A Dose Ranging Safety and Immunogenicity Study of GlaxoSm... | NCT02719743 | Trialant
NCT02719743
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Jun 27, 2019Actual
Enrollment
185Actual
Phase
Phase 2
Conditions
Influenza
Interventions
Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A).
Countries
Taiwan
Thailand
Protocol Section
Identification Module
NCT ID
NCT02719743
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
116938
Secondary IDs
ID
Type
Description
Link
2015-003458-42
EudraCT Number
Brief Title
A Dose Ranging Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' GSK1557484A Vaccine in Children 6 to Less Than 36 Months of Age
Official Title
An Observer-blind, Dose Ranging Safety and Immunogenicity Study of GSK Biologicals' GSK1557484A Vaccine in Children 6 to Less Than 36 Months of Age
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Jun 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 7, 2016Actual
Primary Completion Date
Feb 13, 2018Actual
Completion Date
Feb 13, 2018Actual
First Submitted Date
Mar 21, 2016
First Submission Date that Met QC Criteria
Mar 21, 2016
First Posted Date
Mar 25, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 10, 2018
Results First Submitted that Met QC Criteria
Feb 22, 2019
Results First Posted Date
Jun 3, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 13, 2019
Last Update Posted Date
Jun 27, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to assess the safety and immunogenicity of different formulations of GSK Biologicals' influenza candidate vaccine GSK1557484A, in children 6-35 months of age.
Detailed Description
Safety and immunogenicity of different formulations administered as a 2-dose schedule in children 6-35 months of age will be evaluated. In addition, the quality of the 2-dose priming will be assessed through the anamnestic response elicited by an antigen challenge (unadjuvanted H5N1) administered 12 months later. The persistence of the immune response approximately 12 months (Day 385) after dose 2 will also be evaluated.
Subjects from each group will be enrolled into the CMI sub-cohort comprising of approximately 100 subjects. Within the participating country(ies), these subjects will be enrolled in only selected/qualified sites.
Conditions Module
Conditions
Influenza
Keywords
children
H5N1
observer-blind
Influenza
dose-ranging
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
185Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
H5N1 Formulation 1 Group
Active Comparator
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Biological: Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A).
H5N1 Formulation 2 Group
Experimental
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Biological: Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A).
H5N1 Formulation 3 Group
Experimental
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Biological: Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A).
H5N1 Formulation 4 Group
Experimental
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Biological: Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A).
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A).
Biological
All subjects will receive intramuscularly a two-dose primary series (adjuvanted) at a 21 day interval, and a booster dose (unadjuvanted) at Day 385 of GSK1557484A vaccine.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination
The HI antibody titres were expressed in terms of immunogenicity indices for each group. Immunogenicity index (DGMT) = If the LL of the 95% CI for GMT group ratio is less than 0.25 then DGMT =0. If the LL of the 95% CI for GMT group ratio is greater than 1 then DGMT =1.
At Day 42
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination
The MN antibody titres were expressed in terms of immunogenicity indices for each group. Immunogenicity index (DGMT) = If the LL of the 95% CI for GMT group ratio is less than 0.25 then DGMT =0. If the LL of the 95% CI for GMT group ratio is greater than 1 then DGMT =1.
At Day 42
Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination.
Fever index was defined as the average temperature for each vaccine group. Fever index (DR) = The average temperature measurement for each vaccine group. Fever index from Days 0-2 after each dose Any temperature < 38°C (100.4 F) was assigned a value of 0. Any temperature > 40.5°C was assigned a value of 40.5. DR correspond to 243 minus the sum of recorded temperature values for 3 days after (dose 1 and dose 2)/243.
During the 3-day follow-up period (i.e. on the day of vaccination and 2 subsequent days) after Dose 1 and Dose 2.
Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination.
Fever index was defined as the average temperature for each vaccine group. Fever index (DR)= The average temperature measurement for each vaccine group. Fever index from Days 0-2 after each dose Any temperature < 38°C (100.4 F) was assigned a value of 0. Any temperature > 40.5°C was assigned a value of 40.5. DR correspond to 243 minus the sum of recorded temperature values for 3 days after (dose 1 and dose 2)/243.
Secondary Outcomes
Measure
Description
Time Frame
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
Seroconversion rate (SCR) was defined as the proportion of subjects who have either a pre-vaccination reciprocal HI titer less than (<) 10 and a post-vaccination reciprocal titer greater than or equal to (≥) 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subject's parent(s)/ Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Male or female children 6 months to less than 36 months old at the time of the first vaccination. Children who are not 36 months old as of Day 0, the day of first vaccine dose under this protocol, can be enrolled.
Written informed consent obtained from the parent(s)/legally acceptable representative(s) [LAR(s)] of the subject prior to performance of any study specific procedure.
Healthy subjects as established by medical history and standard physical examination before entering into the study.
Born full-term to be confirmed by interview with parent/LAR or available medical records.
Exclusion Criteria:
Child in care.
Medical history of physician-confirmed infection with an H5N1 virus.
Previous vaccination at any time with an H5N1 vaccine.
Concurrently participating in another clinical study, or use of an investigational or a non-registered vaccine, pharmaceutical product, or device within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Presence in the parent(s) / LAR(s) of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the parent(s)/LAR(s) unable/unlikely to provide accurate safety reports.
Acute disease and/or fever at the time of enrolment.
Administration of immunoglobulins, any blood products, or long-acting immune-modifying drugs during the period starting 3 months before the first dose of study vaccine, or planned administration during the study period.
Diagnosed with excessive daytime sleepiness or narcolepsy; or history of narcolepsy in a subject's parent or sibling.
Administration of an inactive vaccine within 14 days or of a live attenuated vaccine within 30 days before the first vaccination.
Planned administration of any vaccine not foreseen by the study protocol between Day 0 and Day 42 or planned administration of an inactive vaccine within 14 days or of a live attenuated vaccine within 30 days before through 30 days after the booster vaccination. Note: routine vaccinations may be provided on Day 42 after all study assessments have been performed.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine. For corticosteroids, this will mean a dose of prednisone or equivalent of > 2 mg/kg/day of body weight or ≥ 20 mg/day (for persons who weigh ≥ 10 kg). Inhaled and topical steroids are allowed.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Family history of congenital or hereditary immunodeficiency.
Major congenital defects.
Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Kim JH, Drame M, Puthanakit T, Chiu NC, Supparatpinyo K, Huang LM, Chiu CH, Chen PY, Hwang KP, Danier J, Friel D, Salaun B, Woo W, Vaughn DW, Innis B, Schuind A. Immunogenicity and Safety of AS03-adjuvanted H5N1 Influenza Vaccine in Children 6-35 Months of Age: Results From a Phase 2, Randomized, Observer-blind, Multicenter, Dose-ranging Study. Pediatr Infect Dis J. 2021 Sep 1;40(9):e333-e339. doi: 10.1097/INF.0000000000003247.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Biological: Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A).
