Evaluate Reactogenicity & Immunogenicity of an Influenza Pandemic Candidate Vaccine (GSK1562902A) in Primed Adults
Official Title
Evaluate the Reactogenicity & Immunogenicity of 1 or 2 Booster Administrations of an Influenza Pandemic Candidate Vaccine (GSK1562902A) in Primed Adults Aged Between 19 & 61 Years
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Sep 2017
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
Aug 1, 2007Actual
Primary Completion Date
Oct 12, 2009Actual
Completion Date
Oct 12, 2009Actual
First Submitted Date
Jul 24, 2007
First Submission Date that Met QC Criteria
Jul 24, 2007
First Posted Date
Jul 25, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 11, 2017
Results First Submitted that Met QC Criteria
Sep 11, 2017
Results First Posted Date
Oct 4, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 4, 2011
Certification/Extension First Submitted that Passed QC Review
Feb 4, 2011
Certification/Extension First Posted Date
Feb 9, 2011Estimated
Last Update Submitted Date
Sep 11, 2017
Last Update Posted Date
Oct 4, 2017Actual
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 present study is designed to evaluate the reactogenicity and immunogenicity of one or two booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in adults aged between 19 and 61 years, previously vaccinated with 2 doses of a pandemic candidate vaccine. Fifty new subjects who did not participate in a primary study (106750, NCT00309634) will be recruited. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00309634)
Detailed Description
The present study is designed to evaluate the reactogenicity and immunogenicity of one or two booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in adults aged between 19 and 61 years, previously vaccinated with 2 doses of a pandemic candidate vaccine. The persistence of antibodies will be analysed at 6, 12, 18 and 24 months.
Conditions Module
Conditions
Influenza
Keywords
Not provided
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
350Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
GSK1562902A non-AD F1 Primed Group
Experimental
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
A single dose of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.
At Day 0
Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.
At Day 21
Number of Seroconverted Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
Seroconversion rate for HI antibody response was defined as the percentage of vaccines who have either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
At Day 21
Seroconversion Factor (SCF) for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
Seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strain assessed was A/Indonesia/05/2005.
At Day 21
Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was A/Indonesia/05/2005.
At Day 0
Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
Secondary Outcomes
Measure
Description
Time Frame
Titers for Serum Neutralizing HI Antibodies Against A/Indonesia/05/2005 Strain
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strain assessed was A/Indonesia/05/2005. No subject from GSK1562902A AD F1 Primed Group has received a second vaccination.
At Days 0, 21 (post-vaccination one) and 42 (post-vaccination two)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
For previously primed subjects: participation in the primary study (NCT00309634).
For unprimed subjects: male or female between and including, 19 and 61 years of age at the time of the first vaccination.
Written informed consent obtained from the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion Criteria:
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
For unprimed subjects who did not participate in the primary study (NCT00309634): Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Planned administration/ administration of a licenced vaccine not foreseen by the study protocol within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) of the first dose of vaccine(s).
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Applicable for control group only: previous vaccination with a pandemic candidate vaccine or a vaccine containing the investigational vaccine adjuvant.
History of hypersensitivity to vaccines.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
Major congenital defects or serious chronic illness.
History of any neurological disorders or seizures.
Acute disease at the time of enrolment.
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Lactating female.
History of chronic alcohol consumption and/or drug abuse
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
19 Years
Maximum Age
61 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Ghent
9000
Belgium
References Module
Citations
Not provided
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
GSK1562902A Non-AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) 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.
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Two doses of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21.
Control Group
GSK1562902A non-AD F1 Primed Group
GSK1562902A non-AD F2 Primed Group
GSK1562902A non-AD F3 Primed Group
GSK1562902A non-AD F4 Primed Group
A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was A/Indonesia/05/2005.
At Day 21
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. No subject from GSK1562902A AD F1 Primed Group has received Dose 2.
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, headache, myalgia, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination. No subject from GSK1562902A AD F1 Primed Group has received Dose 2.
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
During the 21-day (Days 0-20) follow-up period after the first vaccination and 30-day (Days 0-29) follow-up period after the second vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
During the 30-day (Days 0-29) follow-up period after the first vaccination
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
During the entire study period (From Day 0 up to Month 24)
Titers for Serum Neutralizing HI Antibodies Against A/Indonesia/05/2005 Stain
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strain assessed was A/Indonesia/05/2005.
At Months 6, 12, 18 and 24
Titers for Serum H5N1 Haemaglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.
At Days 0, 7, 14, 21, 28, 35 and 42
Titers for Serum H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.
