Influenza
Conditions
Keywords
pandemic influenza, Clinical trial, H1N1, children
Brief summary
The purpose of this study is to show that vaccination with a single dose of GSK Biologicals' pandemic H1N1 vaccine results in an immune response that meets or exceeds European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) guidance criteria for a pandemic influenza vaccine.
Interventions
BIOLOGICALGSK Biologicals' Influenza investigational vaccine GSK2340274A
One or two doses administered intramuscularly
BIOLOGICALGSK Biologicals' Influenza investigational vaccine GSK2340273A
Two doses intramuscularly
BIOLOGICALPlacebo (saline)
One dose intramuscularly
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female children 10 to \< 18 years of age at the time of the first vaccination. Less than 18 years of age implies inclusion of adolescents who have not reached their 18th birthday as of Day 0, the day of the first vaccine dose under this protocol. * Written informed consent obtained from the subject's parent/legally acceptable representative (LAR); written informed assent obtained from the subject if appropriate. * Good general health as established by medical history and clinical examination before entering into the study. * Parent/LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device. * Subjects who the investigator believes that they and/or their parent(s)/LAR can and will comply with the requirements of the protocol.
Exclusion criteria
* Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus. * Previous vaccination at any time with an A/California/7/2009 (H1N1)v-like virus vaccine. * 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 or parent(s)/ LAR(s) unable/unlikely to provide accurate safety reports. * Presence of a temperature \>= 38.0ºC by any route or method, or acute symptoms greater than mild severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied. * Diagnosed with cancer, or treatment for cancer, within 3 years. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * Receipt of systemic glucocorticoids within 1 month prior to study enrollment (first dose of study vaccine), or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed. * Receipt of any immunoglobulins and/or any blood products within 6 months of study enrollment or planned administration of any of these products during the study period. * Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible. * An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine. * Administration of any licensed vaccine within 30 days before the first dose of study vaccine, with the exception of seasonal influenza vaccine (which may be given within 2 weeks before the first dose of study vaccine). * Planned administration of any A/California H1N1v-like vaccine other than the study vaccine between Day 0 and the Day 189 phlebotomy. * Planned administration of any other vaccine not foreseen by the study protocol between Day 0 and Day 42 after the first vaccine dose, including seasonal influenza vaccine. Routine childhood vaccinations are exempted if they cannot be delayed, but they must not be administered on the same day as the H1N1 vaccine candidate. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine. * Child in care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | At Day 21 | Seroconversion defined as: - For initially seronegative subjects, antibody titre ≥ 1:40 after vaccination - For initially seropositive subjects, antibody titre after vaccination ≥ 4 fold the pre-vaccination antibody titre |
| Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | At Day 0 and Day 21 | A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. |
| HI Antibody Seroconversion Factors Against Flu A/CAL/7/09 H1N1 Strain | At Day 21 | Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | At Day 0 and Day 182 | A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection. |
| Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 | At Day 42 | GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. |
| GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 | At Day 182 | GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. |
| GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 0 as Reference Activity | At Day 189 | GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. |
| GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 182 as Reference Activity | At Day 189 | GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | During the 7-day (Days 0-6) post-vaccination period following each dose | Any was defined as occurrence of any local symptom regardless of their intensity grade.Grade 3 redness and swelling was \> 100 millimeter (mm) and grade 3 pain was defined as pain that prevented normal activity. |
| HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | At Day 0 and Day 42 | Antibody titres were expressed as Geometric mean titers (GMTs). |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | During the 7-day (Days 0-6) post-vaccination period following each dose | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering, sweating and fever (Fever = axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature equal to or above (≥) 39.0°C. |
| Number of Subjects Reporting Any Medically Attended Events (MAEs) | During the entire study period (Days 0-364) following the first vaccination | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. |
| Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs) | During the entire study period (Days 0-364) following first vaccination | pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. |
| Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | At Days 0, 21, 42, 182 and 189 | Subjects were categorized according to their results at pre-vaccination (PRE), Day 21, Day 42, Day 182 and Day 189 which were within normal, above normal, below the normal ranges or unknown. The laboratory parameters assessed were Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), Total Bilirubin, Creatinine, Hematocrit, Hemoglobin, Platelets, Blood urea nitrogen (BUN) and White blood cells (WBCs). |
| Number of Subjects Reporting Any Unsolicited AEs | During the 42-day (Days 0-41) follow up period after first vaccination. | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as any symptom regardless of intensity or relationship to vaccination. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | During the entire study period (Day 0 to Day 364) | SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. |
| Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | During the 7-day (Days 0-6) post-vaccination period following booster dose | Any was defined as occurrence of any local symptom regardless of their intensity grade.Grade 3 redness and swelling was \> 100 millimeter (mm) and grade 3 pain was defined as pain that prevented normal activity |
| Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | At Day 42 | A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre. |
| The Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 | At Day 0 and Day 42 | A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection. |
Countries
Estonia, Slovakia
Participant flow
Pre-assignment details
310 subjects were enrolled in the study, all of which were vaccinated and completed the Day 42 visit.
