Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged 18-64 Years
Official Title
A Trial to Evaluate the Safety & Immunogenicity of Investigational Influenza Vaccine GSK1557484A in Adults 18-64 Yrs of Age
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Oct 2016
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
Oct 16, 2008
Primary Completion Date
May 26, 2009Actual
Completion Date
Dec 4, 2009Actual
First Submitted Date
Oct 10, 2008
First Submission Date that Met QC Criteria
Oct 10, 2008
First Posted Date
Oct 13, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 19, 2013
Results First Submitted that Met QC Criteria
Aug 21, 2014
Results First Posted Date
Sep 4, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 2, 2010
Certification/Extension First Submitted that Passed QC Review
Jul 2, 2010
Certification/Extension First Posted Date
Jul 7, 2010Estimated
Last Update Submitted Date
Aug 22, 2018
Last Update Posted Date
Sep 21, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The purpose of this observer-blind study is to determine whether GSK's avian flu vaccine GSK 1557484A is immunogenic when given to adults aged 18-64 years.
Detailed Description
All enrolled subjects will receive 1 dose of study vaccine. All subjects will attend formal study center visits for safety and immunogenicity assessments on Days 0, 10, 42, 84, and 182 with a telephone safety contact on Day 364.
This Protocol Posting has been updated according to Protocol amendment, 8 Dec 08
Conditions Module
Conditions
Influenza
Keywords
human
Avian
safety
vaccines
influenza
pandemic
immunogenicity
H5N1
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
469Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
A/turkey H5N1 influenza Formulation A Group
Experimental
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: GSK A/turkey H5N1 Influenza vaccine
A/turkey H5N1 influenza Formulation B1 Group
Experimental
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: GSK A/turkey H5N1 Influenza vaccine
A/turkey H5N1 influenza Formulation B2 Group
Experimental
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: GSK A/turkey H5N1 Influenza vaccine
A/turkey H5N1 influenza Formulation C1 Group
Experimental
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GSK A/turkey H5N1 Influenza vaccine
Biological
One dose administered intramuscularly (IM) in the deltoid region. Different formulations are tested.
A/turkey H5N1 influenza Formulation A Group
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.
At Day 10
Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain
A seroprotected subject against the A/turkey virus strain was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.
At Day 10
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
HI antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10.
At Day 10
Secondary Outcomes
Measure
Description
Time Frame
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male and female adults 18 to 64 years of age at time of first vaccination, inclusive.
Written informed consent obtained from the subject.
Stable health status as defined by absence of a health event satisfying the definition of a SAE, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrollment.
Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user device.
Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
Subjects who the investigator believes can and will comply with the requirements of the protocol.
Exclusion Criteria:
Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
Diagnosed with cancer, or treatment for cancer, within 3 years.
Presence of an oral temperature >= 37.8ºC, or acute symptoms greater than "mild" severity on the scheduled date of vaccination.
Any confirmed or suspected immunosuppressive or immunodeficiency condition including history of human immunodeficiency virus (HIV) infection.
Receipt of systemic glucocorticoids (prednisone >= 10 mg/day for more than 14 consecutive days) within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
Administration of any vaccines within 30 days before the first study vaccine dose.
Previous administration of any H5N1 vaccine.
Use of any investigational or non-registered product (drug or vaccine) or planned participation in another investigational study within 30 days prior to study enrollment, or during the 12 months following test article administration. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial.
Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test result prior to vaccination.
Lactating or nursing.
Women of child bearing potential (who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to vaccination.
Known receipt of analgesic or antipyretic medication with the specific intent of prophylaxis of vaccine reactogenicity on the day of vaccination. Subjects on stable chronic regimens of potentially analgesic or anti-pyretic medications for pre-existing diagnoses are not required to discontinue them.
Risi G, Frenette L, Langley JM, Li P, Riff D, Sheldon E, Vaughn DW, Fries L. Immunological priming induced by a two-dose series of H5N1 influenza antigen, administered alone or in combination with two different formulations of AS03 adjuvant in adults: results of a randomised single heterologous booster dose study at 15 months. Vaccine. 2011 Aug 26;29(37):6408-18. doi: 10.1016/j.vaccine.2011.04.072. Epub 2011 May 7.
