Influenza
Conditions
Keywords
elderly, post-marketing, H1N1, Clinical trial, pandemic influenza
Brief summary
The purpose of this study is to comply with the post marketing condition to the exceptional approval of Arepanrix™ in Japan and to assess the immunogenicity and safety of GSK Biologicals' H1N1 influenza vaccine healthy Japanese adults 65 years of age or older.
Interventions
BIOLOGICALArepanrix™
Intramuscular administration, one dose
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Japanese male and female adults 65 years of age or older at time of vaccination. * Subjects who the investigator believes can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject. * Good general health as assessed by medical history and physical examination. * Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device. * Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception and for 2 months after study vaccination.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the dose of study vaccine, or planned use during the study period. * History of previous administration of a pandemic H1N1 vaccine. * Presence of significant acute or chronic, uncontrolled medical or psychiatric illness. * Presence or evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports. * Presence of an axillary temperature \>= 37.5 °C, or acute symptoms greater than mild severity on the scheduled date of vaccination. * Diagnosed with cancer, or treatment for cancer within three years. * Persons with a history of cancer who are disease-free without treatment for three years or more are eligible. * Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are accepted and may enrol, but other histologic types of skin cancer are exclusionary. * Women who are disease-free three years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may enroll. * Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection. * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period. For corticosteroids, this will mean a dose equivalent to 10 mg/day of prednisone or equivalent when administered for \> 2 weeks. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed. * Receipt of any immunoglobulins and/or any blood products within three months of study enrolment or planned administration of any of these products during the study period. * Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible. * An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 months of receipt of seasonal influenza vaccination. * Administration of any vaccines within 30 days before vaccination or planned administration before blood sampling at Day 21 and within 30 days prior to blood sampling at Day 182. * Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine. * Excessive underweight \[Body Mass Index (BMI) \< 18.5\] or excessive obesity (BMI \>= 30). * Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study. * Clinically or virologically confirmed influenza infection within 12 months preceding the study start.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies | At Day 21 | Seroconversion (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09). |
| Number of Seroprotected Subjects for HI Antibodies | At Day 21 | Seroprotection (SPR) was defined as the proportion of subjects with H1N1 reciprocal HI titers equal to or above (≥) 40 against the tested vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09). |
| Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | At Day 21 | GMFR, also known as 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. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects for HI Antibodies | At Days 0 and 182 | Seroprotection (SPR) was defined as the proportion of subjects with H1N1 reciprocal HI titers equal to or above (≥) 40 against the tested vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09). |
| GMFR for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | At Day 182 | GMFR, also known as 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. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09). |
| Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | At Days 0 and 21 | Seropositivity cut-off values assessed were equal to or above (≥) 1:8 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09). |
| Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease | At Days 0 and 21 | Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:8. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09). |
| Number of Subjects With Vaccine Response Rate (VRR) for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease | At Day 21 | VRR for microneutralization titers was defined as the proportion of vaccinees with at least a 4-fold increase in post-vaccination reciprocal titer relative to Day 0. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09). |
| Number of Subjects With VRR for Neutralizing Antibodies Against Flu A/Netherlands/602/2009 Strain of Influenza Disease | At Day 182 | VRR for microneutralization titers was defined as the proportion of vaccinees with at least a 4-fold increase in post-vaccination reciprocal titer relative to Day 0. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09). |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. |
| Number of Days With Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period | The number of days with any solicited local symptoms reported during the solicited post-vaccination period. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day (Days 0-6) post-vaccination period | Assessed solicited general symptoms were Fatigue, Headache, Joint pain at other location, Muscle aches, Shivering, Sweating and Fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C to ≤ 40.0°C. Related = symptom assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | At Days 0 and 21 | Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09). |
| Number of Subjects With Medically Attended AEs (MAEs) | During the 21-day (Days 0-20) post-vaccination period | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. |