Participants by arm
| Arm | Count |
|---|---|
| Arepanrix-adjuvanted F1 2D Group Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. | 66 |
| Arepanrix-adjuvanted F2 2D Group Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. | 66 |
| Arepanrix-adjuvanted F2 3D Group Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster). | 68 |
| Arepanrix-unadjuvanted F2 2D Group Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. | 110 |
| Total | 310 |
Baseline characteristics
| Characteristic | Arepanrix-adjuvanted F1 2D Group | Arepanrix-adjuvanted F2 2D Group | Arepanrix-adjuvanted F2 3D Group | Arepanrix-unadjuvanted F2 2D Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 13.6 Years STANDARD_DEVIATION 2.27 | 14.5 Years STANDARD_DEVIATION 2.2 | 14.6 Years STANDARD_DEVIATION 1.84 | 14.1 Years STANDARD_DEVIATION 2.13 | 14.19 Years STANDARD_DEVIATION 2.14 |
| Sex: Female, Male Female | 37 Participants | 32 Participants | 38 Participants | 59 Participants | 166 Participants |
| Sex: Female, Male Male | 29 Participants | 34 Participants | 30 Participants | 51 Participants | 144 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 60 / 66 | 59 / 66 | 67 / 68 | 94 / 110 |
| serious Total, serious adverse events | 2 / 66 | 2 / 66 | 1 / 68 | 5 / 110 |
Outcome results
Primary
HI Antibody Seroconversion Factors Against Flu A/CAL/7/09 H1N1 Strain
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
Time frame: At Day 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP \& for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 \& 42 were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | HI Antibody Seroconversion Factors Against Flu A/CAL/7/09 H1N1 Strain | 35.6 Fold increase |
| Arepanrix-adjuvanted F2 2D Group | HI Antibody Seroconversion Factors Against Flu A/CAL/7/09 H1N1 Strain | 18.3 Fold increase |
| Arepanrix-adjuvanted F2 3D Group | HI Antibody Seroconversion Factors Against Flu A/CAL/7/09 H1N1 Strain | 28.9 Fold increase |
| Arepanrix-unadjuvanted F2 2D Group | HI Antibody Seroconversion Factors Against Flu A/CAL/7/09 H1N1 Strain | 25.3 Fold increase |
Primary
Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Seroconversion defined as: - For initially seronegative subjects, antibody titre ≥ 1:40 after vaccination - For initially seropositive subjects, antibody titre after vaccination ≥ 4 fold the pre-vaccination antibody titre
Time frame: At Day 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day21,which included all evaluated subjects for whom the injection site was known,who received the vaccine on Day0 as per protocol (PP) \& for whom assay results for antibodies against A/California-like HA antigen for bloodsample taken 21days after the 1st vaccination were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 63 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 58 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 61 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 96 Subjects |
Primary
Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Time frame: At Day 0 and Day 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day21,which included all evaluated subjects for whom the injection site was known,who received the vaccine on Day0 as per protocol (PP) \& for whom assay results for antibodies against A/California-like HA antigen for bloodsample taken 21days after the 1st vaccination were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | Day 0 | 28 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | Day 21 | 66 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | Day 21 | 65 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | Day 0 | 35 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | Day 0 | 30 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | Day 21 | 67 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | Day 0 | 49 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | Day 21 | 107 Subjects |
Secondary
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1
GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Time frame: At Day 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP \& for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 \& 42 were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 | 27.6 Fold increase |
| Arepanrix-adjuvanted F2 2D Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 | 14.2 Fold increase |
| Arepanrix-adjuvanted F2 3D Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 | 41.8 Fold increase |
| Arepanrix-unadjuvanted F2 2D Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 | 19.3 Fold increase |
Secondary
GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1
GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 \& 21 as PP \& for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 \& 182 days after the 1st vaccination were available
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 | 10.5 Fold increase |
| Arepanrix-adjuvanted F2 2D Group | GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 | 5.1 Fold increase |
| Arepanrix-adjuvanted F2 3D Group | GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 | 13.6 Fold increase |
| Arepanrix-unadjuvanted F2 2D Group | GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 | 7.8 Fold increase |
Secondary
GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 0 as Reference Activity
GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Time frame: At Day 189
Population: The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 \& booster on Day182 as PP \& for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182\&189D after the 1st dose were available
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 0 as Reference Activity | 25.2 Fold increase |
| Arepanrix-adjuvanted F2 2D Group | GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 0 as Reference Activity | 12.4 Fold increase |
| Arepanrix-adjuvanted F2 3D Group | GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 0 as Reference Activity | 23.6 Fold increase |
| Arepanrix-unadjuvanted F2 2D Group | GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 0 as Reference Activity | 12.1 Fold increase |
Secondary
GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 182 as Reference Activity
GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Time frame: At Day 189
Population: The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 \& booster on Day182 as PP \& for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182\&189D after the 1st dose were available
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 182 as Reference Activity | 2.5 Fold increase |
| Arepanrix-adjuvanted F2 2D Group | GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 182 as Reference Activity | 2.4 Fold increase |
| Arepanrix-adjuvanted F2 3D Group | GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 182 as Reference Activity | 1.7 Fold increase |
| Arepanrix-unadjuvanted F2 2D Group | GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 182 as Reference Activity | 1.5 Fold increase |
Secondary
HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
Antibody titres were expressed as GMTs.
