Influenza
Conditions
Keywords
H5N1, Influenza vaccine, influenza infection, GSK1557484A
Brief summary
This trial will assess the immunogenicity and safety of GSK Biologicals' vaccine GSK1557484A, prepared from old concentrated monobulk material, in adults aged 18 to 64 years, when administered up to 5 years following production.
Interventions
Intramuscular (IM), two doses
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes can and will comply with the requirements of the protocol. * A male or female 18 to 64 years of age at the time of the first vaccination. * Written informed consent obtained from the subject. * Stable general health as established by medical history and clinical examination before entering into the study. * Subject access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device. * Female subjects of non-childbearing potential may be enrolled in the study. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception for 2 months after completion of the vaccination series.
Exclusion criteria
* Previous vaccination at any time with an H5N1 vaccine. * Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Presence of significant acute or chronic, uncontrolled medical or psychiatric illness. * Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports. * Presence of a temperature ≥ 38.0ºC, or acute symptoms greater than mild severity on the scheduled date of first dose. * 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. * Receipt of systemic glucocorticoids within 1 month prior to study enrolment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrolment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed. * Receipt of any immunoglobulins and/or any blood products within 3 months before first study vaccination 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 dosing, are eligible. Persons receiving prophylactic antiplatelet medications, 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 an inactivated or a live, attenuated seasonal influenza vaccine within 14 days before the first study vaccine dose, or of any other vaccine(s) not foreseen by the study protocol within 30 days before the first study vaccine dose. * Planned administration of any vaccine(s) not foreseen by the study protocol through completion of the Day 42 visit. * Any known or suspected allergy to any constituent of influenza vaccines, or history of severe reaction to a previous influenza vaccination. * Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to the first study vaccine dose. * Lactating or nursing women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease. | At Day 42 | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer less than (\<) 1:10 and a post-vaccination reciprocal HI titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus. |
| Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease. | At Day 42 | MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus. |
| Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease. | At Day 42 | A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease. | At Day 182 | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer \< 1:10 and a post-vaccination reciprocal HI titer (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus. |
| Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease. | At Day 182 | MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day follow-up period (Days 0-6) after any vaccination | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities. Grade 3 Redness/Swelling = Redness/Swelling \>100 millimeters (mm). |
| Duration of Solicited Local Symptoms After Vaccination. | During the 7-day (Days 0-6) post-vaccination period following each dose | Assessed solicited local symptoms were pain, redness and swelling. Duration was defined as the number of days with any grade of local symptoms. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day follow-up period (Days 0-6) after any vaccination | Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination. Any fever was defined as axillary temperature ≥ 38 degrees Celsius (°C). Grade 3 = general symptom that prevented normal activities. Grade 3 fever = fever ≥ 39.0°C. Related = general symptom assessed by the investigator as causally related to the vaccination. |
| Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease. | At Day 0 and Day 42 | A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10. |
| Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | From Day 0 to Day 84 | MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any = occurrence of any MAEs regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities Related = event assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Potential Immune Mediated Disease (s) (pIMDs). | From Day 0 to Day 84 and from Day 0 to Day 385 | pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune aetiology. |
| Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | At Day 0 and Day 42 | Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents BAS, EOS and HCRIT results. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | From Day 0 to Day 20 and from Day 0 to Day 84. | An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an unsolicited AE regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Any and Related Serious Adverse Events (SAEs) | From Day 0 to Day 84 and from Day 0 to Day 385 | A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. |
| Duration of Solicited General Symptoms After Vaccination. | During the 7-day (Days 0-6) post-vaccination period following each dose | Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, increased sweating and shivering. Duration was defined as the number of days with any grade of general symptoms. |
| Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease. | At Day 0 and Day 42 | Titers are presented as geometric mean titers (GMTs). |
| Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease. | At Day 0 and Day 182 | A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus. |
Countries
United States
Participant flow
Recruitment details
This study was conducted in two phases: the Primary Vaccination Phase (up to Day 84) and the Immunogenicity and Safety follow-up Phase (up to Day 385).
Participants by arm
| Arm | Count |
|---|---|
| Influenza A (H5N1) Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm. | 78 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Influenza A (H5N1) Group |
|---|---|
| Age, Continuous | 40.6 Years STANDARD_DEVIATION 13.05 |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 74 / 78 |
| serious Total, serious adverse events | 3 / 78 |
Outcome results
Primary
Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease.
MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.
Time frame: At Day 42
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Influenza A (H5N1) Group | Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease. | 41.7 ratio |
Primary
Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer less than (\<) 1:10 and a post-vaccination reciprocal HI titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus.