H5N1 Formulation 1 Group
H5N1 Formulation 2 Group
H5N1 Formulation 3 Group
H5N1 Formulation 4 Group
H5N1 Formulation 5 Group
During the 3-day follow-up period (i.e. on the day of vaccination and 2 subsequent days) after Dose 1 and Dose 2.
Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains.
MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer (Day 392) to the pre-vaccination (Day 385) reciprocal HI titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).
At Day 392 (relative to Day 385) post booster vaccination
Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains.
MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 392) reciprocal MN titer to the pre-vaccination (Day 385) reciprocal MN titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).
At Day 392 (relative to Day 385) post booster vaccination
At Days 42, 385 and 392
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
Seroprotection rate (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers ≥ 40 against the tested vaccine virus The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).
At Days 0, 42, 385, 392
Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens
GMTs were defined as the geometric mean antibody titres calculated on all subjects post the primary immunization (at Day 0, 42, 385) and 7 days post booster dose (at Day 392). The aggregate variables were calculated for each group. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).
At Days 0, 42 and 385 (post the primary immunization), at Day 392 (7 days post booster dose)
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains
MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 42) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).
At Day 42 (relative to Day 0), at Day 385 (relative to Day 0) and at Day 392 (relative to Day 0)
Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains.
MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 385) reciprocal MN titer to the pre-vaccination (Day 0) reciprocal MN titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).
At Day 385 (relative to Day 0)
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens
MN antibody titers were expressed as Geometric Mean Titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:28. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).
At Days 0, 42, 385 and Day 392
Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains.
VRR for MN was defined as the incidence rate of subjects with at least a 4-fold increase in post vaccination reciprocal titer relative to pre vaccination titers. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).
At Day 42, Day 385 (relative to Day 0), Day 392 (relative to Day 0) and D 392 (relative to Day 385)
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen.
Antigen-specific CD4+/CD8+ T Cells identified as CD4/CD8+ were analysed for T cells expressing two or more of the following immune markers: CD40 Ligand, Interleukin (IL)-2, Tumor Necrosis Factor alpha (TNF-a), Interferon-gamma (IFN-g). The frequency was presented as number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells repsectively. All doubles = T cell expressing at least 2 cytokines.
At Days 0, 42, 385 and 392
Number of Subjects Reporting Solicited Local Symptoms
Solicited local AEs assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb is moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose
Duration of Solicited Local Symptoms
Duration was defined as number of days with any grade of local symptoms.
During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose
Number of Subjects Reporting Solicited General Symptoms.
Assessed solicited general symptoms were fever (defined as temperature ≥ 38.0 degrees Celsius (°C) assessed by any route (oral, axillary, rectal)], irritability/fussiness, drowsiness and. loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 irritability/Fussiness and Drowsiness = Prevented normal activity, Grade3 Loss of appetite = Did not eat at all. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination
During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose
Duration of Solicited General Symptoms.
Duration was defined as number of days with any grade of general symptoms.
During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevents normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
During the 21-day follow-up period (Day 0-Day 20) after each vaccine dose
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevents normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
During the 30-day (Day 385-Day 415) follow-up period after vaccination
Number of Subjects Reporting Medically Attended Events (MAEs)
MAEs are adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as at least 1 MAE experienced.
During the entire study period (Day 0 to Day 415 approximately)
Number of Subjects Reporting Potential Immune Mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. "Any pIMD" = at least one pIMD experienced by the study subject. Related = pIMD assessed by the investigator to be causally related to the study vaccination.
During the entire study period (Day 0 to Day 415 approximately)
Number of Subjects Reporting Serious Adverse Events (SAEs)
A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
During the entire study period (Day 0 to Day 415 approximately)
Number of Subjects Reporting Adverse Events of Special Interest (AESI)
AESI are a subset of adverse events defined in the Committee for Medicinal Products for Human Use (CHMP) Risk Management Plan for Pandemic Vaccines for safety monitoring.
During the entire study period (Day 0 to Day 415 approximately)
Taichung
407
Taiwan
GSK Investigational Site
Taipei
100
Taiwan
GSK Investigational Site
Taipei
104
Taiwan
GSK Investigational Site
Taoyuan
333
Taiwan
GSK Investigational Site
Bangkok
10330
Thailand
GSK Investigational Site
Chiang Mai
50200
Thailand
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
FG002
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
FG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
FG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
FG00038 subjects
FG00137 subjects
FG00238 subjects
FG00337 subjects
FG00435 subjects
COMPLETED
FG00037 subjects
FG00134 subjects
FG00238 subjects
FG00336 subjects
FG00433 subjects
NOT COMPLETED
FG0001 subjects
FG0013 subjects
FG0020 subjects
FG0031 subjects
FG0042 subjects
Type
Comment
Reasons
Consent withdrawal
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
Migrated/moved from study area
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
BG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
BG002
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
BG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
BG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00038
BG00137
BG00238
BG00337
BG00435
BG005185
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Months
Title
Denominators
Categories
Title
Measurements
BG00021.9± 8.0
BG00122.6± 8.1
BG00221.6± 9.2
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00017
BG00114
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Asian - East Asian Heritage
Title
Measurements
BG00021
BG00121
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination
The HI antibody titres were expressed in terms of immunogenicity indices for each group. Immunogenicity index (DGMT) = If the LL of the 95% CI for GMT group ratio is less than 0.25 then DGMT =0. If the LL of the 95% CI for GMT group ratio is greater than 1 then DGMT =1.
Analysis was performed on cohort for analysis of the immunogenicity-fever score which included all subjects who have received all study vaccine dose(s) at Day 42 for whom temperature measurements are available during the first 3 days after both vaccine doses 1 and 2.
Posted
Mean
Full Range
Immunogenicity Index
At Day 42
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG002
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Units
Counts
Participants
OG00036
OG00133
OG00237
OG003
Title
Denominators
Categories
Title
Measurements
OG0001(0 to 1)
OG0010.54(0 to 1)
OG0020.57(0 to 1)
OG003
Primary
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination
The MN antibody titres were expressed in terms of immunogenicity indices for each group. Immunogenicity index (DGMT) = If the LL of the 95% CI for GMT group ratio is less than 0.25 then DGMT =0. If the LL of the 95% CI for GMT group ratio is greater than 1 then DGMT =1.