| Number of Subjects With MAEs | During the 42-day (Days 0-41) post-vaccination period | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. |
| Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | During the entire study period (from Day 0 up to Day 182) | pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. |
| Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | At Day 0 and Day 7 | Among hematological and biochemical parameters assessed were alanine aminotransferase (ALAT), albumin, alkaline phosphatase (AP), aspartate aminotransferase (ASAT), basophils, total bilirubin, bilirubin conjugated/direct, cholesterol, chloride, creatine, creatine kinase (CK), eosinophils, gamma-glutamyl transpeptidase (GGT), hematocrit, hemoglobin, potassium, lactate dyhydrogenase (LDH), lymphocytes, monocytes, sodium, neutrophils, platelets, protein, red blood cells, urate/uric acid, blood urea nitrogen (BUN) and white blood cells. Unknown = value unknown for the specified time point and laboratory parameter; Below = value below the laboratory reference range defined for the specified time point and laboratory parameter; Within = value within the laboratory reference range defined for the specified time point and laboratory parameter; Above = value above the laboratory reference range defined for the specified time point and laboratory parameter. |
| Number of Subjects With Abnormal Urine Sampling Parameters | At Day 0 and Day 7 | Among assessed urine sampling parameters were glucose, protein, red blood cells and urobilinogen. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 21-day (Days 0-20) post-vaccination period | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Unsolicited AEs | During the 42-day (Days 0-41) post-vaccination period | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (from Day 0 up to Day 182) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Days With Solicited General Symptoms | During the 7-day (Days 0-6) post-vaccination period | The number of days with any solicited general symptoms reported during the solicited post-vaccination period. |
| Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain | At Days 0 and 21 | Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09). |
| Number of Seroconverted Subjects for HI Antibodies | At Day 182 | SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09). |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arepanrix Group Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Arepanrix Group |
|---|---|
| Age, Continuous | 69.8 Years STANDARD_DEVIATION 4.17 |
| Race/Ethnicity, Customized Asian - Japanese heritage | 50 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 38 / 50 |
| serious Total, serious adverse events | 4 / 50 |
Outcome results
Primary
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
GMFR, also known as 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. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Time frame: At Day 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Arepanrix Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | 10.2 Fold change |
Primary
Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies
Seroconversion (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Time frame: At Day 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix Group | Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies | 30 Participants |
Primary
Number of Seroprotected Subjects for HI Antibodies
Seroprotection (SPR) was defined as the proportion of subjects with H1N1 reciprocal HI titers equal to or above (≥) 40 against the tested vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Time frame: At Day 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix Group | Number of Seroprotected Subjects for HI Antibodies | 32 Participants |
Secondary
GMFR for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
GMFR, also known as 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. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Arepanrix Group | GMFR for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | 4.2 Fold change |
Secondary
Number of Days With Solicited General Symptoms
The number of days with any solicited general symptoms reported during the solicited post-vaccination period.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arepanrix Group | Number of Days With Solicited General Symptoms | Fatigue | 1.0 Days |
| Arepanrix Group | Number of Days With Solicited General Symptoms | Headache | 1.0 Days |
| Arepanrix Group | Number of Days With Solicited General Symptoms | Joint pain | 1.0 Days |
| Arepanrix Group | Number of Days With Solicited General Symptoms | Muscle aches | 3.0 Days |
| Arepanrix Group | Number of Days With Solicited General Symptoms | Sweating | 1.0 Days |
| Arepanrix Group | Number of Days With Solicited General Symptoms | Shivering | 1.0 Days |
Secondary
Number of Days With Solicited Local Symptoms
The number of days with any solicited local symptoms reported during the solicited post-vaccination period.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arepanrix Group | Number of Days With Solicited Local Symptoms | Pain | 3.0 Days |
| Arepanrix Group | Number of Days With Solicited Local Symptoms | Redness | 3.0 Days |
| Arepanrix Group | Number of Days With Solicited Local Symptoms | Swelling | 2.0 Days |
Secondary
Number of Seroconverted Subjects for HI Antibodies
SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix Group | Number of Seroconverted Subjects for HI Antibodies | 19 Participants |
Secondary
Number of Seroprotected Subjects for HI Antibodies
Seroprotection (SPR) was defined as the proportion of subjects with H1N1 reciprocal HI titers equal to or above (≥) 40 against the tested vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Time frame: At Days 0 and 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 0 | 2 Participants |
| Arepanrix Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 182 | 21 Participants |
Secondary
Number of Subjects With Abnormal Urine Sampling Parameters
Among assessed urine sampling parameters were glucose, protein, red blood cells and urobilinogen.
