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.
Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,343
one or two intramuscular injections
one or two intramuscular injections
One injection
GSK Investigational Site
Huntsville, Alabama, United States
GSK Investigational Site
Jacksonville, Florida, United States
GSK Investigational Site
Miami, Florida, United States
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.
Time frame: At Day 0
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.
Time frame: At Day 21
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.
Time frame: At Day 0
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.
Time frame: At Day 21
Number of Seroconverted (SCR) Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California Virus Strain
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GSK Investigational Site
Meridian, Idaho, United States
GSK Investigational Site
Lenexa, Kansas, United States
GSK Investigational Site
Missoula, Montana, United States
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
Edison, New Jersey, United States
GSK Investigational Site
Rochester, New York, United States
GSK Investigational Site
Cleveland, Ohio, United States
...and 4 more locations
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).
Time frame: At Day 21
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).
Time frame: At Day 21
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).
Time frame: At Day 0
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).
Time frame: At Day 21
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).
Time frame: At Day 0
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).
Time frame: At Day 21
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).
Time frame: At Day 21
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).
Time frame: At Day 21
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.
Time frame: At Days 0 and 21
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.
Time frame: At Days 0 and 21
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.
Time frame: At Day 21
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.
Time frame: At Days 0 and 21
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.
Time frame: At Day 21
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.
Time frame: At Days 0 and 42
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.
Time frame: At Days 0 and 42
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.
Time frame: At Day 42
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.
Time frame: At Days 0 and 42
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.
Time frame: At Day 42
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.
Time frame: At Days 0 and 182
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.
Time frame: At Days 0 and 182
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.
Time frame: At Day 182
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.
Time frame: At Days 0 and 182
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.
Time frame: At Day 182
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.
Time frame: At Day 21
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.
Time frame: At Day 21
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.
Time frame: At Day 21
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.
Time frame: At Day 21
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.
Time frame: At Day 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.
Time frame: At Day 21
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.
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
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.
Time frame: During the 7-day (Day 0-6) post-vaccination period following each dose and across doses, for subjects > 64 years of age
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.
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
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.
Time frame: During the 7-day (Day 0-6) post-vaccination period following each dose and across doses, for subjects > 64 years of age
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).
Time frame: During the 7-day (Days 0-6) post-Dose 3 vaccination period, for subjects > 60 years of age
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).
Time frame: During the 7-day (Days 0-6) post-Dose 3 vaccination period, for subjects > 60 years of age
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.
Time frame: At Days 7, 21, 28, 42 and 182, for subjects between 18-64 years of age
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.
Time frame: At Days 7, 21, 28, 42 and 182, for subjects > 64 years of age
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).
Time frame: Days 0 to 385
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).
Time frame: Days 0 to 365
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.
Time frame: Within the 42-day (Days 0-41) post-vaccination period
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).
Time frame: Within the 84-day (Days 0-83) post-vaccination period
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).
Time frame: During the entire study period (from Day 0 to Day 385)