Analysis was performed on cohort for analysis of the immunogenicity-fever score which included all subjects who have received all study vaccine dose(s) at Day 42 for whom temperature measurements are available during the first 3 days after both vaccine doses 1 & 2 and with pre & post immune result of antibody of interest.
Posted
Mean
Full Range
Immunogenicity Index
At Day 42
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Primary
Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination.
Fever index was defined as the average temperature for each vaccine group. Fever index (DR) = The average temperature measurement for each vaccine group. Fever index from Days 0-2 after each dose Any temperature < 38°C (100.4 F) was assigned a value of 0. Any temperature > 40.5°C was assigned a value of 40.5. DR correspond to 243 minus the sum of recorded temperature values for 3 days after (dose 1 and dose 2)/243.
Analysis was performed on cohort for analysis of the immunogenicity-fever score which included all subjects who have received all study vaccine dose(s) at Day 42 for whom temperature measurements are available during the first 3 days after both vaccine doses 1 and 2.
Posted
Mean
Full Range
Degrees Celsius
During the 3-day follow-up period (i.e. on the day of vaccination and 2 subsequent days) after Dose 1 and Dose 2.
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Primary
Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination.
Fever index was defined as the average temperature for each vaccine group. Fever index (DR)= The average temperature measurement for each vaccine group. Fever index from Days 0-2 after each dose Any temperature < 38°C (100.4 F) was assigned a value of 0. Any temperature > 40.5°C was assigned a value of 40.5. DR correspond to 243 minus the sum of recorded temperature values for 3 days after (dose 1 and dose 2)/243.
Analysis was performed on cohort for analysis of the immunogenicity-fever score which included all subjects who have received all study vaccine dose(s) at Day 42 for whom temperature measurements are available during the first 3 days after both vaccine doses 1 and 2.
Posted
Mean
Full Range
Degrees Celsius
During the 3-day follow-up period (i.e. on the day of vaccination and 2 subsequent days) after Dose 1 and Dose 2.
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Primary
Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains.
MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer (Day 392) to the pre-vaccination (Day 385) reciprocal HI titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).
Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster)
Posted
Geometric Mean
95% Confidence Interval
Fold change
At Day 392 (relative to Day 385) post booster vaccination
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Primary
Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains.
MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 392) reciprocal MN titer to the pre-vaccination (Day 385) reciprocal MN titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).
Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster)
Posted
Geometric Mean
95% Confidence Interval
Fold change
At Day 392 (relative to Day 385) post booster vaccination
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Secondary
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
Seroconversion rate (SCR) was defined as the proportion of subjects who have either a pre-vaccination reciprocal HI titer less than (<) 10 and a post-vaccination reciprocal titer greater than or equal to (≥) 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).
Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster)
Posted
Count of Participants
Participants
At Days 42, 385 and 392
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Secondary
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
Seroprotection rate (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers ≥ 40 against the tested vaccine virus The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).
Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster)
Posted
Count of Participants
Participants
At Days 0, 42, 385, 392
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Secondary
Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens
GMTs were defined as the geometric mean antibody titres calculated on all subjects post the primary immunization (at Day 0, 42, 385) and 7 days post booster dose (at Day 392). The aggregate variables were calculated for each group. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).
Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster).
Posted
Geometric Mean
95% Confidence Interval
Titers
At Days 0, 42 and 385 (post the primary immunization), at Day 392 (7 days post booster dose)
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Secondary
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains
MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 42) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).
Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster).
Posted
Geometric Mean
95% Confidence Interval
Fold change
At Day 42 (relative to Day 0), at Day 385 (relative to Day 0) and at Day 392 (relative to Day 0)
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Secondary
Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains.
MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 385) reciprocal MN titer to the pre-vaccination (Day 0) reciprocal MN titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).
Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster).
Posted
Geometric Mean
95% Confidence Interval
Fold change
At Day 385 (relative to Day 0)
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Secondary
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens
MN antibody titers were expressed as Geometric Mean Titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:28. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).
Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster).
Posted
Geometric Mean
95% Confidence Interval
Titers
At Days 0, 42, 385 and Day 392
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Secondary
Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains.
VRR for MN was defined as the incidence rate of subjects with at least a 4-fold increase in post vaccination reciprocal titer relative to pre vaccination titers. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).
Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster).
Posted
Count of Participants
Participants
At Day 42, Day 385 (relative to Day 0), Day 392 (relative to Day 0) and D 392 (relative to Day 385)
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Secondary
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen.
Antigen-specific CD4+/CD8+ T Cells identified as CD4/CD8+ were analysed for T cells expressing two or more of the following immune markers: CD40 Ligand, Interleukin (IL)-2, Tumor Necrosis Factor alpha (TNF-a), Interferon-gamma (IFN-g). The frequency was presented as number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells repsectively. All doubles = T cell expressing at least 2 cytokines.
Analysis was performed on the Total Vaccinated cohort (CMI sub-cohort) which included all vaccinated subjects for whom data were available. The CMI sub-cohort included approximately 20 vaccinated subjects per group.
Posted
Median
Inter-Quartile Range
cells/million T cells
At Days 0, 42, 385 and 392
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Secondary
Number of Subjects Reporting Solicited Local Symptoms
Solicited local AEs assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb is moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Posted
Count of Participants
Participants
During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG002
H5N1 Formulation 3 Group
Secondary
Duration of Solicited Local Symptoms
Duration was defined as number of days with any grade of local symptoms.
Analysis was performed on the Total Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.cohort which included all vaccinated subjects for whom data were available.
Posted
Median
Inter-Quartile Range
Days
During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG002
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Secondary
Number of Subjects Reporting Solicited General Symptoms.
Assessed solicited general symptoms were fever (defined as temperature ≥ 38.0 degrees Celsius (°C) assessed by any route (oral, axillary, rectal)], irritability/fussiness, drowsiness and. loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 irritability/Fussiness and Drowsiness = Prevented normal activity, Grade3 Loss of appetite = Did not eat at all. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Posted
Count of Participants
Participants
During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Secondary
Duration of Solicited General Symptoms.
Duration was defined as number of days with any grade of general symptoms.
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Posted
Median
Inter-Quartile Range
Days
During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG002
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Secondary
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevents normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Posted
Count of Participants
Participants
During the 21-day follow-up period (Day 0-Day 20) after each vaccine dose
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Secondary
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevents normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Posted
Count of Participants
Participants
During the 30-day (Day 385-Day 415) follow-up period after vaccination
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Secondary
Number of Subjects Reporting Medically Attended Events (MAEs)
MAEs are adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as at least 1 MAE experienced.
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Posted
Count of Participants
Participants
During the entire study period (Day 0 to Day 415 approximately)
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG002
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Secondary
Number of Subjects Reporting Potential Immune Mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. "Any pIMD" = at least one pIMD experienced by the study subject. Related = pIMD assessed by the investigator to be causally related to the study vaccination.