At Months 6, 12, 18 and 24
Number of Seroconverted (SCR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
Seroconversion (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.
At Days 7,14, 21, 35 and 42
Number of Seroconverted (SCR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.
At Months 6, 12, 18 and 24
Number of Seroconverted (SCR) Subjects for Neutralizing HI Antibodies Against the A/Indonesia/05/2005 Strain
Seroconversion rate for anti-HA antibody response was defined as the percentage of vaccines who have either a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:56 and at least a 4-fold increase in post-vaccination titer.
At Days 21 (post-vaccination one) and 42 (post-vaccination two)
Number of Seroconverted (SCR) Subjects for Neutralizing HI Antibodies Against the A/Indonesia/05/2005 Strain
Seroconversion rate for neutralizing antibody response was defined as the percentage of vaccines who have either a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:56 and at least a 4-fold increase in post-vaccination titer.
At Months 6, 12, 18 and 24
Seroconversion Factor (SCF) for H5N1 Haemagglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strain assessed was A/Indonesia/05/2005.
At Days 7, 14, 21, 35 and 42
Seroconversion Factor (SCF) for H5N1 Haemagglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strains assessed were A/Indonesia/05/2005.
At Months 6, 12, 18 and 24
Number of Seroprotected (SPR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
Seroprotection rate was defined as the percentage of vaccines with a serum HI antibody titer ≥ 1:40 that usually is accepted as indicating protection.
The flu strain assessed was A/Indonesia/05/2005 (H5N1).
At Days 0, 7, 14, 21, 28, 35 and 42
Number of Seroprotected (SPR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
Seroprotection rate was defined as the percentage of vaccines with a serum HI antibody titer ≥ 1:40 that usually is accepted as indicating protection. The flu strain assessed was A/Indonesia/05/2005 (H5N1).
At Months 6, 12, 18 and 24
Frequency of Antigen-specific CD4/CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines
Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The flu strains assessed wwere H5N1 A/Indonesia and H5N1 A/Vietnam.
At Days 0 and 21
Frequency of Antigen-specific CD4/CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines
Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The flu strains assessed were H5N1 A/Indonesia and H5N1 A/Vietnam.
At Months 6, 12, 18 and 24
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
GSK1562902A Non-AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
FG002
GSK1562902A Non-AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
FG003
GSK1562902A Non-AD F4 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
FG004
Control Group
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
FG005
GSK1562902A AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
FG006
GSK1562902A AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
FG007
GSK1562902A AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
FG008
GSK1562902A AD Approved F Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
FG00036 subjects
FG00140 subjects
FG00237 subjects
FG00336 subjects
FG00450 subjects
FG00540 subjects
FG00635 subjects
FG00741 subjects
FG00835 subjects
COMPLETED
FG00033 subjects
FG00137 subjects
FG00231 subjects
FG00334 subjects
FG00440 subjects
FG00538 subjects
FG00633 subjects
FG00736 subjects
FG00830 subjects
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0026 subjects
FG0032 subjects
FG00410 subjects
FG0052 subjects
FG0062 subjects
FG0075 subjects
FG0085 subjects
Type
Comment
Reasons
Serious Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Medical Reason
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0001 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
GSK1562902A Non-AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
BG001
GSK1562902A Non-AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
BG002
GSK1562902A Non-AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
BG003
GSK1562902A Non-AD F4 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
BG004
Control Group
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
BG005
GSK1562902A AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
BG006
GSK1562902A AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
BG007
GSK1562902A AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
BG008
GSK1562902A AD Approved F Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00036
BG00140
BG00237
BG00336
BG00450
BG00540
BG00635
BG00741
BG00835
BG009350
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
BG00036.3± 12.80
BG00136.3± 12.36
BG00236.8± 12.87
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00018
BG00119
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Race
Title
Measurements
White - Arabic / North African heritage
BG0000
BG0010
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
Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 0
ID
Title
Description
OG000
GSK1562902A AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG001
GSK1562902A AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG002
GSK1562902A AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG003
GSK1562902A AD Approved F Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00039
OG00133
OG00238
OG003
Title
Denominators
Categories
Title
Measurements
OG0005.1(4.9 to 5.3)
OG0015.6(4.8 to 6.5)
OG0025.3(4.9 to 5.8)
OG003
Primary
Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 21
ID
Title
Description
OG000
GSK1562902A AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG001
GSK1562902A AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Primary
Number of Seroconverted Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
Seroconversion rate for HI antibody response was defined as the percentage of vaccines who have either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Posted
Count of Participants
Participants
At Day 21
ID
Title
Description
OG000
GSK1562902A AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG001
GSK1562902A AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Primary
Seroconversion Factor (SCF) for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
Seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strain assessed was A/Indonesia/05/2005.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Posted
Geometric Mean
95% Confidence Interval
Fold increase
At Day 21
ID
Title
Description
OG000
GSK1562902A AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG001
GSK1562902A AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Primary
Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was A/Indonesia/05/2005.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Posted
Count of Participants
Participants
At Day 0
ID
Title
Description
OG000
GSK1562902A AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG001
GSK1562902A AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Primary
Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was A/Indonesia/05/2005.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Posted
Count of Participants
Participants
At Day 21
ID
Title
Description
OG000
GSK1562902A AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG001
GSK1562902A AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Primary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. No subject from GSK1562902A AD F1 Primed Group has received Dose 2.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in.