Time frame: At Day 0 and Day 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 \& 21 as PP \& for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 \& 182 days after the 1st vaccination were available
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 0 | 22.9 Titers |
| Arepanrix-adjuvanted F1 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 182 | 240.2 Titers |
| Arepanrix-adjuvanted F2 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 182 | 176.1 Titers |
| Arepanrix-adjuvanted F2 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 0 | 34.8 Titers |
| Arepanrix-adjuvanted F2 3D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 0 | 23.4 Titers |
| Arepanrix-adjuvanted F2 3D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 182 | 318.4 Titers |
| Arepanrix-unadjuvanted F2 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 0 | 22.8 Titers |
| Arepanrix-unadjuvanted F2 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 182 | 177.2 Titers |
Secondary
HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
Antibody titres were expressed as Geometric mean titers (GMTs).
Time frame: At Days 0, 182 and 189
Population: The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 \& booster on Day182 as PP \& for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182\&189D after the 1st dose were available
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 0 | 23.4 Titers |
| Arepanrix-adjuvanted F1 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 189 | 589.4 Titers |
| Arepanrix-adjuvanted F1 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 182 | 237.7 Titers |
| Arepanrix-adjuvanted F2 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 0 | 33.5 Titers |
| Arepanrix-adjuvanted F2 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 189 | 416.7 Titers |
| Arepanrix-adjuvanted F2 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 182 | 172.7 Titers |
| Arepanrix-adjuvanted F2 3D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 182 | 318.4 Titers |
| Arepanrix-adjuvanted F2 3D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 0 | 23.4 Titers |
| Arepanrix-adjuvanted F2 3D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 189 | 552.1 Titers |
| Arepanrix-unadjuvanted F2 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 0 | 22.5 Titers |
| Arepanrix-unadjuvanted F2 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 189 | 273.4 Titers |
| Arepanrix-unadjuvanted F2 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 182 | 177.3 Titers |
Secondary
HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
Antibody titers were expressed as GMTs.
Time frame: At Day 0 and Day 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day21,which included all evaluated subjects for whom the injection site was known,who received the vaccine on Day0 as per protocol (PP) \& for whom assay results for antibodies against A/California-like HA antigen for bloodsample taken 21days after the 1st vaccination were available.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 0 | 24.1 Titers |
| Arepanrix-adjuvanted F1 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 21 | 858.7 Titers |
| Arepanrix-adjuvanted F2 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 21 | 603.6 Titers |
| Arepanrix-adjuvanted F2 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 0 | 33 Titers |
| Arepanrix-adjuvanted F2 3D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 0 | 23.4 Titers |
| Arepanrix-adjuvanted F2 3D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 21 | 676.9 Titers |
| Arepanrix-unadjuvanted F2 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 0 | 22.8 Titers |
| Arepanrix-unadjuvanted F2 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 21 | 578.1 Titers |
Secondary
HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
Antibody titres were expressed as Geometric mean titers (GMTs).