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Posted
Count of Participants
Participants
During the entire study period (Day 0 to Day 415 approximately)
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG002
H5N1 Formulation 3 Group
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs)
A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Posted
Count of Participants
Participants
During the entire study period (Day 0 to Day 415 approximately)
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG002
Secondary
Number of Subjects Reporting Adverse Events of Special Interest (AESI)
AESI are a subset of adverse events defined in the Committee for Medicinal Products for Human Use (CHMP) Risk Management Plan for Pandemic Vaccines for safety monitoring.
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Posted
Count of Participants
Participants
During the entire study period (Day 0 to Day 415 approximately)
ID
Title
Description
OG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
OG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG002
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Time Frame
Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately).
Description
The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
H5N1 Formulation 1 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
0
38
5
38
36
38
EG001
H5N1 Formulation 2 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
0
37
6
37
31
37
EG002
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
0
38
10
38
35
38
EG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
0
37
4
37
35
37
EG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
0
35
4
35
32
35
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal hernia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG0030 events0 affected37 at risk
EG0040 events0 affected35 at risk
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Bacteraemia
Infections and infestations
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Bacterial infection
Infections and infestations
Systematic Assessment
EG0001 events1 affected38 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Bronchiolitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Bronchitis
Infections and infestations
Systematic Assessment
EG0001 events1 affected38 at risk
EG0011 events1 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Conjunctivitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Croup infectious
Infections and infestations
Systematic Assessment
EG0001 events1 affected38 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Diarrhoea infectious
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Gastroenteritis
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0023 events3 affected38 at risk
EG003
Herpangina
Infections and infestations
Systematic Assessment
EG0001 events1 affected38 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Influenza
Infections and infestations
Systematic Assessment
EG0001 events1 affected38 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Nasopharyngitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Oral herpes
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Pneumonia
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0012 events2 affected37 at risk
EG0023 events3 affected38 at risk
EG003
Pneumonia respiratory syncytial viral
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Pneumonia viral
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Respiratory syncytial virus bronchiolitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Respiratory syncytial virus bronchitis
Infections and infestations
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected37 at risk
EG0022 events2 affected38 at risk
EG003
Scarlet fever
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0022 events2 affected38 at risk
EG003
Sinusitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Tonsillitis
Infections and infestations
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Varicella
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Viral infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Viral rash
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Febrile convulsion
Nervous system disorders
Systematic Assessment
EG0001 events1 affected38 at risk
EG0011 events1 affected37 at risk
EG0023 events1 affected38 at risk
EG003
Balanoposthitis
Reproductive system and breast disorders
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Kawasaki's disease
Vascular disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal discomfort
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected38 at risk
EG0030 events0 affected37 at risk
EG0040 events0 affected35 at risk
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Acute sinusitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0022 events2 affected38 at risk
EG003
Anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Body height below normal
Investigations
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Body temperature increased
Investigations
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected37 at risk
EG0022 events2 affected38 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Bronchiolitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Bronchitis
Infections and infestations
Systematic Assessment
EG0002 events2 affected38 at risk
EG0012 events2 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Bronchitis viral
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Candida infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Cardiac murmur
Investigations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Cellulitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Conjunctivitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0013 events2 affected37 at risk
EG0022 events2 affected38 at risk
EG003
Constipation
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Contusion
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0012 events2 affected37 at risk
EG0022 events2 affected38 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
Systematic Assessment
EG00039 events25 affected38 at risk
EG00116 events13 affected37 at risk
EG00220 events14 affected38 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0002 events2 affected38 at risk
EG0011 events1 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Device breakage
Product Issues
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Systematic Assessment
EG0002 events2 affected38 at risk
EG0012 events2 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Enterovirus infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Erythema of eyelid
Eye disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Eyelid oedema
Eye disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Febrile convulsion
Nervous system disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Feeling hot
General disorders
Systematic Assessment
EG0004 events2 affected38 at risk
EG0010 events0 affected37 at risk
