Influenza
Conditions
Keywords
GSK Bio's influenza vaccine GSK2340274A, influenza infection, GSK Bio's influenza vaccine GSK2340273A
Brief summary
The purpose of this study is to characterize the safety and immunogenicity of the H1N1 (swine) flu vaccines GSK2340274A and GSK2340273A when co-administered with the seasonal flu vaccine in adults 19 to 40 years of age.
Detailed description
Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority
Interventions
Two intramuscular injections
Two intramuscular injections
Single intramuscular injection
Single intramuscular injection
Sponsors
Study design
Eligibility
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 or female adults, 19-40 years of age at the time of the first vaccination. * Safety laboratory tests results within the parameters specified in the protocol. * Satisfactory baseline medical assessment by 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
* Previous vaccination with an H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-like virus. * Prior receipt at any time of any seasonal influenza vaccine. * Planned administration of any vaccine not foreseen by the study protocol between Day 0 and the Day 63 phlebotomy. * Administration of any licensed vaccine within 4 weeks before the first study vaccine dose. * Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Receipt of systemic glucocorticoids within one month prior to study enrolment, or any other cytotoxic or immunosuppressive drug within six months of study enrolment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed. * Receipt of any immunoglobulins and/or any blood products within three months of study enrolment or planned administration of any of these products during the study period. * 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. * 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 six weeks of receipt of seasonal influenza vaccine. * 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 first vaccination. * Lactating or nursing women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain. | 21 days after the second dose of Arepanrix vaccine (at Day 42). | The A/California vaccine virus-homologous antibody response was measured in subjects having received Flulaval vaccine co-administered with the first dose of Arepanrix vaccine, and in subjects having received two doses of Arepanrix vaccine alone. Titers were expressed as geometric mean antibody titers (GMTs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | On Days 0, 7, 21, 28, 42, 63 and 182 | 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). | On Days 0, 7, 21, 28, 42, 63 and 182 | 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 | On Days 0, 7, 21, 28, 42, 63 and 182 | 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 Solicited Local Symptoms. | During a 7-day follow-up period (Days 0-6) post-vaccination period | Solicited local symptoms assessed were pain, redness and swelling |
| Number of Subjects Reporting Solicited General Symptoms. | During a 7-day follow-up period (Days 0-6) post-vaccination period | 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 Unsolicited Adverse Events (AEs). | Within the 84-day (Days 0-83) post-vaccination period. | 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). | During the entire study period (Days 0-368). | 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). | During the entire study period (Days 0-406). | 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). | During the entire study period (Days 0-329). | 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. |
| Microneutralization Antibody Titers Against A/California/7/2009 (H1N1) Strain. | On Days 0, 21, 42, 63 and 182 | 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. | On Days 0, 21, 42, 63 and 182 | 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. | On Days 0, 21, 42, 63 and 182 | 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. | 21 days after the second dose of Arepanrix vaccine (Day 63 for Flulaval/placebo/Arepanrix Group and Day 42 for Arepanrix/placebo/Flulaval Group) | 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 Each of the Three Flulaval Strains. | 21 days after the Flulaval vaccination (at Day 21). | 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). |
| Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | On Days 0, 21, 42 and 63 | Titers were expressed as geometric mean antibody titers (GMTs). |
| Number of Seroconverted Subjects for Antibodies Against A/ California Strain. | At Day 63 from Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 from Day 0 for the 4 other groups | 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. | At Day 63 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 for the 4 other groups. | 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. | At Day 63 from Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 from Day 0 for the 4 other groups | 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. | At Day 21 from Day 0 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 from Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group | 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 | At Day 21 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group | 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. | At Day 21 from Day 0 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 from Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group | 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 | on Days 21 and 63 from Day 0 for the first 4 groups; on Days 42 and 63 from Day 0 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups | 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. | before vaccination and on days 21 and 63 for the first 4 groups and before vaccination and on days 42 and 63 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups | 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. |
| Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | On Days 0, 21 and 63 for the first 4 groups and on Days 0, 42 and 63 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm. | 102 |
| Flulaval/Placebo/Arepanrix Group subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm. | 104 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm. | 102 |
| Flulaval/Arepanrix/Placebo Group subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm. | 100 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm. | 101 |
| Arepanrix/Placebo/Flulaval Group subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm. | 102 |
| Total | 611 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 7 | 6 | 10 | 5 | 3 |
| Overall Study | Other | 1 | 0 | 1 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 4 | 5 | 2 | 2 | 3 |
Baseline characteristics
| Characteristic | Flulaval/Placebo/Unadjuvanted Arepanrix Group | Flulaval/Placebo/Arepanrix Group | Flulaval/Unadjuvanted Arepanrix/Placebo Group | Flulaval/Arepanrix/Placebo Group | Unadjuvanted Arepanrix/Placebo/Flulaval Group | Arepanrix/Placebo/Flulaval Group | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 29.7 Years STANDARD_DEVIATION 6.2 | 28.6 Years STANDARD_DEVIATION 6.24 | 28.2 Years STANDARD_DEVIATION 6.32 | 29.2 Years STANDARD_DEVIATION 6.12 | 29.3 Years STANDARD_DEVIATION 6.47 | 28.1 Years STANDARD_DEVIATION 6.08 | 28.9 Years STANDARD_DEVIATION 6.2 |
| Sex: Female, Male Female | 53 Participants | 62 Participants | 54 Participants | 48 Participants | 60 Participants | 58 Participants | 335 Participants |
| Sex: Female, Male Male | 49 Participants | 42 Participants | 48 Participants | 52 Participants | 41 Participants | 44 Participants | 276 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 92 / 102 | 91 / 104 | 86 / 102 | 97 / 100 | 84 / 101 | 99 / 102 |
| serious Total, serious adverse events | 3 / 102 | 1 / 104 | 1 / 102 | 2 / 100 | 1 / 101 | 3 / 102 |
Outcome results
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 Flulaval vaccine co-administered with the first dose of the unadjuvanted formulation of Arepanrix vaccine, and in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine alone. Titers were expressed as geometric mean antibody titers (GMTs).
Time frame: 21 days after the second dose of the unadjuvanted formulation of Arepanrix vaccine (at Day 42)
Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain. | 271.2 Titers |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain. | 387.1 Titers |
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 Flulaval vaccine co-administered with the first dose of Arepanrix vaccine, and in subjects having received two doses of Arepanrix vaccine alone. Titers were expressed as geometric mean antibody titers (GMTs).
Time frame: 21 days after the second dose of Arepanrix vaccine (at Day 42).
Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Flulaval/Arepanrix/Placebo Group | Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain. | 589.8 Titers |
| Arepanrix/Placebo/Flulaval Group | Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain. | 933.1 Titers |
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).
Time frame: On Days 0, 21, 42 and 63
Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 0] (N=92;86;92;88;91;91) | 14.6 Titers |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 21] (N=92;86;92;89;91;91) | 31.1 Titers |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 42] (N=92;86;92;89;91;91) | 238.6 Titers |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 63] (N=92;86;92;89;91;91) | 254.2 Titers |
| Flulaval/Placebo/Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 42] (N=92;86;92;89;91;91) | 396.2 Titers |
| Flulaval/Placebo/Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 21] (N=92;86;92;89;91;91) | 26.3 Titers |
| Flulaval/Placebo/Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 0] (N=92;86;92;88;91;91) | 10.9 Titers |
| Flulaval/Placebo/Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 63] (N=92;86;92;89;91;91) | 645.2 Titers |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 63] (N=92;86;92;89;91;91) | 245.0 Titers |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 42] (N=92;86;92;89;91;91) | 271.2 Titers |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 21] (N=92;86;92;89;91;91) | 277.3 Titers |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 0] (N=92;86;92;88;91;91) | 13.0 Titers |
| Flulaval/Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 0] (N=92;86;92;88;91;91) | 10.7 Titers |
| Flulaval/Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 63] (N=92;86;92;89;91;91) | 426.9 Titers |
| Flulaval/Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 21] (N=92;86;92;89;91;91) | 361.0 Titers |
| Flulaval/Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 42] (N=92;86;92;89;91;91) | 589.8 Titers |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 42] (N=92;86;92;89;91;91) | 387.1 Titers |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 63] (N=92;86;92;89;91;91) | 345.3 Titers |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 21] (N=92;86;92;89;91;91) | 358.7 Titers |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 0] (N=92;86;92;88;91;91) | 9.3 Titers |
| Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 21] (N=92;86;92;89;91;91) | 659.8 Titers |
| Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 42] (N=92;86;92;89;91;91) | 933.1 Titers |
| Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 63] (N=92;86;92;89;91;91) | 704.0 Titers |
| Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | Flu A/Cal H1N1 [at Day 0] (N=92;86;92;88;91;91) | 10.1 Titers |
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).
Time frame: At Day 182
Population: The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | 136.6 Titers |
| Flulaval/Placebo/Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | 206.9 Titers |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | 151.7 Titers |
| Flulaval/Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | 171.7 Titers |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | 218.5 Titers |
| Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. | 323.6 Titers |
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.
Time frame: At Day 182 after dose 1 vaccination
Population: The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 Victoria | 339.9 Titers |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 68.5 Titers |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 89.5 Titers |
| Flulaval/Placebo/Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 87.7 Titers |
| Flulaval/Placebo/Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 89.2 Titers |
| Flulaval/Placebo/Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 Victoria | 273.8 Titers |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 87.1 Titers |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 87.4 Titers |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 Victoria | 245.4 Titers |
| Flulaval/Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 87.8 Titers |
| Flulaval/Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 64.6 Titers |
| Flulaval/Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 Victoria | 292.6 Titers |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 110.0 Titers |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 64.6 Titers |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 Victoria | 369.6 Titers |
| Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 83.7 Titers |
| Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 Victoria | 378.4 Titers |
| Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 127.2 Titers |
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.
Time frame: On Days 0, 21 and 63 for the first 4 groups and on Days 0, 42 and 63 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups
Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 63] | 506.7 Titers |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 21 or 42] | 145.1 Titers |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 0] | 10.1 Titers |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 0] | 52.6 Titers |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 21 or 42] | 662.1 Titers |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 63] | 134.4 Titers |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 63] | 120.2 Titers |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 0] | 17.3 Titers |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 21 or 42] | 175.7 Titers |
| Flulaval/Placebo/Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 0] | 11.8 Titers |
| Flulaval/Placebo/Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 0] | 47.3 Titers |
| Flulaval/Placebo/Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 63] | 186.5 Titers |
| Flulaval/Placebo/Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 0] | 16.7 Titers |
| Flulaval/Placebo/Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 63] | 471.2 Titers |
| Flulaval/Placebo/Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 21 or 42] | 183.5 Titers |
| Flulaval/Placebo/Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 21 or 42] | 215.7 Titers |
| Flulaval/Placebo/Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 21 or 42] | 658.3 Titers |
| Flulaval/Placebo/Arepanrix Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 63] | 138.4 Titers |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 63] | 157.0 Titers |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 63] | 132.0 Titers |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 21 or 42] | 181.7 Titers |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 63] | 359.6 Titers |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 0] | 18.8 Titers |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 0] | 8.8 Titers |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 0] | 45.4 Titers |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 21 or 42] | 478.8 Titers |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 21 or 42] | 226.3 Titers |
| Flulaval/Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 0] | 40.1 Titers |
| Flulaval/Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 21 or 42] | 158.7 Titers |
| Flulaval/Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 63] | 124.3 Titers |
| Flulaval/Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 0] | 10.2 Titers |
| Flulaval/Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 21 or 42] | 191.4 Titers |
| Flulaval/Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 63] | 145.6 Titers |
| Flulaval/Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 21 or 42] | 576.1 Titers |
| Flulaval/Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 63] | 433.5 Titers |
| Flulaval/Arepanrix/Placebo Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 0] | 16.2 Titers |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 63] | 216.1 Titers |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 21 or 42] | 12.5 Titers |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 21 or 42] | 74.7 Titers |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 0] | 10.4 Titers |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 21 or 42] | 32.9 Titers |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 63] | 644.9 Titers |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 63] | 137.4 Titers |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 0] | 14.6 Titers |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 0] | 56.7 Titers |
| Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 0] | 58.0 Titers |
| Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 21 or 42] | 19.1 Titers |
| Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 0] | 16.6 Titers |
| Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 21 or 42] | 53.2 Titers |
| Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 63] | 688.1 Titers |
| Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 21 or 42] | 139.5 Titers |
| Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 0] | 11.5 Titers |
| Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 63] | 221.9 Titers |
| Arepanrix/Placebo/Flulaval Group | Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 63] | 166.9 Titers |
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).
Time frame: 21 days after the second dose of Arepanrix vaccine (Day 63 for Flulaval/placebo/Arepanrix Group and Day 42 for Arepanrix/placebo/Flulaval Group)
Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Flulaval/Placebo/Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain. | 645.2 Titers |
| Arepanrix/Placebo/Flulaval Group | Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain. | 933.1 Titers |
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).
Time frame: 21 days after the second dose of the pandemic vaccine (at Day 63)
Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain. | 254.2 Titers |
| Flulaval/Placebo/Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain. | 645.2 Titers |
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).
Time frame: 21 days after the second dose of the unadjuvanted formulation of Arepanrix vaccine (Day 63 for Flulaval/placebo/unadjuvanted Arepanrix Group and Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group)
Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain. | 254.2 Titers |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain. | 387.1 Titers |
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).
Time frame: 21 days after the Flulaval vaccination (at Day 21).
Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/Uru/716/07 H3N2 | 175.7 Titers |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/Brisbane/59/07 H1N1 | 145.1 Titers |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu B/Brisbane/60/08 | 662.1 Titers |
| Flulaval/Placebo/Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/Uru/716/07 H3N2 | 183.5 Titers |
| Flulaval/Placebo/Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/Brisbane/59/07 H1N1 | 215.7 Titers |
| Flulaval/Placebo/Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu B/Brisbane/60/08 | 658.3 Titers |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/Brisbane/59/07 H1N1 | 226.3 Titers |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu B/Brisbane/60/08 | 478.8 Titers |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/Uru/716/07 H3N2 | 181.7 Titers |
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).
Time frame: 21 days after the Flulaval vaccination (Day 63 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups)
Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/Uru/716/07 H3N2 | 175.7 Titers |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/Bri/59/07 H1N1 | 145.1 Titers |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu B/Bri/60/08 | 662.1 Titers |
| Flulaval/Placebo/Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/Uru/716/07 H3N2 | 183.5 Titers |
| Flulaval/Placebo/Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/Bri/59/07 H1N1 | 215.7 Titers |
| Flulaval/Placebo/Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu B/Bri/60/08 | 658.3 Titers |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/Bri/59/07 H1N1 | 137.4 Titers |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu B/Bri/60/08 | 644.9 Titers |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/Uru/716/07 H3N2 | 216.1 Titers |
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).
Time frame: 21 days after the Flulaval vaccination (Day 63 for Arepanrix/placebo/Flulaval Group and Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups)
Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/Uru/716/07 H3N2 | 175.7 Titers |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/BRI/59/07 H1N1 | 145.1 Titers |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu B/Bri/60/08 | 662.1 Titers |
| Flulaval/Placebo/Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/Uru/716/07 H3N2 | 183.5 Titers |
| Flulaval/Placebo/Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/BRI/59/07 H1N1 | 215.7 Titers |
| Flulaval/Placebo/Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu B/Bri/60/08 | 658.3 Titers |
| Arepanrix/Placebo/Flulaval Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/BRI/59/07 H1N1 | 166.9 Titers |
| Arepanrix/Placebo/Flulaval Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu B/Bri/60/08 | 688.1 Titers |
| Arepanrix/Placebo/Flulaval Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/Uru/716/07 H3N2 | 221.9 Titers |
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).
Time frame: 21 days after the Flulaval vaccination (at Day 21).
Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/Uru/716/07 H3N2 | 175.7 Titers |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/BRI/59/07 H1N1 | 145.1 Titers |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu B/Bri/60/08 | 662.1 Titers |
| Flulaval/Placebo/Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/Uru/716/07 H3N2 | 183.5 Titers |
| Flulaval/Placebo/Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/BRI/59/07 H1N1 | 215.7 Titers |
| Flulaval/Placebo/Arepanrix Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu B/Bri/60/08 | 658.3 Titers |
| Flulaval/Arepanrix/Placebo Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/BRI/59/07 H1N1 | 158.7 Titers |
| Flulaval/Arepanrix/Placebo Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu B/Bri/60/08 | 576.1 Titers |
| Flulaval/Arepanrix/Placebo Group | Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. | Flu A/Uru/716/07 H3N2 | 191.4 Titers |
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.
Time frame: On Days 0, 21, 42, 63 and 182
Population: Microneutralization testing was cancelled.
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.