Time frame: At Day 0 and Day 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP \& for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 \& 42 were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 0 | 23.4 Titers |
| Arepanrix-adjuvanted F1 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 42 | 646.9 Titers |
| Arepanrix-adjuvanted F2 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 42 | 469.7 Titers |
| Arepanrix-adjuvanted F2 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 0 | 33 Titers |
| Arepanrix-adjuvanted F2 3D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 0 | 23.4 Titers |
| Arepanrix-adjuvanted F2 3D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 42 | 977 Titers |
| Arepanrix-unadjuvanted F2 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 0 | 22.7 Titers |
| Arepanrix-unadjuvanted F2 2D Group | HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain | Day 42 | 439.6 Titers |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Any was defined as occurrence of any local symptom regardless of their intensity grade.Grade 3 redness and swelling was \> 100 millimeter (mm) and grade 3 pain was defined as pain that prevented normal activity.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any pain | 52 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 pain | 2 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any Redness | 2 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 Redness | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any Swelling | 4 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 Swelling | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 Swelling | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 Redness | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any pain | 48 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any Redness | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 pain | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any Swelling | 1 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 pain | 2 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any Redness | 1 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 Redness | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 Swelling | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any Swelling | 6 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any pain | 61 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any Swelling | 1 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 Swelling | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 pain | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 Redness | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any pain | 51 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any Redness | 0 Subjects |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local AEs
Any was defined as occurrence of any local symptom regardless of their intensity grade.Grade 3 redness and swelling was \> 100 millimeter (mm) and grade 3 pain was defined as pain that prevented normal activity
Time frame: During the 7-day (Days 0-6) post-vaccination period following booster dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Any Pain | 48 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Grade 3 Pain | 3 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Any Redness | 4 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Grade 3 Redness | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Any Swelling | 6 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Grade 3 Swelling | 1 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Grade 3 Swelling | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Grade 3 Redness | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Any Pain | 40 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Any Redness | 1 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Grade 3 Pain | 3 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Any Swelling | 5 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Grade 3 Pain | 4 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Any Redness | 1 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Grade 3 Redness | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Grade 3 Swelling | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Any Swelling | 3 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Any Pain | 54 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Any Swelling | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Grade 3 Swelling | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Grade 3 Pain | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Grade 3 Redness | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Any Pain | 49 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any and Grade 3 Solicited Local AEs | Any Redness | 0 Subjects |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering, sweating and fever (Fever = axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature equal to or above (≥) 39.0°C.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Fever | 2 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Sweating | 6 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Myalgia | 17 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Shivering | 6 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Myalgia | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Fatigue | 26 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Myalgia | 16 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Shivering | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Shivering | 6 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Arthralgia | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Fever | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Fatigue | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Fatigue | 23 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Fever | 2 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Gastrointestinal | 5 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Gastrointestinal | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Sweating | 6 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Gastrointestinal | 3 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Arthralgia | 5 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Headache | 27 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Arthralgia | 5 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Sweating | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Headache | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Headache | 23 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Shivering | 4 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Arthralgia | 6 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Headache | 21 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Myalgia | 20 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Fever | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Gastrointestinal | 3 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Arthralgia | 7 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Myalgia | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Sweating | 3 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Shivering | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Shivering | 5 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Myalgia | 17 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Fatigue | 19 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Gastrointestinal | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Sweating | 8 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Fever | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Headache | 16 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Gastrointestinal | 2 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Headache | 1 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Fatigue | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Arthralgia | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Fever | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Sweating | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Fatigue | 16 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Fatigue | 21 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Arthralgia | 6 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Arthralgia | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Arthralgia | 5 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Fatigue | 24 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Gastrointestinal | 1 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Fatigue | 1 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Gastrointestinal | 9 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Gastrointestinal | 6 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Headache | 39 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Headache | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Headache | 27 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Myalgia | 28 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Myalgia | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Myalgia | 23 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Shivering | 8 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Shivering | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Shivering | 7 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Sweating | 11 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Sweating | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Sweating | 8 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Fever | 1 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Fever | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Fever | 1 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Headache | 31 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Headache | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Fever | 2 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Sweating | 15 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Headache | 45 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Gastrointestinal | 5 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Fever | 1 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Sweating | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Gastrointestinal | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Gastrointestinal | 8 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Arthralgia | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Sweating | 8 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Fatigue | 28 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Fatigue | 1 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Arthralgia | 13 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Fever | 3 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Shivering | 16 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Myalgia | 16 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Myalgia | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Fatigue | 36 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Shivering | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Myalgia | 21 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Arthralgia | 10 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Shivering | 11 Subjects |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering, sweating and fever (Fever = axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature equal to or above (≥) 39.0°C.
Time frame: During the 7-day (Days 0-6) post-vaccination period following booster dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.~Note: 1 subject moved out of the study area thereby withdrawing from the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Arthralgia | 13 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Headache | 23 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Fever | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Myalgia | 19 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Arthralgia | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Myalgia | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Myalgia | 19 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Fever | 10 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Shivering | 9 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Shivering | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Sweating | 5 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Fatigue | 1 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Fatigue | 27 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Shivering | 9 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Gastrointestinal | 4 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Fatigue | 29 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Gastrointestinal | 1 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Sweating | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Arthralgia | 13 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Gastrointestinal | 4 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Fever | 11 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Sweating | 5 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Headache | 24 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Headache | 1 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Fever | 5 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Fatigue | 15 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Headache | 16 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Sweating | 3 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Arthralgia | 8 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Gastrointestinal | 2 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Myalgia | 16 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Fever | 1 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Myalgia | 14 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Gastrointestinal | 2 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Myalgia | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Sweating | 3 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Arthralgia | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Sweating | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Fatigue | 20 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Shivering | 8 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Fatigue | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Shivering | 13 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Fever | 1 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Arthralgia | 5 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Gastrointestinal | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Shivering | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Headache | 1 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Headache | 23 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Arthralgia | 8 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Sweating | 4 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Sweating | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Sweating | 3 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Fatigue | 28 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Fever | 7 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Fever | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Fatigue | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Fever | 6 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Fatigue | 25 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Gastrointestinal | 8 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Gastrointestinal | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Gastrointestinal | 7 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Headache | 32 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Arthralgia | 12 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Headache | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Headache | 24 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Myalgia | 17 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Myalgia | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Myalgia | 15 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Arthralgia | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Shivering | 15 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Shivering | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Shivering | 12 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Fever | 2 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Arthralgia | 6 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Fatigue | 19 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Shivering | 8 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Arthralgia | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Fatigue | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Fatigue | 16 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Gastrointestinal | 4 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Gastrointestinal | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Gastrointestinal | 3 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Headache | 25 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Headache | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Headache | 18 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Myalgia | 20 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Myalgia | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Myalgia | 16 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Shivering | 9 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Shivering | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Sweating | 9 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Sweating | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related Sweating | 6 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Fever | 2 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 Fever | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any Arthralgia | 8 Subjects |
Secondary
Number of Subjects Reporting Any Medically Attended Events (MAEs)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.
Time frame: During the entire study period (Days 0-364) following the first vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any Medically Attended Events (MAEs) | 20 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any Medically Attended Events (MAEs) | 21 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any Medically Attended Events (MAEs) | 22 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any Medically Attended Events (MAEs) | 34 Subjects |
Secondary
Number of Subjects Reporting Any Unsolicited AEs
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as any symptom regardless of intensity or relationship to vaccination.
Time frame: During the 21-day (Days 0-20) follow-up period after booster vaccination.
Population: The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects.~Note: 1 subject moved out of the study area thereby withdrawing from the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any Unsolicited AEs | 4 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any Unsolicited AEs | 7 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any Unsolicited AEs | 3 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any Unsolicited AEs | 6 Subjects |
Secondary
Number of Subjects Reporting Any Unsolicited AEs
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as any symptom regardless of intensity or relationship to vaccination.
Time frame: During the 42-day (Days 0-41) follow up period after first vaccination.
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Any Unsolicited AEs | 13 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Any Unsolicited AEs | 19 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Any Unsolicited AEs | 22 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Any Unsolicited AEs | 39 Subjects |
Secondary
Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)
pIMDs were defined as a subset of AEs that included 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 0-364) following first vaccination
Population: The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs) | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs) | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs) | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs) | 0 Subjects |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: During the entire study period (Day 0 to Day 364)
Population: The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 2 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 2 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 1 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 5 Subjects |
Secondary
Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. Day 182 was used as reference activity.
Time frame: At Day 189
Population: The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 \& booster on Day182 as PP \& for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182\&189D after the 1st dose were available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 17 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 18 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 9 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 11 Subjects |
Secondary
Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre. Day 0 was used as reference activity.
Time frame: At Day 189
Population: The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 \& booster on Day182 as PP \& for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182\&189D after the 1st dose were available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 58 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 47 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 64 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 84 Subjects |
Secondary
Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre.
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 \& 21 as PP \& for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 \& 182 days after the 1st vaccination were available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 48 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 34 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 56 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 67 Subjects |
Secondary
Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre.
Time frame: At Day 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP \& for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 \& 42 were available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 62 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 52 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 65 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain | 93 Subjects |
Secondary
Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Time frame: At Day 0, Day 182 and Day 189
Population: The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 \& booster on Day182 as PP \& for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182\&189D after the 1st dose were available
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 0 | 26 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 189 | 63 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 182 | 61 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 0 | 34 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 189 | 63 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 182 | 59 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 182 | 67 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 0 | 30 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 189 | 68 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 0 | 48 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 189 | 105 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 182 | 97 Subjects |
Secondary
Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1
A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection.
Time frame: At Day 0 and Day 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 \& 21 as PP \& for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 \& 182 days after the 1st vaccination were available
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 0 | 26 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 182 | 62 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 182 | 61 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 0 | 36 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 0 | 30 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 182 | 67 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 0 | 49 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 182 | 98 Subjects |
Secondary
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Subjects were categorized according to their results at pre-vaccination (PRE), Day 21, Day 42, Day 182 and Day 189 which were within normal, above normal, below the normal ranges or unknown. The laboratory parameters assessed were Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), Total Bilirubin, Creatinine, Hematocrit, Hemoglobin, Platelets, Blood urea nitrogen (BUN) and White blood cells (WBCs).
Time frame: At Days 0, 21, 42, 182 and 189
Population: The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects.~Note: 1 subject moved out of the study area thereby withdrawing from the study at Days 182 and 189.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 21 Above | 1 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 182 Below | 10 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 182 Within | 55 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 42 Within | 24 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 189 Below | 8 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 189 Above | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 0 Within | 56 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 0 Above | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 42 Above | 2 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 0 Within | 24 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 21 Within | 54 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 189 Within | 62 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 0 Below | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 21 Above | 1 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 42 Within | 63 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 182 Within | 54 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 189 Above | 3 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 182 Above | 1 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 42 Within | 64 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 189 Above | 1 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 42 Above | 2 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 42 Below | 1 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 182 Below | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 21 Above | 1 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 21 Above | 7 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 182 Within | 64 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 189 Below | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 42 Below | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 21 Within | 56 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 0 Below | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 21 Below | 3 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 0 Within | 63 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 21 Above | 5 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 42 Below | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 0 Above | 2 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 42 Above | 1 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 182 Within | 63 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 0 Within | 64 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 182 Above | 2 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 189 Above | 1 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 182 Above | 2 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 0 Below | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 42 Below | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 0 Within | 21 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 42 Above | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 182 Within | 63 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 21 Within | 23 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 182 Below | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 42 Within | 22 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 42 Above | 2 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 189 Below | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 189 Within | 23 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 182 Within | 22 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 42 Above | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 182 Above | 2 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 189 Within | 22 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 189 Above | 2 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 0 Below | 3 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 42 Within | 64 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 0 Within | 41 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 0 Above | 21 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 42 Below | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 182 Within | 62 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 21 Above | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 42 Below | 4 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 21 Below | 1 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 42 Within | 42 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 182 Within | 51 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 0 Above | 1 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 182 Above | 8 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 182 Above | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 189 Within | 53 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 189 Above | 8 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 189 Below | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 0 Below | 6 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 182 Below | 1 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 0 Within | 60 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 42 Below | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 21 Within | 59 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 42 Within | 57 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 182 Within | 22 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 42 Above | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 0 Below | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 0 Within | 65 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 0 Above | 1 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 21 Below | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 21 Within | 64 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 21 Above | 2 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 182 Above | 1 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 189 Within | 64 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 189 Above | 1 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 0 Above | 3 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 21 Below | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 21 Within | 61 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 42 Within | 65 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 182 Below | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 189 Below | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 189 Within | 64 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 0 Above | 3 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 21 Below | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 182 Below | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 189 Below | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 0 Below | 4 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 21 Below | 4 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 21 Within | 46 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 21 Above | 16 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 42 Above | 20 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 182 Below | 6 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 189 Below | 4 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 0 Above | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 21 Below | 6 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 42 Below | 9 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 182 Above | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 189 Within | 57 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 0 Below | 10 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 21 Below | 11 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 42 Below | 14 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 42 Within | 51 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 42 Above | 1 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 182 Below | 10 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 189 Below | 9 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 189 Within | 55 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 0 Above | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 21 Below | 1 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 21 Within | 23 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 21 Above | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 182 Below | 1 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 182 Above | 1 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 189 Above | 1 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 0 Within | 60 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 21 Within | 63 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 189 Below | 1 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 189 Within | 62 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 189 Above | 0 Subjects |
| Arepanrix-adjuvanted F1 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 0 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 189 Within | 59 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 189 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 182 Below | 5 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 182 Above | 3 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 189 Within | 61 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 182 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 189 Below | 6 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 189 Below | 2 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 189 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 189 Below | 3 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 42 Within | 64 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 0 Below | 3 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 0 Above | 1 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 182 Below | 4 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 0 Within | 62 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 21 Below | 6 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 182 Within | 62 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 42 Above | 1 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 42 Within | 57 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 42 Below | 6 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 182 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 42 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 182 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 21 Within | 56 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 182 Above | 2 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 0 Within | 22 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 21 Below | 9 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 0 Below | 8 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 21 Below | 1 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 182 Above | 1 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 42 Within | 60 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 189 Within | 62 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 21 Above | 2 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 189 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 0 Above | 4 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 21 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 189 Above | 4 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 21 Within | 64 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 21 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 0 Within | 47 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 189 Below | 1 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 0 Above | 1 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 21 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 21 Below | 5 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 0 Above | 1 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 21 Within | 48 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 21 Within | 61 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 0 Within | 65 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 21 Within | 23 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 42 Within | 48 