EG0023 events3 affected38 at risk
EG003
Flatulence
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Food poisoning
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Foreign body in eye
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Gastritis
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Gastroenteritis
Infections and infestations
Systematic Assessment
EG0001 events1 affected38 at risk
EG0013 events2 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Gastroenteritis viral
Infections and infestations
Systematic Assessment
EG0002 events2 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Gastrointestinal inflammation
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Hand-foot-and-mouth disease
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Head injury
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Headache
Nervous system disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Hordeolum
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Impetigo
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Increased upper airway secretion
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Influenza
Infections and infestations
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Influenza like illness
General disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Injection site erythema
General disorders
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Injection site urticaria
General disorders
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Irritability
Psychiatric disorders
Systematic Assessment
EG00039 events24 affected38 at risk
EG00126 events17 affected37 at risk
EG00231 events19 affected38 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Nasopharyngitis
Infections and infestations
Systematic Assessment
EG00013 events10 affected38 at risk
EG00110 events8 affected37 at risk
EG00215 events10 affected38 at risk
EG003
Oral herpes
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Otitis media
Infections and infestations
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Otitis media acute
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Pain
General disorders
Systematic Assessment
EG00039 events20 affected38 at risk
EG00132 events15 affected37 at risk
EG00231 events16 affected38 at risk
EG003
Paronychia
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Periorbital oedema
Eye disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Pharyngitis
Infections and infestations
Systematic Assessment
EG0006 events3 affected38 at risk
EG0011 events1 affected37 at risk
EG0025 events5 affected38 at risk
EG003
Pharyngotonsillitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Pneumonia
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Pyrexia
General disorders
Systematic Assessment
EG00036 events24 affected38 at risk
EG00121 events17 affected37 at risk
EG00216 events15 affected38 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Respiration abnormal
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Respiratory syncytial virus bronchitis
Infections and infestations
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 events1 affected38 at risk
EG0013 events2 affected37 at risk
EG0027 events5 affected38 at risk
EG003
Roseola
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Sinusitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0022 events1 affected38 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Somnolence
Nervous system disorders
Systematic Assessment
EG00042 events25 affected38 at risk
EG00129 events18 affected37 at risk
EG00220 events13 affected38 at risk
EG003
Speech disorder developmental
Nervous system disorders
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Swelling
General disorders
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Tonsillitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0007 events7 affected38 at risk
EG00110 events8 affected37 at risk
EG0026 events6 affected38 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 events1 affected38 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Viral diarrhoea
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Viral infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Viral rash
Infections and infestations
Systematic Assessment
EG0003 events3 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected38 at risk
EG003
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0003 events3 affected38 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected38 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Units
Counts
Participants
OG00036
OG00131
OG00237
OG00329
OG00435
Title
Denominators
Categories
Title
Measurements
OG0001(0 to 1)
OG0010.56(0 to 1)
OG0020.57(0 to 1)
OG0030.32(0 to 1)
OG0040.33(0 to 1)
OG002
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Units
Counts
Participants
OG00036
OG00133
OG00237
OG00331
OG00435
Title
Denominators
Categories
Title
Measurements
OG0000.84(0 to 1)
OG0010.91(0 to 1)
OG0020.95(0 to 1)
OG0030.93(0 to 1)
OG0040.94(0 to 1)
OG002
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Units
Counts
Participants
OG00036
OG00131
OG00237
OG00329
OG00435
Title
Denominators
Categories
Title
Measurements
OG0000.84(0 to 1)
OG0010.91(0 to 1)
OG0020.95(0 to 1)
OG0030.93(0 to 1)
OG0040.94(0 to 1)
OG002
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Units
Counts
Participants
OG00034
OG00133
OG00237
OG00331
OG00432
Title
Denominators
Categories
Flu A/Indonesia/5/2005 H5N1 HI
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00331
ParticipantsOG00432
Title
Measurements
OG0004.9(3.8 to 6.3)
OG0016.6(4.9 to 9.0)
OG0024.2(3.4 to 5.3)
OG003
Flu A/duck/Bangladesh/19097/2013 H5N1 HI
ParticipantsOG00033
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00331
Flu A/Vietnam/1194/2004 H5N1 HI
ParticipantsOG00033
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00331
Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 HI
ParticipantsOG00033
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG003
OG002
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Units
Counts
Participants
OG00034
OG00133
OG00237
OG00331
OG00432
Title
Denominators
Categories
Flu A/Indonesia/5/2005 H5N1 MN
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00331
ParticipantsOG00432
Title
Measurements
OG0004.3(3.3 to 5.7)
OG0014.8(3.4 to 6.6)
OG0023.2(2.3 to 4.3)
OG003
Flu A/Vietnam/1194/2004 H5N1 MN
ParticipantsOG00033
ParticipantsOG00133
ParticipantsOG00235
ParticipantsOG00331
Flu A/duck/Bangladesh/19097/2013 H5N1 MN
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00330
OG002
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Units
Counts
Participants
OG00036
OG00133
OG00237
OG00331
OG00435
Title
Denominators
Categories
Flu A/Indonesia/5/2005 H5N1 HI, Day 42
ParticipantsOG00036
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00331
ParticipantsOG00435
Title
Measurements
OG00036
OG00133
OG00237
OG003
Flu A/Indonesia/5/2005 H5N1 HI, Day 385
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00331