See Also Links
Label
URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
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
A/Turkey H5N1 Influenza Formulation A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Biological: GSK A/turkey H5N1 Influenza vaccine
A/turkey H5N1 influenza Formulation C2 Group
Experimental
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: GSK A/turkey H5N1 Influenza vaccine
A/turkey H5N1 influenza Formulation D1 Group
Experimental
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: GSK A/turkey H5N1 Influenza vaccine
A/turkey H5N1 influenza Formulation D2 Group
Experimental
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: GSK A/turkey H5N1 Influenza vaccine
A/turkey H5N1 influenza Formulation E1 Group
Experimental
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: GSK A/turkey H5N1 Influenza vaccine
A/turkey H5N1 influenza Formulation E2 Group
Experimental
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: GSK A/turkey H5N1 Influenza vaccine
A/turkey H5N1 influenza Formulation B1 Group
A/turkey H5N1 influenza Formulation B2 Group
A/turkey H5N1 influenza Formulation C1 Group
A/turkey H5N1 influenza Formulation C2 Group
A/turkey H5N1 influenza Formulation D1 Group
A/turkey H5N1 influenza Formulation D2 Group
A/turkey H5N1 influenza Formulation E1 Group
A/turkey H5N1 influenza Formulation E2 Group
At Day 0 to Day 42 and at Day 0 to Day 182
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain.
Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10
At Day 0, Day 10, Day 42 and Day 182
HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.
At Day 0 to Day 10, Day 42 and Day 182
HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain.
Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10
At Day 0, Day 10, Day 42 and Day 182
Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.
A seroprotected subject was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.
At Day 0, Day 10, Day 42 and Day 182 for A/Indo and at Day 0, Day 42 and Day 182 for A/turkey virus strains.
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
At Day 0 to Day 10, Day 42 and Day 182
HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.
At Day 10, Day 42 and Day 182
Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
MN antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:28.
At Day 0, Day 10, Day 42 and Day 182
Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
A seropositive subject was defined as a vaccinated subject who had a MN antibody titer ≥ the cut-off value of 1:28.
At Day 0, Day 10, Day 42 and Day 182
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.
At Day 10
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains
VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.
At Day 42
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.
At Day 182
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade.
Within the 7-day (Days 0-6) post vaccination period.
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Solicited general symptoms assessed were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any =occurrence of any solicited general symptoms reported irrespective of intensity grade and relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).
Within the 7-day (Days 0-6) post vaccination period.
Number of Subjects With Medically-attended Adverse Events (MAEs).
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).
From Day 0 to Day 378
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms."Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
From Day 0 to Day 42
Number of Subjects Reporting Serious Adverse Events (SAEs).
A SAE 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.
From Day 0 to Day 378
Anaheim
California
92801
United States
GSK Investigational Site
Miami
Florida
33143
United States
GSK Investigational Site
Stockbridge
Georgia
30281
United States
GSK Investigational Site
Lenexa
Kansas
66219
United States
GSK Investigational Site
Missoula
Montana
59801
United States
GSK Investigational Site
Las Vegas
Nevada
89130
United States
GSK Investigational Site
Halifax
Nova Scotia
B3K 6R8
Canada
GSK Investigational Site
Truro
Nova Scotia
B2N 1L2
Canada
GSK Investigational Site
Sherbrooke
Quebec
J1H 4J6
Canada
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
FG001
A/Turkey H5N1 Influenza Formulation B1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
FG002
A/Turkey H5N1 Influenza Formulation B2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
FG003
A/Turkey H5N1 Influenza Formulation C1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
FG004
A/Turkey H5N1 Influenza Formulation C2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
FG005
A/Turkey H5N1 Influenza Formulation D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
FG006
A/Turkey H5N1 Influenza Formulation D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
FG007
A/Turkey H5N1 Influenza Formulation E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
FG008
A/Turkey H5N1 Influenza Formulation E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
FG00049 subjects
FG00172 subjects
FG00241 subjects
FG00360 subjects
FG00440 subjects
FG00561 subjects
FG00646 subjects
FG00759 subjects
FG00841 subjects
COMPLETED
FG00048 subjectsUp to Day 364
FG00170 subjectsUp to Day 364
FG00240 subjectsUp to Day 364
FG00359 subjectsUp to Day 364
FG00440 subjectsUp to Day 364
FG00560 subjectsUp to Day 364
FG00645 subjectsUp to Day 364
FG00758 subjectsUp to Day 364
FG00841 subjectsUp to Day 364
NOT COMPLETED
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
A/Turkey H5N1 Influenza Formulation A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
BG001
A/Turkey H5N1 Influenza Formulation B1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
BG002
A/Turkey H5N1 Influenza Formulation B2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
BG003
A/Turkey H5N1 Influenza Formulation C1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
BG004
A/Turkey H5N1 Influenza Formulation C2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
BG005
A/Turkey H5N1 Influenza Formulation D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
BG006
A/Turkey H5N1 Influenza Formulation D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
BG007
A/Turkey H5N1 Influenza Formulation E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
BG008
A/Turkey H5N1 Influenza Formulation E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00049
BG00172
BG00241
BG00360
BG00440
BG00561
BG00646
BG00759
BG00841
BG009469
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
Years
Title
Denominators
Categories
Title
Measurements
BG00042.3± 11.47
BG00140.6± 12.02
BG00241.1± 11.82
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00029
BG00142
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
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Posted
Count of Participants
Participants
At Day 10
ID
Title
Description
OG000
A/Turkey H5N1 Influenza A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
A/Turkey H5N1 Influenza B1 + D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG002
A/Turkey H5N1 Influenza C1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
A/Turkey H5N1 Influenza B2 + D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
A/Turkey H5N1 Influenza C2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG005
A/Turkey H5N1 Influenza B1 + C1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG006
A/Turkey H5N1 Influenza D1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG007
A/Turkey H5N1 Influenza B2 + C2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG008
A/Turkey H5N1 Influenza D2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00047
OG001126
OG002113
OG003
Title
Denominators
Categories
Title
Measurements
OG00043
OG001121
OG002109
OG003
Primary
Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain
A seroprotected subject against the A/turkey virus strain was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Posted
Count of Participants
Participants
At Day 10
ID
Title
Description
OG000
A/Turkey H5N1 Influenza A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
A/Turkey H5N1 Influenza B1 + D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Primary
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
HI antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10.