Time frame: On Days 0, 7, 21, 28, 42, 63 and 182
Population: The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at day 182.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool Flu [D0] (N=24,25,24,25,25,24) | 3286.63 Number of T cells/million | Standard Deviation 1710 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool peptides H1 [D7] (N=24,27,24,23,24,25) | 596.42 Number of T cells/million | Standard Deviation 500.15 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/Brisbane [D7] (N=24,27,24,23,24,26) | 4437.33 Number of T cells/million | Standard Deviation 1930.3 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool peptides H1 [D28] (N=26,27,27,26,25,27) | 480.42 Number of T cells/million | Standard Deviation 392.81 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/Brisbane [D0] (N=25,25,24,25,25,26) | 2533.40 Number of T cells/million | Standard Deviation 1225.9 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/Brisbane [D63] (N=26,26,25,25,24,26) | 3407.62 Number of T cells/million | Standard Deviation 1114.62 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool peptides H1 [D42] (N=27,27,27,27,24,28) | 467.70 Number of T cells/million | Standard Deviation 302.91 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/California [D182] (N=26,24,26,26,25,25) | 1461.88 Number of T cells/million | Standard Deviation 735.77 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/Brisbane [D28] (N=27,27,27,26,25,27) | 3500.22 Number of T cells/million | Standard Deviation 1615.89 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/California [D0] (N=25,25,24,25,25,26) | 2176.28 Number of T cells/million | Standard Deviation 1226.08 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool Flu [D42] (N=26,27,27,26,24,27) | 4734.42 Number of T cells/million | Standard Deviation 1823.28 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool Flu [D182] (N=26,24,26,26,25,25) | 3304.50 Number of T cells/million | Standard Deviation 1393.44 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool Flu [D63] (N=25,26,25,25,24,24) | 4405.96 Number of T cells/million | Standard Deviation 1586.42 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool peptides H1 [D63] (N=26,26,25,25,24,26) | 504.92 Number of T cells/million | Standard Deviation 321.17 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/California [D63] (N=26,26,25,25,24,26) | 2768.15 Number of T cells/million | Standard Deviation 1109.96 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool peptides H1 [D0] (N=25,24,24,25,23,25) | 349.64 Number of T cells/million | Standard Deviation 336.13 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool Flu [D28] (N=25,27,27,26,25,26) | 4767.36 Number of T cells/million | Standard Deviation 2217.82 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/Brisbane [D182] (N=26,24,26,26,25,25) | 3190.31 Number of T cells/million | Standard Deviation 1086.38 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/California [D7] (N=24,27,24,23,24,26) | 4089.25 Number of T cells/million | Standard Deviation 2131.69 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool peptides H1 [D21] (N=26,24,27,24,24,26) | 465.42 Number of T cells/million | Standard Deviation 352.18 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/California [D21] (N=26,25,27,24,24,26) | 3144.62 Number of T cells/million | Standard Deviation 1723.51 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool Flu [D21] (N=25,25,27,24,24,25) | 5234.16 Number of T cells/million | Standard Deviation 2513.78 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool Flu [D7] (N=24,27,24,23,24,25) | 6574.50 Number of T cells/million | Standard Deviation 3399.35 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/Brisbane [D42] (N=27,26,27,27,24,28) | 3595.11 Number of T cells/million | Standard Deviation 1268.17 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/Brisbane [D21] (N=26,25,27,24,24,26) | 3561.00 Number of T cells/million | Standard Deviation 1502.24 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool peptides H1 [D182] (N=26,24,26,26,25,25) | 554.65 Number of T cells/million | Standard Deviation 439.3 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/California [D42] (N=27,27,27,27,24,28) | 2931.04 Number of T cells/million | Standard Deviation 1276.42 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/California [D28] (N=27,27,27,26,25,27) | 3061.63 Number of T cells/million | Standard Deviation 1632.58 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool peptides H1 [D21] (N=26,24,27,24,24,26) | 589.79 Number of T cells/million | Standard Deviation 459.57 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/California [D182] (N=26,24,26,26,25,25) | 2333.88 Number of T cells/million | Standard Deviation 925.38 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/California [D28] (N=27,27,27,26,25,27) | 3770.44 Number of T cells/million | Standard Deviation 1460.62 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool Flu [D28] (N=25,27,27,26,25,26) | 5256.07 Number of T cells/million | Standard Deviation 2292.16 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/California [D42] (N=27,27,27,27,24,28) | 4381.48 Number of T cells/million | Standard Deviation 2053.51 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/California [D63] (N=26,26,25,25,24,26) | 5328.19 Number of T cells/million | Standard Deviation 2436.59 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/Brisbane [D182] (N=26,24,26,26,25,25) | 4631.00 Number of T cells/million | Standard Deviation 1834.57 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/Brisbane [D7] (N=24,27,24,23,24,26) | 4595.26 Number of T cells/million | Standard Deviation 2058.76 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool peptides H1 [D182] (N=26,24,26,26,25,25) | 824.17 Number of T cells/million | Standard Deviation 565.53 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool Flu [D0] (N=24,25,24,25,25,24) | 3531.36 Number of T cells/million | Standard Deviation 1972.37 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool Flu [D7] (N=24,27,24,23,24,25) | 6921.85 Number of T cells/million | Standard Deviation 4366.14 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool Flu [D21] (N=25,25,27,24,24,25) | 5124.60 Number of T cells/million | Standard Deviation 2268.53 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool Flu [D182] (N=26,24,26,26,25,25) | 4325.63 Number of T cells/million | Standard Deviation 1541.34 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool peptides H1 [D63] (N=26,26,25,25,24,26) | 1248.54 Number of T cells/million | Standard Deviation 1175.35 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool Flu [D63] (N=25,26,25,25,24,24) | 6639.92 Number of T cells/million | Standard Deviation 3131.66 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool peptides H1 [D42] (N=27,27,27,27,24,28) | 1049.96 Number of T cells/million | Standard Deviation 865.58 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/Brisbane [D0] (N=25,25,24,25,25,26) | 2604.64 Number of T cells/million | Standard Deviation 1435.48 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool peptides H1 [D28] (N=26,27,27,26,25,27) | 704.59 Number of T cells/million | Standard Deviation 518.63 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/Brisbane [D21] (N=26,25,27,24,24,26) | 3756.72 Number of T cells/million | Standard Deviation 1379.69 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool Flu [D42] (N=26,27,27,26,24,27) | 5881.78 Number of T cells/million | Standard Deviation 2641.14 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/Brisbane [D28] (N=27,27,27,26,25,27) | 4269.11 Number of T cells/million | Standard Deviation 1482.01 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/California [D21] (N=26,25,27,24,24,26) | 3032.52 Number of T cells/million | Standard Deviation 1342.3 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/Brisbane [D63] (N=26,26,25,25,24,26) | 6444.50 Number of T cells/million | Standard Deviation 2681.5 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/Brisbane [D42] (N=27,26,27,27,24,28) | 5246.88 Number of T cells/million | Standard Deviation 2407.94 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool peptides H1 [D7] (N=24,27,24,23,24,25) | 581.63 Number of T cells/million | Standard Deviation 527.07 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/California [D0] (N=25,25,24,25,25,26) | 1988.24 Number of T cells/million | Standard Deviation 1072.73 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/California [D7] (N=24,27,24,23,24,26) | 3852.44 Number of T cells/million | Standard Deviation 1970.35 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool peptides H1 [D0] (N=25,24,24,25,23,25) | 428.00 Number of T cells/million | Standard Deviation 296.76 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/Brisbane [D7] (N=24,27,24,23,24,26) | 5560.33 Number of T cells/million | Standard Deviation 3301.9 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/Brisbane [D21] (N=26,25,27,24,24,26) | 5581.78 Number of T cells/million | Standard Deviation 3123.38 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/California [D42] (N=27,27,27,27,24,28) | 3720.07 Number of T cells/million | Standard Deviation 2261.08 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool peptides H1 [D21] (N=26,24,27,24,24,26) | 728.15 Number of T cells/million | Standard Deviation 623.89 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool peptides H1 [D0] (N=25,24,24,25,23,25) | 356.79 Number of T cells/million | Standard Deviation 206.44 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/Brisbane [D28] (N=27,27,27,26,25,27) | 5102.78 Number of T cells/million | Standard Deviation 2856.77 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool peptides H1 [D28] (N=26,27,27,26,25,27) | 528.78 Number of T cells/million | Standard Deviation 322.1 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/California [D28] (N=27,27,27,26,25,27) | 4058.63 Number of T cells/million | Standard Deviation 2349.19 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/California [D182] (N=26,24,26,26,25,25) | 1838.96 Number of T cells/million | Standard Deviation 842.26 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/Brisbane [D63] (N=26,26,25,25,24,26) | 4169.32 Number of T cells/million | Standard Deviation 2216.49 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/California [D7] (N=24,27,24,23,24,26) | 4780.21 Number of T cells/million | Standard Deviation 2828.25 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/Brisbane [D182] (N=26,24,26,26,25,25) | 4132.81 Number of T cells/million | Standard Deviation 1816.7 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/Brisbane [D42] (N=27,26,27,27,24,28) | 4791.41 Number of T cells/million | Standard Deviation 2706.43 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool peptides H1 [D7] (N=24,27,24,23,24,25) | 708.96 Number of T cells/million | Standard Deviation 518.87 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool Flu [D28] (N=25,27,27,26,25,26) | 6090.00 Number of T cells/million | Standard Deviation 3336.49 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool Flu [D63] (N=25,26,25,25,24,24) | 4893.88 Number of T cells/million | Standard Deviation 2322.1 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool peptides H1 [D42] (N=27,27,27,27,24,28) | 514.78 Number of T cells/million | Standard Deviation 296.67 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool Flu [D42] (N=26,27,27,26,24,27) | 5721.70 Number of T cells/million | Standard Deviation 3058.63 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool peptides H1 [D63] (N=26,26,25,25,24,26) | 460.28 Number of T cells/million | Standard Deviation 267.85 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/California [D63] (N=26,26,25,25,24,26) | 3149.00 Number of T cells/million | Standard Deviation 1844.25 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool Flu [D21] (N=25,25,27,24,24,25) | 6579.26 Number of T cells/million | Standard Deviation 3489.2 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool peptides H1 [D182] (N=26,24,26,26,25,25) | 531.73 Number of T cells/million | Standard Deviation 481.91 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/California [D21] (N=26,25,27,24,24,26) | 4455.00 Number of T cells/million | Standard Deviation 2768.12 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/Brisbane [D0] (N=25,25,24,25,25,26) | 3521.33 Number of T cells/million | Standard Deviation 1922.24 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/California [D0] (N=25,25,24,25,25,26) | 2804.63 Number of T cells/million | Standard Deviation 1912.94 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool Flu [D182] (N=26,24,26,26,25,25) | 4006.46 Number of T cells/million | Standard Deviation 1836.3 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool Flu [D7] (N=24,27,24,23,24,25) | 7096.46 Number of T cells/million | Standard Deviation 3777.79 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool Flu [D0] (N=24,25,24,25,25,24) | 4315.71 Number of T cells/million | Standard Deviation 2499.77 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool peptides H1 [D21] (N=26,24,27,24,24,26) | 974.67 Number of T cells/million | Standard Deviation 579.23 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/Brisbane [D7] (N=24,27,24,23,24,26) | 6242.30 Number of T cells/million | Standard Deviation 2773.6 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/Brisbane [D42] (N=27,26,27,27,24,28) | 5607.96 Number of T cells/million | Standard Deviation 2773.17 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/California [D21] (N=26,25,27,24,24,26) | 4986.71 Number of T cells/million | Standard Deviation 2398.42 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool Flu [D7] (N=24,27,24,23,24,25) | 7682.43 Number of T cells/million | Standard Deviation 2951.47 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool Flu [D21] (N=25,25,27,24,24,25) | 6949.96 Number of T cells/million | Standard Deviation 3006.25 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool Flu [D42] (N=26,27,27,26,24,27) | 6239.38 Number of T cells/million | Standard Deviation 2542.17 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool Flu [D182] (N=26,24,26,26,25,25) | 3937.67 Number of T cells/million | Standard Deviation 1413.94 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/Brisbane [D21] (N=26,25,27,24,24,26) | 6069.67 Number of T cells/million | Standard Deviation 3306.79 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/Brisbane [D28] (N=27,27,27,26,25,27) | 6989.15 Number of T cells/million | Standard Deviation 3950.45 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/Brisbane [D63] (N=26,26,25,25,24,26) | 5020.88 Number of T cells/million | Standard Deviation 2346.39 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/Brisbane [D182] (N=26,24,26,26,25,25) | 3988.04 Number of T cells/million | Standard Deviation 1606.16 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/California [D0] (N=25,25,24,25,25,26) | 2055.44 Number of T cells/million | Standard Deviation 1053.95 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/California [D7] (N=24,27,24,23,24,26) | 5265.74 Number of T cells/million | Standard Deviation 2008.41 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/California [D28] (N=27,27,27,26,25,27) | 5979.12 Number of T cells/million | Standard Deviation 3448.84 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/California [D42] (N=27,27,27,27,24,28) | 4658.07 Number of T cells/million | Standard Deviation 1939.82 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/California [D63] (N=26,26,25,25,24,26) | 3967.12 Number of T cells/million | Standard Deviation 1655.09 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/California [D182] (N=26,24,26,26,25,25) | 2068.73 Number of T cells/million | Standard Deviation 939.92 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool peptides H1 [D0] (N=25,24,24,25,23,25) | 320.52 Number of T cells/million | Standard Deviation 216.19 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool peptides H1 [D7] (N=24,27,24,23,24,25) | 857.04 Number of T cells/million | Standard Deviation 474.48 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/Brisbane [D0] (N=25,25,24,25,25,26) | 2612.56 Number of T cells/million | Standard Deviation 1256.47 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool peptides H1 [D28] (N=26,27,27,26,25,27) | 1345.69 Number of T cells/million | Standard Deviation 1536.94 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool peptides H1 [D42] (N=27,27,27,27,24,28) | 1080.93 Number of T cells/million | Standard Deviation 669.26 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool peptides H1 [D63] (N=26,26,25,25,24,26) | 815.24 Number of T cells/million | Standard Deviation 634.45 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool peptides H1 [D182] (N=26,24,26,26,25,25) | 648.69 Number of T cells/million | Standard Deviation 557.34 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool Flu [D0] (N=24,25,24,25,25,24) | 3056.80 Number of T cells/million | Standard Deviation 1096.38 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool Flu [D28] (N=25,27,27,26,25,26) | 7265.23 Number of T cells/million | Standard Deviation 3520.63 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool Flu [D63] (N=25,26,25,25,24,24) | 5323.84 Number of T cells/million | Standard Deviation 2132.52 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D21] (N=26,24,27,24,24,26) | 619.50 Number of T cells/million | Standard Deviation 391.47 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D0] (N=25,24,24,25,23,25) | 443.35 Number of T cells/million | Standard Deviation 356.02 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/California [D0] (N=25,25,24,25,25,26) | 2109.52 Number of T cells/million | Standard Deviation 828.11 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D182] (N=26,24,26,26,25,25) | 3672.16 Number of T cells/million | Standard Deviation 1191.85 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D42] (N=27,26,27,27,24,28) | 3872.67 Number of T cells/million | Standard Deviation 1270.26 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D7] (N=24,27,24,23,24,25) | 692.29 Number of T cells/million | Standard Deviation 454.48 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D63] (N=26,26,25,25,24,26) | 4074.38 Number of T cells/million | Standard Deviation 1639.45 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D28] (N=27,27,27,26,25,27) | 3816.20 Number of T cells/million | Standard Deviation 1290.25 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D21] (N=26,25,27,24,24,26) | 3894.54 Number of T cells/million | Standard Deviation 1596.44 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D0] (N=25,25,24,25,25,26) | 2644.40 Number of T cells/million | Standard Deviation 1219.04 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D28] (N=26,27,27,26,25,27) | 642.00 Number of T cells/million | Standard Deviation 379.9 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D182] (N=26,24,26,26,25,25) | 3918.28 Number of T cells/million | Standard Deviation 1284.32 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D42] (N=27,27,27,27,24,28) | 600.04 Number of T cells/million | Standard Deviation 496.71 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D42] (N=26,27,27,26,24,27) | 4167.63 Number of T cells/million | Standard Deviation 1351.74 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D28] (N=25,27,27,26,25,26) | 4047.92 Number of T cells/million | Standard Deviation 1219 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D63] (N=26,26,25,25,24,26) | 508.58 Number of T cells/million | Standard Deviation 316.75 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D7] (N=24,27,24,23,24,25) | 4668.17 Number of T cells/million | Standard Deviation 1675.47 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D7] (N=24,27,24,23,24,26) | 4269.96 Number of T cells/million | Standard Deviation 1744.37 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D182] (N=26,24,26,26,25,25) | 552.52 Number of T cells/million | Standard Deviation 528.46 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D63] (N=25,26,25,25,24,24) | 4900.17 Number of T cells/million | Standard Deviation 2016.61 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D0] (N=24,25,24,25,25,24) | 3308.08 Number of T cells/million | Standard Deviation 1124.49 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/California [D28] (N=27,27,27,26,25,27) | 2875.52 Number of T cells/million | Standard Deviation 837.73 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D21] (N=25,25,27,24,24,25) | 4329.96 Number of T cells/million | Standard Deviation 1672.2 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/California [D63] (N=26,26,25,25,24,26) | 3246.71 Number of T cells/million | Standard Deviation 1379.49 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/California [D42] (N=27,27,27,27,24,28) | 2838.00 Number of T cells/million | Standard Deviation 1008.2 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/California [D21] (N=26,25,27,24,24,26) | 2975.38 Number of T cells/million | Standard Deviation 1058.31 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/California [D182] (N=26,24,26,26,25,25) | 1630.40 Number of T cells/million | Standard Deviation 592.23 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/California [D7] (N=24,27,24,23,24,26) | 3224.42 Number of T cells/million | Standard Deviation 1238.08 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/California [D21] (N=26,25,27,24,24,26) | 4793.35 Number of T cells/million | Standard Deviation 2194.74 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D42] (N=27,26,27,27,24,28) | 6200.64 Number of T cells/million | Standard Deviation 2733.75 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D21] (N=26,25,27,24,24,26) | 5590.23 Number of T cells/million | Standard Deviation 2407.32 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D0] (N=25,24,24,25,23,25) | 271.76 Number of T cells/million | Standard Deviation 180.44 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/California [D182] (N=26,24,26,26,25,25) | 2513.48 Number of T cells/million | Standard Deviation 1232.2 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D182] (N=26,24,26,26,25,25) | 4568.16 Number of T cells/million | Standard Deviation 2043.61 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D63] (N=26,26,25,25,24,26) | 910.81 Number of T cells/million | Standard Deviation 482.86 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/California [D42] (N=27,27,27,27,24,28) | 5622.14 Number of T cells/million | Standard Deviation 2870.26 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D21] (N=25,25,27,24,24,25) | 5691.08 Number of T cells/million | Standard Deviation 2047.1 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D7] (N=24,27,24,23,24,25) | 718.76 Number of T cells/million | Standard Deviation 663.81 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D63] (N=26,26,25,25,24,26) | 5757.04 Number of T cells/million | Standard Deviation 3131.86 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D182] (N=26,24,26,26,25,25) | 757.68 Number of T cells/million | Standard Deviation 638.4 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D42] (N=27,27,27,27,24,28) | 1228.25 Number of T cells/million | Standard Deviation 637.35 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D7] (N=24,27,24,23,24,26) | 4674.88 Number of T cells/million | Standard Deviation 2325.77 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/California [D0] (N=25,25,24,25,25,26) | 1641.04 Number of T cells/million | Standard Deviation 799.39 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D21] (N=26,24,27,24,24,26) | 1022.38 Number of T cells/million | Standard Deviation 572.5 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D0] (N=25,25,24,25,25,26) | 2016.31 Number of T cells/million | Standard Deviation 822.34 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/California [D63] (N=26,26,25,25,24,26) | 5151.62 Number of T cells/million | Standard Deviation 3008.33 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D28] (N=27,27,27,26,25,27) | 7083.19 Number of T cells/million | Standard Deviation 3227.04 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/California [D7] (N=24,27,24,23,24,26) | 3590.08 Number of T cells/million | Standard Deviation 1912.94 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D28] (N=26,27,27,26,25,27) | 1251.07 Number of T cells/million | Standard Deviation 695.04 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D182] (N=26,24,26,26,25,25) | 4277.76 Number of T cells/million | Standard Deviation 1655.16 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D0] (N=24,25,24,25,25,24) | 2775.50 Number of T cells/million | Standard Deviation 1214.18 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D63] (N=25,26,25,25,24,24) | 6455.25 Number of T cells/million | Standard Deviation 2694.48 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D42] (N=26,27,27,26,24,27) | 6215.93 Number of T cells/million | Standard Deviation 2389.59 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/California [D28] (N=27,27,27,26,25,27) | 6689.44 Number of T cells/million | Standard Deviation 3501.59 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D7] (N=24,27,24,23,24,25) | 4713.28 Number of T cells/million | Standard Deviation 2161.14 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D28] (N=25,27,27,26,25,26) | 6804.42 Number of T cells/million | Standard Deviation 2824.8 |
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.