Flu A/Indonesia/5/2005 H5N1 HI, Day 392
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00331
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42
ParticipantsOG00030
ParticipantsOG00124
ParticipantsOG00234
ParticipantsOG003
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385
ParticipantsOG00031
ParticipantsOG00129
ParticipantsOG00232
ParticipantsOG003
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00235
ParticipantsOG003
Flu A/Vietnam/1194/2004 H5N1 HI, Day 42
ParticipantsOG00030
ParticipantsOG00124
ParticipantsOG00234
ParticipantsOG00325
Flu A/Vietnam/1194/2004 H5N1 HI, Day 385
ParticipantsOG00031
ParticipantsOG00129
ParticipantsOG00232
ParticipantsOG00325
Flu A/Vietnam/1194/2004 H5N1 HI, Day 392
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00235
ParticipantsOG00325
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42
ParticipantsOG00030
ParticipantsOG00124
ParticipantsOG00234
ParticipantsOG003
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385
ParticipantsOG00031
ParticipantsOG00129
ParticipantsOG00232
ParticipantsOG003
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00235
ParticipantsOG003
OG002
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Units
Counts
Participants
OG00036
OG00133
OG00237
OG00331
OG00435
Title
Denominators
Categories
Flu A/Indonesia/5/2005 H5N1 HI, Day 0
ParticipantsOG00036
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00331
ParticipantsOG00435
Title
Measurements
OG0000
OG0010
OG0020
OG003
Flu A/Indonesia/5/2005 H5N1 HI, Day 42
ParticipantsOG00036
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00331
Flu A/Indonesia/5/2005 H5N1 HI, Day 385
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00331
Flu A/Indonesia/5/2005 H5N1 HI, Day 392
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00331
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 0
ParticipantsOG00033
ParticipantsOG00130
ParticipantsOG00235
ParticipantsOG003
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42
ParticipantsOG00032
ParticipantsOG00127
ParticipantsOG00236
ParticipantsOG003
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385
ParticipantsOG00034
ParticipantsOG00132
ParticipantsOG00234
ParticipantsOG003
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392
ParticipantsOG00033
ParticipantsOG00132
ParticipantsOG00236
ParticipantsOG003
Flu A/Vietnam/1194/2004 H5N1 HI, Day 0
ParticipantsOG00033
ParticipantsOG00130
ParticipantsOG00235
ParticipantsOG00325
Flu A/Vietnam/1194/2004 H5N1 HI, Day 42
ParticipantsOG00032
ParticipantsOG00127
ParticipantsOG00236
ParticipantsOG00331
Flu A/Vietnam/1194/2004 H5N1 HI, Day 385
ParticipantsOG00034
ParticipantsOG00132
ParticipantsOG00234
ParticipantsOG00331
Flu A/Vietnam/1194/2004 H5N1 HI, Day 392
ParticipantsOG00033
ParticipantsOG00132
ParticipantsOG00236
ParticipantsOG00331
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 0
ParticipantsOG00033
ParticipantsOG00130
ParticipantsOG00235
ParticipantsOG003
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42
ParticipantsOG00032
ParticipantsOG00127
ParticipantsOG00236
ParticipantsOG003
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385
ParticipantsOG00034
ParticipantsOG00132
ParticipantsOG00234
ParticipantsOG003
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392
ParticipantsOG00033
ParticipantsOG00132
ParticipantsOG00236
ParticipantsOG003
OG002
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Units
Counts
Participants
OG00036
OG00133
OG00237
OG00331
OG00435
Title
Denominators
Categories
Flu A/Indonesia/5/2005 H5N1 HI, Day 0
ParticipantsOG00036
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00331
ParticipantsOG00435
Title
Measurements
OG0005.1(4.9 to 5.3)
OG0015.1(4.9 to 5.3)
OG0025.1(4.9 to 5.4)
OG003
Flu A/Indonesia/5/2005 H5N1 HI, Day 42
ParticipantsOG00036
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00331
Flu A/Indonesia/5/2005 H5N1 HI, Day 385
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00331
Flu A/Indonesia/5/2005 H5N1 HI, Day 392
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00331
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 0
ParticipantsOG00033
ParticipantsOG00130
ParticipantsOG00235
ParticipantsOG003
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42
ParticipantsOG00032
ParticipantsOG00127
ParticipantsOG00236
ParticipantsOG003
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385
ParticipantsOG00034
ParticipantsOG00132
ParticipantsOG00234
ParticipantsOG003
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392
ParticipantsOG00033
ParticipantsOG00132
ParticipantsOG00236
ParticipantsOG003
Flu A/Vietnam/1194/2004 H5N1 HI, Day 0
ParticipantsOG00033
ParticipantsOG00130
ParticipantsOG00235
ParticipantsOG00325
Flu A/Vietnam/1194/2004 H5N1 HI, Day 42
ParticipantsOG00032
ParticipantsOG00127
ParticipantsOG00236
ParticipantsOG00331
Flu A/Vietnam/1194/2004 H5N1 HI, Day 385
ParticipantsOG00034
ParticipantsOG00132
ParticipantsOG00234
ParticipantsOG00331
Flu A/Vietnam/1194/2004 H5N1 HI, Day 392
ParticipantsOG00033
ParticipantsOG00132
ParticipantsOG00236
ParticipantsOG00331
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 0
ParticipantsOG00033
ParticipantsOG00130
ParticipantsOG00235
ParticipantsOG003
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42
ParticipantsOG00032
ParticipantsOG00127
ParticipantsOG00236
ParticipantsOG003
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385
ParticipantsOG00034
ParticipantsOG00132
ParticipantsOG00234
ParticipantsOG003
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392
ParticipantsOG00033
ParticipantsOG00132
ParticipantsOG00236
ParticipantsOG003
OG002
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Units
Counts
Participants
OG00036
OG00133
OG00237
OG00331
OG00435
Title
Denominators
Categories
Flu A/Indonesia/5/2005 H5N1 HI, Day 42
ParticipantsOG00036
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00331
ParticipantsOG00435
Title
Measurements
OG000219.5(172.6 to 279.0)
OG001168.2(127.4 to 222.0)
OG002177.7(131.5 to 240.1)
OG003
Flu A/Indonesia/5/2005 H5N1 HI, Day 385
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00331
Flu A/Indonesia/5/2005 H5N1 HI, Day 392
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00331
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42
ParticipantsOG00032
ParticipantsOG00127
ParticipantsOG00236
ParticipantsOG003
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385
ParticipantsOG00034
ParticipantsOG00132
ParticipantsOG00234
ParticipantsOG003
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392
ParticipantsOG00033
ParticipantsOG00132
ParticipantsOG00236
ParticipantsOG003
Flu A/Vietnam/1194/2004 H5N1 HI, Day 42
ParticipantsOG00032
ParticipantsOG00127
ParticipantsOG00236
ParticipantsOG00331
Flu A/Vietnam/1194/2004 H5N1 HI, Day 385
ParticipantsOG00034
ParticipantsOG00132
ParticipantsOG00234
ParticipantsOG00331
Flu A/Vietnam/1194/2004 H5N1 HI, Day 392
ParticipantsOG00033
ParticipantsOG00132
ParticipantsOG00236
ParticipantsOG00331