Time frame: At Day 0 and Day 7
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix Group | Number of Subjects With Abnormal Urine Sampling Parameters | Protein Positive, Day 0 | 1 Participants |
| Arepanrix Group | Number of Subjects With Abnormal Urine Sampling Parameters | Glucose Negative, Day 0 | 49 Participants |
| Arepanrix Group | Number of Subjects With Abnormal Urine Sampling Parameters | Glucose Positive, Day 0 | 1 Participants |
| Arepanrix Group | Number of Subjects With Abnormal Urine Sampling Parameters | Glucose Negative, Day 7 | 45 Participants |
| Arepanrix Group | Number of Subjects With Abnormal Urine Sampling Parameters | Glucose Positive, Day 7 | 5 Participants |
| Arepanrix Group | Number of Subjects With Abnormal Urine Sampling Parameters | Protein Negative, Day 0 | 49 Participants |
| Arepanrix Group | Number of Subjects With Abnormal Urine Sampling Parameters | Protein Negative, Day 7 | 50 Participants |
| Arepanrix Group | Number of Subjects With Abnormal Urine Sampling Parameters | Protein Positive, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Abnormal Urine Sampling Parameters | Red Blood Cells Negative, Day 0 | 45 Participants |
| Arepanrix Group | Number of Subjects With Abnormal Urine Sampling Parameters | Red Blood Cells Positive, Day 0 | 5 Participants |
| Arepanrix Group | Number of Subjects With Abnormal Urine Sampling Parameters | Red Blood Cells Negative, Day 7 | 43 Participants |
| Arepanrix Group | Number of Subjects With Abnormal Urine Sampling Parameters | Red Blood Cells Positive, Day 7 | 7 Participants |
| Arepanrix Group | Number of Subjects With Abnormal Urine Sampling Parameters | Urobilinogen Negative, Day 0 | 49 Participants |
| Arepanrix Group | Number of Subjects With Abnormal Urine Sampling Parameters | Urobilinogen Positive, Day 0 | 1 Participants |
| Arepanrix Group | Number of Subjects With Abnormal Urine Sampling Parameters | Urobilinogen Negative, Day 7 | 50 Participants |
| Arepanrix Group | Number of Subjects With Abnormal Urine Sampling Parameters | Urobilinogen Positive, Day 7 | 0 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 33 Participants |
| Arepanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| Arepanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Arepanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 5 Participants |
| Arepanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Arepanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 8 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were Fatigue, Headache, Joint pain at other location, Muscle aches, Shivering, Sweating and Fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C to ≤ 40.0°C. Related = symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 10 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 1 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 9 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 7 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 1 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 2 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating | 2 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 7 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain | 1 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain | 1 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches | 10 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches | 10 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 2 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating | 2 Participants |
| Arepanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 0 Participants |
Secondary
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Time frame: At Days 0 and 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 0 | 11 Participants |
| Arepanrix Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 182 | 40 Participants |
Secondary
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Time frame: At Days 0 and 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 0 | 12 Participants |
| Arepanrix Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 21 | 48 Participants |
Secondary
Number of Subjects With MAEs
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Time frame: During the 42-day (Days 0-41) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix Group | Number of Subjects With MAEs | 7 Participants |
Secondary
Number of Subjects With Medically Attended AEs (MAEs)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Time frame: During the 21-day (Days 0-20) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix Group | Number of Subjects With Medically Attended AEs (MAEs) | 1 Participants |
Secondary
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Seropositivity cut-off values assessed were equal to or above (≥) 1:8 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
Time frame: At Days 0 and 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09, Day 0 | 18 Participants |
| Arepanrix Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09, Day 182 | 41 Participants |
Secondary
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Seropositivity cut-off values assessed were equal to or above (≥) 1:8 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
Time frame: At Days 0 and 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 days after vaccination were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09, Day 0 | 19 Participants |
| Arepanrix Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09, Day 21 | 41 Participants |
Secondary
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Among hematological and biochemical parameters assessed were alanine aminotransferase (ALAT), albumin, alkaline phosphatase (AP), aspartate aminotransferase (ASAT), basophils, total bilirubin, bilirubin conjugated/direct, cholesterol, chloride, creatine, creatine kinase (CK), eosinophils, gamma-glutamyl transpeptidase (GGT), hematocrit, hemoglobin, potassium, lactate dyhydrogenase (LDH), lymphocytes, monocytes, sodium, neutrophils, platelets, protein, red blood cells, urate/uric acid, blood urea nitrogen (BUN) and white blood cells. Unknown = value unknown for the specified time point and laboratory parameter; Below = value below the laboratory reference range defined for the specified time point and laboratory parameter; Within = value within the laboratory reference range defined for the specified time point and laboratory parameter; Above = value above the laboratory reference range defined for the specified time point and laboratory parameter.
Time frame: At Day 0 and Day 7