Posted
Count of Participants
Participants
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
ID
Title
Description
OG000
GSK1562902A Non-AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001
GSK1562902A Non-AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Primary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, headache, myalgia, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination. No subject from GSK1562902A AD F1 Primed Group has received Dose 2.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in.
Posted
Count of Participants
Participants
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
ID
Title
Description
OG000
GSK1562902A Non-AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001
GSK1562902A Non-AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Primary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Posted
Count of Participants
Participants
During the 21-day (Days 0-20) follow-up period after the first vaccination and 30-day (Days 0-29) follow-up period after the second vaccination
ID
Title
Description
OG000
GSK1562902A Non-AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001
GSK1562902A Non-AD F2 Primed Group
Primary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Posted
Count of Participants
Participants
During the 30-day (Days 0-29) follow-up period after the first vaccination
ID
Title
Description
OG000
GSK1562902A AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG001
GSK1562902A AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Primary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Posted
Count of Participants
Participants
During the entire study period (From Day 0 up to Month 24)
ID
Title
Description
OG000
GSK1562902A Non-AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001
GSK1562902A Non-AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Secondary
Titers for Serum Neutralizing HI Antibodies Against A/Indonesia/05/2005 Strain
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strain assessed was A/Indonesia/05/2005. No subject from GSK1562902A AD F1 Primed Group has received a second vaccination.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Days 0, 21 (post-vaccination one) and 42 (post-vaccination two)
ID
Title
Description
OG000
GSK1562902A Non-AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001
GSK1562902A AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Secondary
Titers for Serum Neutralizing HI Antibodies Against A/Indonesia/05/2005 Stain
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strain assessed was A/Indonesia/05/2005.
The analysis was performed on the ATP cohort for persistence, which included all subjects who had serologic results available at the antibody persistence time-point.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Months 6, 12, 18 and 24
ID
Title
Description
OG000
GSK1562902A AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG001
GSK1562902A Non-AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Secondary
Titers for Serum H5N1 Haemaglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.
The analysis was performed on the ATP cohort for immunogenicity, whiich included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Days 0, 7, 14, 21, 28, 35 and 42
ID
Title
Description
OG000
GSK1562902A Non-AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001
GSK1562902A Non-AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Secondary
Titers for Serum H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.
The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Months 6, 12, 18 and 24
ID
Title
Description
OG000
GSK1562902A Non-AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001
GSK1562902A Non-AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Secondary
Number of Seroconverted (SCR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
Seroconversion (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Posted
Count of Participants
Participants
At Days 7,14, 21, 35 and 42
ID
Title
Description
OG000
GSK1562902A Non-AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001
GSK1562902A Non-AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Secondary
Number of Seroconverted (SCR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.
The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.
Posted
Count of Participants
Participants
At Months 6, 12, 18 and 24
ID
Title
Description
OG000
GSK1562902A Non-AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001
GSK1562902A Non-AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Secondary
Number of Seroconverted (SCR) Subjects for Neutralizing HI Antibodies Against the A/Indonesia/05/2005 Strain
Seroconversion rate for anti-HA antibody response was defined as the percentage of vaccines who have either a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:56 and at least a 4-fold increase in post-vaccination titer.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Posted
Count of Participants
Participants
At Days 21 (post-vaccination one) and 42 (post-vaccination two)
ID
Title
Description
OG000
GSK1562902A Non-AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001
GSK1562902A AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Secondary
Number of Seroconverted (SCR) Subjects for Neutralizing HI Antibodies Against the A/Indonesia/05/2005 Strain
Seroconversion rate for neutralizing antibody response was defined as the percentage of vaccines who have either a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:56 and at least a 4-fold increase in post-vaccination titer.
The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.
