immunogenicity of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older. This protocol posting has been updated for sections impacted by the Protocol amendment 1, Sept 2009. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
GSK2340274A and GSK2340273A
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,343 participants
Where
14 sitesin 2 countries
Study dates
11 Oct 2009to 16 Dec 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects who the investigator believes can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • Male and female adults, >= 18 years of age at the time of the first vaccination.
  • Safety laboratory test results within the parameters specified in the protocol.
  • Satisfactory baseline medical assessment by history and physical examination.
  • Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits as documented by signature on the informed consent document.
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  • Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:
  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of first vaccination, and
  • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Who cannot join

  • Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus
  • Previous vaccination at any time with an H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-like virus.
  • Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
  • Presence of a temperature >= 38.0ºC (>=100.4ºF), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
  • Diagnosed with cancer, or treatment for cancer, within 3 years.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
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  • Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed.
  • Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
  • Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination, are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
  • An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine
  • With the exception of seasonal influenza vaccination, administration of any vaccine(s) within 30 days before study vaccination on Day 0. Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination on Day 0.
  • Planned administration of any vaccine not foreseen by the study protocol between Day 0 and the Day 42 phlebotomy, including seasonal influenza vaccine or a monovalent pandemic H1N1 vaccine other than the study vaccines.
  • 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/product, or planned use during the study period.
  • Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
  • Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to the first vaccination.
  • Lactating or nursing women.

Trial locations and contacts

14 sites in 2 countries.

14 sites in 2 countries

United States10 sites

  • GSK Investigational Site

    Cleveland, Ohio, 44122

  • GSK Investigational Site

    Edison, New Jersey, 08817

  • GSK Investigational Site

    Huntsville, Alabama, 35802

  • GSK Investigational Site

    Jacksonville, Florida, 32216

  • GSK Investigational Site

    Las Vegas, Nevada, 89104

  • GSK Investigational Site

    Lenexa, Kansas, 66219

  • GSK Investigational Site

    Meridian, Idaho, 83642

  • GSK Investigational Site

    Miami, Florida, 33143

  • GSK Investigational Site

    Missoula, Montana, 59801

  • GSK Investigational Site

    Rochester, New York, 14609

Other trials in United States

Canada4 sites

  • GSK Investigational Site

    Pointe-Claire, Quebec, H9R 4S3

  • GSK Investigational Site

    Surrey, British Columbia, V3R 8P8

  • GSK Investigational Site

    Toronto, Ontario, M9W 4L6

  • GSK Investigational Site

    Truro, Nova Scotia, B2N 1L2

Other trials in Canada

About this study

Official title: A Study to Evaluate the Safety and Immunogenicity of A/California/7/2009 (H1N1)V-like Vaccines GSK2340273A and GSK2340274A in Adults Aged 18 Years and Older

The purpose of this study is to characterize the safety and immunogenicity of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older.

This protocol posting has been updated for sections impacted by the Protocol amendment 1, Sept 2009.

Read the detailed description

Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority

Conditions
Influenza
Being tested
GSK2340274A, GSK2340273A, Saline placebo
Keywords
GSK Bio's influenza vaccine GSK2340274A, influenza infection, GSK Bio's influenza vaccine GSK2340273A
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK2340274ABiological

    one or two intramuscular injections

  • GSK2340273ABiological

    one or two intramuscular injections

  • Saline placeboBiological

    One injection

Study groups in NCT00985088
Study groupRoleWhat they receive
GSK2340274A F1_2D GroupExperimentalHealthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Receives: Biological: GSK2340274A
GSK2340274A F2_2D GroupExperimentalHealthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Receives: Biological: GSK2340274A
GSK2340274A F2_1D GroupExperimentalHealthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Receives: Biological: GSK2340274A; Biological: Saline placebo
GSK2340274A F1_1D GroupExperimentalHealthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Receives: Biological: GSK2340274A; Biological: Saline placebo
GSK2340273A F1_1D GroupExperimentalHealthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Receives: Biological: GSK2340273A; Biological: Saline placebo
GSK2340273A F2_2D GroupExperimentalHealthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Receives: Biological: GSK2340273A
GSK2340273A F2_1D GroupExperimentalHealthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
Receives: Biological: GSK2340273A; Biological: Saline placebo
GSK2340273A F3_2D GroupExperimentalHealthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Receives: Biological: GSK2340273A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects Seropositive for Haemagglutination Inhibition (HI) Antibodies Against the A/California Virus Strain

    A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and subjects older than (>) 60 years.