Time frame: At Day 42
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Influenza A (H5N1) Group | Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease. | 72 Participants |
Primary
Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus.
Time frame: At Day 42
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Influenza A (H5N1) Group | Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease. | 74 Participants |
Secondary
Duration of Solicited General Symptoms After Vaccination.
Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, increased sweating and shivering. Duration was defined as the number of days with any grade of general symptoms.
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 who received at least one study vaccination, on subjects who experienced the specific symptom.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Influenza A (H5N1) Group | Duration of Solicited General Symptoms After Vaccination. | Fatigue, Dose 1 | 2.0 days |
| Influenza A (H5N1) Group | Duration of Solicited General Symptoms After Vaccination. | Fatigue, Dose 2 | 2.0 days |
| Influenza A (H5N1) Group | Duration of Solicited General Symptoms After Vaccination. | Gastrointestinal, Dose 1 | 2.0 days |
| Influenza A (H5N1) Group | Duration of Solicited General Symptoms After Vaccination. | Gastrointestinal, Dose 2 | 2.0 days |
| Influenza A (H5N1) Group | Duration of Solicited General Symptoms After Vaccination. | Headache, Dose 1 | 1.5 days |
| Influenza A (H5N1) Group | Duration of Solicited General Symptoms After Vaccination. | Headache, Dose 2 | 1.5 days |
| Influenza A (H5N1) Group | Duration of Solicited General Symptoms After Vaccination. | Joint Pain, Dose 1 | 1.5 days |
| Influenza A (H5N1) Group | Duration of Solicited General Symptoms After Vaccination. | Joint Pain, Dose 2 | 2.0 days |
| Influenza A (H5N1) Group | Duration of Solicited General Symptoms After Vaccination. | Muscle aches, Dose 1 | 2.0 days |
| Influenza A (H5N1) Group | Duration of Solicited General Symptoms After Vaccination. | Muscle aches, Dose 2 | 2.0 days |
| Influenza A (H5N1) Group | Duration of Solicited General Symptoms After Vaccination. | Increased sweating, Dose 1 | 2.0 days |
| Influenza A (H5N1) Group | Duration of Solicited General Symptoms After Vaccination. | Increased sweating, Dose 2 | 2.5 days |
| Influenza A (H5N1) Group | Duration of Solicited General Symptoms After Vaccination. | Shivering, Dose 1 | 2.0 days |
| Influenza A (H5N1) Group | Duration of Solicited General Symptoms After Vaccination. | Shivering, Dose 2 | 1.0 days |
Secondary
Duration of Solicited Local Symptoms After Vaccination.
Assessed solicited local symptoms were pain, redness and swelling. Duration was defined as the number of days with any grade of local symptoms.
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 who received at least one study vaccination, on subjects who experienced the specific symptom.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Influenza A (H5N1) Group | Duration of Solicited Local Symptoms After Vaccination. | Pain, Dose 1 | 3.0 days |
| Influenza A (H5N1) Group | Duration of Solicited Local Symptoms After Vaccination. | Pain, Dose 2 | 3.0 days |
| Influenza A (H5N1) Group | Duration of Solicited Local Symptoms After Vaccination. | Redness, Dose1 | 2.0 days |
| Influenza A (H5N1) Group | Duration of Solicited Local Symptoms After Vaccination. | Redness, Dose 2 | 3.0 days |
| Influenza A (H5N1) Group | Duration of Solicited Local Symptoms After Vaccination. | Swelling, Dose 1 | 2.0 days |
| Influenza A (H5N1) Group | Duration of Solicited Local Symptoms After Vaccination. | Swelling, Dose 2 | 1.0 days |
Secondary
Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease.
MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.
Time frame: At Day 182
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Influenza A (H5N1) Group | Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease. | 7.2 ratio |
Secondary
Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer \< 1:10 and a post-vaccination reciprocal HI titer (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus.
Time frame: At Day 182
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Influenza A (H5N1) Group | Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease. | 48 Participants |
Secondary
Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.
A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10.
Time frame: At Day 0 and Day 182
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) Group | Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease. | H5N1 at Day 182 | 73 Participants |
| Influenza A (H5N1) Group | Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease. | H5N1 at Day 0 | 27 Participants |
Secondary
Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.
A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10.
Time frame: At Day 0 and Day 42
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) Group | Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease. | H5N1 at Day 0 | 26 Participants |
| Influenza A (H5N1) Group | Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease. | H5N1 at Day 42 | 75 Participants |
Secondary
Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus.