Posted
Count of Participants
Participants
At Months 6, 12, 18 and 24
ID
Title
Description
OG000
GSK1562902A Non-AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001
GSK1562902A AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Secondary
Seroconversion Factor (SCF) for H5N1 Haemagglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strain assessed was A/Indonesia/05/2005.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Posted
Geometric Mean
95% Confidence Interval
Fold increase
At Days 7, 14, 21, 35 and 42
ID
Title
Description
OG000
GSK1562902A Non-AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001
GSK1562902A Non-AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Secondary
Seroconversion Factor (SCF) for H5N1 Haemagglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strains assessed were A/Indonesia/05/2005.
The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.
Posted
Geometric Mean
95% Confidence Interval
Fold increase
At Months 6, 12, 18 and 24
ID
Title
Description
OG000
GSK1562902A Non-AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001
GSK1562902A Non-AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Secondary
Number of Seroprotected (SPR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
Seroprotection rate was defined as the percentage of vaccines with a serum HI antibody titer ≥ 1:40 that usually is accepted as indicating protection.
The flu strain assessed was A/Indonesia/05/2005 (H5N1).
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Posted
Count of Participants
Participants
At Days 0, 7, 14, 21, 28, 35 and 42
ID
Title
Description
OG000
GSK1562902A Non-AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001
GSK1562902A Non-AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Secondary
Number of Seroprotected (SPR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
Seroprotection rate was defined as the percentage of vaccines with a serum HI antibody titer ≥ 1:40 that usually is accepted as indicating protection. The flu strain assessed was A/Indonesia/05/2005 (H5N1).
The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.
Posted
Count of Participants
Participants
At Months 6, 12, 18 and 24
ID
Title
Description
OG000
GSK1562902A Non-AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001
GSK1562902A Non-AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Secondary
Frequency of Antigen-specific CD4/CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines
Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The flu strains assessed wwere H5N1 A/Indonesia and H5N1 A/Vietnam.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Posted
Median
Inter-Quartile Range
T-cells/million cells
At Days 0 and 21
ID
Title
Description
OG000
GSK1562902A Non-AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001
GSK1562902A AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Secondary
Frequency of Antigen-specific CD4/CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines
Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The flu strains assessed were H5N1 A/Indonesia and H5N1 A/Vietnam.
The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.
Posted
Median
Inter-Quartile Range
T-cell/million cells
At Months 6, 12, 18 and 24
ID
Title
Description
OG000
GSK1562902A AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG001
GSK1562902A Non-AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Time Frame
Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 21-day (Days 0-20) or 30-day (Days 0-29) post-vaccination 1 period and the 30-day (Days 0-29) post-vaccination 2 period; Serious adverse events (SAEs): during the whole study period (from Day 0 up to Month 24).
Description
Not provided
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
GSK1562902A Non-AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
0
36
4
36
34
36
EG001
GSK1562902A Non-AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
0
40
3
40
40
40
EG002
GSK1562902A Non-AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
0
37
2
37
33
37
EG003
GSK1562902A Non-AD F4 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
0
36
0
36
35
36
EG004
Control Group
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
0
50
4
50
48
50
EG005
GSK1562902A AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
0
40
2
40
39
40
EG006
GSK1562902A AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
0
35
1
35
34
35
EG007
GSK1562902A AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
1
41
4
41
41
41
EG008
GSK1562902A AD Approved F Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
1
35
3
35
33
35
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Arrhythmia
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG0030 events0 affected36 at risk
EG0040 events0 affected50 at risk
EG0050 events0 affected40 at risk
EG0060 events0 affected35 at risk
EG0070 events0 affected41 at risk
EG0081 events1 affected35 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0012 events1 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Chest pain
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Ill-defined disorder
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Abscess
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected37 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Jaw fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Multiple injuries
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Traumatic fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected37 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG003
High grade b-cell lymphoma burkitt-like lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Pre-eclampsia
Pregnancy, puerperium and perinatal conditions
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Major depression
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Aortic aneurysm rupture
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG00016 events15 affected36 at risk
EG00111 events8 affected40 at risk
EG0027 events6 affected37 at risk
EG00312 events11 affected36 at risk
EG00420 events15 affected50 at risk
EG0057 events6 affected40 at risk
EG0065 events5 affected35 at risk