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Posted
Geometric Mean
95% Confidence Interval
Titer
At Day 10
ID
Title
Description
OG000
A/Turkey H5N1 Influenza A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
A/Turkey H5N1 Influenza B1 + D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Secondary
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Posted
Count of Participants
Participants
At Day 0 to Day 42 and at Day 0 to Day 182
ID
Title
Description
OG000
A/Turkey H5N1 Influenza A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
A/Turkey H5N1 Influenza B1 + D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Secondary
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain.
Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Posted
Geometric Mean
95% Confidence Interval
Titer
At Day 0, Day 10, Day 42 and Day 182
ID
Title
Description
OG000
A/Turkey H5N1 Influenza A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
A/Turkey H5N1 Influenza B1 + D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Secondary
HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Posted
Geometric Mean
95% Confidence Interval
fold change
At Day 0 to Day 10, Day 42 and Day 182
ID
Title
Description
OG000
A/Turkey H5N1 Influenza A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
A/Turkey H5N1 Influenza B1 + D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Secondary
HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain.
Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Posted
Geometric Mean
95% Confidence Interval
Titer
At Day 0, Day 10, Day 42 and Day 182
ID
Title
Description
OG000
A/Turkey H5N1 Influenza A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
A/Turkey H5N1 Influenza B1 + D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Secondary
Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.
A seroprotected subject was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Posted
Count of Participants
Participants
At Day 0, Day 10, Day 42 and Day 182 for A/Indo and at Day 0, Day 42 and Day 182 for A/turkey virus strains.
ID
Title
Description
OG000
A/Turkey H5N1 Influenza A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
A/Turkey H5N1 Influenza B1 + D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Secondary
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Posted
Count of Participants
Participants
At Day 0 to Day 10, Day 42 and Day 182
ID
Title
Description
OG000
A/Turkey H5N1 Influenza A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
A/Turkey H5N1 Influenza B1 + D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Secondary
HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Posted
Geometric Mean
95% Confidence Interval
fold change
At Day 10, Day 42 and Day 182
ID
Title
Description
OG000
A/Turkey H5N1 Influenza A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
A/Turkey H5N1 Influenza B1 + D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Secondary
Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
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 analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Posted
Geometric Mean
95% Confidence Interval
Titer
At Day 0, Day 10, Day 42 and Day 182
ID
Title
Description
OG000
A/Turkey H5N1 Influenza A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
A/Turkey H5N1 Influenza B1 + D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Secondary
Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
A seropositive subject was defined as a vaccinated subject who had a MN antibody titer ≥ the cut-off value of 1:28.
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Posted
Count of Participants
Participants
At Day 0, Day 10, Day 42 and Day 182
ID
Title
Description
OG000
A/Turkey H5N1 Influenza A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
A/Turkey H5N1 Influenza B1 + D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Secondary
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Posted
Count of Participants
Participants
At Day 10
ID
Title
Description
OG000
A/Turkey H5N1 Influenza A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
A/Turkey H5N1 Influenza B1 + D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Secondary
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains
VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Posted
Count of Participants
Participants
At Day 42
ID
Title
Description
OG000
A/Turkey H5N1 Influenza A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
A/Turkey H5N1 Influenza B1 + D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Secondary
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Posted
Count of Participants
Participants
At Day 182
ID
Title
Description
OG000
A/Turkey H5N1 Influenza A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
A/Turkey H5N1 Influenza B1 + D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade.
The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.
Posted
Count of Participants
Participants
Within the 7-day (Days 0-6) post vaccination period.
ID
Title
Description
OG000
A/Turkey H5N1 Influenza Formulation A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
A/Turkey H5N1 Influenza Formulation B1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG002
A/Turkey H5N1 Influenza Formulation B2 Group
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Solicited general symptoms assessed were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any =occurrence of any solicited general symptoms reported irrespective of intensity grade and relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).
The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.
