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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00985088
Recruitment Status : Completed
First Posted : September 28, 2009
Results First Posted : December 12, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Influenza Biological: GSK2340274A Biological: GSK2340273A Biological: Saline placebo Phase 2

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1343 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : October 11, 2009
Primary Completion Date : November 9, 2009
Study Completion Date : December 16, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: GSK2340274A F1_2D Group
Healthy 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.
Biological: GSK2340274A
one or two intramuscular injections
Experimental: GSK2340274A F2_2D Group
Healthy 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.
Biological: GSK2340274A
one or two intramuscular injections
Experimental: GSK2340274A F2_1D Group
Healthy 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.
Biological: GSK2340274A
one or two intramuscular injections
Biological: Saline placebo
One injection
Experimental: GSK2340274A F1_1D Group
Healthy 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.
Biological: GSK2340274A
one or two intramuscular injections
Biological: Saline placebo
One injection
Experimental: GSK2340273A F1_1D Group
Healthy 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.
Biological: GSK2340273A
one or two intramuscular injections
Biological: Saline placebo
One injection
Experimental: GSK2340273A F2_2D Group
Healthy 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.
Biological: GSK2340273A
one or two intramuscular injections
Experimental: GSK2340273A F2_1D Group
Healthy 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.
Biological: GSK2340273A
one or two intramuscular injections
Biological: Saline placebo
One injection
Experimental: GSK2340273A F3_2D Group
Healthy 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.
Biological: GSK2340273A
one or two intramuscular injections


Outcome Measures

Primary Outcome Measures :
  1. Number of Subjects Seropositive for Haemagglutination Inhibition (HI) Antibodies Against the A/California Virus Strain [ Time Frame: At Day 0 ]
    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.

  2. Number of Subjects Seropositive for Haemagglutination Inhibition (HI) Antibodies Against the A/California Virus Strain [ Time Frame: At Day 21 ]
    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.

  3. Number of Subjects Seropositive for (HI) Antibodies Against the A/California Virus Strain [ Time Frame: At Day 0 ]
    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.

  4. Number of Subjects Seropositive for (HI) Antibodies Against the A/California Virus Strain [ Time Frame: At Day 21 ]
    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.

  5. Number of Seroconverted (SCR) Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California Virus Strain [ Time Frame: At Day 21 ]
    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).

  6. Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Strain [ Time Frame: At Day 21 ]
    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).

  7. Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain [ Time Frame: At Day 0 ]
    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).

  8. Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain [ Time Frame: At Day 21 ]
    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).

  9. Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain [ Time Frame: At Day 0 ]
    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).

  10. Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain [ Time Frame: At Day 21 ]
    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).

  11. Seroconversion Factor (SCF) for Haemagglutination Inhibition (HI) Antibodies Against A/California Virus Strain [ Time Frame: At Day 21 ]
    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).

  12. Seroconversion Factor (SCF) for HI Antibodies Against A/California Strain [ Time Frame: At Day 21 ]
    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).


Secondary Outcome Measures :
  1. Number of Subjects Seropositive for HI Antibodies Against A/California Virus Strain [ Time Frame: At Days 0 and 21 ]
    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.

  2. Titers for HI Antibodies Against A/California Strain [ Time Frame: At Days 0 and 21 ]
    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.

  3. Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Virus Strain [ Time Frame: At Day 21 ]
    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.

  4. Number of Seroprotected (SPR) Subjects Against HI Antibodies for the A/California Virus Strain [ Time Frame: At Days 0 and 21 ]
    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.

  5. Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain [ Time Frame: At Day 21 ]
    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.

  6. Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain [ Time Frame: At Days 0 and 42 ]
    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.

  7. Titers for HI Antibodies Against the A/California Virus Strain [ Time Frame: At Days 0 and 42 ]
    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.

  8. Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Virus Strain [ Time Frame: At Day 42 ]
    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.

  9. Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain [ Time Frame: At Days 0 and 42 ]
    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.

  10. Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain [ Time Frame: At Day 42 ]
    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.

  11. Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain [ Time Frame: At Days 0 and 182 ]
    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.

  12. Titers for HI Antibodies Against the A/California Virus Strain [ Time Frame: At Days 0 and 182 ]
    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.