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 21 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 0 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 42 Above | 15 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 21 Within | 21 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 0 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 189 Within | 61 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 189 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 21 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 182 Within | 23 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 0 Above | 9 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 189 Above | 1 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 42 Within | 60 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 182 Within | 52 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 42 Within | 60 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 42 Above | 6 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 42 Within | 23 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 182 Above | 4 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 182 Below | 3 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 0 Within | 54 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 182 Within | 61 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 42 Above | 2 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 182 Below | 1 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 0 Below | 2 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 182 Within | 61 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 189 Below | 3 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 21 Above | 6 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 42 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 189 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 0 Below | 1 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 182 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 182 Above | 4 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 0 Within | 57 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 189 Above | 3 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 0 Within | 23 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 189 Within | 62 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 0 Above | 1 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 42 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 189 Above | 5 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 182 Within | 60 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 0 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 42 Below | 2 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 182 Above | 8 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 182 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 21 Above | 1 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 42 Below | 8 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 0 Above | 17 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 0 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 182 Within | 60 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 0 Within | 59 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 182 Within | 61 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 182 Above | 1 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 189 Above | 3 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 21 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 21 Above | 13 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 189 Above | 1 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 42 Within | 66 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 21 Within | 60 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 42 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 182 Below | 1 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 42 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 42 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 42 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 182 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 42 Within | 21 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 189 Below | 3 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 21 Above | 2 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 21 Within | 60 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 42 Above | 2 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 189 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 21 Within | 62 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 0 Below | 6 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 42 Below | 3 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 42 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 21 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 42 Above | 1 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 0 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 182 Within | 21 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 21 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 189 Within | 54 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 0 Within | 62 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 189 Within | 60 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 0 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 189 Within | 22 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 21 Above | 5 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 189 Within | 22 Subjects |
| Arepanrix-adjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 0 Within | 59 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 42 Above | 2 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 21 Above | 5 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 42 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 182 Above | 1 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 189 Above | 1 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 21 Within | 21 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 182 Within | 21 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 189 Below | 2 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 21 Below | 1 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 21 Above | 7 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 189 Within | 61 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 42 Within | 66 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 182 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 189 Above | 1 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 0 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 0 Within | 64 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 21 Within | 63 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 42 Above | 1 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 182 Within | 67 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 189 Within | 67 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 0 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 21 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 42 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 42 Within | 20 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 42 Above | 4 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 182 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 189 Within | 21 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 189 Above | 2 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 0 Below | 4 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 0 Within | 46 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 0 Above | 18 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 21 Above | 19 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 42 Below | 6 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 182 Within | 53 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 182 Above | 10 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 189 Within | 52 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 0 Below | 9 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 21 Within | 61 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 21 Above | 1 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 42 Within | 61 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 182 Within | 62 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 182 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 189 Below | 4 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 0 Within | 58 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 0 Above | 2 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 21 Below | 7 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 21 Within | 59 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 21 Above | 2 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 42 Below | 9 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 182 Within | 62 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 182 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 189 Below | 4 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 189 Within | 64 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 189 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 0 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 0 Within | 24 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 42 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 42 Within | 24 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 182 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 189 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 0 Below | 3 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 0 Within | 63 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 21 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 21 Within | 66 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 42 Below | 1 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 42 Within | 65 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 42 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 182 Below | 2 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 182 Within | 64 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 0 Within | 62 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 0 Above | 6 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 21 Within | 60 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 42 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 42 Within | 64 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 42 Above | 4 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 182 Below | 2 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 182 Within | 64 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 182 Above | 2 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 189 Below | 1 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 182 Within | 67 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 42 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 182 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 189 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 189 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 0 Within | 19 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 0 Above | 5 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 21 Above | 3 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 182 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 182 Within | 24 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 182 Above | 3 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 189 Below | 1 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 189 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 21 Below | 4 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 21 Within | 45 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 189 Within | 24 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 42 Within | 43 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 42 Above | 19 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 189 Above | 6 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 182 Below | 5 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 189 Below | 3 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 189 Above | 13 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 0 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 0 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 21 Below | 6 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 42 Below | 7 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 42 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 182 Below | 6 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 189 Within | 64 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 189 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 0 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 0 Below | 8 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 21 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 42 Within | 58 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 182 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 42 Above | 1 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 189 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 182 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 182 Below | 6 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 0 Above | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 0 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 0 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 189 Within | 64 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 0 Within | 66 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 0 Above | 2 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 21 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 21 Within | 64 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 21 Above | 4 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 21 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 42 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 42 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 42 Within | 67 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 182 Above | 1 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 189 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 189 Within | 67 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 21 Within | 24 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 0 Above | 4 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 21 Unknown | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 21 Below | 0 Subjects |