    Measured: At Day 0

  2. Number of Subjects Seropositive for Haemagglutination Inhibition (HI) Antibodies Against the A/California Virus Strain

    A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and subjects > 60 years.

    Measured: At Day 21

  3. Number of Subjects Seropositive for (HI) Antibodies Against the A/California Virus Strain

    A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 64 years (y) old and subjects > 64 years.

    Measured: At Day 0

  4. Number of Subjects Seropositive for (HI) Antibodies Against the A/California Virus Strain

    A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 64 years (y) old and subjects > 64 years.

    Measured: At Day 21

  5. Number of Seroconverted (SCR) Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California Virus Strain

    A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18 and 60 years of age and older (>60y).

    Measured: At Day 21

  6. Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Strain

    A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18 and 64 years and older (>64y).

    Measured: At Day 21

  7. Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain

    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) and results were tabulated for subjects between 18 and 60 years and older (>60y).

    Measured: At Day 0

  8. Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain

    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 60 years and older (>60y).

    Measured: At Day 21

  9. Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain

    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 64 years and older (>64y).

    Measured: At Day 0

  10. Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain

    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 64 years and older (>64y).

    Measured: At Day 21

  11. Seroconversion Factor (SCF) for Haemagglutination Inhibition (HI) Antibodies Against A/California Virus Strain

    SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 60 years of age and older (>60y).

    Measured: At Day 21

  12. Seroconversion Factor (SCF) for HI Antibodies Against A/California Strain

    SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 64 years of age and older (>64y).

    Measured: At Day 21

Secondary outcomes (34)

  1. Number of Subjects Seropositive for HI Antibodies Against A/California Virus Strain

    A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.

    Measured: At Days 0 and 21

  2. Titers for HI Antibodies Against A/California Strain

    Antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.

    Measured: At Days 0 and 21

  3. Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Virus Strain

    A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.

    Measured: At Day 21

  4. Number of Seroprotected (SPR) Subjects Against HI Antibodies for the A/California Virus Strain

    A seroprotected subject was defined as a vaccinated subject with serum HI antibody titers ≥ 1:40. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.

    Measured: At Days 0 and 21

  5. Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain

    SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18-60 years of age and older (> 60y) and for subjects between 18-64 years old and > 64 years.

    Measured: At Day 21

  6. Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain

    A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal HI antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.

    Measured: At Days 0 and 42

  7. Titers for HI Antibodies Against the A/California Virus Strain

    Antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.

    Measured: At Days 0 and 42

  8. Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Virus Strain

    A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.

    Measured: At Day 42

  9. Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain

    A seroprotected subject was defined as a vaccinated subject with serum HI antibody titers ≥ 1:40. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.

    Measured: At Days 0 and 42

  10. Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain

    SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18-60 years of age and older (> 60y) and for subjects between 18-64 years old and > 64 years.

    Measured: At Day 42

  11. Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain

    A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal HI antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.

    Measured: At Days 0 and 182

  12. Titers for HI Antibodies Against the A/California Virus Strain

    Antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.

    Measured: At Days 0 and 182

  13. Number of Seroconverted (SCR) Subjects for HI Antibodies

    A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.

    Measured: At Day 182

  14. Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain

    A seroprotected subject was defined as a vaccinated subject with serum HI antibody titers ≥ 1:40. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.

    Measured: At Days 0 and 182

  15. Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain

    SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18-60 years of age and older (> 60y) and for subjects between 18-64 years old and > 64 years.

    Measured: At Day 182

  16. Adjusted Geometric Mean Titer (GMT) Ratios of A/California Virus Strain

    Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled group GSK2340274A F1 and GSK2340273A F3_2D Group.

    Measured: At Day 21

  17. Adjusted Geometric Mean Titer (GMT) Ratios of A/California Strain

    Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled groups GSK2340274A F1 and GSK2340273A F2.

    Measured: At Day 21

  18. Adjusted GMT Ratios of A/California Virus Strain

    Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled group GSK2340274A F1 and the GSK2340273A F1_1D Group.

    Measured: At Day 21

  19. Adjusted GMT Ratios of A/California Strain

    Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled group GSK2340274A F2 and the GSK2340273A F3_2D Group.