Time frame: On Days 0, 7, 21, 28, 42, 63 and 182
Population: The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at day 182.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool Flu [D42] (N=26,27,27,26,24,27) | 506.35 Number of T cells/million | Standard Deviation 560.83 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/Brisbane [D182] (N=26,24,26,26,25,25) | 550.27 Number of T cells/million | Standard Deviation 1948.06 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool peptides H1 [D42] (N=27,27,27,27,24,28) | 143.67 Number of T cells/million | Standard Deviation 189.28 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/California [D21] (N=26,25,27,24,24,26) | 332.00 Number of T cells/million | Standard Deviation 539.48 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/California [D7] (N=24,27,24,23,24,26) | 610.29 Number of T cells/million | Standard Deviation 744.7 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/Brisbane [D21] (N=26,25,27,24,24,26) | 601.31 Number of T cells/million | Standard Deviation 1154.73 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool Flu [D63] (N=25,26,25,25,24,24) | 461.20 Number of T cells/million | Standard Deviation 698.48 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/California [D0] (N=25,25,24,25,25,26) | 357.40 Number of T cells/million | Standard Deviation 800.46 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool peptides H1 [D182] (N=26,24,26,26,25,25) | 287.31 Number of T cells/million | Standard Deviation 511.19 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool peptides H1 [D28] (N=26,27,27,26,25,27) | 100.08 Number of T cells/million | Standard Deviation 132.13 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/Brisbane [D0] (N=25,25,24,25,25,26) | 515.36 Number of T cells/million | Standard Deviation 1191.1 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool peptides H1 [D21] (N=26,24,27,24,24,26) | 103.81 Number of T cells/million | Standard Deviation 160.76 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool Flu [D7] (N=24,27,24,23,24,25) | 986.92 Number of T cells/million | Standard Deviation 863.16 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool Flu [D21] (N=25,25,27,24,24,25) | 586.32 Number of T cells/million | Standard Deviation 876.08 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool Flu [D0] (N=24,25,24,25,25,24) | 351.38 Number of T cells/million | Standard Deviation 467.93 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool Flu [D182] (N=26,24,26,26,25,25) | 404.77 Number of T cells/million | Standard Deviation 981.01 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool peptides H1 [D7] (N=24,27,24,23,24,25) | 205.33 Number of T cells/million | Standard Deviation 288.67 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/California [D28] (N=27,27,27,26,25,27) | 470.33 Number of T cells/million | Standard Deviation 655.02 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool peptides H1 [D0] (N=25,24,24,25,23,25) | 110.48 Number of T cells/million | Standard Deviation 140.31 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/Brisbane [D28] (N=27,27,27,26,25,27) | 629.22 Number of T cells/million | Standard Deviation 964.11 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/Brisbane [D63] (N=26,26,25,25,24,26) | 620.00 Number of T cells/million | Standard Deviation 1393.77 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/California [D182] (N=26,24,26,26,25,25) | 214.85 Number of T cells/million | Standard Deviation 326.43 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/Brisbane [D7] (N=24,27,24,23,24,26) | 772.96 Number of T cells/million | Standard Deviation 716.4 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/Brisbane [D42] (N=27,26,27,27,24,28) | 666.67 Number of T cells/million | Standard Deviation 1180.05 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool peptides H1 [D63] (N=26,26,25,25,24,26) | 85.96 Number of T cells/million | Standard Deviation 97.66 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/California [D63] (N=26,2625,25,24,26) | 203.62 Number of T cells/million | Standard Deviation 197.89 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | Pool Flu [D28] (N=25,27,27,26,25,26) | 484.48 Number of T cells/million | Standard Deviation 587.46 |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | 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). | A/California [D42] (N=27,27,27,27,24,28) | 314.89 Number of T cells/million | Standard Deviation 289.95 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool Flu [D63] (N=25,26,25,25,24,24) | 325.12 Number of T cells/million | Standard Deviation 270.84 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool Flu [D21] (N=25,25,27,24,24,25) | 268.24 Number of T cells/million | Standard Deviation 324.48 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool Flu [D28] (N=25,27,27,26,25,26) | 508.11 Number of T cells/million | Standard Deviation 559.97 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/Brisbane [D0] (N=25,25,24,25,25,26) | 382.84 Number of T cells/million | Standard Deviation 595.58 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/California [D28] (N=27,27,27,26,25,27) | 452.93 Number of T cells/million | Standard Deviation 547.61 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/Brisbane [D7] (N=24,27,24,23,24,26) | 884.81 Number of T cells/million | Standard Deviation 1225.9 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/Brisbane [D63] (N=26,26,25,25,24,26) | 420.50 Number of T cells/million | Standard Deviation 486.62 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/Brisbane [D182] (N=26,24,26,26,25,25) | 436.79 Number of T cells/million | Standard Deviation 653.5 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/California [D0] (N=25,25,24,25,25,26) | 189.28 Number of T cells/million | Standard Deviation 197.92 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/Brisbane [D21] (N=26,25,27,24,24,26) | 517.44 Number of T cells/million | Standard Deviation 799.2 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/California [D7] (N=24,27,24,23,24,26) | 466.93 Number of T cells/million | Standard Deviation 573.69 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool Flu [D42] (N=26,27,27,26,24,27) | 356.41 Number of T cells/million | Standard Deviation 392.23 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/California [D21] (N=26,25,27,24,24,26) | 275.04 Number of T cells/million | Standard Deviation 334.83 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/California [D42] (N=27,27,27,27,24,28) | 304.00 Number of T cells/million | Standard Deviation 255.38 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/California [D63] (N=26,2625,25,24,26) | 260.54 Number of T cells/million | Standard Deviation 359.88 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/California [D182] (N=26,24,26,26,25,25) | 220.71 Number of T cells/million | Standard Deviation 330.88 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool peptides H1 [D0] (N=25,24,24,25,23,25) | 180.38 Number of T cells/million | Standard Deviation 359.58 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/Brisbane [D28] (N=27,27,27,26,25,27) | 642.22 Number of T cells/million | Standard Deviation 850.79 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool Flu [D7] (N=24,27,24,23,24,25) | 843.44 Number of T cells/million | Standard Deviation 826.65 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool peptides H1 [D7] (N=24,27,24,23,24,25) | 185.15 Number of T cells/million | Standard Deviation 243.88 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool peptides H1 [D21] (N=26,24,27,24,24,26) | 194.92 Number of T cells/million | Standard Deviation 384.18 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool peptides H1 [D28] (N=26,27,27,26,25,27) | 170.04 Number of T cells/million | Standard Deviation 385.99 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool peptides H1 [D42] (N=27,27,27,27,24,28) | 157.41 Number of T cells/million | Standard Deviation 350.83 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool Flu [D182] (N=26,24,26,26,25,25) | 315.75 Number of T cells/million | Standard Deviation 441.5 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool peptides H1 [D63] (N=26,26,25,25,24,26) | 173.88 Number of T cells/million | Standard Deviation 244.91 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool Flu [D0] (N=24,25,24,25,25,24) | 224.60 Number of T cells/million | Standard Deviation 251.59 |
| Flulaval/Placebo/Arepanrix Group | 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). | Pool peptides H1 [D182] (N=26,24,26,26,25,25) | 265.63 Number of T cells/million | Standard Deviation 343.36 |
| Flulaval/Placebo/Arepanrix Group | 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). | A/Brisbane [D42] (N=27,26,27,27,24,28) | 551.88 Number of T cells/million | Standard Deviation 911.02 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/California [D42] (N=27,27,27,27,24,28) | 247.89 Number of T cells/million | Standard Deviation 459.58 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/Brisbane [D7] (N=24,27,24,23,24,26) | 1115.96 Number of T cells/million | Standard Deviation 1545.07 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/Brisbane [D63] (N=26,26,25,25,24,26) | 428.92 Number of T cells/million | Standard Deviation 687.17 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/California [D63] (N=26,2625,25,24,26) | 242.36 Number of T cells/million | Standard Deviation 357.21 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool Flu [D182] (N=26,24,26,26,25,25) | 334.23 Number of T cells/million | Standard Deviation 447.12 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/California [D28] (N=27,27,27,26,25,27) | 332.63 Number of T cells/million | Standard Deviation 553.07 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/California [D182] (N=26,24,26,26,25,25) | 225.50 Number of T cells/million | Standard Deviation 366.51 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool Flu [D7] (N=24,27,24,23,24,25) | 1042.17 Number of T cells/million | Standard Deviation 1237.44 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/Brisbane [D0] (N=25,25,24,25,25,26) | 489.08 Number of T cells/million | Standard Deviation 520.3 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool Flu [D0] (N=24,25,24,25,25,24) | 478.42 Number of T cells/million | Standard Deviation 463.43 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool peptides H1 [D0] (N=25,24,24,25,23,25) | 101.04 Number of T cells/million | Standard Deviation 158.31 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool Flu [D63] (N=25,26,25,25,24,24) | 402.24 Number of T cells/million | Standard Deviation 418.89 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool peptides H1 [D63] (N=26,26,25,25,24,26) | 113.20 Number of T cells/million | Standard Deviation 193.78 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool peptides H1 [D7] (N=24,27,24,23,24,25) | 202.13 Number of T cells/million | Standard Deviation 293.11 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/Brisbane [D28] (N=27,27,27,26,25,27) | 498.33 Number of T cells/million | Standard Deviation 730.34 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool Flu [D42] (N=26,27,27,26,24,27) | 471.30 Number of T cells/million | Standard Deviation 610.38 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool peptides H1 [D21] (N=26,24,27,24,24,26) | 101.30 Number of T cells/million | Standard Deviation 148.62 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool Flu [D28] (N=25,27,27,26,25,26) | 505.33 Number of T cells/million | Standard Deviation 595.15 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool Flu [D21] (N=25,25,27,24,24,25) | 609.07 Number of T cells/million | Standard Deviation 997.1 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool peptides H1 [D28] (N=26,27,27,26,25,27) | 124.56 Number of T cells/million | Standard Deviation 181.86 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/California [D0] (N=25,25,24,25,25,26) | 271.58 Number of T cells/million | Standard Deviation 192.68 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/California [D7] (N=24,27,24,23,24,26) | 716.88 Number of T cells/million | Standard Deviation 1251.2 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/Brisbane [D21] (N=26,25,27,24,24,26) | 655.22 Number of T cells/million | Standard Deviation 1327 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/Brisbane [D42] (N=27,26,27,27,24,28) | 525.07 Number of T cells/million | Standard Deviation 938.18 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/Brisbane [D182] (N=26,24,26,26,25,25) | 377.65 Number of T cells/million | Standard Deviation 426.59 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool peptides H1 [D182] (N=26,24,26,26,25,25) | 306.04 Number of T cells/million | Standard Deviation 630.16 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | A/California [D21] (N=26,25,27,24,24,26) | 324.37 Number of T cells/million | Standard Deviation 668.77 |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | 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). | Pool peptides H1 [D42] (N=27,27,27,27,24,28) | 87.41 Number of T cells/million | Standard Deviation 115.12 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool peptides H1 [D63] (N=26,26,25,25,24,26) | 88.28 Number of T cells/million | Standard Deviation 162.1 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/California [D7] (N=24,27,24,23,24,26) | 553.78 Number of T cells/million | Standard Deviation 639.15 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/Brisbane [D63] (N=26,26,25,25,24,26) | 230.84 Number of T cells/million | Standard Deviation 226.1 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool peptides H1 [D21] (N=26,24,27,24,24,26) | 140.75 Number of T cells/million | Standard Deviation 155.63 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool peptides H1 [D42] (N=27,27,27,27,24,28) | 103.89 Number of T cells/million | Standard Deviation 139.95 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/Brisbane [D28] (N=27,27,27,26,25,27) | 508.88 Number of T cells/million | Standard Deviation 540.73 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/California [D63] (N=26,2625,25,24,26) | 114.24 Number of T cells/million | Standard Deviation 165.15 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool Flu [D28] (N=25,27,27,26,25,26) | 458.12 Number of T cells/million | Standard Deviation 496.69 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool Flu [D7] (N=24,27,24,23,24,25) | 788.78 Number of T cells/million | Standard Deviation 947.53 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/Brisbane [D42] (N=27,26,27,27,24,28) | 209.07 Number of T cells/million | Standard Deviation 171.21 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/California [D21] (N=26,25,27,24,24,26) | 183.00 Number of T cells/million | Standard Deviation 146.43 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/Brisbane [D21] (N=26,25,27,24,24,26) | 319.17 Number of T cells/million | Standard Deviation 315.86 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/California [D182] (N=26,24,26,26,25,25) | 139.50 Number of T cells/million | Standard Deviation 273.43 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/Brisbane [D0] (N=25,25,24,25,25,26) | 183.96 Number of T cells/million | Standard Deviation 226.54 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/California [D28] (N=27,27,27,26,25,27) | 344.54 Number of T cells/million | Standard Deviation 288.96 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool peptides H1 [D28] (N=26,27,27,26,25,27) | 277.77 Number of T cells/million | Standard Deviation 329.71 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool Flu [D182] (N=26,24,26,26,25,25) | 291.73 Number of T cells/million | Standard Deviation 790.15 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/California [D0] (N=25,25,24,25,25,26) | 365.72 Number of T cells/million | Standard Deviation 985.87 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool peptides H1 [D0] (N=25,24,24,25,23,25) | 150.08 Number of T cells/million | Standard Deviation 215.56 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool Flu [D21] (N=25,25,27,24,24,25) | 266.63 Number of T cells/million | Standard Deviation 252.28 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool peptides H1 [D182] (N=26,24,26,26,25,25) | 241.42 Number of T cells/million | Standard Deviation 353.02 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/Brisbane [D7] (N=24,27,24,23,24,26) | 725.39 Number of T cells/million | Standard Deviation 585.98 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool Flu [D42] (N=26,27,27,26,24,27) | 344.77 Number of T cells/million | Standard Deviation 709.66 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/Brisbane [D182] (N=26,24,26,26,25,25) | 86.81 Number of T cells/million | Standard Deviation 99.38 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool peptides H1 [D7] (N=24,27,24,23,24,25) | 254.65 Number of T cells/million | Standard Deviation 417.53 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool Flu [D0] (N=24,25,24,25,25,24) | 344.60 Number of T cells/million | Standard Deviation 641.98 |
| Flulaval/Arepanrix/Placebo Group | 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). | Pool Flu [D63] (N=25,26,25,25,24,24) | 296.08 Number of T cells/million | Standard Deviation 624.75 |
| Flulaval/Arepanrix/Placebo Group | 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). | A/California [D42] (N=27,27,27,27,24,28) | 157.67 Number of T cells/million | Standard Deviation 192.15 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D0] (N=24,25,24,25,25,24) | 761.68 Number of T cells/million | Standard Deviation 2411 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D7] (N=24,27,24,23,24,26) | 1611.96 Number of T cells/million | Standard Deviation 4894.45 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D21] (N=26,25,27,24,24,26) | 1184.17 Number of T cells/million | Standard Deviation 4146.13 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D28] (N=27,27,27,26,25,27) | 1466.76 Number of T cells/million | Standard Deviation 5768.96 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D42] (N=27,26,27,27,24,28) | 1737.50 Number of T cells/million | Standard Deviation 6861.67 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D63] (N=26,26,25,25,24,26) | 1493.46 Number of T cells/million | Standard Deviation 5828.76 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D182] (N=26,24,26,26,25,25) | 1474.56 Number of T cells/million | Standard Deviation 6012.19 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/California [D0] (N=25,25,24,25,25,26) | 482.64 Number of T cells/million | Standard Deviation 1286.27 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/California [D7] (N=24,27,24,23,24,26) | 834.50 Number of T cells/million | Standard Deviation 2063.34 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/California [D21] (N=26,25,27,24,24,26) | 428.92 Number of T cells/million | Standard Deviation 1071.57 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/California [D42] (N=27,27,27,27,24,28) | 702.50 Number of T cells/million | Standard Deviation 2209.62 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/California [D63] (N=26,2625,25,24,26) | 853.83 Number of T cells/million | Standard Deviation 3236.11 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/California [D182] (N=26,24,26,26,25,25) | 598.92 Number of T cells/million | Standard Deviation 2344.64 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D0] (N=25,24,24,25,23,25) | 111.26 Number of T cells/million | Standard Deviation 162.75 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D7] (N=24,27,24,23,24,25) | 243.46 Number of T cells/million | Standard Deviation 382.39 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D21] (N=26,24,27,24,24,26) | 211.96 Number of T cells/million | Standard Deviation 482.54 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D28] (N=26,27,27,26,25,27) | 160.80 Number of T cells/million | Standard Deviation 216.87 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D42] (N=27,27,27,27,24,28) | 266.75 Number of T cells/million | Standard Deviation 481.5 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D63] (N=26,26,25,25,24,26) | 210.33 Number of T cells/million | Standard Deviation 403.19 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D182] (N=26,24,26,26,25,25) | 255.44 Number of T cells/million | Standard Deviation 425.71 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D21] (N=25,25,27,24,24,25) | 693.88 Number of T cells/million | Standard Deviation 2082.82 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D63] (N=25,26,25,25,24,24) | 1123.13 Number of T cells/million | Standard Deviation 4008.27 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D182] (N=26,24,26,26,25,25) | 926.40 Number of T cells/million | Standard Deviation 3463.27 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D0] (N=25,25,24,25,25,26) | 1222.40 Number of T cells/million | Standard Deviation 4485.04 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | A/California [D28] (N=27,27,27,26,25,27) | 973.96 Number of T cells/million | Standard Deviation 3644.93 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D7] (N=24,27,24,23,24,25) | 1094.96 Number of T cells/million | Standard Deviation 3111.41 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D28] (N=25,27,27,26,25,26) | 963.20 Number of T cells/million | Standard Deviation 3548.16 |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D42] (N=26,27,27,26,24,27) | 996.67 Number of T cells/million | Standard Deviation 3648.68 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D7] (N=24,27,24,23,24,25) | 522.84 Number of T cells/million | Standard Deviation 514.35 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D182] (N=26,24,26,26,25,25) | 198.44 Number of T cells/million | Standard Deviation 561.99 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D42] (N=27,26,27,27,24,28) | 501.54 Number of T cells/million | Standard Deviation 1329.9 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D63] (N=26,26,25,25,24,26) | 88.19 Number of T cells/million | Standard Deviation 206.24 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D42] (N=27,27,27,27,24,28) | 145.96 Number of T cells/million | Standard Deviation 261.67 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D28] (N=26,27,27,26,25,27) | 187.37 Number of T cells/million | Standard Deviation 361.53 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D21] (N=26,24,27,24,24,26) | 173.77 Number of T cells/million | Standard Deviation 432.74 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D0] (N=24,25,24,25,25,24) | 157.63 Number of T cells/million | Standard Deviation 166.45 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D7] (N=24,27,24,23,24,25) | 173.48 Number of T cells/million | Standard Deviation 202.67 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool peptides H1 [D0] (N=25,24,24,25,23,25) | 70.92 Number of T cells/million | Standard Deviation 113.24 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/California [D182] (N=26,24,26,26,25,25) | 138.52 Number of T cells/million | Standard Deviation 245.14 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/California [D63] (N=26,2625,25,24,26) | 194.73 Number of T cells/million | Standard Deviation 453.09 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D28] (N=27,27,27,26,25,27) | 1735.48 Number of T cells/million | Standard Deviation 5219.43 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D21] (N=25,25,27,24,24,25) | 406.28 Number of T cells/million | Standard Deviation 620.1 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/California [D42] (N=27,27,27,27,24,28) | 291.96 Number of T cells/million | Standard Deviation 654.16 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D21] (N=26,25,27,24,24,26) | 501.08 Number of T cells/million | Standard Deviation 1319.91 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D28] (N=25,27,27,26,25,26) | 423.62 Number of T cells/million | Standard Deviation 430.29 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/California [D28] (N=27,27,27,26,25,27) | 497.67 Number of T cells/million | Standard Deviation 612.95 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/California [D7] (N=24,27,24,23,24,26) | 348.69 Number of T cells/million | Standard Deviation 326.74 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/California [D0] (N=25,25,24,25,25,26) | 93.50 Number of T cells/million | Standard Deviation 114.9 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D7] (N=24,27,24,23,24,26) | 529.73 Number of T cells/million | Standard Deviation 416.76 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D42] (N=26,27,27,26,24,27) | 391.11 Number of T cells/million | Standard Deviation 755.53 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D182] (N=26,24,26,26,25,25) | 370.64 Number of T cells/million | Standard Deviation 955.57 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D63] (N=26,26,25,25,24,26) | 529.81 Number of T cells/million | Standard Deviation 1383.73 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/Brisbane [D0] (N=25,25,24,25,25,26) | 119.46 Number of T cells/million | Standard Deviation 113.79 |
| Arepanrix/Placebo/Flulaval Group | 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). | A/California [D21] (N=26,25,27,24,24,26) | 351.69 Number of T cells/million | Standard Deviation 713.52 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D182] (N=26,24,26,26,25,25) | 234.92 Number of T cells/million | Standard Deviation 398.06 |
| Arepanrix/Placebo/Flulaval Group | 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). | Pool Flu [D63] (N=25,26,25,25,24,24) | 432.08 Number of T cells/million | Standard Deviation 1145.71 |
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
Time frame: At Day 63 from Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 from Day 0 for the 4 other groups
Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Seroconverted Subjects for Antibodies Against A/ California Strain. | 66 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Seroconverted Subjects for Antibodies Against A/ California Strain. | 77 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against A/ California Strain. | 84 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against A/ California Strain. | 85 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against A/ California Strain. | 88 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against A/ California Strain. | 90 Subjects |
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.