  13. Number of Seroconverted (SCR) Subjects for HI Antibodies [ Time Frame: At Day 182 ]
    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.

  14. Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain [ Time Frame: At Days 0 and 182 ]
    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.

  15. Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain [ Time Frame: At Day 182 ]
    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.

  16. Adjusted Geometric Mean Titer (GMT) Ratios of A/California Virus Strain [ Time Frame: At Day 21 ]
    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.

  17. Adjusted Geometric Mean Titer (GMT) Ratios of A/California Strain [ Time Frame: At Day 21 ]
    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.

  18. Adjusted GMT Ratios of A/California Virus Strain [ Time Frame: At Day 21 ]
    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.

  19. Adjusted GMT Ratios of A/California Strain [ Time Frame: At Day 21 ]
    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.

  20. Adjusted GMT Ratios for A/California Virus Strain [ Time Frame: At Day 21 ]
    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.

  21. Adjusted GMT Ratios for A/California Strain [ Time Frame: At Day 21 ]
    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.

  22. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses, for subjects between 18-64 years of age ]
    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.

  23. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 7-day (Day 0-6) post-vaccination period following each dose and across doses, for subjects > 64 years of age ]
    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.

  24. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 7-day (Day 0-6) post-vaccination period following each dose and across doses, for subjects between 18-64 years of age ]
    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.

  25. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 7-day (Day 0-6) post-vaccination period following each dose and across doses, for subjects > 64 years of age ]
    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.

  26. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-Dose 3 vaccination period, for subjects > 60 years of age ]
    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).

  27. Number of Subjects With Any and Grade 3 Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) post-Dose 3 vaccination period, for subjects > 60 years of age ]
    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).

  28. Number of Subjects With Abnormal Biochemical and Haematological Levels [ Time Frame: At Days 7, 21, 28, 42 and 182, for subjects between 18-64 years of age ]

    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.


  29. Number of Subjects With Abnormal Biochemical and Haematological Levels [ Time Frame: At Days 7, 21, 28, 42 and 182, for subjects > 64 years of age ]
    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.

  30. Number of Subjects With Any Medically-attended Adverse Events (MAEs) [ Time Frame: Days 0 to 385 ]
    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).

  31. Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) [ Time Frame: Days 0 to 365 ]
    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).

  32. Number of Subjects With Any Unsolicited Adverse Events (AEs) [ Time Frame: Within the 42-day (Days 0-41) post-vaccination period ]
    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.

  33. Number of Subjects With Any Unsolicited Adverse Events (AEs) [ Time Frame: Within the 84-day (Days 0-83) post-vaccination period ]
    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).

  34. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Day 0 to Day 385) ]
    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).


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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).
  • 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.
Contacts and Locations

Information from the National Library of Medicine

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

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00985088


Locations
United States, Alabama
GSK Investigational Site
Huntsville, Alabama, United States, 35802
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32216
GSK Investigational Site
Miami, Florida, United States, 33143
United States, Idaho
GSK Investigational Site
Meridian, Idaho, United States, 83642
United States, Kansas
GSK Investigational Site
Lenexa, Kansas, United States, 66219
United States, Montana
GSK Investigational Site
Missoula, Montana, United States, 59801
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89104
United States, New Jersey
GSK Investigational Site
Edison, New Jersey, United States, 08817
United States, New York
GSK Investigational Site
Rochester, New York, United States, 14609
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44122
Canada, British Columbia
GSK Investigational Site
Surrey, British Columbia, Canada, V3R 8P8
Canada, Nova Scotia
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2
Canada, Ontario
GSK Investigational Site
Toronto, Ontario, Canada, M9W 4L6
Canada, Quebec
GSK Investigational Site
Pointe-Claire, Quebec, Canada, H9R 4S3
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 113440
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 113440
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 113440
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 113440
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 113440
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 113440
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 113440
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00985088     History of Changes
Other Study ID Numbers: 113440
First Posted: September 28, 2009    Key Record Dates
Results First Posted: December 12, 2017
Last Update Posted: December 12, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL: http://

Keywords provided by GlaxoSmithKline:
GSK Bio's influenza vaccine GSK2340274A
influenza infection
GSK Bio's influenza vaccine GSK2340273A

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs