Influenza
Conditions
Keywords
Immunogenicity, Safety, Pandemic Influenza
Brief summary
This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK Biologicals' (pre-) pandemic influenza candidate vaccine in healthy Japanese adults.
Interventions
All subjects will receive 2 doses administered as an intramuscular (IM) injection.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Japanese male and female adults 20 to 64 years of age at time of the first vaccination, inclusive. * 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. * Written informed consent obtained from the subject. * Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits. * Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
Exclusion criteria
* 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. * Diagnosed with cancer, or treatment for cancer within 3 years. * Presence of an axillary temperature \>= 37.5 °C, or acute symptoms greater than mild severity on the scheduled date of first vaccination. * Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection. * Receipt of systemic glucocorticoids within 1 month of study enrolment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrolment. * Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin. * Administration of any registered vaccine within 30 days before study enrolment or planned administration within the first vaccination up to blood sampling at Day 42 and within 30 days prior to blood sampling at Day 182. * Use of any investigational or non-registered product within 30 days prior to study enrolment or planned use during the study period. * History of previous H5N1 vaccination, or history of H5N1 influenza infection. * Receipt of any immunoglobulins and/or any blood products within 6 months of study enrolment or planned administration of any of these products during the study period. * 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. * Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to the time of first vaccination. * Lactating or nursing. * Women of child-bearing potential who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments; all women will have urine pregnancy tests regardless of their status. * Known receipt of analgesic or antipyretic medication on the day of treatment (Day 0).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain | At Day 0 and Day 42 | Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia/05/2005 antigen (A/Indonesia). |
| Number of Subjects Seroconverted for H5N1 HI Antibodies | At Day 42 | A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The H5N1 vaccine strain included A/Indonesia antigen. |
| HI Antibody Seroconversion Factors for H5N1 HI Antibodies | At Day 0 and Day 42 | Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen. |
| Number of Subjects Seroprotected for H5N1 HI Antibodies | At Day 42 | A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Seroconverted for Serum Anti-H5N1 Neutralising Antibodies | At Day 42 and Day 182 | A seroconverted subject was defined as a subject with a minimum 4 fold increase in titer at post-vaccination for neutralising antibody response at Days 42 and 182. The H5N1 vaccine strain included A/Indonesia antigen. |
| Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | At Day 0, Day 7 and Day 42 | Biochemical and haematological parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS) and blood urea nitrogen (BUN ). Categories = unknown, below, within, or above the normal ranges. |
| Number of Subjects With Any Normal or Abnormal Urine Values | At Day 0, Day 7 and Day 42 | Urine parameters assessed were blood, glucose, protein and urobilinogen. Categories = negative, positive |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | During the 7-day post vaccination period (Days 0-6) after any vaccination | Solicited local symptoms assessed were pain, redness and swelling/induration. Any=any solicited local symptom reported regardless of their intensity. Grade 3 pain= significant pain at rest that prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness and swelling/induration=redness and swelling/induration above 100 millimetres (mm). |
| Number of Subjects Seroconverted for H5N1 HI Antibodies | At Day 21 and Day 182 | A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen. |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During the 21-day (Days 0-20) following vaccination | Unsolicited AE is any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination. |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | From Day 0 to Day 83 following vaccination | Unsolicited AE is any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination. |
| Number of Subjects Reporting Any Medically-significant Conditions (MSCs) | During the 182-day (Days 0-181) post-vaccination period | MSCs were defined as AEs with a medically-attended visit (s) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | During the entire study period (Day 0 to Day 181) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | During the 7-day post vaccination period (Days 0-6) after any vaccination | Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increase sweating and fever. Any=any solicited general symptom reported regardless of their intensity grade or their relationship to vaccination. Any fever was ≥ 38.0 degrees celsius (°C). Grade 3 = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever was≥ 39.0°C. Related= general symptom assessed by the investigator as causally related to the study vaccination. |
| Seroconversion Factors for H5N1 HI Antibodies | At Day 21 and Day 182 | Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen. |
| Number of Subjects Seroprotected for H5N1 HI Antibodies | At Day 0, Day 21 and Day 182 | A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen. |
| Antibody Titers for Serum Anti-H5N1 Neutralising Antibodies | At Day 0, Day 42 and Day 182 | Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Influenza A (H5N1) 20-40 Years Group Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm. | 50 |
| Influenza A (H5N1) 41-64 Years Group Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm. | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Influenza A (H5N1) 20-40 Years Group | Influenza A (H5N1) 41-64 Years Group | Total |
|---|---|---|---|
| Age, Continuous | 31.1 Years STANDARD_DEVIATION 5.69 | 49.6 Years STANDARD_DEVIATION 6.04 | 40.3 Years STANDARD_DEVIATION 10.98 |
| Sex: Female, Male Female | 25 Participants | 32 Participants | 57 Participants |
| Sex: Female, Male Male | 25 Participants | 18 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 50 / 50 | 50 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain
Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen.
Time frame: At Day 0, Day 21 and Day 182
Population: Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Influenza A (H5N1) 20-40 Years Group | Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain | A/Indonesia at Day 0 | 5.0 Titer |
| Influenza A (H5N1) 20-40 Years Group | Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain | A/Indonesia at Day 21 | 15.8 Titer |
| Influenza A (H5N1) 20-40 Years Group | Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain | A/Indonesia at Day 182 | 25.6 Titer |
| Influenza A (H5N1) 41-64 Years Group | Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain | A/Indonesia at Day 0 | 5.4 Titer |
| Influenza A (H5N1) 41-64 Years Group | Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain | A/Indonesia at Day 21 | 15.4 Titer |
| Influenza A (H5N1) 41-64 Years Group | Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain | A/Indonesia at Day 182 | 37.4 Titer |
Primary
Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain
Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia/05/2005 antigen (A/Indonesia).
Time frame: At Day 0 and Day 42
Population: Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Influenza A (H5N1) 20-40 Years Group | Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain | A/Indonesia at Day 0 | 5.0 Titer |
| Influenza A (H5N1) 20-40 Years Group | Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain | A/Indonesia at Day 42 | 156.8 Titer |
| Influenza A (H5N1) 41-64 Years Group | Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain | A/Indonesia at Day 0 | 5.4 Titer |
| Influenza A (H5N1) 41-64 Years Group | Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain | A/Indonesia at Day 42 | 142.1 Titer |
Primary
HI Antibody Seroconversion Factors for H5N1 HI Antibodies
Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen.
Time frame: At Day 0 and Day 42
Population: Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Influenza A (H5N1) 20-40 Years Group | HI Antibody Seroconversion Factors for H5N1 HI Antibodies | 31.4 Fold Increase |
| Influenza A (H5N1) 41-64 Years Group | HI Antibody Seroconversion Factors for H5N1 HI Antibodies | 26.2 Fold Increase |
Primary
Number of Subjects Seroconverted for H5N1 HI Antibodies
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The H5N1 vaccine strain included A/Indonesia antigen.
Time frame: At Day 42
Population: Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Seroconverted for H5N1 HI Antibodies | 45 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Seroconverted for H5N1 HI Antibodies | 46 Participants |
Primary
Number of Subjects Seroprotected for H5N1 HI Antibodies
A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen.
Time frame: At Day 42
Population: Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Seroprotected for H5N1 HI Antibodies | 45 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Seroprotected for H5N1 HI Antibodies | 46 Participants |
Secondary
Antibody Titers for Serum Anti-H5N1 Neutralising Antibodies
Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen.
Time frame: At Day 0, Day 42 and Day 182
Population: Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Influenza A (H5N1) 20-40 Years Group | Antibody Titers for Serum Anti-H5N1 Neutralising Antibodies | A/Indonesia at Day 0 | 14.4 Titer |
| Influenza A (H5N1) 20-40 Years Group | Antibody Titers for Serum Anti-H5N1 Neutralising Antibodies | A/Indonesia at Day 42 | 579.6 Titer |
| Influenza A (H5N1) 20-40 Years Group | Antibody Titers for Serum Anti-H5N1 Neutralising Antibodies | A/Indonesia at Day 182 | 240.5 Titer |
| Influenza A (H5N1) 41-64 Years Group | Antibody Titers for Serum Anti-H5N1 Neutralising Antibodies | A/Indonesia at Day 0 | 18.3 Titer |
| Influenza A (H5N1) 41-64 Years Group | Antibody Titers for Serum Anti-H5N1 Neutralising Antibodies | A/Indonesia at Day 42 | 473.8 Titer |
| Influenza A (H5N1) 41-64 Years Group | Antibody Titers for Serum Anti-H5N1 Neutralising Antibodies | A/Indonesia at Day 182 | 240.1 Titer |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling/induration. Any=any solicited local symptom reported regardless of their intensity. Grade 3 pain= significant pain at rest that prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness and swelling/induration=redness and swelling/induration above 100 millimetres (mm).