Time frame: on Days 21 and 63 from Day 0 for the first 4 groups; on Days 42 and 63 from Day 0 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups
Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Bri/59/07 H1N1 [Day 21 or 42 after dose 1] | 71 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu B/Bri/60/08 [Day 21 or 42 after dose 1] | 76 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Uru/716/07 H3N2 [Day 63 after dose 1] | 71 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Uru/716/07 H3N2 [Day 21 or 42 after dose 1] | 72 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Bri/59/07 H1N1 [Day 63 after dose 1] | 63 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu B/Bri/60/08 [Day 63 after dose 1] | 73 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu B/Bri/60/08 [Day 21 or 42 after dose 1] | 76 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Bri/59/07 H1N1 [Day 63 after dose 1] | 76 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Uru/716/07 H3N2 [Day 63 after dose 1] | 69 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Bri/59/07 H1N1 [Day 21 or 42 after dose 1] | 74 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Uru/716/07 H3N2 [Day 21 or 42 after dose 1] | 73 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu B/Bri/60/08 [Day 63 after dose 1] | 73 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu B/Bri/60/08 [Day 21 or 42 after dose 1] | 74 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Bri/59/07 H1N1 [Day 21 or 42 after dose 1] | 76 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Bri/59/07 H1N1 [Day 63 after dose 1] | 69 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Uru/716/07 H3N2 [Day 21 or 42 after dose 1] | 72 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Uru/716/07 H3N2 [Day 63 after dose 1] | 69 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu B/Bri/60/08 [Day 63 after dose 1] | 67 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu B/Bri/60/08 [Day 21 or 42 after dose 1] | 78 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu B/Bri/60/08 [Day 63 after dose 1] | 73 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Bri/59/07 H1N1 [Day 21 or 42 after dose 1] | 70 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Bri/59/07 H1N1 [Day 63 after dose 1] | 64 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Uru/716/07 H3N2 [Day 21 or 42 after dose 1] | 76 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Uru/716/07 H3N2 [Day 63 after dose 1] | 69 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Uru/716/07 H3N2 [Day 21 or 42 after dose 1] | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Uru/716/07 H3N2 [Day 63 after dose 1] | 75 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Bri/59/07 H1N1 [Day 63 after dose 1] | 71 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu B/Bri/60/08 [Day 21 or 42 after dose 1] | 6 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu B/Bri/60/08 [Day 63 after dose 1] | 78 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Bri/59/07 H1N1 [Day 21 or 42 after dose 1] | 17 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Uru/716/07 H3N2 [Day 63 after dose 1] | 78 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Uru/716/07 H3N2 [Day 21 or 42 after dose 1] | 6 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu B/Bri/60/08 [Day 63 after dose 1] | 76 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Bri/59/07 H1N1 [Day 63 after dose 1] | 76 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Bri/59/07 H1N1 [Day 21 or 42 after dose 1] | 28 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu B/Bri/60/08 [Day 21 or 42 after dose 1] | 24 Subjects |
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.
Time frame: At Day 182 from Day 0
Population: The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Uru/716/07 H3N2 | 58 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Bri/59/07 H1N1 | 45 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu B/Bri/60/08 Victoria | 68 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Uru/716/07 H3N2 | 56 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Bri/59/07 H1N1 | 57 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu B/Bri/60/08 Victoria | 54 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Uru/716/07 H3N2 | 54 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Bri/59/07 H1N1 | 45 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu B/Bri/60/08 Victoria | 48 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Uru/716/07 H3N2 | 56 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Bri/59/07 H1N1 | 38 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu B/Bri/60/08 Victoria | 64 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Uru/716/07 H3N2 | 60 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Bri/59/07 H1N1 | 46 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu B/Bri/60/08 Victoria | 67 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Bri/59/07 H1N1 | 54 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu B/Bri/60/08 Victoria | 62 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Uru/716/07 H3N2 | 61 Subjects |
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.
Time frame: At Day 21 from Day 0 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 from Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group
Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 76 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 | 74 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 72 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 76 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 70 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 | 78 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 73 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 50 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 | 71 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 33 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 | 57 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 72 Subjects |
| Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 145 Subjects |
| Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 145 Subjects |
| Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group | Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 | 152 Subjects |
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.
Time frame: At Day 63 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 for the 4 other groups.
Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against A/California Strain. | 90 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against A/California Strain. | 86 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against A/California Strain. | 92 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against A/California Strain. | 89 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against A/California Strain. | 91 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against A/California Strain. | 91 Subjects |
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.
Time frame: At Day 21 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group
Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Bri/59/07 H1N1 | 89 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains | Flu B/Bri/60/08 | 90 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Uru/716/07 H3N2 | 77 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Uru/716/07 H3N2 | 79 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Bri/59/07 H1N1 | 82 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains | Flu B/Bri/60/08 | 89 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Uru/716/07 H3N2 | 81 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Bri/59/07 H1N1 | 81 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains | Flu B/Bri/60/08 | 91 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Bri/59/07 H1N1 | 87 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains | Flu B/Bri/60/08 | 91 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Uru/716/07 H3N2 | 83 Subjects |
| Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Uru/716/07 H3N2 | 155 Subjects |
| Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains | Flu A/Bri/59/07 H1N1 | 170 Subjects |
| Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains | Flu B/Bri/60/08 | 176 Subjects |
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.
Time frame: At Day 182 after the first dose
Population: The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 63 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 66 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 Victoria | 90 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 64 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 74 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 Victoria | 88 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 66 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 60 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 Victoria | 79 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 Victoria | 89 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 61 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 64 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 68 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 67 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 Victoria | 88 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 Victoria | 91 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 71 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 70 Subjects |
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.
Time frame: before vaccination and on days 21 and 63 for the first 4 groups and before vaccination and on days 42 and 63 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups
Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [Days 21 or 42 post dose 1] | 86 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [Days 21 or 42 post dose 1] | 91 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 63 post dose 1] | 84 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [Days 21 or 42 post dose 1] | 78 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 0] | 62 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 63 post dose 1] | 78 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 0] | 20 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 63 post dose 1] | 91 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 0] | 12 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 63 post dose 1] | 75 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [Days 21 or 42 post dose 1] | 84 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [Days 21 or 42 post dose 1] | 77 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [Days 21 or 42 post dose 1] | 85 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 0] | 16 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 63 post dose 1] | 86 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 0] | 50 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 0] | 18 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 63 post dose 1] | 86 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 63 post dose 1] | 85 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 63 post dose 1] | 73 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [Days 21 or 42 post dose 1] | 89 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 0] | 26 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 0] | 56 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 0] | 8 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 63 post dose 1] | 91 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [Days 21 or 42 post dose 1] | 90 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [Days 21 or 42 post dose 1] | 77 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [Days 21 or 42 post dose 1] | 89 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 0] | 18 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [Days 21 or 42 post dose 1] | 82 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 63 post dose 1] | 79 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 0] | 13 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [Days 21 or 42 post dose 1] | 79 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 63 post dose 1] | 75 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 0] | 49 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 63 post dose 1] | 89 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 63 post dose 1] | 81 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [Days 21 or 42 post dose 1] | 18 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 0] | 66 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 0] | 15 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [Days 21 or 42 post dose 1] | 75 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 63 post dose 1] | 81 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 0] | 23 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 63 post dose 1] | 91 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [Days 21 or 42 post dose 1] | 47 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 0] | 62 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [Days 21 or 42 post dose 1] | 62 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 0] | 20 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 63 post dose 1] | 83 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 0] | 17 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 63 post dose 1] | 91 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [Days 21 or 42 post dose 1] | 28 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [Days 21 or 42 post dose 1] | 89 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 63 post dose 1] | 87 Subjects |
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.
Time frame: On Days 0, 7, 21, 28, 42, 63 and 182
Population: The Total Vaccinated cohort included all vaccinated subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Unknown (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Below (N=101,97,95,95,96,97) | 6 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Below (N=102,101,100,99,100,99) | 7 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Within (N=102,104,102,100,101,102) | 97 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Within (N=99,91,88,91,93,97) | 84 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Below (N=99,91,88,91,93,97) | 14 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Within (N=101,97,95,95,96,97) | 95 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Within (N=102,101,100,99,100,99) | 94 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Within (N=100,95,95,95,97,97) | 92 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Below (N=100,95,95,95,97,97) | 7 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Below (N=100,95,95,95,97,97) | 8 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Within (N=101,100,97,97,99,99) | 101 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Below (N=102,104,102,100,101,102) | 8 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Unknown (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Within (N=102,104,102,100,101,102) | 101 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Within (N=101,100,97,97,99,99) | 97 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Within (N=99,91,88,91,93,97) | 89 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Below (N=101,100,97,97,99,99) | 12 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Below (N=101,98,96,98,98,97) | 4 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Below (N=100,95,95,95,97,97) | 8 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Below (N=101,97,95,95,96,97) | 7 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Within (N=101,100,97,97,99,99) | 88 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Within (N=101,98,96,98,98,97) | 90 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Above (N=101,100,97,97,99,99) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Below (N=101,100,97,97,99,99) | 6 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Within (N=102,104,102,100,101,102) | 97 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Above (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Within (N=101,97,95,95,96,97) | 90 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Below (N=101,97,95,95,96,97) | 11 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Below (N=101,98,96,98,98,97) | 5 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Within (N=101,98,96,98,98,97) | 89 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Below (N=101,98,96,98,98,97) | 10 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Within (N=101,98,96,98,98,97) | 95 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Within (N=99,91,88,91,93,97) | 99 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Above (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Within (N=101,97,95,95,96,97) | 96 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Below (N=101,97,95,95,96,97) | 4 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Unknown (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Below (N=101,100,97,97,99,99) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Below (N=100,95,95,95,97,97) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Above (N=102,101,100,99,100,99) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Within (N=102,101,100,99,100,99) | 93 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Unknown (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Above (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Within (N=100,95,95,95,97,97) | 97 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Below (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Within (N=102,104,102,100,101,102) | 94 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Below (N=102,104,102,100,101,102) | 4 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Above (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Within (N=99,91,88,91,93,97) | 94 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Below (N=99,91,88,91,93,97) | 3 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Within (N=101,97,95,95,96,97) | 101 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Below (N=102,101,100,99,100,99) | 7 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Within (N=101,98,96,98,98,97) | 100 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Unknown(N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Within (N=102,101,100,99,100,99) | 102 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Within (N=102,101,100,99,100,99) | 93 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Within (N=102,104,102,100,101,102) | 93 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Below (N=99,91,88,91,93,97) | 9 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Above (N=102,101,100,99,100,99) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Within (N=100,95,95,95,97,97) | 92 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Within (N=101,97,95,95,96,97) | 94 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Above (N=101,100,97,97,99,99) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Below (N=102,101,100,99,100,99) | 8 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Below (N=101,98,96,98,98,97) | 10 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Within (N=101,100,97,97,99,99) | 93 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Above (N=102,101,100,99,100,99) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Within (N=102,101,100,99,100,99) | 94 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Below (N=102,101,100,99,100,99) | 6 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Unknown (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Below (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Within (N=99,91,88,91,93,97) | 93 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Below (N=99,91,88,91,93,97) | 4 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Within (N=101,98,96,98,98,97) | 94 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Within (N=100,95,95,95,97,97) | 92 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Within (N=100,95,95,95,97,97) | 99 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Within (N=101,100,97,97,99,99) | 92 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Below (N=101,100,97,97,99,99) | 8 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Within (N=101,100,97,97,99,99) | 94 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Unknown (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Below (N=102,104,102,100,101,102) | 6 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Below (N=102,101,100,99,100,99) | 4 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Within (N=102,101,100,99,100,99) | 93 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Above (N=102,101,100,99,100,99) | 3 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Above (N=101,100,97,97,99,99) | 4 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Within (N=101,98,96,98,98,97) | 90 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Below (N=100,95,95,95,97,97) | 9 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Within (N=100,95,95,95,97,97) | 82 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Below (N=99,91,88,91,93,97) | 4 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Within (N=99,91,88,91,93,97) | 86 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Below (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Within (N=102,104,102,100,101,102) | 99 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Above (N=102,104,102,100,101,102) | 3 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Below (N=102,101,100,99,100,99) | 7 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Above (N=102,101,100,99,100,99) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Unknown (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Below (N=101,100,97,97,99,99) | 4 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Below (N=101,97,95,95,96,97) | 9 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Within (N=101,97,95,95,96,97) | 86 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Below (N=100,95,95,95,97,97) | 10 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Within (N=100,95,95,95,97,97) | 84 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Below (N=99,91,88,91,93,97) | 6 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Within (N=99,91,88,91,93,97) | 84 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Below (N=102,101,100,99,100,99) | 7 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Within (N=102,101,100,99,100,99) | 91 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Above (N=102,101,100,99,100,99) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Within (N=101,100,97,97,99,99) | 94 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Below (N=101,98,96,98,98,97) | 7 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Within (N=101,97,95,95,96,97) | 87 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Within (N=100,95,95,95,97,97) | 83 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Below (N=99,91,88,91,93,97) | 6 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Within (N=99,91,88,91,93,97) | 84 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Within (N=102,101,100,99,100,99) | 101 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Unknown(N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Within (N=101,98,96,98,98,97) | 98 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Within (N=101,97,95,95,96,97) | 97 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Within (N=100,95,95,95,97,97) | 94 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Within (N=102,104,102,100,101,102) | 97 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Within (N=102,101,100,99,100,99) | 91 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Below (N=101,98,96,98,98,97) | 4 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Below (N=101,98,96,98,98,97) | 6 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Above (N=102,101,100,99,100,99) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Below (N=101,100,97,97,99,99) | 6 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Within (N=101,100,97,97,99,99) | 92 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Above (N=101,100,97,97,99,99) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Below (N=101,98,96,98,98,97) | 8 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Within (N=101,98,96,98,98,97) | 90 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Below (N=101,97,95,95,96,97) | 5 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Within (N=101,97,95,95,96,97) | 90 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Above (N=101,97,95,95,96,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Below (N=100,95,95,95,97,97) | 7 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Within (N=100,95,95,95,97,97) | 86 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Below (N=99,91,88,91,93,97) | 7 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Within (N=99,91,88,91,93,97) | 82 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Within (N=102,104,102,100,101,102) | 96 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Above (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Unknown (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Below (N=101,100,97,97,99,99) | 8 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Within (N=101,100,97,97,99,99) | 87 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Above (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Unknown (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Below (N=101,97,95,95,96,97) | 9 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Within (N=101,97,95,95,96,97) | 86 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Above (N=101,97,95,95,96,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Above (N=100,95,95,95,97,97) | 4 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Within (N=101,98,96,98,98,97) | 88 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Above (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Unknown (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Above (N=101,97,95,95,96,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Below (N=102,104,102,100,101,102) | 6 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Within (N=102,104,102,100,101,102) | 97 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Unknown (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Below (N=101,100,97,97,99,99) | 5 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Within (N=101,98,96,98,98,97) | 88 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Unknown (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Below (N=101,97,95,95,96,97) | 8 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Above (N=101,97,95,95,96,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Below (N=100,95,95,95,97,97) | 10 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Above (N=100,95,95,95,97,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Within (N=102,104,102,100,101,102) | 104 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Within (N=101,100,97,97,99,99) | 100 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Within (N=99,91,88,91,93,97) | 90 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Unknown (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Below (N=102,104,102,100,101,102) | 6 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Below (N=102,101,100,99,100,99) | 6 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Within (N=102,101,100,99,100,99) | 93 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Below (N=101,98,96,98,98,97) | 5 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Below (N=99,91,88,91,93,97) | 7 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Within (N=102,101,100,99,100,99) | 91 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Within (N=101,98,96,98,98,97) | 89 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Within (N=101,100,97,97,99,99) | 92 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Below (N=101,97,95,95,96,97) | 6 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Within (N=101,97,95,95,96,97) | 89 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Unknown(N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Below (N=101,100,97,97,99,99) | 5 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Below (N=101,98,96,98,98,97) | 7 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Within (N=100,95,95,95,97,97) | 89 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Unknown (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Below (N=101,100,97,97,99,99) | 9 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Within (N=102,104,102,100,101,102) | 101 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Above (N=100,95,95,95,97,97) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Within (N=101,97,95,95,96,97) | 88 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Within (N=101,98,96,98,98,97) | 89 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Within (N=101,100,97,97,99,99) | 85 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Below (N=101,98,96,98,98,97) | 8 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Unknown (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Within (N=101,98,96,98,98,97) | 86 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Within (N=102,104,102,100,101,102) | 93 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Above (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Below (N=101,98,96,98,98,97) | 6 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Within (N=100,95,95,95,97,97) | 87 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Below (N=101,97,95,95,96,97) | 5 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Below (N=100,95,95,95,97,97) | 7 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Below (N=100,95,95,95,97,97) | 11 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Unknown (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Above (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Within (N=102,101,100,99,100,99) | 95 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Above (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Below (N=102,101,100,99,100,99) | 9 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Within (N=99,91,88,91,93,97) | 88 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Below (N=102,104,102,100,101,102) | 5 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Within (N=99,91,88,91,93,97) | 80 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Within (N=102,104,102,100,101,102) | 95 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Below (N=102,101,100,99,100,99) | 5 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Above (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Above (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Below (N=101,100,97,97,99,99) | 3 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Below (N=101,97,95,95,96,97) | 6 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Below (N=102,104,102,100,101,102) | 6 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Within (N=101,100,97,97,99,99) | 97 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Within (N=102,101,100,99,100,99) | 91 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Below (N=101,97,95,95,96,97) | 9 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Below (N=102,104,102,100,101,102) | 4 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Below (N=100,95,95,95,97,97) | 8 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Above (N=102,101,100,99,100,99) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Above (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Within (N=102,101,100,99,100,99) | 100 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Above (N=102,104,102,100,101,102) | 3 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Within (N=102,104,102,100,101,102) | 94 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Within (N=101,100,97,97,99,99) | 88 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Above (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Unknown (N=101,100,97,97,99,99) | 3 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Within (N=99,91,88,91,93,97) | 78 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Below (N=102,101,100,99,100,99) | 7 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Within (N=102,101,100,99,100,99) | 94 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Below (N=102,101,100,99,100,99) | 4 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Within (N=101,98,96,98,98,97) | 89 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Within (N=102,104,102,100,101,102) | 95 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Within (N=100,95,95,95,97,97) | 84 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Below (N=101,100,97,97,99,99) | 5 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Within (N=101,100,97,97,99,99) | 90 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Below (N=102,104,102,100,101,102) | 7 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Unknown (N=101,100,97,97,99,99) | 3 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Within (N=100,95,95,95,97,97) | 85 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Below (N=99,91,88,91,93,97) | 9 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Within (N=101,97,95,95,96,97) | 94 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Below (N=99,91,88,91,93,97) | 4 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Within (N=101,98,96,98,98,97) | 96 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Above (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Below (N=99,91,88,91,93,97) | 5 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Within (N=100,95,95,95,97,97) | 94 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Above (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Within (N=99,91,88,91,93,97) | 81 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Within (N=101,97,95,95,96,97) | 89 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Unknown (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Within (N=99,91,88,91,93,97) | 82 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Below (N=100,95,95,95,97,97) | 6 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Within (N=101,97,95,95,96,97) | 86 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Unknown (N=101,100,97,97,99,99) | 3 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Unknown (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Below (N=102,101,100,99,100,99) | 4 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Above (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Above (N=102,104,102,100,101,102) | 3 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Within (N=99,91,88,91,93,97) | 84 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Below (N=101,97,95,95,96,97) | 7 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Within (N=100,95,95,95,97,97) | 95 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Below (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Within (N=102,101,100,99,100,99) | 95 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Within (N=102,104,102,100,101,102) | 88 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Unknown (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Within (N=101,97,95,95,96,97) | 88 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Within (N=102,101,100,99,100,99) | 99 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Above (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Within (N=102,104,102,100,101,102) | 92 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Below (N=99,91,88,91,93,97) | 3 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Below (N=101,100,97,97,99,99) | 8 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Below (N=102,104,102,100,101,102) | 3 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Below (N=100,95,95,95,97,97) | 4 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Within (N=99,91,88,91,93,97) | 85 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Above (N=102,101,100,99,100,99) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Below (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Unknown (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Within (N=100,95,95,95,97,97) | 90 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Above (N=99,91,88,91,93,97) | 3 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Below (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Unknown (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Within (N=101,100,97,97,99,99) | 88 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Within (N=99,91,88,91,93,97) | 83 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Within (N=101,97,95,95,96,97) | 95 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Within (N=102,101,100,99,100,99) | 96 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Unknown (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Below (N=101,100,97,97,99,99) | 6 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Below (N=99,91,88,91,93,97) | 3 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Unknown (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Above (N=102,101,100,99,100,99) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Below (N=102,104,102,100,101,102) | 9 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Within (N=101,97,95,95,96,97) | 92 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Within (N=101,98,96,98,98,97) | 97 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Below (N=100,95,95,95,97,97) | 4 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Below (N=101,98,96,98,98,97) | 8 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Within (N=101,98,96,98,98,97) | 88 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Within (N=101,100,97,97,99,99) | 81 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Within (N=101,98,96,98,98,97) | 93 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Within (N=101,98,96,98,98,97) | 89 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Within (N=100,95,95,95,97,97) | 78 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Below (N=101,97,95,95,96,97) | 5 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Unknown (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Below (N=100,95,95,95,97,97) | 14 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Below (N=101,97,95,95,96,97) | 3 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Within (N=101,97,95,95,96,97) | 89 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Below (N=99,91,88,91,93,97) | 10 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Unknown(N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Below (N=101,100,97,97,99,99) | 16 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Below (N=102,104,102,100,101,102) | 5 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Below (N=101,97,95,95,96,97) | 10 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Within (N=99,91,88,91,93,97) | 91 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Unknown (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Within (N=100,95,95,95,97,97) | 91 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Above (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Within (N=102,101,100,99,100,99) | 81 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Below (N=99,91,88,91,93,97) | 5 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Within (N=102,104,102,100,101,102) | 97 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Below (N=100,95,95,95,97,97) | 6 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Unknown (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Unknown (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Within (N=102,104,102,100,101,102) | 99 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Below (N=101,100,97,97,99,99) | 8 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Below (N=102,101,100,99,100,99) | 17 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Within (N=101,98,96,98,98,97) | 81 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Within (N=99,91,88,91,93,97) | 81 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Below (N=102,101,100,99,100,99) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Within (N=102,104,102,100,101,102) | 92 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Above (N=100,95,95,95,97,97) | 3 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Within (N=100,95,95,95,97,97) | 89 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Unknown (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Unknown (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Within (N=101,100,97,97,99,99) | 97 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Below (N=101,98,96,98,98,97) | 9 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Within (N=101,100,97,97,99,99) | 87 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Above (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Within (N=101,100,97,97,99,99) | 90 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Within (N=102,101,100,99,100,99) | 92 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Within (N=101,97,95,95,96,97) | 84 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Below (N=101,98,96,98,98,97) | 15 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Within (N=100,95,95,95,97,97) | 87 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Below (N=102,101,100,99,100,99) | 7 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Below (N=101,100,97,97,99,99) | 9 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Unknown (N=101,97,95,95,96,97) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Within (N=101,100,97,97,99,99) | 85 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Within (N=101,98,96,98,98,97) | 90 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Below (N=101,97,95,95,96,97) | 8 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Within (N=101,97,95,95,96,97) | 85 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Within (N=101,98,96,98,98,97) | 91 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Above (N=99,91,88,91,93,97) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Below (N=101,98,96,98,98,97) | 5 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Below (N=101,98,96,98,98,97) | 7 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Within (N=101,98,96,98,98,97) | 92 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Below (N=101,97,95,95,96,97) | 10 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Below (N=100,95,95,95,97,97) | 10 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Below (N=102,104,102,100,101,102) | 4 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Within (N=102,104,102,100,101,102) | 97 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Below (N=102,101,100,99,100,99) | 4 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Within (N=99,91,88,91,93,97) | 92 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Within (N=101,100,97,97,99,99) | 92 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Within (N=101,100,97,97,99,99) | 89 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Below (N=101,98,96,98,98,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Within (N=101,98,96,98,98,97) | 96 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Below (N=101,100,97,97,99,99) | 10 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Within (N=100,95,95,95,97,97) | 88 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Below (N=99,91,88,91,93,97) | 6 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Within (N=102,104,102,100,101,102) | 100 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Unknown (N=99,91,88,91,93,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Unknown (N=102,104,102,100,101,102) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Unknown(N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Within (N=102,101,100,99,100,99) | 93 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Within (N=101,100,97,97,99,99) | 99 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Unknown (N=101,97,95,95,96,97) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Below (N=100,95,95,95,97,97) | 7 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Within (N=101,97,95,95,96,97) | 85 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Within (N=100,95,95,95,97,97) | 89 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Below (N=99,91,88,91,93,97) | 6 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Below (N=101,97,95,95,96,97) | 9 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Within (N=99,91,88,91,93,97) | 86 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Below (N=102,104,102,100,101,102) | 9 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Within (N=102,104,102,100,101,102) | 90 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Above (N=102,104,102,100,101,102) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Within (N=99,91,88,91,93,97) | 86 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Below (N=101,100,97,97,99,99) | 6 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Within (N=101,100,97,97,99,99) | 91 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Unknown (N=99,91,88,91,93,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Above (N=101,97,95,95,96,97) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Unknown (N=101,100,97,97,99,99) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Within (N=101,97,95,95,96,97) | 86 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Within (N=100,95,95,95,97,97) | 96 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Below (N=99,91,88,91,93,97) | 7 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Below (N=101,98,96,98,98,97) | 7 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Unknown (N=101,100,97,97,99,99) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Within (N=102,101,100,99,100,99) | 96 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Above (N=101,100,97,97,99,99) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Below (N=101,100,97,97,99,99) | 5 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Unknown (N=101,100,97,97,99,99) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Above (N=102,101,100,99,100,99) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Below (N=101,97,95,95,96,97) | 6 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Within (N=101,97,95,95,96,97) | 90 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Below (N=100,95,95,95,97,97) | 9 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Below (N=102,104,102,100,101,102) | 8 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Unknown (N=102,104,102,100,101,102) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Within (N=99,91,88,91,93,97) | 87 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Within (N=102,101,100,99,100,99) | 92 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Within (N=102,104,102,100,101,102) | 92 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Within (N=102,101,100,99,100,99) | 100 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Below (N=102,101,100,99,100,99) | 5 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Within (N=101,98,96,98,98,97) | 98 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Below (N=99,91,88,91,93,97) | 6 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Within (N=99,91,88,91,93,97) | 84 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Within (N=100,95,95,95,97,97) | 88 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Within (N=101,97,95,95,96,97) | 94 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Below (N=102,104,102,100,101,102) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Within (N=102,104,102,100,101,102) | 97 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Below (N=100,95,95,95,97,97) | 8 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Below (N=102,101,100,99,100,99) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Within (N=102,101,100,99,100,99) | 97 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Within (N=101,97,95,95,96,97) | 86 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Unknown (N=101,100,97,97,99,99) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Within (N=101,98,96,98,98,97) | 96 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Above (N=102,101,100,99,100,99) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Below (N=101,97,95,95,96,97) | 11 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Within (N=102,101,100,99,100,99) | 92 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Unknown (N=100,95,95,95,97,97) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Within (N=101,98,96,98,98,97) | 90 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Unknown (N=101,100,97,97,99,99) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Below (N=101,100,97,97,99,99) | 4 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Within (N=101,100,97,97,99,99) | 91 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Below (N=99,91,88,91,93,97) | 5 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Within (N=102,101,100,99,100,99) | 95 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D21] Below (N=101,100,97,97,99,99) | 4 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Within (N=99,91,88,91,93,97) | 89 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Within (N=102,104,102,100,101,102) | 97 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Unknown (N=99,91,88,91,93,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Unknown (N=101,100,97,97,99,99) | 4 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Within (N=101,97,95,95,96,97) | 97 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Below (N=99,91,88,91,93,97) | 10 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D7] Below (N=102,101,100,99,100,99) | 6 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Below (N=102,104,102,100,101,102) | 5 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Below (N=101,98,96,98,98,97) | 5 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Within (N=100,95,95,95,97,97) | 95 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Within (N=102,104,102,100,101,102) | 92 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Below (N=102,101,100,99,100,99) | 8 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Below (N=100,95,95,95,97,97) | 10 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Within (N=102,101,100,99,100,99) | 99 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Within (N=102,104,102,100,101,102) | 97 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Below (N=100,95,95,95,97,97) | 10 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Within (N=99,91,88,91,93,97) | 87 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Within (N=102,101,100,99,100,99) | 89 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Within (N=101,97,95,95,96,97) | 83 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D0] Below (N=102,104,102,100,101,102) | 9 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Below (N=100,95,95,95,97,97) | 10 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Within (N=99,91,88,91,93,97) | 83 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Within (N=101,100,97,97,99,99) | 98 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Within (N=101,100,97,97,99,99) | 87 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D21] Within (N=101,100,97,97,99,99) | 91 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Within (N=99,91,88,91,93,97) | 96 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Above (N=102,101,100,99,100,99) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Within (N=102,101,100,99,100,99) | 90 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D7] Below (N=102,101,100,99,100,99) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D0] Below (N=102,104,102,100,101,102) | 5 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Above (N=101,100,97,97,99,99) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D182] Within (N=99,91,88,91,93,97) | 86 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D63] Within (N=100,95,95,95,97,97) | 87 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Within (N=101,97,95,95,96,97) | 86 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Below (N=102,104,102,100,101,102) | 5 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D42] Below (N=101,97,95,95,96,97) | 14 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Within (N=101,98,96,98,98,97) | 87 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Below (N=100,95,95,95,97,97) | 9 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Unknown (N=101,98,96,98,98,97) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Within (N=101,100,97,97,99,99) | 92 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Within (N=100,95,95,95,97,97) | 85 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Within (N=101,98,96,98,98,97) | 84 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D28] Below (N=101,98,96,98,98,97) | 9 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Below (N=101,98,96,98,98,97) | 7 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D182] Above (N=99,91,88,91,93,97) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D63] Within (N=100,95,95,95,97,97) | 86 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D28] Within (N=101,98,96,98,98,97) | 89 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D21] Below (N=101,100,97,97,99,99) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D63] Unknown (N=100,95,95,95,97,97) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D42] Below (N=101,97,95,95,96,97) | 11 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Within (N=101,97,95,95,96,97) | 88 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Above (N=102,101,100,99,100,99) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D42] Below (N=101,97,95,95,96,97) | 9 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Within (N=102,104,102,100,101,102) | 102 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Below (N=102,101,100,99,100,99) | 8 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D7] Above (N=102,101,100,99,100,99) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D182] Below (N=99,91,88,91,93,97) | 9 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D182] Below (N=99,91,88,91,93,97) | 14 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D63] Within (N=100,95,95,95,97,97) | 87 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D0] Within (N=102,104,102,100,101,102) | 97 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Unknown (N=101,98,96,98,98,97) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D7] Unknown(N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | CREA [D21] Below (N=101,100,97,97,99,99) | 9 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hct [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Unknown (N=101,98,96,98,98,97) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | Hgb [D28] Below (N=101,98,96,98,98,97) | 4 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | EOS [D28] Above (N=101,98,96,98,98,97) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL D [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
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.