    Measured: At Day 21

  20. Adjusted GMT Ratios for A/California Virus Strain

    Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled groups GSK2340274A F2 and GSK2340273A F2.

    Measured: At Day 21

  21. Adjusted GMT Ratios for A/California Strain

    Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled group GSK2340274A F2 and the GSK2340273A F1_1D Group.

    Measured: At Day 21

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

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

    Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses, for subjects between 18-64 years of age

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

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

    Measured: During the 7-day (Day 0-6) post-vaccination period following each dose and across doses, for subjects > 64 years of age

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

    Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

    Measured: During the 7-day (Day 0-6) post-vaccination period following each dose and across doses, for subjects between 18-64 years of age

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

    Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

    Measured: During the 7-day (Day 0-6) post-vaccination period following each dose and across doses, for subjects > 64 years of age

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

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Results were tabulated for subjects in GSK2340273A F2_1D Group, who were older than 60 years of age (>60y).

    Measured: During the 7-day (Days 0-6) post-Dose 3 vaccination period, for subjects > 60 years of age

  27. Number of Subjects With Any and Grade 3 Solicited General Symptoms

    Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Results were tabulated for subjects in GSK2340273A F2_1D Group, who were older than 60 years of age (>60y).

    Measured: During the 7-day (Days 0-6) post-Dose 3 vaccination period, for subjects > 60 years of age

  28. Number of Subjects With Abnormal Biochemical and Haematological Levels

    Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], alkaline phosphatase [AP], aspartate aminotransferase [AST], basophils [BAS], bilirubin [BIL], bilirubin conjugated/direct [BIL/CD] creatinine [CREA], eosinophils [EOS], hematocrit [HEM], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC], blood urea nitrogen [BUN] and white blood cells [WBC].

    Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above the reference range defined for the specified time point and laboratory parameter.

    Measured: At Days 7, 21, 28, 42 and 182, for subjects between 18-64 years of age

  29. Number of Subjects With Abnormal Biochemical and Haematological Levels

    Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], alkaline phosphatase [AP], aspartate aminotransferase [AST], basophils [BAS], bilirubin [BIL], bilirubin conjugated/direct [BIL/CD] creatinine [CREA], eosinophils [EOS], hematocrit [HEM], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC], blood urea nitrogen [BUN] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above the reference range defined for the specified time point and laboratory parameter.

    Measured: At Days 7, 21, 28, 42 and 182, for subjects > 64 years of age

  30. Number of Subjects With Any Medically-attended Adverse Events (MAEs)

    MAEs were defined as events for which the subject 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 the occurrence of any MAE regardless of intensity grade or relation to vaccination. Results were tabulated for subjects aged between 18 and 64 years and older (>64y).

    Measured: Days 0 to 385

  31. Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)

    Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Results were tabulated for subjects aged between 18-64 years and above 65 years (+65y).

    Measured: Days 0 to 365

  32. Number of Subjects With Any Unsolicited Adverse Events (AEs)

    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.

    Measured: Within the 42-day (Days 0-41) post-vaccination period

  33. Number of Subjects With Any Unsolicited Adverse Events (AEs)

    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. Results were tabulated for subjects aged between 18-64 years and older (>64y).

    Measured: Within the 84-day (Days 0-83) post-vaccination period

  34. 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 or result in disability/incapacity. Results were tabulated for subjects aged between 18-64 years and older (>64y).

    Measured: During the entire study period (from Day 0 to Day 385)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2009 (estimated)
  2. Study start11 Oct 2009
  3. Primary completion9 Nov 2009
  4. Study completion16 Dec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,343 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00985088
Sponsor's protocol ID
113440
Status last verified
Nov 2017
First submitted
24 Sep 2009
Last updated
12 Dec 2017
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Ferguson M, Risi G, Davis M, Sheldon E, Baron M, Li P, Madariaga M, Fries L, Godeaux O, Vaughn D. Safety and long-term humoral immune response in adults after vaccination with an H1N1 2009 pandemic influenza vaccine with or without AS03 adjuvant. J Infect Dis. 2012 Mar 1;205(5):733-44. doi: 10.1093/infdis/jir641.

    PubMed 22315336

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK2340274A and GSK2340273A in people with Influenza, run by GlaxoSmithKline at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects Seropositive for Haemagglutination Inhibition (HI) Antibodies Against the A/California Virus Strain (time frame: At Day 0). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00985088, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2017.

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