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | ALAT Below, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | ALAT Below, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | ALAT Within, Day 0 | 49 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | ALAT Within, Day 7 | 50 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Albumin Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Albumin Within, Day 7 | 44 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | AP Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | AP Below, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | AP Within, Day 0 | 48 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | AP Above, Day 7 | 2 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | ASAT Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | ASAT Below, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | ASAT Below, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | ASAT Within, Day 0 | 49 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | ASAT Above, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Basophils Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Basophils Below, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Basophils Within, Day 0 | 50 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Basophils Within, Day 7 | 49 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Total Bilirubin Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Total Bilirubin Below, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Hemoglobin Above, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Total Bilirubin Below, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Total Bilirubin Above, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Bilirubin Conjugated/Direct Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Hemoglobin Above, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Cholesterol Above, Day 0 | 17 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Chloride Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Chloride Below, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Chloride Within, Day 7 | 44 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Creatine Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Creatine Below, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Creatine Above, Day 0 | 6 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Eosinophils Below, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | GGT Above, Day 0 | 9 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | GGT Above, Day 7 | 9 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Hematocrit Below, Day 7 | 3 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Hemoglobin Within, Day 0 | 43 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Hemoglobin Within, Day 7 | 42 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Potassium Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Potassium Below, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Potassium Below, Day 7 | 1 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Potassium Above, Day 7 | 1 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | LDH Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | LDH Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | LDH Below, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | LDH Within, Day 0 | 50 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | LDH Within, Day 7 | 49 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | LDH Above, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Total Bilirubin Within, Day 0 | 50 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Total Bilirubin Within, Day 7 | 50 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Total Bilirubin Above, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Bilirubin Conjugated/Direct Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Bilirubin Conjugated/Direct Below, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Bilirubin Conjugated/Direct Below, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Bilirubin Conjugated/Direct Within, Day 0 | 50 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Bilirubin Conjugated/Direct Within, Day 7 | 50 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Bilirubin Conjugated/Direct Above, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Bilirubin Conjugated/Direct Above, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Cholesterol Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Cholesterol Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Cholesterol Below, Day 0 | 2 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Cholesterol Below, Day 7 | 2 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Cholesterol Within, Day 0 | 31 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Cholesterol Above, Day 7 | 12 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Cholesterol Within, Day 7 | 36 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Chloride Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Chloride Below, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Chloride Within, Day 0 | 46 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Chloride Above, Day 0 | 4 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Chloride Above, Day 7 | 6 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Creatine Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Creatine Below, Day 7 | 1 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Creatine Within, Day 7 | 43 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Creatine Within, Day 0 | 44 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Creatine Above, Day 7 | 6 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | CK Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | CK Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | CK Below, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | CK Below, Day 7 | 1 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | CK Within, Day 0 | 45 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | CK Within, Day 7 | 43 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | CK Above, Day 0 | 5 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | CK Above, Day 7 | 6 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Eosinophils Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Eosinophils Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Eosinophils Below, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Eosinophils Within, Day 0 | 48 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Eosinophils Within, Day 7 | 48 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Eosinophils Above, Day 0 | 2 