EG0075 events5 affected41 at risk
EG0085 events5 affected35 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0002 events2 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Chills
General disorders
MedDRA 13.0
Systematic Assessment
EG00011 events10 affected36 at risk
EG0014 events3 affected40 at risk
EG0025 events4 affected37 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected40 at risk
EG0022 events2 affected37 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0002 events2 affected36 at risk
EG0013 events3 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0003 events1 affected36 at risk
EG0014 events3 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0012 events1 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Fatigue
General disorders
MedDRA 13.0
Systematic Assessment
EG00025 events20 affected36 at risk
EG00128 events22 affected40 at risk
EG00225 events18 affected37 at risk
EG003
Headache
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG00033 events22 affected36 at risk
EG00130 events19 affected40 at risk
EG00232 events18 affected37 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0009 events9 affected36 at risk
EG0016 events4 affected40 at risk
EG0029 events6 affected37 at risk
EG003
Induration
General disorders
MedDRA 13.0
Systematic Assessment
EG0006 events6 affected36 at risk
EG0016 events5 affected40 at risk
EG0026 events5 affected37 at risk
EG003
Influenza like illness
General disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected36 at risk
EG0012 events2 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Injection site pruritus
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected40 at risk
EG0022 events1 affected37 at risk
EG003
Injection site reaction
General disorders
MedDRA 13.0
Systematic Assessment
EG0003 events2 affected36 at risk
EG0010 events0 affected40 at risk
EG0021 events1 affected37 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0002 events2 affected36 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG00024 events18 affected36 at risk
EG00127 events21 affected40 at risk
EG00223 events15 affected37 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0012 events2 affected40 at risk
EG0022 events2 affected37 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected36 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0015 events5 affected40 at risk
EG0024 events3 affected37 at risk
EG003
Pain
General disorders
MedDRA 13.0
Systematic Assessment
EG00061 events34 affected36 at risk
EG00165 events36 affected40 at risk
EG00256 events32 affected37 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0012 events2 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected40 at risk
EG0020 events0 affected37 at risk
EG003
Pyrexia
General disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected36 at risk
EG0011 events1 affected40 at risk
EG0021 events1 affected37 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0003 events3 affected36 at risk
EG0013 events3 affected40 at risk
EG0023 events3 affected37 at risk
EG003
Swelling
General disorders
MedDRA 13.0
Systematic Assessment
EG0007 events5 affected36 at risk
EG0012 events2 affected40 at risk
EG0026 events5 affected37 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0003 events3 affected36 at risk
EG0013 events3 affected40 at risk
EG0023 events3 affected37 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected36 at risk
EG0011 events1 affected40 at risk
EG0020 events0 affected37 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
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
4 subjects
FG0051 subjects
FG0061 subjects
FG0072 subjects
FG0080 subjects
2 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
3 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0082 subjects
39.5
± 13.27
BG00432.1± 9.96
BG00538.5± 13.43
BG00638.3± 14.61
BG00734.8± 14.57
BG00835.9± 12.78
BG00936.32± 12.97
16
BG00321
BG00434
BG00527
BG00618
BG00723
BG00818
BG009194
Male
BG00018
BG00121
BG00221
BG00315
BG00416
BG00513
BG00617
BG00718
BG00817
BG009156
0
BG0030
BG0041
BG0050
BG0060
BG0070
BG0080
BG0091
White - Caucasian / European heritage
BG00036
BG00138
BG00237
BG00336
BG00448
BG00540
BG00634
BG00741
BG00835
BG009345
Other
BG0000
BG0012
BG0020
BG0030
BG0041
BG0050
BG0061
BG0070
BG0080
BG0094
32
5.2
(4.8 to 5.5)
OG002
GSK1562902A AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG003
GSK1562902A AD Approved F Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00039
OG00133
OG00238
OG00333
Title
Denominators
Categories
Title
Measurements
OG000406.8(225.9 to 732.7)
OG001429.5(281.2 to 655.9)
OG002208.4(126.3 to 343.9)
OG003347.9(213.6 to 566.8)
OG002
GSK1562902A AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG003
GSK1562902A AD Approved F Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00039
OG00133
OG00238
OG00332
Title
Denominators
Categories
Title
Measurements
OG00036
OG00133
OG00234
OG00331
OG002
GSK1562902A AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG003
GSK1562902A AD Approved F Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00039
OG00133
OG00238
OG00332
Title
Denominators
Categories
Title
Measurements
OG00079.9(44.5 to 143.6)
OG00176.5(50.7 to 115.6)
OG00239.1(24.2 to 63.1)
OG00376.9(51.5 to 115.0)
OG002
GSK1562902A AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG003
GSK1562902A AD Approved F Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00039
OG00133
OG00238
OG00332
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG002
GSK1562902A AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG003
GSK1562902A AD Approved F Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00039
OG00133
OG00238
OG00333
Title
Denominators
Categories
Title
Measurements
OG00036
OG00133
OG00234
OG00331
OG002
GSK1562902A Non-AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG003
GSK1562902A Non-AD F4 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG004
Control Group
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG005
GSK1562902A AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG006
GSK1562902A AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG007