Time frame: During the 7-day post vaccination period (Days 0-6) after any vaccination
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 1 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 redness | 2 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain | 49 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any swelling/induration | 17 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any redness | 12 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 swelling/induration | 3 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 swelling/induration | 2 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain | 49 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any redness | 16 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 redness | 2 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any swelling/induration | 23 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increase sweating and fever. Any=any solicited general symptom reported regardless of their intensity grade or their relationship to vaccination. Any fever was ≥ 38.0 degrees celsius (°C). Grade 3 = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever was≥ 39.0°C. Related= general symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During the 7-day post vaccination period (Days 0-6) after any vaccination
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 fatigue | 3 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 muscle aches | 1 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 headache | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any shivering | 13 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any fatigue | 39 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 shivering | 2 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related headache | 27 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related shivering | 11 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related fatigue | 39 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any increase sweating | 13 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any joint pain | 16 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 increase sweating | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related muscle aches | 36 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related increase sweating | 12 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 joint pain | 1 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any fever | 6 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related joint pain | 16 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 fever | 1 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any headache | 30 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related fever | 6 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any muscle aches | 36 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related fever | 5 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 muscle aches | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any fatigue | 32 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 fatigue | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related fatigue | 32 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any headache | 21 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 headache | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related headache | 21 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any joint pain | 18 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related joint pain | 17 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any muscle aches | 34 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related muscle aches | 33 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any shivering | 7 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 shivering | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related shivering | 7 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any increase sweating | 8 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 increase sweating | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related increase sweating | 8 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any fever | 5 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 fever | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 joint pain | 0 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Unsolicited AE is any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Time frame: During the 21-day (Days 0-20) following vaccination
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any unsolicited AE (s) | 27 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 unsolicited AE (s) | 3 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related unsolicited AE (s) | 11 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any unsolicited AE (s) | 24 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 unsolicited AE (s) | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related unsolicited AE (s) | 17 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Unsolicited AE is any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Time frame: From Day 0 to Day 83 following vaccination
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Any unsolicited AE (s) | 33 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Grade 3 unsolicited AE (s | 3 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Related unsolicited AE (s) | 11 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Any unsolicited AE (s) | 36 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Grade 3 unsolicited AE (s | 2 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Related unsolicited AE (s) | 17 Participants |
Secondary
Number of Subjects Reporting Any Medically-significant Conditions (MSCs)
MSCs were defined as AEs with a medically-attended visit (s) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination.
Time frame: During the 182-day (Days 0-181) post-vaccination period
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Any Medically-significant Conditions (MSCs) | 34 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Any Medically-significant Conditions (MSCs) | 26 Participants |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: During the entire study period (Day 0 to Day 181)
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Number of Subjects Seroconverted for H5N1 HI Antibodies
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.
Time frame: At Day 21 and Day 182
Population: Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Seroconverted for H5N1 HI Antibodies | A/Indonesia at Day 21 | 19 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Seroconverted for H5N1 HI Antibodies | A/Indonesia at Day 182 | 29 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Seroconverted for H5N1 HI Antibodies | A/Indonesia at Day 21 | 16 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Seroconverted for H5N1 HI Antibodies | A/Indonesia at Day 182 | 38 Participants |
Secondary
Number of Subjects Seroconverted for Serum Anti-H5N1 Neutralising Antibodies
A seroconverted subject was defined as a subject with a minimum 4 fold increase in titer at post-vaccination for neutralising antibody response at Days 42 and 182. The H5N1 vaccine strain included A/Indonesia antigen.
Time frame: At Day 42 and Day 182
Population: Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Seroconverted for Serum Anti-H5N1 Neutralising Antibodies | A/Indonesia at Day 42 | 49 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Seroconverted for Serum Anti-H5N1 Neutralising Antibodies | A/Indonesia at Day 182 | 48 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Seroconverted for Serum Anti-H5N1 Neutralising Antibodies | A/Indonesia at Day 42 | 47 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Seroconverted for Serum Anti-H5N1 Neutralising Antibodies | A/Indonesia at Day 182 | 44 Participants |
Secondary
Number of Subjects Seroprotected for H5N1 HI Antibodies
A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.