Time frame: At Day 0 and Day 182
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) Group | Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease. | H5N1 at Day 0 | 3 Participants |
| Influenza A (H5N1) Group | Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease. | H5N1 at Day 182 | 56 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 any solicited local symptoms regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities. Grade 3 Redness/Swelling = Redness/Swelling \>100 millimeters (mm).
Time frame: During the 7-day follow-up period (Days 0-6) after any vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 71 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 7 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 12 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 6 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
Secondary
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time frame: From Day 0 to Day 84 and from Day 0 to Day 385
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAEs [Days 0-84] | 2 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAEs [Days 0-385] | 3 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAEs [Days 0-84] | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAEs [Days 0-385] | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any = occurrence of any MAEs regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities Related = event assessed by the investigator as causally related to the study vaccination.
Time frame: From Day 0 to Day 84
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Any MAEs | 20 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Grade 3 MAEs | 6 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Related MAEs | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason. Any = occurrence of any MAEs regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.
Time frame: From Day 0 to Day 385
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Any MAEs | 49 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Grade 3 MAEs | 9 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Related MAEs | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination. Any fever was defined as axillary temperature ≥ 38 degrees Celsius (°C). Grade 3 = general symptom that prevented normal activities. Grade 3 fever = fever ≥ 39.0°C. Related = general symptom assessed by the investigator as causally related to the vaccination.
Time frame: During the 7-day follow-up period (Days 0-6) after any vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 35 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 3 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 26 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal | 13 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal | 6 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 28 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 20 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint Pain | 13 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint Pain | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint Pain | 13 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle Aches | 31 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle Aches | 3 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle Aches | 27 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 10 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 10 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating | 11 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating | 8 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an unsolicited AE regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.
Time frame: From Day 0 to Day 20 and from Day 0 to Day 84.
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any unsolicited AEs [Days 0-20] | 38 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 unsolicited AEs [Days 0-20] | 5 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related unsolicited AEs [Days 0-20] | 7 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any unsolicited AEs [Days 0-84] | 46 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 unsolicited AEs [Days 0-84] | 7 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related unsolicited AEs [Days 0-84] | 7 Participants |
Secondary
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents BAS, EOS and HCRIT results.
Time frame: At Day 0 and Day 42
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BAS, above, Day 0 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | EOS, above, Day 42 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | HCRIT, unknown, Day 0 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | HCRIT, within, Day 0 | 68 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | HCRIT, within, Day 42 | 66 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | HCRIT, above, Day 0 | 8 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | HCRIT, above, Day 42 | 5 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BAS, unknown, Day 0 | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BAS, unknown, Day 42 | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BAS, below, Day 0 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BAS, below, Day 42 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BAS, within, Day 0 | 77 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BAS, within, Day 42 | 76 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BAS, above, Day 42 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | EOS, unknown, Day 0 | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | EOS, unknown, Day 42 | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | EOS, below, Day 0 | 23 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | EOS, below, Day 42 | 12 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | EOS, within, Day 0 | 53 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | EOS, within, Day 42 | 64 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | EOS, above, Day 0 | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | HCRIT, unknown, Day 42 | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | HCRIT, below, Day 0 | 2 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | HCRIT, below, Day 42 | 5 Participants |
Secondary
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents HBIN, LYM and MON results.
Time frame: At Day 0 and Day 42
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | HBIN, below, Day 0 | 7 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | HBIN, below, Day 42 | 6 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | HBIN, unknown, Day 0 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | HBIN, unknown, Day 42 | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | HBIN, within, Day 0 | 68 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | HBIN, within, Day 42 | 68 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | HBIN, above, Day 0 | 3 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | HBIN, above, Day 42 | 2 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | LYM, unknown, Day 0 | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | LYM, unknown, Day 42 | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | LYM, below, Day 0 | 2 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | LYM, below, Day 42 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | LYM, within, Day 0 | 75 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | LYM, within, Day 42 | 76 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | LYM, above, Day 0 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | LYM, above, Day 42 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | MON, unknown, Day 0 | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | MON, unknown, Day 42 | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | MON, below, Day 0 | 46 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | MON, below, Day 42 | 9 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | MON, within, Day 0 | 31 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | MON, within, Day 42 | 67 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | MON, above, Day 0 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | MON, above, Day 42 | 0 Participants |
Secondary
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIL), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents Total BIL, BIL con/dir, CREA and BUN results.