| Arepanrix-adjuvanted F2 3D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 21 Above | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 0 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 189 Above | 13 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 189 Below | 14 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 189 Below | 6 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 189 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 182 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 42 Above | 23 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 189 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 189 Within | 39 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 189 Below | 1 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 0 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 0 Above | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 42 Within | 80 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 21 Within | 34 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 0 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 42 Within | 103 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 21 Within | 74 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 189 Within | 110 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 0 Within | 108 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 189 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 21 Below | 8 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 21 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 0 Above | 2 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 182 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 21 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 21 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 21 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 21 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 0 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 0 Within | 36 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 21 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 189 Within | 104 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 0 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 182 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 21 Within | 108 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 189 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 182 Within | 39 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 0 Above | 2 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 21 Above | 2 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 189 Below | 8 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 21 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 189 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 21 Within | 37 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 189 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 189 Above | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 189 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 42 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 182 Within | 102 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 182 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 21 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 42 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 182 Below | 8 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 42 Above | 1 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 21 Above | 2 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 0 Within | 104 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 42 Below | 13 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 182 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 42 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 21 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 42 Below | 13 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 42 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 42 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 182 Within | 109 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 42 Within | 97 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 21 Below | 1 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 21 Below | 13 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 21 Above | 5 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 42 Above | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 42 Above | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 21 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 182 Above | 1 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 182 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 189 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 0 Above | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 189 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 182 Below | 12 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 0 Within | 99 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 0 Below | 11 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 0 Below | 1 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 189 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 0 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 189 Above | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 189 Above | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 189 Within | 91 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 182 Above | 11 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 0 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 189 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 182 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 0 Within | 106 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 182 Within | 94 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 182 Below | 5 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 21 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 42 Below | 7 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 189 Below | 2 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 42 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 182 Within | 106 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 21 Above | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 21 Above | 28 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 0 Above | 28 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 0 Within | 77 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 182 Above | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 42 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Creatinine, Day 0 Below | 5 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 189 Above | 4 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 182 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 42 Within | 105 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 182 Within | 36 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 182 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 21 Within | 106 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 42 Above | 1 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 42 Above | 2 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 42 Within | 37 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 0 Above | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 182 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 42 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 42 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 189 Above | 4 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 182 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 21 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 0 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 182 Within | 106 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 0 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | BUN, Day 182 Above | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 189 Above | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 189 Within | 110 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 182 Within | 110 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 42 Above | 7 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 42 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 42 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 42 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 189 Within | 35 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 0 Above | 5 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 21 Within | 104 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 0 Within | 108 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 21 Above | 6 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 21 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 0 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ASAT, Day 0 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 189 Above | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 189 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 182 Above | 4 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 21 Within | 103 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 182 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 42 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 182 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 42 Within | 104 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 182 Above | 3 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 189 Within | 96 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 189 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 42 Below | 2 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 189 Above | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 182 Above | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 182 Within | 98 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 189 Within | 105 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 0 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 21 Within | 93 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 21 Below | 15 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Total Bilirubin, Day 0 Above | 3 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 0 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 0 Above | 1 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 0 Within | 92 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 42 Within | 103 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 0 Within | 39 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 21 Above | 1 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 0 Below | 17 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hemoglobin, Day 0 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 21 Above | 5 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 189 Within | 102 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 21 Below | 2 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 42 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 182 Above | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 182 Unknown | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | ALAT, Day 42 Above | 6 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 42 Within | 39 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 182 Below | 0 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 42 Within | 96 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 21 Above | 2 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Hematocrit, Day 21 Within | 95 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | WBCs, Day 42 Above | 5 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges | Platelets, Day 182 Above | 0 Subjects |
Secondary
The Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1
A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection.
Time frame: At Day 0 and Day 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP \& for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 \& 42 were available
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arepanrix-adjuvanted F1 2D Group | The Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 0 | 27 Subjects |
| Arepanrix-adjuvanted F1 2D Group | The Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 42 | 65 Subjects |
| Arepanrix-adjuvanted F2 2D Group | The Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 42 | 64 Subjects |
| Arepanrix-adjuvanted F2 2D Group | The Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 0 | 35 Subjects |
| Arepanrix-adjuvanted F2 3D Group | The Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 0 | 30 Subjects |
| Arepanrix-adjuvanted F2 3D Group | The Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 42 | 68 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | The Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 0 | 48 Subjects |
| Arepanrix-unadjuvanted F2 2D Group | The Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 | Day 42 | 105 Subjects |