Time frame: At Day 0, Day 21 and Day 182
Population: Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Seroprotected for H5N1 HI Antibodies | A/Indonesia at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Seroprotected for H5N1 HI Antibodies | A/Indonesia at Day 21 | 19 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects Seroprotected for H5N1 HI Antibodies | A/Indonesia at Day 182 | 29 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Seroprotected for H5N1 HI Antibodies | A/Indonesia at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Seroprotected for H5N1 HI Antibodies | A/Indonesia at Day 21 | 16 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects Seroprotected for H5N1 HI Antibodies | A/Indonesia at Day 182 | 38 Participants |
Secondary
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
Biochemical and haematological parameters assessed in blood samples include lymphocytes (LYM), monocytes (MON) and neutrophils (NEU). Categories = unknown, below, within, or above the normal ranges.
Time frame: At Day 0, Day 7 and Day 42
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Above] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Above] at Day 42 | 4 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Below] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Below] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Below] at Day 42 | 5 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Within] at Day 0 | 50 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Within] at Day 7 | 50 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Within] at Day 42 | 45 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Above] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Below] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Below] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Below] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Within] at Day 0 | 50 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Within] at Day 7 | 48 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Within] at Day 42 | 49 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Above] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Above] at Day 7 | 2 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Above] at Day 42 | 1 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Above] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Below] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Below] at Day 7 | 1 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Below] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Within] at Day 0 | 50 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Within] at Day 7 | 48 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Within] at Day 42 | 46 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Above] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Above] at Day 7 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Below] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Above] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Below] at Day 7 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Below] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Above] at Day 42 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Within] at Day 0 | 48 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Within] at Day 0 | 49 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Within] at Day 7 | 49 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Below] at Day 0 | 2 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Above] at Day 7 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Below] at Day 7 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Within] at Day 42 | 50 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Below] at Day 42 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Below] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Within] at Day 0 | 48 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Above] at Day 0 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Within] at Day 7 | 49 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Within] at Day 7 | 48 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Within] at Day 42 | 49 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Above] at Day 7 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Above] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | LYM [Above] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Above] at Day 0 | 2 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Above] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Below] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | MON [Below] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | NEU [Within] at Day 42 | 49 Participants |
Secondary
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
Biochemical and haematological parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS) and blood urea nitrogen (BUN ). Categories = unknown, below, within, or above the normal ranges.
Time frame: At Day 0, Day 7 and Day 42
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Above] at Day 0 | 3 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Below] at Day 7 | 1 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Below] at Day 42 | 1 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Within] at Day 0 | 47 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Within] at Day 7 | 47 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Within] at Day 42 | 45 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Above] at Day 7 | 2 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Above] at Day 42 | 4 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Below] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Below] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Below] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Below] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Within] at Day 0 | 49 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Within] at Day 7 | 50 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Within] at Day 42 | 49 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Above] at Day 0 | 1 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Above] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Above] at Day 42 | 1 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Below] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Below] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Below] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Within] at Day 0 | 50 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Within] at Day 7 | 50 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Within] at Day 42 | 50 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Above] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Above] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Above] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Below] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Below] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Below] at Day 42 | 1 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Within] at Day 0 | 50 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Within] at Day 7 | 50 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Within] at Day 42 | 49 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Above] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Above] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Above] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Above] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Below] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Within] at Day 42 | 46 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Within] at Day 0 | 48 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Below] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Below] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Below] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Within] at Day 0 | 46 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Above] at Day 0 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Within] at Day 7 | 45 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Below] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Above] at Day 0 | 4 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Above] at Day 7 | 5 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Below] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | ALT [Above] at Day 42 | 4 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Within] at Day 7 | 50 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Within] at Day 0 | 49 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Below] at Day 0 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Within] at Day 7 | 50 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Below] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Above] at Day 42 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Below] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Within] at Day 42 | 50 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Below] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Below] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Within] at Day 0 | 49 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Above] at Day 0 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Within] at Day 7 | 49 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Within] at Day 42 | 49 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Within] at Day 42 | 50 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Above] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Above] at Day 0 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BUN [Below] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Above] at Day 7 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | BAS [Above] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | AST [Above] at Day 42 | 0 Participants |
Secondary
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
Biochemical and haematological parameters assessed in blood samples include lymphocytes (LYM), monocytes (MON) and neutrophils (NEU). Categories = unknown, below, within, or above the normal ranges.