GSK1562902A AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG008
GSK1562902A AD Approved F Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00036
OG00140
OG00236
OG00336
OG00450
OG00540
OG00635
OG00741
OG00835
Title
Denominators
Categories
Any Ecchymosis, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
ParticipantsOG00450
ParticipantsOG00540
ParticipantsOG00635
ParticipantsOG00741
ParticipantsOG00835
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Ecchymosis, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Any Induration, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Grade 3 Induration, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Any Pain, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Grade 3 Pain, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Any Redness, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Grade 3 Redness, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Any Swelling, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Grade 3 Swelling, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Any Ecchymosis, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Grade 3 Ecchymosis, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Any Induration, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Grade 3 Induration, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Any Pain, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Grade 3 Pain, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Any Redness, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Grade 3 Redness, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Any Swelling, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Grade 3 Swelling, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Any Ecchymosis, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Grade 3 Ecchymosis, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Any Induration, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Grade 3 Induration, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Any Pain, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Grade 3 Pain, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Any Redness, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Grade 3 Redness, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Any Swelling, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Grade 3 Swelling, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
OG002
GSK1562902A Non-AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG003
GSK1562902A Non-AD F4 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG004
Control Group
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG005
GSK1562902A AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG006
GSK1562902A AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG007
GSK1562902A AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG008
GSK1562902A AD Approved F Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00036
OG00140
OG00236
OG00336
OG00450
OG00540
OG00635
OG00741
OG00835
Title
Denominators
Categories
Any Arthralgia, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
ParticipantsOG00450
ParticipantsOG00540
ParticipantsOG00635
ParticipantsOG00741
ParticipantsOG00835
Title
Measurements
OG0005
OG0017
OG0022
OG003
Grade 3 Arthralgia, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Related Arthralgia, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Any Fatigue, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Grade 3 Fatigue, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Related Fatigue, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Any Fever, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Grade 3 Fever, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Related Fever, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Any Headache, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Grade 3 Headache, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Related Headache, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Any Myalgia, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Grade 3 Myalgia, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Related Myalgia, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Any Shivering, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Grade 3 Shivering, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Related Shivering, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Any Sweating, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Grade 3 Sweating, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Related Sweating, Dose 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Any Arthralgia, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Grade 3 Arthralgia, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Related Arthralgia, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Any Fatigue, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Grade 3 Fatigue, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Related Fatigue, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Any Fever, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Grade 3 Fever, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Related Fever, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Any Headache, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Grade 3 Headache, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Related Headache, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Any Myalgia, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Grade 3 Myalgia, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Related Myalgia, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Any Shivering, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Grade 3 Shivering, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Related Shivering, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Any Sweating, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Grade 3 Sweating, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Related Sweating, Dose 2
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00333