Posted
Count of Participants
Participants
Within the 7-day (Days 0-6) post vaccination period.
ID
Title
Description
OG000
A/Turkey H5N1 Influenza Formulation A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
A/Turkey H5N1 Influenza Formulation B1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Secondary
Number of Subjects With Medically-attended Adverse Events (MAEs).
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).
The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.
Posted
Count of Participants
Participants
From Day 0 to Day 378
ID
Title
Description
OG000
A/Turkey H5N1 Influenza Formulation A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
A/Turkey H5N1 Influenza Formulation B1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Secondary
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms."Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.
Posted
Count of Participants
Participants
From Day 0 to Day 42
ID
Title
Description
OG000
A/Turkey H5N1 Influenza Formulation A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
A/Turkey H5N1 Influenza Formulation B1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs).
A SAE 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.
The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.
Posted
Count of Participants
Participants
From Day 0 to Day 378
ID
Title
Description
OG000
A/Turkey H5N1 Influenza Formulation A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
A/Turkey H5N1 Influenza Formulation B1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Time Frame
Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 378; Systematically assessed adverse events (AEs): During the 7-day (Days 0-6) post vaccination period. Non-systematically assessed AE: During Days 0 - 42.
Description
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
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
A/Turkey H5N1 Influenza Formulation A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1
49
45
49
EG001
A/Turkey H5N1 Influenza Formulation B1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
0
72
60
72
EG002
A/Turkey H5N1 Influenza Formulation B2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1
41
15
41
EG003
A/Turkey H5N1 Influenza Formulation C1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1
60
54
60
EG004
A/Turkey H5N1 Influenza Formulation C2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
3
40
19
40
EG005
A/Turkey H5N1 Influenza Formulation D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1
61
52
61
EG006
A/Turkey H5N1 Influenza Formulation D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1
46
21
46
EG007
A/Turkey H5N1 Influenza Formulation E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
0
59
51
59
EG008
A/Turkey H5N1 Influenza Formulation E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
0
41
21
41
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Appendicitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected72 at risk
EG0020 affected41 at risk
EG0030 affected60 at risk
EG0042 affected40 at risk
EG0050 affected61 at risk
EG0060 affected46 at risk
EG0070 affected59 at risk
EG0080 affected41 at risk
Pneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected72 at risk
EG0020 affected41 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected72 at risk
EG0020 affected41 at risk
EG003
Drug abuse
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected72 at risk
EG0020 affected41 at risk
EG003
Lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected72 at risk
EG0020 affected41 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected72 at risk
EG0020 affected41 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected72 at risk
EG0021 affected41 at risk
EG003
Status epilepticus
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected72 at risk
EG0020 affected41 at risk
EG003
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected72 at risk
EG0020 affected41 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pain
General disorders
MedDRA
Systematic Assessment
EG00041 affected49 at risk
EG00159 affected72 at risk
EG0029 affected40 at risk
EG00353 affected60 at risk
EG00410 affected40 at risk
EG00548 affected60 at risk
EG00613 affected46 at risk
EG00746 affected58 at risk
EG0086 affected41 at risk
Redness
General disorders
MedDRA
Systematic Assessment
EG0001 affected49 at risk
EG0013 affected72 at risk
EG0020 affected40 at risk
EG003
Swelling
General disorders
MedDRA
Systematic Assessment
EG0006 affected49 at risk
EG0012 affected72 at risk
EG0020 affected40 at risk
EG003
Fatigue
General disorders
MedDRA
Systematic Assessment
EG00010 affected49 at risk
EG00118 affected72 at risk
EG0023 affected40 at risk
EG003
Headache
General disorders
MedDRA
Systematic Assessment
EG00011 affected49 at risk
EG00122 affected72 at risk
EG0024 affected40 at risk
EG003
Joint pain
Infections and infestations
MedDRA
Systematic Assessment
EG0005 affected49 at risk
EG00116 affected72 at risk
EG0021 affected40 at risk
EG003
Muscle aches
General disorders
MedDRA
Systematic Assessment
EG00010 affected49 at risk
EG00129 affected72 at risk
EG0023 affected40 at risk
EG003
Shivering
General disorders
MedDRA
Systematic Assessment
EG0003 affected49 at risk
EG0019 affected72 at risk
EG0021 affected40 at risk
EG003
Sweating
General disorders
MedDRA
Systematic Assessment
EG0004 affected49 at risk
EG0014 affected72 at risk
EG0020 affected40 at risk
EG003
Fever
General disorders
MedDRA
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected72 at risk
EG0020 affected40 at risk
EG003
Headache
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0003 affected49 at risk
EG0014 affected72 at risk
EG0020 affected41 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected49 at risk
EG0013 affected72 at risk
EG0020 affected41 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected72 at risk
EG0021 affected41 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected72 at risk
EG0021 affected41 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected72 at risk
EG0021 affected41 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected72 at risk
EG0022 affected41 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0002 affected49 at risk
EG0010 affected72 at risk
EG0020 affected41 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected72 at risk
EG0020 affected41 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.