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Eosinophils Above, Day 7 | 2 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | GGT Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | GGT Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | GGT Below, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | GGT Below, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | GGT Within, Day 0 | 41 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | GGT Within, Day 7 | 41 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Hematocrit Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Hematocrit Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Hematocrit Below, Day 0 | 2 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Hematocrit Within, Day 0 | 46 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Hematocrit Within, Day 7 | 47 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Hematocrit Above, Day 0 | 2 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Hematocrit Above, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Hemoglobin Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Hemoglobin Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Hemoglobin Below, Day 0 | 7 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Hemoglobin Below, Day 7 | 8 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | ALAT Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | ALAT Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | ALAT Above, Day 0 | 1 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | ALAT Above, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Albumin Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Albumin Below, Day 0 | 4 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Albumin Below, Day 7 | 6 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Albumin Within, Day 0 | 46 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Albumin Above, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Albumin Above, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | AP Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Potassium Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | AP Below, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | AP Within, Day 7 | 48 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | AP Above, Day 0 | 2 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | ASAT Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | ASAT Within, Day 7 | 50 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | ASAT Above, Day 0 | 1 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Basophils Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Basophils Below, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Basophils Above, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Basophils Above, Day 7 | 1 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Total Bilirubin Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | LDH Above, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Monocytes Within, Day 7 | 47 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Monocytes Above, Day 0 | 3 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Sodium Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Sodium Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Sodium Within, Day 0 | 50 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | LDH Below, Day 7 | 1 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Potassium Within, Day 0 | 49 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Potassium Within, Day 7 | 48 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Potassium Above, Day 0 | 1 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Lymphocytes Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Lymphocytes Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Lymphocytes Below, Day 0 | 1 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Lymphocytes Below, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Lymphocytes Within, Day 0 | 49 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Lymphocytes Within, Day 7 | 50 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Lymphocytes Above, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Lymphocytes Above, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Monocytes Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Monocytes Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Monocytes Below, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Monocytes Below, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Monocytes Within, Day 0 | 47 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Monocytes Above, Day 7 | 3 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Sodium Below, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Sodium Below, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Sodium Within, Day 7 | 50 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Sodium Above, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Sodium Above, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Neutrophils Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Neutrophils Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Neutrophils Below, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Neutrophils Below, Day 7 | 1 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Neutrophils Within, Day 0 | 47 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Neutrophils Within, Day 7 | 49 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Neutrophils Above, Day 0 | 3 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Neutrophils Above, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Platelets Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Platelets Unknown, Day 7 | 1 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Platelets Below, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Platelets Below, Day 7 | 1 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Platelets Within, Day 0 | 50 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Platelets Within, Day 7 | 48 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Platelets Above, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Platelets Above, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Protein Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Protein Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Protein Below, Day 0 | 2 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Protein Below, Day 7 | 3 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Protein Within, Day 0 | 45 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Protein Within, Day 7 | 46 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Protein