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42
ParticipantsOG00032
ParticipantsOG00127
ParticipantsOG00236
ParticipantsOG003
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385
ParticipantsOG00034
ParticipantsOG00132
ParticipantsOG00234
ParticipantsOG003
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392
ParticipantsOG00033
ParticipantsOG00132
ParticipantsOG00236
ParticipantsOG003
OG002
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Units
Counts
Participants
OG00034
OG00132
OG00237
OG00330
OG00432
Title
Denominators
Categories
Flu A/Indonesia/5/2005 H5N1 MN
ParticipantsOG00034
ParticipantsOG00132
ParticipantsOG00237
ParticipantsOG00329
ParticipantsOG00432
Title
Measurements
OG00017.5(13.7 to 22.4)
OG00114.8(12.6 to 17.5)
OG00215.3(12.5 to 18.6)
OG003
Flu A/Vietnam/1194/2004 H5N1 MN
ParticipantsOG00031
ParticipantsOG00132
ParticipantsOG00235
ParticipantsOG00330
Flu A/duck/Bangladesh/19097/2013 H5N1 MN
ParticipantsOG00033
ParticipantsOG00132
ParticipantsOG00237
ParticipantsOG00330
OG002
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Units
Counts
Participants
OG00036
OG00133
OG00237
OG00331
OG00435
Title
Denominators
Categories
Flu A/Indonesia/5/2005 H5N1 MN, Day 0
ParticipantsOG00036
ParticipantsOG00132
ParticipantsOG00237
ParticipantsOG00329
ParticipantsOG00435
Title
Measurements
OG00014.3(13.7 to 14.8)
OG00114.0(14.0 to 14.0)
OG00214.0(14.0 to 14.0)
OG003
Flu A/Indonesia/5/2005 H5N1 MN, Day 42
ParticipantsOG00036
ParticipantsOG00132
ParticipantsOG00237
ParticipantsOG00331
Flu A/Indonesia/5/2005 H5N1 MN, Day 385
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00331
Flu A/Indonesia/5/2005 H5N1 MN, Day 392
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00331
Flu A/Vietnam/1194/2004 H5N1 MN, Day 0
ParticipantsOG00034
ParticipantsOG00132
ParticipantsOG00237
ParticipantsOG00330
Flu A/Vietnam/1194/2004 H5N1 MN, Day 42
ParticipantsOG00036
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00331
Flu A/Vietnam/1194/2004 H5N1 MN, Day 385
ParticipantsOG00033
ParticipantsOG00133
ParticipantsOG00235
ParticipantsOG00331
Flu A/Vietnam/1194/2004 H5N1 MN, Day 392
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00331
Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 0
ParticipantsOG00035
ParticipantsOG00132
ParticipantsOG00237
ParticipantsOG003
Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 42
ParticipantsOG00036
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG003
Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 385
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG003
Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 392
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG003
OG002
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Units
Counts
Participants
OG00036
OG00133
OG00237
OG00331
OG00435
Title
Denominators
Categories
Flu A/Indonesia/5/2005 H5N1 MN, Day 42
ParticipantsOG00036
ParticipantsOG00132
ParticipantsOG00237
ParticipantsOG00329
ParticipantsOG00435
Title
Measurements
OG00036
OG00131
OG00237
OG003
Flu A/Indonesia/5/2005 H5N1 MN, Day 385
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00329
Flu A/Indonesia/5/2005 H5N1 MN, Day 392
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00329
Flu A/Indonesia/5/2005 H5N1 MN, D 392
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG00331
Flu A/Vietnam/1194/2004 H5N1 MN, Day 42
ParticipantsOG00034
ParticipantsOG00132
ParticipantsOG00237
ParticipantsOG00330
Flu A/Vietnam/1194/2004 H5N1 MN, Day 385
ParticipantsOG00031
ParticipantsOG00132
ParticipantsOG00235
ParticipantsOG00330
Flu A/Vietnam/1194/2004 H5N1 MN, Day 392
ParticipantsOG00032
ParticipantsOG00132
ParticipantsOG00237
ParticipantsOG00330
Flu A/Vietnam/1194/2004 H5N1 MN, D 392
ParticipantsOG00033
ParticipantsOG00133
ParticipantsOG00235
ParticipantsOG00331
Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 42
ParticipantsOG00035
ParticipantsOG00132
ParticipantsOG00237
ParticipantsOG003
Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 385
ParticipantsOG00033
ParticipantsOG00132
ParticipantsOG00237
ParticipantsOG003
Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 392
ParticipantsOG00033
ParticipantsOG00132
ParticipantsOG00237
ParticipantsOG003
Flu A/duck/Bangladesh/19097/2013 H5N1 MN, D 392
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00237
ParticipantsOG003
OG002
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Units
Counts
Participants
OG00020
OG00119
OG00219
OG00318
OG00419
Title
Denominators
Categories
CD4 dble_All (Polypositives), Day 0
ParticipantsOG00020
ParticipantsOG00119
ParticipantsOG00217
ParticipantsOG00318
ParticipantsOG00419
Title
Measurements
OG00055.5(1.0 to 227.0)
OG00142.0(3.0 to 185.0)
OG00243.0(1.0 to 90.0)
OG003
CD4 dble_All (Polypositives), Day 42
ParticipantsOG00018
ParticipantsOG00119
ParticipantsOG00217
ParticipantsOG00316
CD4 dble_All (Polypositives), Day 385
ParticipantsOG00020
ParticipantsOG00118
ParticipantsOG00218
ParticipantsOG00318
CD4 dble_All (Polypositives), Day 392
ParticipantsOG00020
ParticipantsOG00117
ParticipantsOG00219
ParticipantsOG00318
CD4 dble_CD40L, Day 0
ParticipantsOG00020
ParticipantsOG00119
ParticipantsOG00217
ParticipantsOG00318
CD4 dble_CD40L, Day 42
ParticipantsOG00018
ParticipantsOG00119
ParticipantsOG00217
ParticipantsOG00316
CD4 dble_CD40L, Day 385
ParticipantsOG00020
ParticipantsOG00118
ParticipantsOG00218
ParticipantsOG00318
CD4 dble_CD40L, Day 392
ParticipantsOG00020
ParticipantsOG00117
ParticipantsOG00219
ParticipantsOG00318
CD4 dble_IFNγ, Day 0
ParticipantsOG00020
ParticipantsOG00119
ParticipantsOG00217
ParticipantsOG00318
CD4 dble_IFNγ, Day 42
ParticipantsOG00018
ParticipantsOG00119
ParticipantsOG00217
ParticipantsOG00316
CD4 dble_IFNγ, Day 385
ParticipantsOG00020
ParticipantsOG00118
ParticipantsOG00218
ParticipantsOG00318
CD4 dble_IFNγ, Day 392
ParticipantsOG00020
ParticipantsOG00117
ParticipantsOG00219
ParticipantsOG00318
CD4 dble_IL2, Day 0
ParticipantsOG00020
ParticipantsOG00119
ParticipantsOG00217
ParticipantsOG00318
CD4 dble_IL2, Day 42
ParticipantsOG00018
ParticipantsOG00119
ParticipantsOG00217
ParticipantsOG00316
CD4 dble_IL2, Day 385
ParticipantsOG00020
ParticipantsOG00118
ParticipantsOG00218
ParticipantsOG00318
CD4 dble_IL2, Day 392
ParticipantsOG00020
ParticipantsOG00117
ParticipantsOG00219
ParticipantsOG00318
CD4 dble_TNFα, Day 0
ParticipantsOG00020
ParticipantsOG00119
ParticipantsOG00217
ParticipantsOG00318
CD4 dble_TNFα, Day 42
ParticipantsOG00018
ParticipantsOG00119
ParticipantsOG00217
ParticipantsOG00316
CD4 dble_TNFα, Day 385
ParticipantsOG00020
ParticipantsOG00118
ParticipantsOG00218
ParticipantsOG00318
CD4 dble_TNFα, Day 392
ParticipantsOG00020
ParticipantsOG00117
ParticipantsOG00219
ParticipantsOG00318
CD8 dble_All (Polypositives), Day 0
ParticipantsOG00020
ParticipantsOG00119
ParticipantsOG00217
ParticipantsOG00318
CD8 dble_All (Polypositives), Day 42
ParticipantsOG00017
ParticipantsOG00119
ParticipantsOG00217
ParticipantsOG00316
CD8 dble_All (Polypositives), Day 385
ParticipantsOG00020
ParticipantsOG00118