Point of Contact
Title
Organization
Phone
Extension
Email
GSK Response Center
GlaxoSmithKline
866-435-7343
ID
Term
D007251
Influenza, Human
Ancestor Terms
ID
Term
D012141
Respiratory Tract Infections
D007239
Infections
D009976
Orthomyxoviridae Infections
D012327
RNA Virus Infections
D014777
Virus Diseases
D012140
Respiratory Tract Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
41.2
± 12.33
BG00441.1± 12.46
BG00542.4± 11.15
BG00641.2± 9.78
BG00740.6± 12.01
BG00841.6± 11.60
BG00941.3± 11.55
20
BG00338
BG00421
BG00540
BG00631
BG00737
BG00819
BG009277
Male
BG00020
BG00130
BG00221
BG00322
BG00419
BG00521
BG00615
BG00722
BG00822
BG009192
84
OG00480
OG005127
OG006112
OG00779
OG00885
57
OG00456
OG005122
OG006108
OG00751
OG00862
OG002
A/Turkey H5N1 Influenza C1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
A/Turkey H5N1 Influenza B2 + D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
A/Turkey H5N1 Influenza C2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG005
A/Turkey H5N1 Influenza B1 + C1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG006
A/Turkey H5N1 Influenza D1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG007
A/Turkey H5N1 Influenza B2 + C2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG008
A/Turkey H5N1 Influenza D2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00047
OG001126
OG002113
OG00384
OG00480
OG005127
OG006112
OG00779
OG00885
Title
Denominators
Categories
Title
Measurements
OG00044
OG001125
OG002113
OG00376
OG00467
OG005127
OG006111
OG00769
OG00874
OG002
A/Turkey H5N1 Influenza C1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
A/Turkey H5N1 Influenza B2 + D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
A/Turkey H5N1 Influenza C2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG005
A/Turkey H5N1 Influenza B1 + C1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG006
A/Turkey H5N1 Influenza D1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG007
A/Turkey H5N1 Influenza B2 + C2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG008
A/Turkey H5N1 Influenza D2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00047
OG001126
OG002113
OG00384
OG00480
OG005127
OG006112
OG00779
OG00885
Title
Denominators
Categories
Title
Measurements
OG000229.6(148.6 to 354.9)
OG001847.3(686.1 to 1046.4)
OG002810.5(666.6 to 985.3)
OG003121.9(89.7 to 165.7)
OG00486.9(64.7 to 116.7)
OG005838.5(703.1 to 1000.1)
OG006819.8(647.8 to 1037.3)
OG00797.9(70.3 to 136.4)
OG008108.6(82.3 to 143.3)
OG002
A/Turkey H5N1 Influenza C1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
A/Turkey H5N1 Influenza B2 + D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
A/Turkey H5N1 Influenza C2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG005
A/Turkey H5N1 Influenza B1 + C1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG006
A/Turkey H5N1 Influenza D1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG007
A/Turkey H5N1 Influenza B2 + C2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG008
A/Turkey H5N1 Influenza D2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00047
OG001128
OG002113
OG00385
OG00480
OG005129
OG006112
OG00779
OG00886
Title
Denominators
Categories
A/turkey, D 42
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
ParticipantsOG00480
ParticipantsOG005129
ParticipantsOG006112
ParticipantsOG00779
ParticipantsOG00886
Title
Measurements
OG00041
OG001123
OG002108
OG003
A/turkey, D 182
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00384
OG002
A/Turkey H5N1 Influenza C1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
A/Turkey H5N1 Influenza B2 + D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
A/Turkey H5N1 Influenza C2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG005
A/Turkey H5N1 Influenza B1 + C1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG006
A/Turkey H5N1 Influenza D1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG007
A/Turkey H5N1 Influenza B2 + C2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG008
A/Turkey H5N1 Influenza D2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00047
OG001128
OG002113
OG00385
OG00480
OG005129
OG006112
OG00779
OG00886
Title
Denominators
Categories
A/turkey, D 0
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
ParticipantsOG00480
ParticipantsOG005129
ParticipantsOG006112
ParticipantsOG00779
ParticipantsOG00886
Title
Measurements
OG0006.1(5.0 to 7.5)
OG00113.5(11.3 to 16.3)
OG00214.4(11.6 to 18.0)
OG003
A/turkey, D 10
ParticipantsOG00047
ParticipantsOG001126
ParticipantsOG002113
ParticipantsOG00384
A/turkey, D 42
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
A/turkey, D 182
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00384
OG002
A/Turkey H5N1 Influenza C1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
A/Turkey H5N1 Influenza B2 + D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
A/Turkey H5N1 Influenza C2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG005
A/Turkey H5N1 Influenza B1 + C1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG006
A/Turkey H5N1 Influenza D1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG007
A/Turkey H5N1 Influenza B2 + C2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG008
A/Turkey H5N1 Influenza D2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00047
OG001128
OG002113
OG00385
OG00480
OG005129
OG006112
OG00779
OG00886
Title
Denominators
Categories
A/turkey, D 10
ParticipantsOG00047