Time frame: At Day 0, Day 7 and Day 42
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC[Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Below] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC [Below] at Day 42 | 2 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC [Below] at Day 7 | 2 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC [Within] at Day 0 | 48 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Below] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC [Within] at Day 7 | 48 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Above] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC [Within] at Day 42 | 46 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Below] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC [Above] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC[Above] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC[Above] at Day 42 | 2 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Within] at Day 0 | 50 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC[Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Within] at Day 7 | 50 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC [Below] at Day 0 | 2 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Above] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC [Below] at Day 7 | 1 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Within] at Day 42 | 50 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC [Below] at Day 42 | 1 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC [Within] at Day 0 | 47 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC [Below] at Day 0 | 2 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC [Within] at Day 7 | 49 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Above] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC [Within] at Day 42 | 47 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC [Above] at Day 0 | 1 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC [Above] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC [Above] at Day 42 | 2 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC [Above] at Day 42 | 2 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Unknown] at Day 0 | 2 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Above] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC[Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC [Below] at Day 0 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC [Above] at Day 0 | 2 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Unknown] at Day 7 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Below] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Below] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Below] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Within] at Day 0 | 48 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Within] at Day 7 | 48 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Within] at Day 42 | 50 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Above] at Day 7 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | PLA [Above] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC [Below] at Day 7 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC [Below] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC [Within] at Day 0 | 47 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC [Within] at Day 7 | 46 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC [Within] at Day 42 | 48 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC[Above] at Day 7 | 3 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | RBC[Above] at Day 42 | 2 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC[Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC [Below] at Day 0 | 2 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC [Below] at Day 7 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC [Below] at Day 42 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC [Within] at Day 0 | 46 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC [Within] at Day 7 | 48 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC [Within] at Day 42 | 47 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC [Above] at Day 0 | 2 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | WBC [Above] at Day 7 | 1 Participants |
Secondary
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
Biochemical and haematological parameters assessed in blood samples include creatinine (CREA), eosinophils (EOS), hemoglobin (HB) and hematocrit (HC). Categories = unknown, below, within, or above the normal ranges.
Time frame: At Day 0, Day 7 and Day 42
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB[Above] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Within] at Day 42 | 47 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Above] at Day 42 | 1 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB [Above] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Below] at Day 0 | 1 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Below] at Day 7 | 1 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Below] at Day 42 | 2 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Within] at Day 0 | 48 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Within] at Day 7 | 46 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Above] at Day 0 | 1 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Above] at Day 7 | 3 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Below] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Below] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Below] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Within] at Day 0 | 44 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Within] at Day 7 | 45 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Within] at Day 42 | 47 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Above] at Day 0 | 6 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Above] at Day 7 | 5 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Above] at Day 42 | 3 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB [Below] at Day 0 | 1 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB [Below] at Day 7 | 1 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB [Below] at Day 42 | 2 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB [Within] at Day 0 | 49 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB [Within] at Day 7 | 49 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB [Within] at Day 42 | 48 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB [Above] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC [Above] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC[Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC [Below] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC [Below] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC [Below] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC [Within] at Day 0 | 50 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC [Within] at Day 7 | 50 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC [Within] at Day 42 | 49 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC [Above] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC [Above] at Day 42 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB[Above] at Day 42 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Above] at Day 7 | 4 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Above] at Day 7 | 3 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC [Above] at Day 0 | 4 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Above] at Day 42 | 2 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB [Above] at