ParticipantsOG00219
ParticipantsOG00318
CD8 dble_All (Polypositives), Day 392
ParticipantsOG00019
ParticipantsOG00117
ParticipantsOG00219
ParticipantsOG00318
CD8 dble_CD40L, Day 0
ParticipantsOG00020
ParticipantsOG00119
ParticipantsOG00217
ParticipantsOG00318
CD8 dble_CD40L, Day 42
ParticipantsOG00017
ParticipantsOG00119
ParticipantsOG00217
ParticipantsOG00316
CD8 dble_CD40L, Day 385
ParticipantsOG00020
ParticipantsOG00118
ParticipantsOG00219
ParticipantsOG00318
CD8 dble_CD40L, Day 392
ParticipantsOG00019
ParticipantsOG00117
ParticipantsOG00219
ParticipantsOG00318
CD8 dble_IFNγ, Day 0
ParticipantsOG00020
ParticipantsOG00119
ParticipantsOG00217
ParticipantsOG00318
CD8 dble_IFNγ, Day 42
ParticipantsOG00017
ParticipantsOG00119
ParticipantsOG00217
ParticipantsOG00316
CD8 dble_IFNγ, Day 385
ParticipantsOG00020
ParticipantsOG00118
ParticipantsOG00219
ParticipantsOG00318
CD8 dble_IFNγ, Day 392
ParticipantsOG00019
ParticipantsOG00117
ParticipantsOG00219
ParticipantsOG00318
CD8 dble_IL2, Day 0
ParticipantsOG00020
ParticipantsOG00119
ParticipantsOG00217
ParticipantsOG00318
CD8 dble_IL2, Day 42
ParticipantsOG00017
ParticipantsOG00119
ParticipantsOG00217
ParticipantsOG00316
CD8 dble_IL2, Day 385
ParticipantsOG00020
ParticipantsOG00118
ParticipantsOG00219
ParticipantsOG00318
CD8 dble_IL2, Day 392
ParticipantsOG00019
ParticipantsOG00117
ParticipantsOG00219
ParticipantsOG00318
CD8 dble_TNFα, Day 0
ParticipantsOG00020
ParticipantsOG00119
ParticipantsOG00217
ParticipantsOG00318
CD8 dble_TNFα, Day 42
ParticipantsOG00017
ParticipantsOG00119
ParticipantsOG00217
ParticipantsOG00316
CD8 dble_TNFα, Day 385
ParticipantsOG00020
ParticipantsOG00118
ParticipantsOG00219
ParticipantsOG00318
CD8 dble_TNFα, Day 392
ParticipantsOG00019
ParticipantsOG00117
ParticipantsOG00219
ParticipantsOG00318
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Units
Counts
Participants
OG00038
OG00137
OG00238
OG00337
OG00435
Title
Denominators
Categories
Pain, Any
Title
Measurements
OG00020
OG00115
OG00216
OG00320
OG00417
Pain, Grade 3
Title
Measurements
OG0002
OG0011
OG0021
OG003
Redness (mm), Any
Title
Measurements
OG0000
OG0010
OG0020
OG003
Redness (mm), Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Swelling (mm), Any
Title
Measurements
OG0000
OG0010
OG0020
OG003
Swelling (mm), Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Units
Counts
Participants
OG00038
OG00137
OG00238
OG00337
OG00435
Title
Denominators
Categories
Pain, Dose 1
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00313
ParticipantsOG00412
Title
Measurements
OG0003.0(1.0 to 4.0)
OG0012.0(1.0 to 3.0)
OG0021.0(1.0 to 2.0)
OG003
Pain, Dose 2
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG0038
Pain, Dose 3
ParticipantsOG00017
ParticipantsOG00113
ParticipantsOG00210
ParticipantsOG00310
Swelling, Dose 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
OG002
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Units
Counts
Participants
OG00038
OG00137
OG00238
OG00337
OG00435
Title
Denominators
Categories
Drowsiness, Any
Title
Measurements
OG00025
OG00118
OG00213
OG00317
OG00416
Drowsiness, Grade 3
Title
Measurements
OG0002
OG0013
OG0021
OG003
Drowsiness, Related
Title
Measurements
OG00022
OG00114
OG00212
OG003
Irritability / Fussiness, Any
Title
Measurements
OG00024
OG00117
OG00219
OG003
Irritability / Fussiness, Grade 3
Title
Measurements
OG0003
OG0012
OG0023
OG003
Irritability / Fussiness, Related
Title
Measurements
OG00022
OG00114
OG00217
OG003
Loss Of Appetite, Any
Title
Measurements
OG00024
OG00113
OG00214
OG003
Loss Of Appetite, Grade 3
Title
Measurements
OG0000
OG0011
OG0022
OG003
Loss Of Appetite, Related
Title
Measurements
OG00021
OG0017
OG00211
OG003
Temperature/(Axillary) (°C), Any
Title
Measurements
OG00024
OG00117
OG00214
OG003
Temperature/(Axillary) (°C), Grade 3
Title
Measurements
OG0000
OG0010
OG0021
OG003
Temperature/(Axillary) (°C), Related
Title
Measurements
OG00022
OG00112
OG00212
OG003
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Units
Counts
Participants
OG00038
OG00137
OG00238
OG00337
OG00435
Title
Denominators
Categories
Drowsiness, Dose 1
ParticipantsOG00015
ParticipantsOG00110
ParticipantsOG0027
ParticipantsOG00310
ParticipantsOG00411
Title
Measurements
OG0002.0(1.0 to 3.0)
OG0011.5(1.0 to 3.0)
OG0022.0(1.0 to 2.0)
OG003
Drowsiness, Dose 2
ParticipantsOG00015
ParticipantsOG00112
ParticipantsOG0028
ParticipantsOG0039
Drowsiness, Dose 3
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG00310
Irritability / fussiness, Dose 1
ParticipantsOG00013
ParticipantsOG0019
ParticipantsOG00211
ParticipantsOG00313
Irritability / fussiness, Dose 2
ParticipantsOG00017
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Irritability / fussiness, Dose 3
ParticipantsOG0008
ParticipantsOG0015
ParticipantsOG0028
ParticipantsOG00310
Loss of appetite, Dose 1
ParticipantsOG00012
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG00310
Loss of appetite, Dose 2
ParticipantsOG00014
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0039
Loss of appetite, Dose 3
ParticipantsOG00012
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG00311
Temperature, Dose 1
ParticipantsOG00011
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG0037
Temperature, Dose 2
ParticipantsOG00018
ParticipantsOG00112
ParticipantsOG0029
ParticipantsOG0038
Temperature, Dose 3
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0033
OG002
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Units
Counts
Participants
OG00038
OG00137
OG00238
OG00337
OG00435
Title
Denominators
Categories
Any
Title
Measurements
OG00021
OG00120
OG00223
OG00320
OG00421
Grade 3
Title
Measurements
OG0003
OG0011
OG0021
OG003
Related
Title
Measurements
OG0002
OG0010
OG0021
OG003
OG002
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Units
Counts
Participants
OG00036
OG00134
OG00238
OG00335
OG00433
Title
Denominators
Categories
Any
Title
Measurements
OG00016
OG0018
OG00216
OG00319
OG00414
Grade 3
Title
Measurements
OG0001
OG0010
OG0020
OG003
Related
Title
Measurements
OG0001
OG0010
OG0021
OG003
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Units
Counts
Participants
OG00038
OG00137
OG00238
OG00337
OG00435
Title
Denominators
Categories
Any
Title
Measurements
OG00029
OG00128
OG00233
OG00327
OG00426
Related
Title
Measurements
OG0001
OG0010
OG0020
OG003
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Units
Counts
Participants
OG00038
OG00137
OG00238
OG00337
OG00435
Title
Denominators
Categories
Any
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
Related
Title
Measurements
OG0000
OG0010
OG0020
OG003
H5N1 Formulation 3 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Units
Counts
Participants
OG00038
OG00137
OG00238
OG00337
OG00435
Title
Denominators
Categories
Any
Title
Measurements
OG0005
OG0016
OG00210
OG0034
OG0044
Related
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
H5N1 Formulation 4 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
OG004
H5N1 Formulation 5 Group
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.