ParticipantsOG001126
ParticipantsOG002113
ParticipantsOG00384
ParticipantsOG00480
ParticipantsOG005127
ParticipantsOG006112
ParticipantsOG00779
ParticipantsOG00885
Title
Measurements
OG00037.4(23.3 to 59.9)
OG00161.6(47.4 to 80.1)
OG00256.3(43.5 to 72.8)
OG003
A/turkey, D 42
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
A/turkey, D 182
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00384
OG002
A/Turkey H5N1 Influenza C1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
A/Turkey H5N1 Influenza B2 + D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
A/Turkey H5N1 Influenza C2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG005
A/Turkey H5N1 Influenza B1 + C1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG006
A/Turkey H5N1 Influenza D1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG007
A/Turkey H5N1 Influenza B2 + C2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG008
A/Turkey H5N1 Influenza D2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00047
OG001128
OG002113
OG00385
OG00480
OG005129
OG006112
OG00779
OG00886
Title
Denominators
Categories
A/Indo, D 0
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
ParticipantsOG00480
ParticipantsOG005129
ParticipantsOG006112
ParticipantsOG00779
ParticipantsOG00886
Title
Measurements
OG0007.3(5.6 to 9.4)
OG00126.1(20.8 to 32.7)
OG00223.8(18.6 to 30.5)
OG003
A/Indo, D 10
ParticipantsOG00047
ParticipantsOG001126
ParticipantsOG002113
ParticipantsOG00384
A/Indo, D 42
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
A/Indo, D182
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00384
OG002
A/Turkey H5N1 Influenza C1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
A/Turkey H5N1 Influenza B2 + D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
A/Turkey H5N1 Influenza C2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG005
A/Turkey H5N1 Influenza B1 + C1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG006
A/Turkey H5N1 Influenza D1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG007
A/Turkey H5N1 Influenza B2 + C2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG008
A/Turkey H5N1 Influenza D2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00047
OG001128
OG002113
OG00385
OG00480
OG005129
OG006112
OG00779
OG00886
Title
Denominators
Categories
A/Indo, D 0
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
ParticipantsOG00480
ParticipantsOG005129
ParticipantsOG006112
ParticipantsOG00779
ParticipantsOG00886
Title
Measurements
OG0005
OG00170
OG00256
OG003
A/Indo, D 10
ParticipantsOG00047
ParticipantsOG001126
ParticipantsOG002113
ParticipantsOG00384
A/Indo, D 42
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
A/Indo, D 182
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00384
A/turkey, D 0
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
A/turkey, D 42
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
A/turkey, D 182
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00384
OG002
A/Turkey H5N1 Influenza C1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
A/Turkey H5N1 Influenza B2 + D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
A/Turkey H5N1 Influenza C2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG005
A/Turkey H5N1 Influenza B1 + C1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG006
A/Turkey H5N1 Influenza D1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG007
A/Turkey H5N1 Influenza B2 + C2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG008
A/Turkey H5N1 Influenza D2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00047
OG001128
OG002113
OG00385
OG00480
OG005129
OG006112
OG00779
OG00886
Title
Denominators
Categories
A/Indo, D 10
ParticipantsOG00047
ParticipantsOG001126
ParticipantsOG002113
ParticipantsOG00384
ParticipantsOG00480
ParticipantsOG005127
ParticipantsOG006112
ParticipantsOG00779
ParticipantsOG00885
Title
Measurements
OG00042
OG001122
OG002108
OG003
A/Indo, D 42
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
A/Indo, D 182
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00384
OG002
A/Turkey H5N1 Influenza C1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
A/Turkey H5N1 Influenza B2 + D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
A/Turkey H5N1 Influenza C2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG005
A/Turkey H5N1 Influenza B1 + C1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG006
A/Turkey H5N1 Influenza D1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG007
A/Turkey H5N1 Influenza B2 + C2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG008
A/Turkey H5N1 Influenza D2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00047
OG001128
OG002113
OG00385
OG00480
OG005129
OG006112
OG00779
OG00886
Title
Denominators
Categories
A/Indo, D 10
ParticipantsOG00047
ParticipantsOG001126
ParticipantsOG002113
ParticipantsOG00384
ParticipantsOG00480
ParticipantsOG005127
ParticipantsOG006112
ParticipantsOG00779
ParticipantsOG00885
Title
Measurements
OG00039.3(24.8 to 62.4)
OG00134.7(26.8 to 44.8)
OG00237.3(28.5 to 48.8)
OG003
A/Indo, D 42
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
A/Indo, D 182
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00384
OG002
A/Turkey H5N1 Influenza C1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
A/Turkey H5N1 Influenza B2 + D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
A/Turkey H5N1 Influenza C2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG005