Any Arthralgia, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Grade 3 Arthralgia, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Related Arthralgia, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Any Fatigue, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Grade 3 Fatigue, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Related Fatigue, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Any Fever, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Grade 3 Fever, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Related Fever, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Any Headache, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Grade 3 Headache, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Related Headache, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Any Myalgia, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Grade 3 Myalgia, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Related Myalgia, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Any Shivering, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Grade 3 Shivering, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Related Shivering, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Any Sweating, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Grade 3 Sweating, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Related Sweating, Across doses
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00336
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG002
GSK1562902A Non-AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG003
GSK1562902A Non-AD F4 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG004
Control Group
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00036
OG00140
OG00237
OG00336
OG00450
Title
Denominators
Categories
Any AE(s)
Title
Measurements
OG00022
OG00124
OG00221
OG00326
OG00433
Grade 3 AE(s)
Title
Measurements
OG0002
OG0014
OG0021
OG003
Related AE(s)
Title
Measurements
OG0004
OG0011
OG0024
OG003
OG002
GSK1562902A AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG003
GSK1562902A AD Approved F Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00040
OG00135
OG00241
OG00335
Title
Denominators
Categories
Any AE(s)
Title
Measurements
OG00013
OG00117
OG00217
OG00317
Grade 3 AE(s)
Title
Measurements
OG0003
OG0012
OG0025
OG003
Related AE(s)
Title
Measurements
OG0005
OG0014
OG0024
OG003
OG002
GSK1562902A Non-AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG003
GSK1562902A Non-AD F4 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG004
Control Group
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG005
GSK1562902A AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG006
GSK1562902A AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG007
GSK1562902A AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG008
GSK1562902A AD Approved F Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00036
OG00140
OG00237
OG00336
OG00450
OG00540
OG00635
OG00741
OG00835
Title
Denominators
Categories
Day 0 - Month 6
Title
Measurements
OG0001
OG0011
OG0021
OG0030
OG0043
OG0051
OG0060
OG0071
OG0080
Month 6 - Month 12
Title
Measurements
OG0002
OG0011
OG0020
OG003
Month 12 - Month 18
Title
Measurements
OG0001
OG0011
OG0020
OG003
Month 18 - Month 24
Title
Measurements
OG0001
OG0011
OG0021
OG003
OG002
Control Group
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00034
OG00138
OG00249
Title
Denominators
Categories
A/Indonesia/05/2005, Day 0
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00249
Title
Measurements
OG00047.0(34.2 to 64.6)
OG001157.8(130.3 to 191.2)
OG00219.9(15.7 to 25.2)
A/Indonesia/05/2005, Day 21
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG00249
Title
Measurements
OG000
A/Indonesia/05/2005, Day 42
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00249
Title
Measurements
OG000
OG002
Control Group
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00037
OG00135
OG00246
Title
Denominators
Categories
A/Indonesia/05/2005, Month 6
ParticipantsOG00037
ParticipantsOG00135
ParticipantsOG00246
Title
Measurements
OG0001422.2(916.8 to 2206.2)
OG001502.3(349.2 to 722.5)
OG002751.3(611.4 to 923.3)
A/Indonesia/05/2005, Month 12
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00244
Title
Measurements
OG000
A/Indonesia/05/2005, Month 18
ParticipantsOG00034
ParticipantsOG00131
ParticipantsOG00237
Title
Measurements
OG000
A/Indonesia/05/2005, Month 24
ParticipantsOG00034
ParticipantsOG00130
ParticipantsOG00232
Title
Measurements
OG000
OG002
GSK1562902A Non-AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG003
GSK1562902A Non-AD F4 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG004
Control Group
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00034
OG00138
OG00233
OG00328
OG00449
Title
Denominators
Categories
A/Indonesia/05/2005, Day 0
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00233
ParticipantsOG00328
ParticipantsOG00449
Title
Measurements
OG0005.1(4.9 to 5.3)
OG0015.0(5.0 to 5.0)
OG0025.0(5.0 to 5.0)
OG003
A/Indonesia/05/2005, Day 7
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00233
ParticipantsOG00328
A/Indonesia/05/2005, Day 14
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00232
ParticipantsOG00328
A/Indonesia/05/2005, Day 21
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00232
ParticipantsOG00328
A/Indonesia/05/2005, Day 28
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00232
ParticipantsOG00328
A/Indonesia/05/2005, Day 35
ParticipantsOG00033
ParticipantsOG00136
ParticipantsOG00232
ParticipantsOG00328
A/Indonesia/05/2005, Day 42
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00232
ParticipantsOG00328
OG002
GSK1562902A Non-AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG003
GSK1562902A Non-AD F4 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG004
Control Group
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG005
GSK1562902A AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG006
GSK1562902A AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG007
GSK1562902A AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG008
GSK1562902A AD Approved F Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00035
OG00140
OG00236
OG00335
OG00446
OG00539