Time frame: On Days 0, 7, 21, 28, 42, 63 and 182
Population: The Total Vaccinated cohort included all vaccinated subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Above (N=102,104,102,100101,102) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Below (N=102,104,102,100101,102) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Within (N=101,97,95,95,96,97) | 99 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Within (N=102,101,100,99,100,99) | 99 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Below (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Within (N=102,104,102,100101,102) | 100 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Within (N=99,91,88,91,93,97) | 93 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Above (N=99,91,88,91,93,97) | 4 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Below (N=102,101,100,99,100,99) | 3 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Above (N=102,104,102,100,101,102) | 4 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Below (N=102,104,102,100101,102) | 4 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Unknown (N=102,104,102,100101,102) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Within (N=102,104,102,100101,102) | 96 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Above (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Within (N=101,98,96,98,98,97) | 98 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Above (N=102,104,102,100101,102) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Below (N=101,97,95,95,96,97) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Within (N=102,101,100,99,100,99) | 100 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Unknown (N=102,104,102,100101,102) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Within (N=102,104,102,100,101,102) | 95 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Below (N=102,101,100,99,100,99) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Below (N=100,95,95,95,97,97) | 6 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Below (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Below (N=102,101,100,99,100,99) | 3 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Below (N=99,91,88,91,93,97) | 6 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Within (N=101,100,97,97,99,99) | 100 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Within (N=102,101,100,99,100,99) | 99 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Below (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Within (N=99,91,88,91,93,97) | 92 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Within (N=101,98,96,98,98,97) | 95 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Below (N=101,98,96,98,98,97) | 5 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Within (N=101,100,97,97,99,99) | 98 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Above (N=101,100,97,97,99,99) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Below (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Within (N=101,98,96,98,98,97) | 98 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Within (N=100,95,95,95,97,97) | 94 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Below (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Unknown (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Within (N=101,100,97,97,99,99) | 96 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Below (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Within (N=101,97,95,95,96,97) | 100 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Within (N=100,95,95,95,97,97) | 98 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Below (N=101,100,97,97,99,99) | 5 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Within (N=101,97,95,95,96,97) | 100 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Within (N=99,91,88,91,93,97) | 99 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Unknown (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Below (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Below (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Within (N=100,95,95,95,97,97) | 98 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Below (N=102,104,102,100101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Unknown (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Below (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Within (N=101,98,96,98,98,97) | 87 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Within (N=101,97,95,95,96,97) | 91 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Within (N=102,101,100,99,100,99) | 94 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Above (N=101,98,96,98,98,97) | 3 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Below (N=101,100,97,97,99,99) | 4 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Above (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Below (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Above (N=101,97,95,95,96,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Unknown (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Below (N=101,98,96,98,98,97) | 8 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Within (N=101,100,97,97,99,99) | 92 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Within (N=99,91,88,91,93,97) | 87 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Within (N=102,104,102,100101,102) | 104 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Below (N=102,101,100,99,100,99) | 5 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Within (N=101,97,95,95,96,97) | 96 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Within (N=101,100,97,97,99,99) | 94 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Above (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Within (N=99,91,88,91,93,97) | 85 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Within (N=102,104,102,100,101,102) | 100 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Below (N=100,95,95,95,97,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Within (N=100,95,95,95,97,97) | 86 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Unknown (N=102,104,102,100101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Within (N=102,101,100,99,100,99) | 99 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Unknown (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Below (N=102,104,102,100101,102) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Within (N=100,95,95,95,97,97) | 92 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Below (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Within (N=101,98,96,98,98,97) | 97 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Within (N=102,104,102,100101,102) | 100 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Above (N=102,104,102,100101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Within (N=100,95,95,95,97,97) | 94 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Above (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Above (N=102,104,102,100101,102) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Below (N=100,95,95,95,97,97) | 8 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Below (N=101,97,95,95,96,97) | 9 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Unknown (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Above (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Unknown (N=102,104,102,100101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Below (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Unknown (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Within (N=99,91,88,91,93,97) | 88 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Below (N=101,97,95,95,96,97) | 4 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Below (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Below (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Below (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Above (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Below (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Within (N=101,97,95,95,96,97) | 87 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Within (N=102,101,100,99,100,99) | 97 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Below (N=99,91,88,91,93,97) | 6 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Below (N=101,100,97,97,99,99) | 7 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Within (N=101,98,96,98,98,97) | 92 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Above (N=102,101,100,99,100,99) | 3 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Within (N=101,100,97,97,99,99) | 99 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Below (N=102,104,102,100101,102) | 7 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Above (N=102,104,102,100,101,102) | 3 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Below (N=99,91,88,91,93,97) | 9 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Within (N=99,91,88,91,93,97) | 77 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Above (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Below (N=102,104,102,100101,102) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Within (N=102,101,100,99,100,99) | 96 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Within (N=102,104,102,100101,102) | 100 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Above (N=102,104,102,100101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Unknown (N=102,104,102,100101,102) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Below (N=102,101,100,99,100,99) | 4 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Below (N=102,101,100,99,100,99) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Within (N=102,101,100,99,100,99) | 98 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Unknown (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Below (N=101,100,97,97,99,99) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Within (N=101,100,97,97,99,99) | 90 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Above (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Above (N=101,100,97,97,99,99) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Unknown (N=101,100,97,97,99,99) | 3 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Below (N=101,98,96,98,98,97) | 3 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Within (N=101,98,96,98,98,97) | 92 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Below (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Within (N=101,97,95,95,96,97) | 91 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Below (N=101,97,95,95,96,97) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Within (N=101,97,95,95,96,97) | 92 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Below (N=101,97,95,95,96,97) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Above (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Within (N=99,91,88,91,93,97) | 87 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Within (N=100,95,95,95,97,97) | 93 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Within (N=100,95,95,95,97,97) | 93 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Below (N=99,91,88,91,93,97) | 4 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Within (N=99,91,88,91,93,97) | 82 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Above (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Within (N=101,98,96,98,98,97) | 96 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Within (N=100,95,95,95,97,97) | 90 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Within (N=102,104,102,100101,102) | 95 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Above (N=102,104,102,100101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Unknown (N=102,104,102,100101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Below (N=102,101,100,99,100,99) | 5 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Within (N=102,101,100,99,100,99) | 95 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Below (N=101,100,97,97,99,99) | 5 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Within (N=101,100,97,97,99,99) | 89 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Unknown (N=101,100,97,97,99,99) | 3 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Below (N=102,104,102,100,101,102) | 5 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Below (N=101,98,96,98,98,97) | 8 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Within (N=101,100,97,97,99,99) | 96 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Within (N=101,98,96,98,98,97) | 88 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Below (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Below (N=101,97,95,95,96,97) | 9 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Within (N=101,97,95,95,96,97) | 86 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Within (N=102,104,102,100,101,102) | 94 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Below (N=100,95,95,95,97,97) | 5 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Below (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Within (N=101,97,95,95,96,97) | 89 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Unknown (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Within (N=101,97,95,95,96,97) | 90 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Below (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Within (N=100,95,95,95,97,97) | 93 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Below (N=101,100,97,97,99,99) | 6 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Below (N=101,97,95,95,96,97) | 3 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Unknown (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Unknown (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Below (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Within (N=101,100,97,97,99,99) | 90 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Within (N=101,98,96,98,98,97) | 92 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Within (N=101,97,95,95,96,97) | 94 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Below (N=101,98,96,98,98,97) | 3 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Within (N=101,100,97,97,99,99) | 93 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Within (N=100,95,95,95,97,97) | 89 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Within (N=101,100,97,97,99,99) | 95 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Within (N=102,104,102,100,101,102) | 93 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Below (N=101,98,96,98,98,97) | 7 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Below (N=102,104,102,100,101,102) | 3 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Within (N=99,91,88,91,93,97) | 84 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Below (N=101,100,97,97,99,99) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Unknown (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Above (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Within (N=101,98,96,98,98,97) | 89 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Below (N=99,91,88,91,93,97) | 4 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Above (N=102,101,100,99,100,99) | 5 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Within (N=102,101,100,99,100,99) | 92 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Below (N=100,95,95,95,97,97) | 5 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Below (N=100,95,95,95,97,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Below (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Below (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Unknown (N=102,104,102,100101,102) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Below (N=101,100,97,97,99,99) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Unknown (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Above (N=102,104,102,100101,102) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Above (N=102,104,102,100101,102) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Within (N=102,104,102,100101,102) | 93 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Below (N=102,104,102,100101,102) | 3 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Unknown (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Below (N=101,97,95,95,96,97) | 6 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Unknown (N=102,104,102,100101,102) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Within (N=101,98,96,98,98,97) | 97 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Above (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Within (N=99,91,88,91,93,97) | 84 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Within (N=102,104,102,100101,102) | 98 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Below (N=102,101,100,99,100,99) | 4 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Below (N=99,91,88,91,93,97) | 3 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Below (N=102,104,102,100101,102) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Within (N=102,101,100,99,100,99) | 93 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Within (N=102,101,100,99,100,99) | 98 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Above (N=100,95,95,95,97,97) | 4 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Within (N=100,95,95,95,97,97) | 89 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Within (N=99,91,88,91,93,97) | 90 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Above (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Below (N=100,95,95,95,97,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Above (N=101,97,95,95,96,97) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Below (N=99,91,88,91,93,97) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Below (N=99,91,88,91,93,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Within (N=99,91,88,91,93,97) | 91 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Unknown (N=99,91,88,91,93,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Below (N=102,104,102,100,101,102) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Within (N=102,104,102,100,101,102) | 95 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Above (N=102,104,102,100,101,102) | 4 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Below (N=102,101,100,99,100,99) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Within (N=102,101,100,99,100,99) | 94 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Above (N=102,101,100,99,100,99) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Below (N=101,100,97,97,99,99) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Within (N=101,100,97,97,99,99) | 91 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Above (N=101,100,97,97,99,99) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Unknown (N=101,100,97,97,99,99) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Below (N=101,98,96,98,98,97) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Within (N=101,98,96,98,98,97) | 93 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Above (N=101,98,96,98,98,97) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Below (N=101,97,95,95,96,97) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Within (N=101,97,95,95,96,97) | 92 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Above (N=101,97,95,95,96,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Below (N=100,95,95,95,97,97) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Within (N=100,95,95,95,97,97) | 91 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Above (N=100,95,95,95,97,97) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Within (N=99,91,88,91,93,97) | 88 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Above (N=99,91,88,91,93,97) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Below (N=102,104,102,100101,102) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Within (N=102,104,102,100101,102) | 99 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Above (N=102,104,102,100101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Unknown (N=102,104,102,100101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Below (N=102,101,100,99,100,99) | 5 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Within (N=102,101,100,99,100,99) | 95 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Below (N=101,100,97,97,99,99) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Within (N=101,100,97,97,99,99) | 94 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Unknown (N=101,100,97,97,99,99) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Below (N=101,98,96,98,98,97) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Within (N=101,98,96,98,98,97) | 95 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Below (N=101,97,95,95,96,97) | 7 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Within (N=101,97,95,95,96,97) | 89 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Below (N=100,95,95,95,97,97) | 6 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Within (N=100,95,95,95,97,97) | 91 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Below (N=99,91,88,91,93,97) | 5 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Within (N=99,91,88,91,93,97) | 88 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Below (N=102,104,102,100101,102) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Within (N=102,104,102,100101,102) | 98 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Above (N=102,104,102,100101,102) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Unknown (N=102,104,102,100101,102) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Within (N=102,101,100,99,100,99) | 99 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Above (N=102,101,100,99,100,99) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Below (N=101,100,97,97,99,99) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Within (N=101,100,97,97,99,99) | 98 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Within (N=101,98,96,98,98,97) | 98 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Below (N=101,97,95,95,96,97) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Within (N=101,97,95,95,96,97) | 92 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Unknown (N=101,97,95,95,96,97) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Within (N=100,95,95,95,97,97) | 96 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Below (N=100,95,95,95,97,97) | 12 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Above (N=102,104,102,100,101,102) | 5 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Within (N=101,97,95,95,96,97) | 85 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D42] Below (N=101,97,95,95,96,97) | 12 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Unknown (N=101,98,96,98,98,97) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Within (N=102,104,102,100,101,102) | 95 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Below (N=101,100,97,97,99,99) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Within (N=101,98,96,98,98,97) | 86 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D28] Below (N=101,98,96,98,98,97) | 8 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Unknown (N=101,100,97,97,99,99) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Below (N=102,104,102,100,101,102) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Within (N=101,100,97,97,99,99) | 95 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Within (N=101,100,97,97,99,99) | 90 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D21] Below (N=101,100,97,97,99,99) | 6 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Within (N=102,101,100,99,100,99) | 96 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D7] Below (N=102,101,100,99,100,99) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Unknown (N=102,104,102,100101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Below (N=100,95,95,95,97,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Above (N=102,104,102,100101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Below (N=101,98,96,98,98,97) | 4 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Within (N=102,104,102,100101,102) | 98 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D0] Below (N=102,104,102,100101,102) | 4 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Unknown (N=99,91,88,91,93,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Within (N=101,98,96,98,98,97) | 91 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Within (N=99,91,88,91,93,97) | 91 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D182] Below (N=99,91,88,91,93,97) | 4 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Within (N=99,91,88,91,93,97) | 94 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Above (N=100,95,95,95,97,97) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Within (N=100,95,95,95,97,97) | 91 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D63] Below (N=100,95,95,95,97,97) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Above (N=101,97,95,95,96,97) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Within (N=101,97,95,95,96,97) | 91 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D42] Below (N=101,97,95,95,96,97) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D182] Below (N=99,91,88,91,93,97) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Unknown (N=101,98,96,98,98,97) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Above (N=101,98,96,98,98,97) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Within (N=101,98,96,98,98,97) | 91 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Below (N=101,97,95,95,96,97) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Within (N=101,97,95,95,96,97) | 95 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Unknown (N=101,100,97,97,99,99) | 4 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Above (N=101,100,97,97,99,99) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Within (N=101,100,97,97,99,99) | 90 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D21] Below (N=101,100,97,97,99,99) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Within (N=100,95,95,95,97,97) | 94 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Above (N=102,101,100,99,100,99) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Within (N=102,101,100,99,100,99) | 94 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D7] Below (N=102,101,100,99,100,99) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Unknown (N=102,104,102,100101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D63] Unknown (N=100,95,95,95,97,97) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Above (N=102,104,102,100101,102) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Within (N=102,104,102,100101,102) | 99 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D0] Below (N=102,104,102,100101,102) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Within (N=102,101,100,99,100,99) | 99 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Within (N=99,91,88,91,93,97) | 87 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D182] Below (N=99,91,88,91,93,97) | 10 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | WBC [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | SUN [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | RBC [D63] Within (N=100,95,95,95,97,97) | 85 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.
Time frame: On Days 0, 7, 21, 28, 42, 63 and 182
Population: The Total Vaccinated cohort included all vaccinated subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Below (N=99,91,88,91,93,97) | 3 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Within (N=99,91,88,91,93,97) | 82 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Within (N=100,95,95,95,97,97) | 100 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Below (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Below (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Above (N=101,100,98,97,97,97) | 3 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Within (N=101,97,95,95,96,97) | 100 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Below (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Within (N=101,98,96,98,98,97) | 99 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Below (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Within (N=102,104,102,100,101,102) | 89 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Unknown (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Unknown (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Within (N=101,97,95,95,96,97) | 98 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Within (N=102,101,100,99,100,99) | 100 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Below (N=102,104,102,100,101,102) | 11 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Within (N=100,95,95,95,97,97) | 100 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Below (N=101,97,95,95,96,97) | 16 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Within (N=101,98,96,98,98,97) | 98 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Within (N=101,100,97,97,99,99) | 100 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Within (N=102,104,102,100,101,102) | 98 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Unknown (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Below (N=100,95,95,95,97,97) | 17 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Within (N=101,97,95,95,96,97) | 101 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Below (N=101,97,95,95,96,97) | 3 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Below (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Below (N=99,91,88,91,93,97) | 17 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Within (N=101,98,96,98,98,97) | 82 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Within (N=101,100,98,97,97,97) | 96 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Unknown (N=101,100,98,97,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Within (N=99,91,88,91,93,97) | 97 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Within (N=101,100,97,97,99,99) | 101 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Below (N=101,100,97,97,99,99) | 25 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Below (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Above (N=99,91,88,91,93,97) | 3 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Within (N=101,100,97,97,99,99) | 97 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Within (N=100,95,95,95,97,97) | 82 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Within (N=99,91,88,91,93,97) | 98 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Below (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Within (N=102,101,100,99,100,99) | 82 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Below (N=101,100,97,97,99,99) | 3 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Below (N=101,98,96,98,98,97) | 17 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Unknown (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Within (N=101,100,97,97,99,99) | 76 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Below (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Within (N=102,104,102,100,101,102) | 100 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Within (N=102,101,100,99,100,99) | 101 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Above (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Within (N=101,97,95,95,96,97) | 85 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Within (N=99,91,88,91,93,97) | 93 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Below (N=102,101,100,99,100,99) | 20 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Within (N=101,98,96,98,98,97) | 98 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Unknown (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Unknown (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Below (N=101,100,98,97,97,97) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Unknown (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Within (N=102,104,102,100,101,102) | 100 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Below (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Within (N=100,95,95,95,97,97) | 98 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Below (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Within (N=100,95,95,95,97,97) | 95 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Within (N=102,104,102,100,101,102) | 98 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Within (N=102,101,100,99,100,99) | 100 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Below (N=101,100,97,97,99,99) | 5 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Below (N=101,98,96,98,98,97) | 5 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Unknown (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Unknown (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Unknown (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Unknown (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Below (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Within (N=101,97,95,95,96,97) | 95 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Within (N=101,100,97,97,99,99) | 98 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Below (N=99,91,88,91,93,97) | 20 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Below (N=101,97,95,95,96,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Within (N=101,100,98,97,97,97) | 94 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Above (N=101,100,97,97,99,99) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Within (N=99,91,88,91,93,97) | 71 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Within (N=101,100,97,97,99,99) | 92 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Within (N=101,98,96,98,98,97) | 96 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Unknown (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Within (N=100,95,95,95,97,97) | 93 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Below (N=101,97,95,95,96,97) | 19 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Below (N=101,98,96,98,98,97) | 19 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Below (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Below (N=102,104,102,100,101,102) | 4 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Within (N=102,101,100,99,100,99) | 86 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Above (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Below (N=102,101,100,99,100,99) | 14 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Within (N=101,97,95,95,96,97) | 78 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Within (N=101,98,96,98,98,97) | 96 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Above (N=101,97,95,95,96,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Unknown (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Below (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Within (N=101,97,95,95,96,97) | 96 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Within (N=102,104,102,100,101,102) | 86 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Above (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Within (N=101,97,95,95,96,97) | 91 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Above (N=101,100,98,97,97,97) | 3 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Below (N=102,104,102,100,101,102) | 18 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Below (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Below (N=99,91,88,91,93,97) | 3 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Within (N=99,91,88,91,93,97) | 86 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Within (N=100,95,95,95,97,97) | 94 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Below (N=101,97,95,95,96,97) | 4 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Below (N=100,95,95,95,97,97) | 20 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Below (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Within (N=99,91,88,91,93,97) | 90 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Below (N=101,100,98,97,97,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Within (N=99,91,88,91,93,97) | 90 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Within (N=101,100,97,97,99,99) | 99 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Within (N=101,100,97,97,99,99) | 79 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Unknown (N=101,100,98,97,97,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Unknown (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Within (N=100,95,95,95,97,97) | 