Day 0 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Above] at Day 42 | 4 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB [Above] at Day 7 | 2 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC [Within] at Day 0 | 45 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Below] at Day 0 | 2 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Below] at Day 7 | 3 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Below] at Day 42 | 3 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC [Above] at Day 42 | 5 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Within] at Day 0 | 44 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB [Below] at Day 0 | 4 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Within] at Day 42 | 45 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC[Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Above] at Day 0 | 4 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC [Within] at Day 7 | 46 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB [Below] at Day 42 | 5 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Unknown] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC [Below] at Day 0 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Unknown] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB [Within] at Day 0 | 45 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Unknown] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC [Above] at Day 7 | 3 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Below] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB [Within] at Day 7 | 44 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Below] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC [Below] at Day 7 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Below] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB [Within] at Day 42 | 44 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Within] at Day 0 | 46 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HB [Below] at Day 7 | 4 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC [Within] at Day 42 | 44 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Within] at Day 7 | 46 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | HC [Below] at Day 42 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Within] at Day 42 | 46 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | CREA [Within] at Day 7 | 44 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | EOS [Above] at Day 0 | 4 Participants |
Secondary
Number of Subjects With Any Normal or Abnormal Urine Values
Urine parameters assessed were blood, glucose, protein and urobilinogen. Categories = negative, positive
Time frame: At Day 0, Day 7 and Day 42
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Blood [Positive] at Day 42 | 4 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Protein [Positive] at Day 7 | 2 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Blood [Negative] at Day 0 | 48 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Blood [Positive] at Day 0 | 2 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Blood [Negative] at Day 7 | 47 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Blood [Positive] at Day 7 | 3 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Blood [Negative] at Day 42 | 46 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Glucose [Negative] at Day 0 | 50 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Glucose [Positive] at Day 0 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Glucose [Negative] at Day 7 | 50 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Glucose [Positive] at Day 7 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Glucose [Negative] at Day 42 | 50 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Glucose [Positive] at Day 42 | 0 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Protein [Negative] at Day 0 | 49 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Protein [Positive] at Day 0 | 1 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Protein [Negative] at Day 7 | 48 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Protein [Negative] at Day 42 | 49 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Protein [Positive] at Day 42 | 1 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Urobilinogen [Negative] at Day 0 | 47 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Urobilinogen [Positive] at Day 0 | 3 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Urobilinogen [Negative] at Day 7 | 49 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Urobilinogen [Positive] at Day 7 | 1 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Urobilinogen [Negative] at Day 42 | 49 Participants |
| Influenza A (H5N1) 20-40 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Urobilinogen [Positive] at Day 42 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Urobilinogen [Negative] at Day 42 | 50 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Glucose [Positive] at Day 42 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Urobilinogen [Negative] at Day 0 | 50 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Blood [Negative] at Day 0 | 44 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Protein [Negative] at Day 0 | 50 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Blood [Positive] at Day 0 | 6 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Urobilinogen [Positive] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Blood [Negative] at Day 7 | 43 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Protein [Positive] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Blood [Positive] at Day 7 | 7 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Urobilinogen [Positive] at Day 0 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Blood [Negative] at Day 42 | 46 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Protein [Negative] at Day 7 | 50 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Blood [Positive] at Day 42 | 4 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Protein [Positive] at Day 7 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Glucose [Negative] at Day 0 | 49 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Urobilinogen [Positive] at Day 42 | 0 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Glucose [Positive] at Day 0 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Protein [Negative] at Day 42 | 49 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Glucose [Negative] at Day 7 | 47 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Urobilinogen [Negative] at Day 7 | 50 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Glucose [Positive] at Day 7 | 3 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Protein [Positive] at Day 42 | 1 Participants |
| Influenza A (H5N1) 41-64 Years Group | Number of Subjects With Any Normal or Abnormal Urine Values | Glucose [Negative] at Day 42 | 49 Participants |
Secondary
Seroconversion Factors for H5N1 HI Antibodies
Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.
Time frame: At Day 21 and Day 182
Population: Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Influenza A (H5N1) 20-40 Years Group | Seroconversion Factors for H5N1 HI Antibodies | A/Indonesia at Day 21 | 3.2 Fold Increase |
| Influenza A (H5N1) 20-40 Years Group | Seroconversion Factors for H5N1 HI Antibodies | A/Indonesia at Day 182 | 5.1 Fold Increase |
| Influenza A (H5N1) 41-64 Years Group | Seroconversion Factors for H5N1 HI Antibodies | A/Indonesia at Day 21 | 2.8 Fold Increase |
| Influenza A (H5N1) 41-64 Years Group | Seroconversion Factors for H5N1 HI Antibodies | A/Indonesia at Day 182 | 6.9 Fold Increase |