Above, Day 0 | 3 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Protein Above, Day 7 | 1 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Red Blood Cells Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Red Blood Cells Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Red Blood Cells Below, Day 0 | 4 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Red Blood Cells Below, Day 7 | 4 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Red Blood Cells Within, Day 0 | 46 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Red Blood Cells Within, Day 7 | 46 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Red Blood Cells Above, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Red Blood Cells Above, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Urate/Uric acid Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Urate/Uric acid Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Urate/Uric acid Below, Day 0 | 1 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Urate/Uric acid Below, Day 7 | 1 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Urate/Uric acid Within, Day 0 | 45 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Urate/Uric acid Within, Day 7 | 45 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Urate/Uric acid Above, Day 0 | 4 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | Urate/Uric acid Above, Day 7 | 4 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | BUN Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | BUN Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | BUN Below, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | BUN Below, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | BUN Within, Day 0 | 44 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | BUN Within, Day 7 | 44 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | BUN Above, Day 0 | 6 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | BUN Above, Day 7 | 6 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | White Blood Cells Unknown, Day 0 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | White Blood Cells Unknown, Day 7 | 0 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | White Blood Cells Below, Day 0 | 2 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | White Blood Cells Below, Day 7 | 2 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | White Blood Cells Within, Day 0 | 46 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | White Blood Cells Within, Day 7 | 48 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | White Blood Cells Above, Day 0 | 2 Participants |
| Arepanrix Group | Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels | White Blood Cells Above, Day 7 | 0 Participants |
Secondary
Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time frame: During the entire study period (from Day 0 up to Day 182)
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix Group | Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the entire study period (from Day 0 up to Day 182)
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix Group | Number of Subjects With Serious Adverse Events (SAEs) | 4 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: During the 21-day (Days 0-20) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AE(s) | 4 Participants |
| Arepanrix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 0 Participants |
| Arepanrix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AE(s) | 1 Participants |
Secondary
Number of Subjects With Unsolicited AEs
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: During the 42-day (Days 0-41) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arepanrix Group | Number of Subjects With Unsolicited AEs | Any AE(s) | 10 Subjects |
| Arepanrix Group | Number of Subjects With Unsolicited AEs | Grade 3 AE(s) | 2 Subjects |
| Arepanrix Group | Number of Subjects With Unsolicited AEs | Related AE(s) | 1 Subjects |
Secondary
Number of Subjects With Vaccine Response Rate (VRR) for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease
VRR for microneutralization titers was defined as the proportion of vaccinees with at least a 4-fold increase in post-vaccination reciprocal titer relative to Day 0. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
Time frame: At Day 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 days after vaccination were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix Group | Number of Subjects With Vaccine Response Rate (VRR) for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease | 20 Participants |
Secondary
Number of Subjects With VRR for Neutralizing Antibodies Against Flu A/Netherlands/602/2009 Strain of Influenza Disease
VRR for microneutralization titers was defined as the proportion of vaccinees with at least a 4-fold increase in post-vaccination reciprocal titer relative to Day 0. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix Group | Number of Subjects With VRR for Neutralizing Antibodies Against Flu A/Netherlands/602/2009 Strain of Influenza Disease | 15 Participants |
Secondary
Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:8. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
Time frame: At Days 0 and 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arepanrix Group | Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 0 | 7.5 Titers |
| Arepanrix Group | Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 182 | 20.4 Titers |
Secondary
Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:8. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
Time frame: At Days 0 and 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 days after vaccination were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arepanrix Group | Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 0 | 7.7 Titers |
| Arepanrix Group | Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 21 | 29.3 Titers |
Secondary
Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Time frame: At Days 0 and 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arepanrix Group | Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain | Flu A/CAL/7/09, Day 0 | 6.6 Titers |
| Arepanrix Group | Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain | Flu A/CAL/7/09, Day 21 | 67.2 Titers |
Secondary
Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Time frame: At Days 0 and 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arepanrix Group | Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain | Flu A/CAL/7/09, Day 0 | 6.5 Titers |
| Arepanrix Group | Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain | Flu A/CAL/7/09, Day 182 | 27.6 Titers |