Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Influenza-specific CD4 T-Cells were stimulated in vitro with A/California virus and seasonal Influenza viruses, related antigens or derived peptides.
Stimulating antigens were A/Brisbane, A/California, pool peptides H1N1 and pool FLU.
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Influenza-specific CD8 T-Cells were stimulated in vitro with A/California virus and seasonal Influenza viruses, related antigens or derived peptides.
Stimulating antigens were A/Brisbane, A/California, pool peptides H1N1 and pool FLU.
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatase (AP), bilirubin (BIL) (total (T)), basophils (BAS). For each parameter and for each range it was assessed whether the values of the subjects were in unkown, above, below or within the range.
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Laboratory parameters assessed were creatinine (CREA), bilirubin (BIL) (direct (D)), eosinophils (EOS), hemoglobin (Hgb), hematocrit (Hct). For each parameter and for each range it was assessed whether the values of the subjects were unknown, in above, below or within the range.
Number of Subjects Reporting Solicited Local Symptoms.
Solicited local symptoms assessed were pain, redness and swelling
Number of Subjects Reporting Solicited General Symptoms.
Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature. Temperature is defined as an axillary temperature equal to or above 38.0 degrees Celsius (°C).
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Laboratory parameters assessed were serum urea nitrogen (SUN), white blood cells (WBC), red blood cells (RBC). For each parameter and for each range it was assessed whether the values of the subjects were unknown, above, below or within the range.
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.
Number of Subjects Reporting Medically Attended Visits (MAEs).
The day 368 was the last contact day for the last subject reporting the event. For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.
Number of Subjects Reporting Potential Immune Diseases (pIMDs).
The day 406 was the last contact day with the subjects reporting the event. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Number of Subjects Reporting Serious Adverse Events (SAEs).
The day 329 was the last contact day with the subjects reporting serious adverse events.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Laboratory parameters assessed were neutrophils (NEU), lymphocytes (LYM), monocytes (MON) and platelets (PLA). For each parameter and for each range it was assessed whether the values of the subjects were unknown, in above, below or within the range.
Microneutralization Antibody Titers Against A/California/7/2009 (H1N1) Strain.
Titers were expressed as geometric mean titers (GMTs) and measured by microneutralization.
Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1).
Microneutralization testing was cancelled.
Number of Subjects With a Microneutralization Titer Greater Than or Equal to 1:28 for Antibodies Against A/California/7/2009 (H1N1) Strain.
Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1).
The antibody cut-off value assessed was a titer of 1:10 and this value was considered as seropositivity.
Seronegative subject is a subject whose antibody titer is below the cut-off value, a seropositive subject is a subject whose antibody titer is greater than or equal to the cut-off value. Microneutralization titers < 1:28 were considered below the cut-off.
Microneutralization testing was cancelled.
Vaccine Response Rates (VRR) for Microneutralization Antibody Titers Against A/California/7/2009 (H1N1) Strain.
Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1).
Vaccine Response Rate for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0.
Microneutralization testing was cancelled.
Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.
The A/California vaccine virus-homologous antibody response was measured in subjects having received two doses of Arepanrix vaccine, with prior treatment with Flulaval vaccine 21 days before the first dose and in subjects having received two doses of Arepanrix vaccine alone.
Titers were expressed as geometric mean antibody titers (GMTs).
Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.
The A/California vaccine virus-homologous antibody response was measured in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine, with prior treatment with Flulaval vaccine 21 days before the first dose and in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine alone.
Titers were expressed as geometric mean antibody titers (GMTs).
Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.
The A/California vaccine virus-homologous antibody response was measured in subjects pre-treated with Flulaval who subsequently received two doses of the unadjuvanted formulation of Arepanrix vaccine compared to subjects pre-treated with Flulaval vaccine who subsequently received two doses of Arepanrix vaccine.
Titers were expressed as geometric mean antibody titers (GMTs).
Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.
The antibody response against each of the three Flulaval vaccine components in subjects exposed to co-administration of Flulaval vaccine with the first of two doses of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.
Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.
Titers were expressed as geometric mean antibody titers (GMTs).
Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.
The antibody response against each of the three Flulaval vaccine components in subjects exposed to co-administration of Flulaval vaccine with the first of two doses of the unadjuvanted formulation of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.
Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.
Titers were expressed as geometric mean antibody titers (GMTs).
Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.
The antibody response against each of the three Flulaval vaccine components in subjects exposed to pre-treatment with two doses of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.
Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.
Titers were expressed as geometric mean antibody titers (GMTs).
Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.
The antibody response against each of the three Flulaval vaccine components in subjects exposed to pre-treatment with two doses of the unadjuvanted formulation of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.
Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.
Titers were expressed as geometric mean antibody titers (GMTs).
Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain.
Titers were expressed as geometric mean antibody titers (GMTs).
Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain.
Titers were expressed as geometric mean antibody titers (GMTs).
Number of Seroconverted Subjects for Antibodies Against A/ California Strain.
Seroconversion rate was defined as the incidence rate of vaccinees who had either a pre-vaccination titer recorded as < 1:10 and a post-vaccination reciprocal titer ≥ 40 or a pre-vaccination reciprocal titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer.
Seroconversion defined as:
For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer
Number of Seroprotected Subjects for Antibodies Against A/California Strain.
Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.
Seroconversion Factor for Antibodies Against A/California Strain.
Seroconversion factor was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the prevaccination reciprocal HI titer.
Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains.
Seroconversion defined as:
For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled.
Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains
Seroprotection was defined as the proportion of subjects with H1N1 reciprocal Hemagglutination Inhibition (HI) titers ≥ 1:40 against the tested vaccine virus.
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled.
Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.
Seroconversion factor was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal Hemagglutination Inhibition (HI) titer to the prevaccination reciprocal HI titer.
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled.
Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains
Seroconversion defined as:
For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains
Seroconversion defined as:
For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.
Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.
Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.
Seroconversion factor of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.
Seroconversion factor of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.
Titers were expressed as geometric mean titers (GMTs).
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.
Titers were expressed as geometric mean titers (GMTs).
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.