Time frame: At Day 0 and Day 42
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | Total BIL, unknown, Day 0 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | Total BIL, unknown, Day 42 | 2 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | Total BIL, below, Day 0 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | Total BIL, below, Day 42 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | Total BIL, within, Day 0 | 76 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | Total BIL, within, Day 42 | 74 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | Total BIL, above, Day 0 | 2 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | Total BIL, above, Day 42 | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BIL con/dir, unknown, Day 0 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BIL con/dir, unknown, Day 42 | 2 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BIL con/dir, below, Day 0 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BIL con/dir, below, Day 42 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BIL con/dir, within, Day 0 | 78 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BIL con/dir, within, Day 42 | 75 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BIL con/dir, above, Day 0 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BIL con/dir, above, Day 42 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | CREA, unknown, Day 0 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | CREA, unknown, Day 42 | 2 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | CREA, below, Day 0 | 5 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | CREA, below, Day 42 | 5 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | CREA, within, Day 0 | 73 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | CREA, within, Day 42 | 68 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | CREA, above, Day 0 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | CREA, above, Day 42 | 2 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BUN, unknown, Day 0 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BUN, unknown, Day 42 | 2 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BUN, below, Day 0 | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BUN, below, Day 42 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BUN, within, Day 0 | 76 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BUN, within, Day 42 | 74 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BUN, above, Day 0 | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | BUN, above, Day 42 | 1 Participants |
Secondary
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents NEU, PLA and RBC results.
Time frame: At Day 0 and Day 42
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | NEU, unknown, Day 0 | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | NEU, unknown, Day 42 | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | NEU, below, Day 0 | 2 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | NEU, below, Day 42 | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | NEU, within, Day 0 | 71 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | NEU, within, Day 42 | 75 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | NEU, above, Day 0 | 4 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | NEU, above, Day 42 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | PLA, unknown, Day 0 | 3 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | PLA, unknown, Day 42 | 2 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | PLA, below, Day 0 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | PLA, below, Day 42 | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | PLA, within, Day 0 | 74 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | PLA, within, Day 42 | 74 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | PLA, above, Day 0 | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | PLA, above, Day 42 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | RBC, unknown, Day 0 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | RBC, unknown, Day 42 | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | RBC, below, Day 0 | 5 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | RBC, below, Day 42 | 3 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | RBC, within, Day 0 | 72 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | RBC, within, Day 42 | 72 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | RBC, above, Day 0 | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | RBC, above, Day 42 | 1 Participants |
Secondary
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents WBC, ALT and AST results.
Time frame: At Day 0 and Day 42
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | WBC, unknown, Day 0 | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | WBC, unknown, Day 42 | 1 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | WBC, below, Day 0 | 2 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | WBC, below, Day 42 | 2 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | WBC, within, Day 0 | 72 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | WBC, within, Day 42 | 74 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | WBC, above, Day 0 | 3 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | WBC, above, Day 42 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | ALT, unknown, Day 0 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | ALT, unknown, Day 42 | 2 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | ALT, below, Day 0 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | ALT, below, Day 42 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | ALT, within, Day 0 | 76 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | ALT, within, Day 42 | 73 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | ALT, above, Day 0 | 2 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | ALT, above, Day 42 | 2 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | AST, unknown, Day 0 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | AST, unknown, Day 42 | 2 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | AST, below, Day 0 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | AST, below, Day 42 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | AST, within, Day 0 | 78 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | AST, within, Day 42 | 74 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | AST, above, Day 0 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | AST, above, Day 42 | 1 Participants |
Secondary
Number of Subjects With Potential Immune Mediated Disease (s) (pIMDs).
pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune aetiology.
Time frame: From Day 0 to Day 84 and from Day 0 to Day 385
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) Group | Number of Subjects With Potential Immune Mediated Disease (s) (pIMDs). | pIMD(s), Day 0 to Day 84 | 0 Participants |
| Influenza A (H5N1) Group | Number of Subjects With Potential Immune Mediated Disease (s) (pIMDs). | pIMD(s), Day 0 to Day 385 | 0 Participants |
Secondary
Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.
Titers are presented as geometric mean titers (GMTs).
Time frame: At Day 0 and Day 42
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Influenza A (H5N1) Group | Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease. | H5N1 at Day 0 | 7.5 titers |
| Influenza A (H5N1) Group | Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease. | H5N1 at Day 42 | 311.3 titers |
Secondary
Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.
Titers are presented as geometric mean titers (GMTs).
Time frame: At Day 0 and Day 182
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Influenza A (H5N1) Group | Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease. | H5N1 at Day 0 | 7.8 titers |
| Influenza A (H5N1) Group | Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease. | H5N1 at Day 182 | 56.3 titers |