A/Turkey H5N1 Influenza B1 + C1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG006
A/Turkey H5N1 Influenza D1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG007
A/Turkey H5N1 Influenza B2 + C2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG008
A/Turkey H5N1 Influenza D2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00047
OG001128
OG002113
OG00385
OG00480
OG005129
OG006112
OG00779
OG00886
Title
Denominators
Categories
A/turkey, D 0
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
ParticipantsOG00480
ParticipantsOG005129
ParticipantsOG006112
ParticipantsOG00779
ParticipantsOG00886
Title
Measurements
OG00027.5(20.6 to 36.7)
OG001115.4(92.7 to 143.7)
OG002114.6(91.0 to 144.4)
OG003
A/turkey, D 10
ParticipantsOG00047
ParticipantsOG001126
ParticipantsOG002113
ParticipantsOG00384
A/turkey, D 42
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
A/turkey, D 182
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00384
A/Indo, D 0
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
A/Indo, D 10
ParticipantsOG00047
ParticipantsOG001126
ParticipantsOG002113
ParticipantsOG00385
A/Indo, D 42
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
A/Indo, D 182
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00384
A/Vie, D 0
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
A/Vie, D 10
ParticipantsOG00047
ParticipantsOG001126
ParticipantsOG002113
ParticipantsOG00384
A/Vie, D 42
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
A/Vie, D 182
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00384
OG002
A/Turkey H5N1 Influenza C1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
A/Turkey H5N1 Influenza B2 + D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
A/Turkey H5N1 Influenza C2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG005
A/Turkey H5N1 Influenza B1 + C1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG006
A/Turkey H5N1 Influenza D1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG007
A/Turkey H5N1 Influenza B2 + C2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG008
A/Turkey H5N1 Influenza D2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00047
OG001128
OG002113
OG00385
OG00480
OG005129
OG006112
OG00779
OG00886
Title
Denominators
Categories
A/turkey, D 0
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
ParticipantsOG00480
ParticipantsOG005129
ParticipantsOG006112
ParticipantsOG00779
ParticipantsOG00886
Title
Measurements
OG00020
OG001116
OG002102
OG003
A/turkey, D 10
ParticipantsOG00047
ParticipantsOG001126
ParticipantsOG002113
ParticipantsOG00384
A/turkey, D 42
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
A/turkey, D 182
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00384
A/Indo, D 0
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
A/Indo, D 10
ParticipantsOG00047
ParticipantsOG001126
ParticipantsOG002113
ParticipantsOG00384
A/Indo, D 42
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
A/Indo, D 182
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00384
A/Vie, D 0
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
A/Vie, D10
ParticipantsOG00047
ParticipantsOG001126
ParticipantsOG002113
ParticipantsOG00384
A/Vie, D 42
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
A/Vie, D 182
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00384
OG002
A/Turkey H5N1 Influenza C1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
A/Turkey H5N1 Influenza B2 + D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
A/Turkey H5N1 Influenza C2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG005
A/Turkey H5N1 Influenza B1 + C1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG006
A/Turkey H5N1 Influenza D1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG007
A/Turkey H5N1 Influenza B2 + C2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG008
A/Turkey H5N1 Influenza D2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00047
OG001126
OG002113
OG00384
OG00480
OG005127
OG006112
OG00779
OG00885
Title
Denominators
Categories
A/turkey, Day 10
Title
Measurements
OG00046
OG001122
OG002112
OG00366
OG00456
OG005124
OG006110
OG00755
OG00867
A/Indo, Day 10
Title
Measurements
OG00045
OG001121
OG002105
OG003
A/Vie, Day 10
Title
Measurements
OG00019
OG00184
OG00264
OG003
OG002
A/Turkey H5N1 Influenza C1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
A/Turkey H5N1 Influenza B2 + D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
A/Turkey H5N1 Influenza C2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG005
A/Turkey H5N1 Influenza B1 + C1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG006
A/Turkey H5N1 Influenza D1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG007
A/Turkey H5N1 Influenza B2 + C2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG008
A/Turkey H5N1 Influenza D2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00047
OG001128
OG002113
OG00385
OG00480
OG005129
OG006112
OG00779
OG00886
Title
Denominators
Categories
A/turkey, Day 42
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
ParticipantsOG00479
ParticipantsOG005129
ParticipantsOG006112
ParticipantsOG00779
ParticipantsOG00885
Title
Measurements
OG00046
OG001121
OG002110
OG003
A/Indo, D 42
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
A/Vie, D 42
ParticipantsOG00047
ParticipantsOG001128
ParticipantsOG002113
ParticipantsOG00385
OG002
A/Turkey H5N1 Influenza C1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