75 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Within (N=102,101,100,99,100,99) | 100 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Within (N=101,98,96,98,98,97) | 89 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Within (N=101,98,96,98,98,97) | 77 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Above (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Within (N=102,104,102,100,101,102) | 104 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Below (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Within (N=102,104,102,100,101,102) | 101 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Below (N=101,100,97,97,99,99) | 20 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Below (N=101,98,96,98,98,97) | 26 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Within (N=101,98,96,98,98,97) | 70 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Below (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Below (N=101,97,95,95,96,97) | 20 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Within (N=101,97,95,95,96,97) | 75 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Below (N=100,95,95,95,97,97) | 21 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Within (N=100,95,95,95,97,97) | 73 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Within (N=101,100,97,97,99,99) | 93 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Within (N=102,104,102,100,101,102) | 97 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Below (N=99,91,88,91,93,97) | 20 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Within (N=99,91,88,91,93,97) | 68 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Below (N=102,104,102,100,101,102) | 4 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Unknown (N=101,100,97,97,99,99) | 3 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Within (N=101,98,96,98,98,97) | 96 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Within (N=101,97,95,95,96,97) | 93 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Within (N=101,97,95,95,96,97) | 94 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Above (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Unknown (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Below (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Within (N=100,95,95,95,97,97) | 94 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Below (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Below (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Within (N=99,91,88,91,93,97) | 87 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Below (N=99,91,88,91,93,97) | 4 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Below (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Within (N=102,104,102,100,101,102) | 102 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Within (N=101,98,96,98,98,97) | 92 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Within (N=102,104,102,100,101,102) | 102 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Below (N=101,98,96,98,98,97) | 3 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Within (N=102,101,100,99,100,99) | 99 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Unknown (N=101,100,97,97,99,99) | 3 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Within (N=101,100,97,97,99,99) | 94 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Within (N=100,95,95,95,97,97) | 94 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Unknown (N=101,100,97,97,99,99) | 3 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Within (N=101,98,96,98,98,97) | 95 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Within (N=101,100,97,97,99,99) | 91 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Within (N=101,97,95,95,96,97) | 95 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Below (N=101,100,97,97,99,99) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Within (N=100,95,95,95,97,97) | 95 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Unknown (N=101,100,98,97,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Within (N=99,91,88,91,93,97) | 88 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Within (N=102,101,100,99,100,99) | 100 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Above (N=101,100,98,97,97,97) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Below (N=102,104,102,100,101,102) | 26 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Within (N=102,104,102,100,101,102) | 75 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Within (N=101,100,98,97,97,97) | 94 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Below (N=102,101,100,99,100,99) | 22 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Within (N=99,91,88,91,93,97) | 83 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Within (N=102,101,100,99,100,99) | 78 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Below (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Below (N=101,100,97,97,99,99) | 20 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Below (N=101,100,98,97,97,97) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Within (N=101,100,97,97,99,99) | 74 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Unknown (N=101,100,97,97,99,99) | 3 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Below (N=101,100,98,97,97,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Within (N=100,95,95,95,97,97) | 95 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Within (N=102,104,102,100,101,102) | 97 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Unknown (N=101,100,98,97,97,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Within (N=102,104,102,100,101,102) | 98 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Within (N=101,100,97,97,99,99) | 96 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Within (N=101,98,96,98,98,97) | 93 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Unknown (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Above (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Below (N=101,100,97,97,99,99) | 12 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Unknown (N=99,91,88,91,93,97) | 3 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Below (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Within (N=99,91,88,91,93,97) | 87 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Below (N=101,97,95,95,96,97) | 25 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Within (N=99,91,88,91,93,97) | 89 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Unknown (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Unknown (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Within (N=100,95,95,95,97,97) | 76 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Within (N=102,101,100,99,100,99) | 97 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Above (N=101,100,98,97,97,97) | 4 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Within (N=100,95,95,95,97,97) | 93 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Within (N=102,104,102,100,101,102) | 92 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Unknown (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Below (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Below (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Unknown (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Within (N=101,100,97,97,99,99) | 84 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Below (N=102,104,102,100,101,102) | 18 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Below (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Within (N=101,97,95,95,96,97) | 95 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Unknown (N=102,101,100,99,100,99) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Within (N=102,104,102,100,101,102) | 79 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Within (N=101,97,95,95,96,97) | 92 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Below (N=100,95,95,95,97,97) | 19 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Within (N=101,100,98,97,97,97) | 90 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Within (N=101,98,96,98,98,97) | 96 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Unknown (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Within (N=101,98,96,98,98,97) | 70 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Above (N=101,97,95,95,96,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Below (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Below (N=102,101,100,99,100,99) | 12 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Within (N=99,91,88,91,93,97) | 86 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Within (N=101,97,95,95,96,97) | 70 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Within (N=102,101,100,99,100,99) | 86 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Above (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Unknown (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Within (N=99,91,88,91,93,97) | 68 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Within (N=101,100,97,97,99,99) | 93 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Within (N=101,98,96,98,98,97) | 96 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Unknown (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Unknown (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Below (N=102,104,102,100,101,102) | 4 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Within (N=101,100,97,97,99,99) | 95 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Within (N=101,97,95,95,96,97) | 94 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Below (N=99,91,88,91,93,97) | 21 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Below (N=101,100,97,97,99,99) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Above (N=100,95,95,95,97,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Below (N=101,98,96,98,98,97) | 26 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Unknown (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Unknown (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Within (N=102,101,100,99,100,99) | 98 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Below (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Within (N=100,95,95,95,97,97) | 92 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Unknown (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Below (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Below (N=99,91,88,91,93,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Within (N=99,91,88,91,93,97) | 89 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Above (N=99,91,88,91,93,97) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Below (N=102,104,102,100,101,102) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Within (N=102,104,102,100,101,102) | 98 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Above (N=102,104,102,100,101,102) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Within (N=102,101,100,99,100,99) | 99 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Above (N=102,101,100,99,100,99) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Within (N=101,100,97,97,99,99) | 97 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Unknown (N=101,100,97,97,99,99) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Within (N=101,98,96,98,98,97) | 95 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Unknown (N=101,98,96,98,98,97) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Below (N=101,97,95,95,96,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Within (N=101,97,95,95,96,97) | 93 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Unknown (N=101,97,95,95,96,97) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Within (N=100,95,95,95,97,97) | 96 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Below (N=99,91,88,91,93,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Within (N=99,91,88,91,93,97) | 91 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Within (N=102,104,102,100,101,102) | 101 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Within (N=102,101,100,99,100,99) | 100 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Within (N=101,100,97,97,99,99) | 97 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Unknown (N=101,100,97,97,99,99) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Within (N=101,98,96,98,98,97) | 97 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Below (N=101,97,95,95,96,97) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Within (N=101,97,95,95,96,97) | 93 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Below (N=100,95,95,95,97,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Within (N=100,95,95,95,97,97) | 96 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Below (N=99,91,88,91,93,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Within (N=99,91,88,91,93,97) | 91 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Below (N=102,104,102,100,101,102) | 13 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Within (N=102,104,102,100,101,102) | 88 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Below (N=102,101,100,99,100,99) | 13 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Within (N=102,101,100,99,100,99) | 87 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Below (N=101,100,97,97,99,99) | 18 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Within (N=101,100,97,97,99,99) | 79 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Unknown (N=101,100,97,97,99,99) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Below (N=101,98,96,98,98,97) | 17 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Within (N=101,98,96,98,98,97) | 80 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Below (N=101,97,95,95,96,97) | 20 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Within (N=101,97,95,95,96,97) | 76 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Below (N=100,95,95,95,97,97) | 15 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Within (N=100,95,95,95,97,97) | 82 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Below (N=99,91,88,91,93,97) | 20 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Within (N=99,91,88,91,93,97) | 73 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Within (N=102,104,102,100,101,102) | 98 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Above (N=102,104,102,100,101,102) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Below (N=101,100,98,97,97,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Within (N=101,100,98,97,97,97) | 93 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Above (N=101,100,98,97,97,97) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Unknown (N=101,100,98,97,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Below (N=101,100,97,97,99,99) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Within (N=101,100,97,97,99,99) | 92 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Above (N=101,100,97,97,99,99) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Unknown (N=101,100,97,97,99,99) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Below (N=101,98,96,98,98,97) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Within (N=101,98,96,98,98,97) | 93 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Below (N=101,97,95,95,96,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Within (N=101,97,95,95,96,97) | 93 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Above (N=101,97,95,95,96,97) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Below (N=100,95,95,95,97,97) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Within (N=100,95,95,95,97,97) | 92 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Above (N=100,95,95,95,97,97) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Within (N=101,100,97,97,99,99) | 75 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Below (N=101,100,97,97,99,99) | 20 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Below (N=101,100,98,97,97,97) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Within (N=102,101,100,99,100,99) | 77 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Within (N=101,100,98,97,97,97) | 91 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Within (N=102,104,102,100,101,102) | 79 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D0] Below (N=102,104,102,100,101,102) | 23 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Unknown (N=99,91,88,91,93,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Within (N=102,101,100,99,100,99) | 99 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Above (N=101,100,98,97,97,97) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Within (N=99,91,88,91,93,97) | 95 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Within (N=100,95,95,95,97,97) | 96 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Above (N=100,95,95,95,97,97) | 4 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D7] Unknown (N=101,100,98,97,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Within (N=101,97,95,95,96,97) | 97 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Below (N=100,95,95,95,97,97) | 5 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Below (N=101,100,97,97,99,99) | 4 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Unknown (N=101,98,96,98,98,97) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Within (N=101,98,96,98,98,97) | 93 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Within (N=101,100,97,97,99,99) | 88 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Unknown (N=101,100,97,97,99,99) | 4 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Within (N=101,100,97,97,99,99) | 94 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Unknown (N=101,100,97,97,99,99) | 4 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Within (N=102,101,100,99,100,99) | 98 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D7] Below (N=102,101,100,99,100,99) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Within (N=102,104,102,100,101,102) | 101 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Below (N=101,98,96,98,98,97) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Within (N=102,104,102,100,101,102) | 101 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D21] Above (N=101,100,97,97,99,99) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Below (N=99,91,88,91,93,97) | 6 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Within (N=101,98,96,98,98,97) | 91 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Within (N=101,98,96,98,98,97) | 75 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D7] Below (N=102,101,100,99,100,99) | 22 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | LYM [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Within (N=100,95,95,95,97,97) | 88 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Within (N=99,91,88,91,93,97) | 95 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D182] Below (N=99,91,88,91,93,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D0] Below (N=102,104,102,100,101,102) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D28] Unknown (N=101,98,96,98,98,97) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Within (N=100,95,95,95,97,97) | 96 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D63] Below (N=100,95,95,95,97,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Unknown (N=99,91,88,91,93,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Below (N=101,97,95,95,96,97) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Within (N=101,97,95,95,96,97) | 97 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Within (N=101,97,95,95,96,97) | 93 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Unknown (N=101,98,96,98,98,97) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Within (N=101,98,96,98,98,97) | 94 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D182] Within (N=99,91,88,91,93,97) | 89 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Above (N=101,97,95,95,96,97) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Unknown (N=101,100,97,97,99,99) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Unknown (N=99,91,88,91,93,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Within (N=99,91,88,91,93,97) | 73 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D182] Below (N=99,91,88,91,93,97) | 23 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Within (N=101,100,97,97,99,99) | 96 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Below (N=102,104,102,100,101,102) | 4 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Within (N=100,95,95,95,97,97) | 79 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D63] Below (N=100,95,95,95,97,97) | 18 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Within (N=102,104,102,100,101,102) | 93 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Within (N=101,97,95,95,96,97) | 77 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D42] Below (N=101,97,95,95,96,97) | 20 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Above (N=102,104,102,100,101,102) | 5 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Unknown (N=101,98,96,98,98,97) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D28] Below (N=101,98,96,98,98,97) | 19 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | MON [D21] Unknown (N=101,100,97,97,99,99) | 4 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | PLA [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | NEU [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
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.
Time frame: On Days 0, 7, 21, 28, 42, 63 and 182
Population: The Total Vaccinated Cohort included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Within (N=101,98,96,98,98,97) | 99 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Within (N=101,98,96,98,98,97) | 99 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Above (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Within (N=102,101,100,99,100,99) | 102 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Within (N=100,95,95,95,97,97) | 98 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Within (N=102,104,102,100,101,102) | 101 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Above (N=101,98,96,98,98,97) | 4 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Unknown (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Within (N=99,91,88,91,93,97) | 99 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Within (N=101,98,96,98,98,97) | 96 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Above (N=101,100,97,97,99,99) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Above (N=102,101,100,99,100,99) | 3 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Within (N=102,101,100,99,100,99) | 99 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Below (N=102,101,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Within (N=100,95,95,95,97,97) | 100 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Within (N=100,95,95,95,97,97) | 99 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Above (N=101,97, 95,95,96,97) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Within (N=101,97, 95,95,96,97) | 99 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Above (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Within (N=102,101,100,99,100,99) | 101 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Above (N=102,104, 102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Within (N=102,104, 102,100,101,102) | 102 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Below (N=102,104, 102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Within (N=102,101,100,99,100,99) | 100 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Above (N=102,101,102,100,101,102) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Within (N=101,98,96,98,98,97) | 96 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Within (N=102,101,102,100,101,102) | 100 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Above (N=101,98,96,98,98,97) | 4 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Within (N=101,97,95,95,96,97) | 97 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Unknown (N=101,97, 95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Within (N=101,100,97,97,99,99) | 101 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Unknown (N=102,104, 102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Unknown (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Above (N=101,97,95,95,96,97) | 3 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Above (N=100,95,95,95,97,97) | 6 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Within (N=99,91,88,91,93,97) | 96 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Within (N=101,97,95,95,96,97) | 98 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Within (N=101,100,97,97,99,99) | 96 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Above (N=101,100,97,97,99,99) | 5 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Above (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Above (N=101,100,97,97,99,99) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Within (N=99,91,88,91,93,97) | 97 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Within (N=99,91,88,91,93,97) | 98 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Unknown (N=102,101,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Within (N=100,95,95,95,97,97) | 98 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Within (N=102,104,102,100,101,102) | 100 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Within (N=99,91,88,91,93,97) | 99 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Within (N=102,104,102,100,101,102) | 101 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Within (N=101,98,96,98,98,97) | 99 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Within (N=101,100,97,97,99,99) | 101 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Within (N=101,100,97,97,99,99) | 99 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Above (N=101,97,95,95,96,97) | 4 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Below (N=101,97, 95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Unknown (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Within (N=100,95,95,95,97,97) | 93 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Within (N=101,97,95,95,96,97) | 95 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Above (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Above (N=101,97,95,95,96,97) | 6 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Within (N=102,101,100,99,100,99) | 101 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Above (N=102,101,100,99,100,99) | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Within (N=101,97,95,95,96,97) | 101 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Within (N=101,100,97,97,99,99) | 99 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Above (N=101,100,97,97,99,99) | 3 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Within (N=99,91,88,91,93,97) | 90 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Below (N=101,97, 95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Within (N=100,95,95,95,97,97) | 89 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Within (N=99,91,88,91,93,97) | 89 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Within (N=101,98,96,98,98,97) | 97 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Above (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Within (N=102,101,100,99,100,99) | 100 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Above (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Within (N=101,100,97,97,99,99) | 97 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Unknown (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Above (N=101,100,97,97,99,99) | 3 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Within (N=100,95,95,95,97,97) | 95 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Within (N=102,104,102,100,101,102) | 104 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Within (N=101,97,95,95,96,97) | 97 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Unknown (N=102,101,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Above (N=99,91,88,91,93,97) | 4 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Above (N=101,97,95,95,96,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Unknown (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Within (N=101,97,95,95,96,97) | 95 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Within (N=101,100,97,97,99,99) | 99 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Above (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Above (N=102,101,100,99,100,99) | 5 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Within (N=102,104,102,100,101,102) | 102 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Within (N=101,100,97,97,99,99) | 97 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Unknown (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Below (N=102,101,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Within (N=102,101,102,100,101,102) | 101 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Within (N=102,101,100,99,100,99) | 96 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Within (N=101,98,96,98,98,97) | 96 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Within (N=101,97,95,95,96,97) | 94 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Above (N=101,97,95,95,96,97) | 3 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Above (N=100,95,95,95,97,97) | 5 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Within (N=101,100,97,97,99,99) | 100 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Above (N=101,97, 95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Within (N=102,104,102,100,101,102) | 102 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Within (N=100,95,95,95,97,97) | 94 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Within (N=101,98,96,98,98,97) | 96 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Within (N=101,98,96,98,98,97) | 96 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Above (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Within (N=101,97,95,95,96,97) | 93 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Above (N=101,97,95,95,96,97) | 4 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Within (N=100,95,95,95,97,97) | 92 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Above (N=100,95,95,95,97,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Within (N=99,91,88,91,93,97) | 87 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Above (N=99,91,88,91,93,97) | 3 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Unknown (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Unknown (N=102,104, 102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Unknown (N=101,97, 95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Unknown (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Unknown (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Within (N=102,101,100,99,100,99) | 100 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Above (N=102,101,102,100,101,102) | 3 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Above (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Below (N=102,104, 102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Within (N=102,104, 102,100,101,102) | 104 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Above (N=102,104, 102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Within (N=102,101,100,99,100,99) | 101 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Within (N=101,97, 95,95,96,97) | 97 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Within (N=100,95,95,95,97,97) | 94 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Within (N=102,101,100,99,100,99) | 99 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Above (N=102,101,100,99,100,99) | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Within (N=101,98,96,98,98,97) | 97 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Within (N=99,91,88,91,93,97) | 86 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Within (N=101,100,97,97,99,99) | 99 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Within (N=99,91,88,91,93,97) | 91 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Within (N=101,97,95,95,96,97) | 93 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Above (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Within (N=99,91,88,91,93,97) | 87 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Within (N=101,97,95,95,96,97) | 92 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Within (N=100,95,95,95,97,97) | 92 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Above (N=100,95,95,95,97,97) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Within (N=101,100,97,97,99,99) | 94 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Within (N=99,91,88,91,93,97) | 86 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Above (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Above (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Unknown (N=102,104, 102,100,101,102) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Unknown (N=101,97, 95,95,96,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Unknown (N=100,95,95,95,97,97) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Unknown (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Unknown (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Unknown (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Unknown (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Within (N=102,101,100,99,100,99) | 100 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Within (N=101,98,96,98,98,97) | 94 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Above (N=102,101,102,100,101,102) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Above (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Below (N=102,104, 102,100,101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Within (N=99,91,88,91,93,97) | 88 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Within (N=102,104, 102,100,101,102) | 100 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Above (N=102,104, 102,100,101,102) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Within (N=102,101,100,99,100,99) | 99 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Within (N=102,101,100,99,100,99) | 100 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Within (N=101,97, 95,95,96,97) | 94 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Within (N=102,101,102,100,101,102) | 99 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Within (N=100,95,95,95,97,97) | 93 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Below (N=102,101,102,100,101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Unknown (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Within (N=102,101,100,99,100,99) | 97 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Above (N=102,101,100,99,100,99) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Within (N=101,98,96,98,98,97) | 93 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Above (N=101,98,96,98,98,97) | 3 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Within (N=101,100,97,97,99,99) | 96 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Above (N=101,97, 95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Unknown (N=101,100,97,97,99,99) | 3 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Within (N=102,104,102,100,101,102) | 100 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Within (N=101,98,96,98,98,97) | 96 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Within (N=101,97,95,95,96,97) | 95 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Above (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Above (N=102,101,100,99,100,99) | 3 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Within (N=101,97,95,95,96,97) | 93 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Within (N=102,101,100,99,100,99) | 97 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Within (N=101,100,97,97,99,99) | 96 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Within (N=101,98,96,98,98,97) | 94 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Unknown (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Within (N=100,95,95,95,97,97) | 93 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Above (N=101,97,95,95,96,97) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Below (N=101,97, 95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Within (N=102,104,102,100,101,102) | 100 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Within (N=101,100,97,97,99,99) | 97 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Within (N=99,91,88,91,93,97) | 88 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Within (N=102,104,102,100,101,102) | 102 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Within (N=99,91,88,91,93,97) | 88 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Unknown (N=102,101,102,100,101,102) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Within (N=100,95,95,95,97,97) | 95 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Above (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Within (N=101,98,96,98,98,97) | 95 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Unknown (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Above (N=101,100,97,97,99,99) | 2 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Within (N=100,95,95,95,97,97) | 92 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Within (N=101,100,97,97,99,99) | 95 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Within (N=100,95,95,95,97,97) | 95 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Within (N=102,104,102,100,101,102) | 98 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Within (N=102,101,100,99,100,99) | 98 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Above (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Within (N=101,100,97,97,99,99) | 96 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Above (N=101,97,95,95,96,97) | 4 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Unknown (N=102,101,102,100,101,102) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Unknown (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Unknown (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Within (N=100,95,95,95,97,97) | 95 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Above (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Within (N=99,91,88,91,93,97) | 90 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Within (N=102,104,102,100,101,102) | 98 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Within (N=101,100,97,97,99,99) | 97 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Within (N=101,97,95,95,96,97) | 95 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Above (N=99,91,88,91,93,97) | 3 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Within (N=101,98,96,98,98,97) | 96 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Within (N=101,97,95,95,96,97) | 95 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Within (N=102,104, 102,100,101,102) | 98 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Within (N=102,101,100,99,100,99) | 97 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Within (N=99,91,88,91,93,97) | 89 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Above (N=102,104, 102,100,101,102) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Within (N=102,101,100,99,100,99) | 98 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Within (N=101,100,97,97,99,99) | 96 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Within (N=102,101,100,99,100,99) | 98 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Within (N=99,91,88,91,93,97) | 89 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Above (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Unknown (N=102,101,100,99,100,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Within (N=101,97, 95,95,96,97) | 92 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Within (N=102,101,100,99,100,99) | 99 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Within (N=102,101,102,100,101,102) | 95 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Unknown (N=102,104,102,100,101,102) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Within (N=101,98,96,98,98,97) | 95 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Unknown (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Within (N=101,97,95,95,96,97) | 94 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Within (N=101,98,96,98,98,97) | 95 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Within (N=100,95,95,95,97,97) | 94 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Within (N=100,95,95,95,97,97) | 92 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Within (N=100,95,95,95,97,97) | 94 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Below (N=102,101,102,100,101,102) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Above (N=100,95,95,95,97,97) | 3 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Within (N=101,97,95,95,96,97) | 91 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Within (N=102,104,102,100,101,102) | 98 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Above (N=101,97,95,95,96,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Below (N=101,97, 95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Within (N=99,91,88,91,93,97) | 88 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Above (N=101,97, 95,95,96,97) | 3 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Above (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Above (N=102,101,102,100,101,102) | 4 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Above (N=101,98,96,98,98,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Unknown (N=101,97, 95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Within (N=101,100,97,97,99,99) | 96 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Within (N=101,98,96,98,98,97) | 95 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Unknown (N=102,104,102,100,101,102) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Above (N=99,91,88,91,93,97) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Within (N=101,98,96,98,98,97) | 93 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Above (N=101,98,96,98,98,97) | 4 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Below (N=102,104, 102,100,101,102) | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Within (N=101,100,97,97,99,99) | 96 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Above (N=102,101,100,99,100,99) | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Unknown (N=102,104, 102,100,101,102) | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Within (N=99,91,88,91,93,97) | 90 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Unknown (N=101,97, 95,95,96,97) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Within (N=101,100,97,97,99,99) | 97 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Unknown (N=99,91,88,91,93,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Unknown (N=102,104,102,100,101,102) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Unknown (N=99,91,88,91,93,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Unknown (N=101,97,95,95,96,97) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Within (N=101,98,96,98,98,97) | 98 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Above (N=101,97, 95,95,96,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Above (N=102,101,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Within (N=101,100,97,97,99,99) | 96 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Unknown (N=102,104, 102,100,101,102) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Above (N=99,91,88,91,93,97) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Within (N=101,98,96,98,98,97) | 96 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Below (N=102,104, 102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Within (N=102,104, 102,100,101,102) | 99 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Above (N=102,104, 102,100,101,102) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Within (N=99,91,88,91,93,97) | 93 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Within (N=102,101,100,99,100,99) | 99 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Above (N=102,101,100,99,100,99) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Within (N=102,101,102,100,101,102) | 100 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Within (N=101,97, 95,95,96,97) | 93 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Unknown (N=101,97,95,95,96,97) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Within (N=101,98,96,98,98,97) | 98 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Below (N=102,101,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Within (N=100,95,95,95,97,97) | 95 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Within (N=102,101,100,99,100,99) | 99 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Unknown (N=102,104,102,100,101,102) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Above (N=102,101,100,99,100,99) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Unknown (N=99,91,88,91,93,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Within (N=102,101,100,99,100,99) | 100 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Within (N=101,98,96,98,98,97) | 97 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Above (N=100,95,95,95,97,97) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Unknown (N=101,100,97,97,99,99) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Within (N=101,97,95,95,96,97) | 93 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Within (N=99,91,88,91,93,97) | 91 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Within (N=100,95,95,95,97,97) | 93 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Within (N=100,95,95,95,97,97) | 95 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Within (N=99,91,88,91,93,97) | 90 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Within (N=101,100,97,97,99,99) | 97 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Above (N=101,97,95,95,96,97) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Unknown (N=100,95,95,95,97,97) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Within (N=101,97,95,95,96,97) | 96 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Unknown (N=99,91,88,91,93,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Within (N=99,91,88,91,93,97) | 91 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Above (N=101,98,96,98,98,97) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Within (N=99,91,88,91,93,97) | 89 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Above (N=101,100,97,97,99,99) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Within (N=102,101,100,99,100,99) | 100 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Within (N=102,104,102,100,101,102) | 99 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Within (N=102,104,102,100,101,102) | 99 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Within (N=102,104,102,100,101,102) | 101 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Within (N=101,100,97,97,99,99) | 98 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Unknown (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Within (N=101,97,95,95,96,97) | 94 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Unknown (N=100,95,95,95,97,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Unknown (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Unknown (N=101,97,95,95,96,97) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Unknown (N=102,101,102,100,101,102) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Within (N=100,95,95,95,97,97) | 97 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Above (N=100,95,95,95,97,97) | 3 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Above (N=101,97,95,95,96,97) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Within (N=101,98,96,98,98,97) | 97 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Above (N=101,100,97,97,99,99) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Within (N=101,100,97,97,99,99) | 97 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Above (N=102,101,100,99,100,99) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Within (N=102,101,100,99,100,99) | 99 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Above (N=99,91,88,91,93,97) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Above (N=101,100,97,97,99,99) | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Within (N=100,95,95,95,97,97) | 93 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Within (N=101,97,95,95,96,97) | 92 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Below (N=101,97, 95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Unknown (N=102,101,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Above (N=99,91,88,91,93,97) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Above (N=99,91,88,91,93,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Within (N=100,95,95,95,97,97) | 97 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Within (N=102,101,100,99,100,99) | 97 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Above (N=101,98,96,98,98,97) | 4 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Unknown (N=99,91,88,91,93,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Within (N=99,91,88,91,93,97) | 97 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Within (N=101,100,97,97,99,99) | 97 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Within (N=101,98,96,98,98,97) | 96 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Within (N=102,101,100,99,100,99) | 98 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Within (N=102,104,102,100,101,102) | 101 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Above (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Within (N=101,97,95,95,96,97) | 95 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Within (N=102,104,102,100,101,102) | 102 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Above (N=101,97,95,95,96,97) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Above (N=102,104,102,100,101,102) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Unknown (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Within (N=100,95,95,95,97,97) | 92 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Within (N=101,100,97,97,99,99) | 97 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Within (N=101,98,96,98,98,97) | 94 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Within (N=99,91,88,91,93,97) | 96 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Within (N=102,104,102,100,101,102) | 101 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Within (N=101,100,97,97,99,99) | 97 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Unknown (N=100,95,95,95,97,97) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Within (N=101,97,95,95,96,97) | 97 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Within (N=101,97,95,95,96,97) | 97 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Above (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Above (N=102,101,100,99,100,99) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Within (N=99,91,88,91,93,97) | 97 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Unknown (N=101,100,97,97,99,99) | 4 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Within (N=102,104, 102,100,101,102) | 101 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Above (N=101,98,96,98,98,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Below (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Unknown (N=100,95,95,95,97,97) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D63] Above (N=100,95,95,95,97,97) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Below (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Above (N=102,101,100,99,100,99) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Within (N=101,98,96,98,98,97) | 95 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Above (N=102,101,102,100,101,102) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Above (N=101,98,96,98,98,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Below (N=102,101,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Above (N=101,97,95,95,96,97) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Above (N=101,98,96,98,98,97) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Below (N=101,100,97,97,99,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Within (N=101,100,97,97,99,99) | 95 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Above (N=102,101,100,99,100,99) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Above (N=100,95,95,95,97,97) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Unknown (N=100,95,95,95,97,97) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Within (N=101,97,95,95,96,97) | 95 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D21] Unknown (N=101,100,97,97,99,99) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Above (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Unknown (N=100,95,95,95,97,97) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D28] Within (N=101,98,96,98,98,97) | 92 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D42] Below (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D63] Within (N=100,95,95,95,97,97) | 94 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Above (N=100,95,95,95,97,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Unknown (N=101,98,96,98,98,97) | 3 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Below (N=102,104, 102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D21] Above (N=101,100,97,97,99,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Within (N=100,95,95,95,97,97) | 94 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Above (N=101,97, 95,95,96,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Below (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Within (N=101,97, 95,95,96,97) | 96 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D63] Within (N=100,95,95,95,97,97) | 93 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Within (N=102,101,100,99,100,99) | 97 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D63] Above (N=100,95,95,95,97,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Unknown (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D7] Above (N=102,101,100,99,100,99) | 2 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D0] Unknown (N=102,104,102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Below (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Below (N=101,97, 95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Within (N=101,100,97,97,99,99) | 97 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D182] Within (N=99,91,88,91,93,97) | 96 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D42] Unknown (N=101,97, 95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BIL T [D7] Unknown (N=102,101,100,99,100,99) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D182] Above (N=99,91,88,91,93,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Above (N=102,104, 102,100,101,102) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D21] Above (N=101,100,97,97,99,99) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D0] Within (N=102,101,102,100,101,102) | 99 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D42] Unknown (N=101,97,95,95,96,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D7] Within (N=102,101,100,99,100,99) | 98 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Unknown (N=101,98,96,98,98,97) | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Below (N=101,98,96,98,98,97) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ALAT [D182] Within (N=99,91,88,91,93,97) | 95 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | AP [D0] Unknown (N=102,104, 102,100,101,102) | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | BAS [D7] Within (N=102,101,100,99,100,99) | 99 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed | ASAT [D28] Within (N=101,98,96,98,98,97) | 93 Subjects |
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.
Time frame: During the entire study period (Days 0-368).
Population: The Total Vaccinated Cohort included all vaccinated subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Medically Attended Visits (MAEs). | 51 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Medically Attended Visits (MAEs). | 42 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Medically Attended Visits (MAEs). | 40 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Medically Attended Visits (MAEs). | 42 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Medically Attended Visits (MAEs). | 38 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Medically Attended Visits (MAEs). | 45 Subjects |
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.
Time frame: During the entire study period (Days 0-406).
Population: The Total Vaccinated Cohort included all vaccinated subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Potential Immune Diseases (pIMDs). | 0 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Potential Immune Diseases (pIMDs). | 0 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Potential Immune Diseases (pIMDs). | 0 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Potential Immune Diseases (pIMDs). | 0 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Potential Immune Diseases (pIMDs). | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Potential Immune Diseases (pIMDs). | 1 Subjects |
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.
Time frame: During the entire study period (Days 0-329).
Population: The Total Vaccinated Cohort included all vaccinated subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Serious Adverse Events (SAEs). | 3 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Serious Adverse Events (SAEs). | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Serious Adverse Events (SAEs). | 1 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Serious Adverse Events (SAEs). | 2 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Serious Adverse Events (SAEs). | 1 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Serious Adverse Events (SAEs). | 3 Subjects |
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).
Time frame: During a 7-day follow-up period (Days 0-6) post-vaccination period
Population: The Total Vaccinated cohort included all vaccinated subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Solicited General Symptoms. | Temperature (axillary) >=38°C | 3 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Solicited General Symptoms. | Shivering | 21 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Solicited General Symptoms. | Headache | 52 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Solicited General Symptoms. | Fatigue | 54 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Solicited General Symptoms. | Muscle aches | 38 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Solicited General Symptoms. | Sweating | 22 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Solicited General Symptoms. | Joint pain at other location | 24 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Solicited General Symptoms. | Shivering | 30 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Solicited General Symptoms. | Fatigue | 62 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Solicited General Symptoms. | Sweating | 21 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Solicited General Symptoms. | Joint pain at other location | 34 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Solicited General Symptoms. | Headache | 58 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Solicited General Symptoms. | Temperature (axillary) >=38°C | 9 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Solicited General Symptoms. | Muscle aches | 52 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Solicited General Symptoms. | Fatigue | 41 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Solicited General Symptoms. | Headache | 51 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Solicited General Symptoms. | Joint pain at other location | 24 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Solicited General Symptoms. | Muscle aches | 39 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Solicited General Symptoms. | Shivering | 19 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Solicited General Symptoms. | Sweating | 21 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Solicited General Symptoms. | Temperature (axillary) >=38°C | 3 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Solicited General Symptoms. | Headache | 51 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Solicited General Symptoms. | Muscle aches | 53 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Solicited General Symptoms. | Shivering | 24 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Solicited General Symptoms. | Fatigue | 58 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Solicited General Symptoms. | Temperature (axillary) >=38°C | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Solicited General Symptoms. | Sweating | 17 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Solicited General Symptoms. | Joint pain at other location | 28 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Solicited General Symptoms. | Sweating | 12 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Solicited General Symptoms. | Joint pain at other location | 26 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Solicited General Symptoms. | Muscle aches | 43 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Solicited General Symptoms. | Temperature (axillary) >=38°C | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Solicited General Symptoms. | Shivering | 21 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Solicited General Symptoms. | Fatigue | 57 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Solicited General Symptoms. | Headache | 49 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Solicited General Symptoms. | Temperature (axillary) >=38°C | 4 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Solicited General Symptoms. | Shivering | 25 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Solicited General Symptoms. | Joint pain at other location | 23 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Solicited General Symptoms. | Sweating | 25 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Solicited General Symptoms. | Muscle aches | 54 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Solicited General Symptoms. | Fatigue | 56 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Solicited General Symptoms. | Headache | 54 Subjects |
Number of Subjects Reporting Solicited Local Symptoms.
Solicited local symptoms assessed were pain, redness and swelling
Time frame: During a 7-day follow-up period (Days 0-6) post-vaccination period
Population: The Total Vaccinated cohort included all vaccinated subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Solicited Local Symptoms. | Redness | 2 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Solicited Local Symptoms. | Pain | 75 Subjects |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Solicited Local Symptoms. | Swelling | 2 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Solicited Local Symptoms. | Redness | 6 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Solicited Local Symptoms. | Pain | 89 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Solicited Local Symptoms. | Swelling | 15 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Solicited Local Symptoms. | Redness | 1 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Solicited Local Symptoms. | Pain | 66 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Solicited Local Symptoms. | Swelling | 2 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Solicited Local Symptoms. | Redness | 5 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Solicited Local Symptoms. | Pain | 94 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Solicited Local Symptoms. | Swelling | 9 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Solicited Local Symptoms. | Redness | 1 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Solicited Local Symptoms. | Pain | 69 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Solicited Local Symptoms. | Swelling | 0 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Solicited Local Symptoms. | Pain | 95 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Solicited Local Symptoms. | Swelling | 16 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Solicited Local Symptoms. | Redness | 11 Subjects |
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.
Time frame: Within the 84-day (Days 0-83) post-vaccination period.
Population: The Total Vaccinated Cohort included all vaccinated subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs). | 68 Subjects |
| Flulaval/Placebo/Arepanrix Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs). | 65 Subjects |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs). | 57 Subjects |
| Flulaval/Arepanrix/Placebo Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs). | 57 Subjects |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs). | 62 Subjects |
| Arepanrix/Placebo/Flulaval Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs). | 63 Subjects |
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.
Time frame: On Days 0, 21, 42, 63 and 182
Population: Microneutralization testing was cancelled.
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.
Time frame: At Day 63 from Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 from Day 0 for the 4 other groups
Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Seroconversion Factor for Antibodies Against A/California Strain. | 8.2 Fold |
| Flulaval/Placebo/Arepanrix Group | Seroconversion Factor for Antibodies Against A/California Strain. | 24.6 Fold |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against A/California Strain. | 20.9 Fold |
| Flulaval/Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against A/California Strain. | 54.9 Fold |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against A/California Strain. | 41.5 Fold |
| Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against A/California Strain. | 92.4 Fold |
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.
Time frame: On Days 21 and 63 from Day 0 for the first 4 groups and on Days 42 and 63 from Day 0 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups
Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 63 post dose 1] | 13.3 Fold |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu B:Bri/60/08 [Day 21 or 42 post dose 1] | 12.6 Fold |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [Day 21 or 42 post dose 1] | 17.4 Fold |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 63 post dose 1] | 6.9 Fold |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [Day 21 or 42 post dose 1] | 8.4 Fold |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 63 post dose 1] | 9.6 Fold |
| Flulaval/Placebo/Arepanrix Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 63 post dose 1] | 11.2 Fold |
| Flulaval/Placebo/Arepanrix Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 63 post dose 1] | 11.7 Fold |
| Flulaval/Placebo/Arepanrix Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu B:Bri/60/08 [Day 21 or 42 post dose 1] | 13.9 Fold |
| Flulaval/Placebo/Arepanrix Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 63 post dose 1] | 10.0 Fold |
| Flulaval/Placebo/Arepanrix Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [Day 21 or 42 post dose 1] | 12.9 Fold |
| Flulaval/Placebo/Arepanrix Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [Day 21 or 42 post dose 1] | 15.5 Fold |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 63 post dose 1] | 7.9 Fold |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [Day 21 or 42 post dose 1] | 20.6 Fold |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 63 post dose 1] | 8.4 Fold |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu B:Bri/60/08 [Day 21 or 42 post dose 1] | 10.5 Fold |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 63 post dose 1] | 15.0 Fold |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [Day 21 or 42 post dose 1] | 12.0 Fold |
| Flulaval/Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [Day 21 or 42 post dose 1] | 9.6 Fold |
| Flulaval/Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [Day 21 or 42 post dose 1] | 19.3 Fold |
| Flulaval/Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 63 post dose 1] | 10.8 Fold |
| Flulaval/Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 63 post dose 1] | 14.6 Fold |
| Flulaval/Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 63 post dose 1] | 7.6 Fold |
| Flulaval/Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu B:Bri/60/08 [Day 21 or 42 post dose 1] | 14.3 Fold |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [Day 21 or 42 post dose 1] | 2.3 Fold |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 63 post dose 1] | 20.8 Fold |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 63 post dose 1] | 11.4 Fold |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [Day 21 or 42 post dose 1] | 1.2 Fold |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu B:Bri/60/08 [Day 21 or 42 post dose 1] | 1.3 Fold |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 63 post dose 1] | 9.4 Fold |
| Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [at Day 63 post dose 1] | 10.1 Fold |
| Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 [Day 21 or 42 post dose 1] | 3.2 Fold |
| Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [at Day 63 post dose 1] | 19.3 Fold |
| Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 [at Day 63 post dose 1] | 11.9 Fold |
| Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 [Day 21 or 42 post dose 1] | 1.7 Fold |
| Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu B:Bri/60/08 [Day 21 or 42 post dose 1] | 2.4 Fold |
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.
Time frame: At Day 21 from Day 0 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 from Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group
Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 12.0 Fold |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 | 10.5 Fold |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 20.6 Fold |
| Flulaval/Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 19.3 Fold |
| Flulaval/Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 9.6 Fold |
| Flulaval/Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 | 14.3 Fold |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 17.3 Fold |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 4.2 Fold |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 | 8.6 Fold |
| Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 3.1 Fold |
| Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 | 4.9 Fold |
| Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 11.6 Fold |
| Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 16.5 Fold |
| Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 10.3 Fold |
| Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 | 13.2 Fold |
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.
Time frame: At Day 182 from Day 0
Population: The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 4.0 Fold |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 9.0 Fold |
| Flulaval/Placebo/Unadjuvanted Arepanrix Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 Victoria | 6.7 Fold |
| Flulaval/Placebo/Arepanrix Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 Victoria | 5.7 Fold |
| Flulaval/Placebo/Arepanrix Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 7.2 Fold |
| Flulaval/Placebo/Arepanrix Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 5.2 Fold |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 Victoria | 5.5 Fold |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 9.7 Fold |
| Flulaval/Unadjuvanted Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 4.7 Fold |
| Flulaval/Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 3.7 Fold |
| Flulaval/Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 8.5 Fold |
| Flulaval/Arepanrix/Placebo Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 Victoria | 6.8 Fold |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 Victoria | 6.9 Fold |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 9.9 Fold |
| Unadjuvanted Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 4.4 Fold |
| Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Bri/59/07 H1N1 | 5.0 Fold |
| Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu B/Bri/60/08 Victoria | 6.4 Fold |
| Arepanrix/Placebo/Flulaval Group | Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. | Flu A/Uru/716/07 H3N2 | 10.6 Fold |
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.
Time frame: On Days 0, 21, 42, 63 and 182
Population: Microneutralization testing was cancelled.