A/Turkey H5N1 Influenza B2 + D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
A/Turkey H5N1 Influenza C2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG005
A/Turkey H5N1 Influenza B1 + C1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG006
A/Turkey H5N1 Influenza D1 + E1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG007
A/Turkey H5N1 Influenza B2 + C2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
OG008
A/Turkey H5N1 Influenza D2 + E2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00047
OG001128
OG002113
OG00384
OG00479
OG005129
OG006112
OG00779
OG00884
Title
Denominators
Categories
A/turkey, Day 182
Title
Measurements
OG00034
OG001103
OG00289
OG00343
OG00436
OG005102
OG00690
OG00735
OG00844
A/Indo, Day 182
Title
Measurements
OG00028
OG00168
OG00272
OG003
A/Vie, Day 182
Title
Measurements
OG0005
OG00132
OG00222
OG003
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
A/Turkey H5N1 Influenza Formulation C1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
A/Turkey H5N1 Influenza Formulation C2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG005
A/Turkey H5N1 Influenza Formulation D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG006
A/Turkey H5N1 Influenza Formulation D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG007
A/Turkey H5N1 Influenza Formulation E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG008
A/Turkey H5N1 Influenza Formulation E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00049
OG00172
OG00240
OG00360
OG00440
OG00560
OG00646
OG00758
OG00841
Title
Denominators
Categories
Any Pain
Title
Measurements
OG00041
OG00159
OG0029
OG00353
OG00410
OG00548
OG00613
OG00746
OG0086
Any Redness
Title
Measurements
OG0001
OG0013
OG0020
OG003
Any Swelling
Title
Measurements
OG0006
OG0012
OG0020
OG003
OG002
A/Turkey H5N1 Influenza Formulation B2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
A/Turkey H5N1 Influenza Formulation C1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
A/Turkey H5N1 Influenza Formulation C2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG005
A/Turkey H5N1 Influenza Formulation D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG006
A/Turkey H5N1 Influenza Formulation D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG007
A/Turkey H5N1 Influenza Formulation E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG008
A/Turkey H5N1 Influenza Formulation E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00049
OG00172
OG00240
OG00360
OG00440
OG00560
OG00646
OG00758
OG00841
Title
Denominators
Categories
Any Fatigue
Title
Measurements
OG00010
OG00118
OG0023
OG00320
OG0046
OG00518
OG0064
OG00723
OG00811
Any Headache
Title
Measurements
OG00011
OG00122
OG0024
OG003
Any Joint pain
Title
Measurements
OG0005
OG00116
OG0021
OG003
Any Muscle aches
Title
Measurements
OG00010
OG00129
OG0023
OG003
Any Shivering
Title
Measurements
OG0003
OG0019
OG0021
OG003
Any Sweating
Title
Measurements
OG0004
OG0014
OG0020
OG003
Any Fever
Title
Measurements
OG0000
OG0011
OG0020
OG003
OG002
A/Turkey H5N1 Influenza Formulation B2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
A/Turkey H5N1 Influenza Formulation C1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
A/Turkey H5N1 Influenza Formulation C2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG005
A/Turkey H5N1 Influenza Formulation D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG006
A/Turkey H5N1 Influenza Formulation D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG007
A/Turkey H5N1 Influenza Formulation E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG008
A/Turkey H5N1 Influenza Formulation E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00049
OG00172
OG00241
OG00360
OG00440
OG00561
OG00646
OG00759
OG00841
Title
Denominators
Categories
Title
Measurements
OG00017
OG00124
OG00213
OG00318
OG00413
OG00521
OG00616
OG00720
OG00810
OG002
A/Turkey H5N1 Influenza Formulation B2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
A/Turkey H5N1 Influenza Formulation C1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
A/Turkey H5N1 Influenza Formulation C2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG005
A/Turkey H5N1 Influenza Formulation D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG006
A/Turkey H5N1 Influenza Formulation D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG007
A/Turkey H5N1 Influenza Formulation E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG008
A/Turkey H5N1 Influenza Formulation E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00049
OG00172
OG00241
OG00360
OG00440
OG00561
OG00646
OG00759
OG00841
Title
Denominators
Categories
Title
Measurements
OG0009
OG00127
OG00212
OG00326
OG00411
OG00521
OG00612
OG00723
OG0089
OG002
A/Turkey H5N1 Influenza Formulation B2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
A/Turkey H5N1 Influenza Formulation C1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
A/Turkey H5N1 Influenza Formulation C2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG005
A/Turkey H5N1 Influenza Formulation D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG006
A/Turkey H5N1 Influenza Formulation D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG007
A/Turkey H5N1 Influenza Formulation E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG008
A/Turkey H5N1 Influenza Formulation E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.