OG00633
OG00740
OG00833
Title
Denominators
Categories
A/Indonesia/05/2005, Month 6
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00335
ParticipantsOG00446
ParticipantsOG00539
ParticipantsOG00633
ParticipantsOG00740
ParticipantsOG00833
Title
Measurements
OG00017.6(10.9 to 28.4)
OG00117.6(11.6 to 26.6)
OG00218.5(12.1 to 28.5)
OG003
A/Indonesia/05/2005, Month 12
ParticipantsOG00032
ParticipantsOG00139
ParticipantsOG00236
ParticipantsOG00333
A/Indonesia/05/2005, Month 18
ParticipantsOG00031
ParticipantsOG00136
ParticipantsOG00229
ParticipantsOG00330
A/Indonesia/05/2005, Month 24
ParticipantsOG00030
ParticipantsOG00136
ParticipantsOG00229
ParticipantsOG00327
OG002
GSK1562902A Non-AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG003
GSK1562902A Non-AD F4 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG004
Control Group
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00034
OG00138
OG00233
OG00328
OG00449
Title
Denominators
Categories
A/Indonesia/05/2005, Day 7
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00233
ParticipantsOG00328
ParticipantsOG00449
Title
Measurements
OG00012
OG00117
OG00218
OG003
A/Indonesia/05/2005, Day 14
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00232
ParticipantsOG00328
A/Indonesia/05/2005, Day 21
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00232
ParticipantsOG00328
A/Indonesia/05/2005, Day 35
ParticipantsOG00033
ParticipantsOG00136
ParticipantsOG00232
ParticipantsOG00328
A/Indonesia/05/2005, Day 42
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00232
ParticipantsOG00328
OG002
GSK1562902A Non-AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG003
GSK1562902A Non-AD F4 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG004
Control Group
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG005
GSK1562902A AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG006
GSK1562902A AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG007
GSK1562902A AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG008
GSK1562902A AD Approved F Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00035
OG00140
OG00236
OG00335
OG00446
OG00538
OG00632
OG00740
OG00832
Title
Denominators
Categories
A/Indonesia/05/2005, Month 6
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00335
ParticipantsOG00446
ParticipantsOG00538
ParticipantsOG00632
ParticipantsOG00740
ParticipantsOG00832
Title
Measurements
OG00012
OG00112
OG00215
OG003
A/Indonesia/05/2005, Month 12
ParticipantsOG00032
ParticipantsOG00139
ParticipantsOG00236
ParticipantsOG00333
A/Indonesia/05/2005, Month 18
ParticipantsOG00031
ParticipantsOG00136
ParticipantsOG00229
ParticipantsOG00330
A/Indonesia/05/2005, Month 24
ParticipantsOG00030
ParticipantsOG00136
ParticipantsOG00229
ParticipantsOG00327
OG002
Control Group
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00034
OG00138
OG00249
Title
Denominators
Categories
A/Indonesia/05/2005, Day 21
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG00249
Title
Measurements
OG00029
OG00244
A/Indonesia/05/2005, Day 42
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00249
Title
Measurements
OG000
OG002
Control Group
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00037
OG00135
OG00246
Title
Denominators
Categories
A/Indonesia/05/2005, Month 6
ParticipantsOG00037
ParticipantsOG00135
ParticipantsOG00246
Title
Measurements
OG00029
OG00129
OG00244
A/Indonesia/05/2005, Month 12
ParticipantsOG00036
ParticipantsOG00132
ParticipantsOG00244
Title
Measurements
OG000
A/Indonesia/05/2005, Month 18
ParticipantsOG00033
ParticipantsOG00131
ParticipantsOG00237
Title
Measurements
OG000
A/Indonesia/05/2005, Month 24
ParticipantsOG00033
ParticipantsOG00130
ParticipantsOG00232
Title
Measurements
OG000
OG002
GSK1562902A Non-AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG003
GSK1562902A Non-AD F4 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG004
Control Group
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00034
OG00138
OG00233
OG00328
OG00449
Title
Denominators
Categories
A/Indonesia/05/2005, Day 7
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00233
ParticipantsOG00328
ParticipantsOG00449
Title
Measurements
OG0004.3(2.3 to 8.2)
OG0015.1(2.9 to 8.9)
OG0025.5(3.2 to 9.5)
OG003
A/Indonesia/05/2005, Day 14
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00232
ParticipantsOG00328
A/Indonesia/05/2005, Day 21
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00232
ParticipantsOG00328
A/Indonesia/05/2005, Day 35
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00232
ParticipantsOG00328
A/Indonesia/05/2005, Day 42
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00232
ParticipantsOG00328
OG002
GSK1562902A Non-AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG003
GSK1562902A Non-AD F4 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG004
Control Group
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG005
GSK1562902A AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG006
GSK1562902A AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG007
GSK1562902A AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG008
GSK1562902A AD Approved F Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00035
OG00140
OG00236
OG00335
OG00446
OG00538
OG00632
OG00740
OG00832
Title
Denominators
Categories
A/Indonesia/05/2005, Month 6
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00335
ParticipantsOG00446
ParticipantsOG00538
ParticipantsOG00632
ParticipantsOG00740
ParticipantsOG00832
Title
Measurements
OG0003.4(2.1 to 5.5)
OG0013.3(2.3 to 4.8)
OG0023.7(2.4 to 5.7)
OG003
A/Indonesia/05/2005, Month 12
ParticipantsOG00032
ParticipantsOG00139
ParticipantsOG00236
ParticipantsOG00333
A/Indonesia/05/2005, Month 18
ParticipantsOG00031
ParticipantsOG00136
ParticipantsOG00229
ParticipantsOG00330
A/Indonesia/05/2005, Month 24
ParticipantsOG00030
ParticipantsOG00136
ParticipantsOG00229
ParticipantsOG00327
OG002
GSK1562902A Non-AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG003
GSK1562902A Non-AD F4 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG004
Control Group
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00034
OG00138
OG00233
OG00328
OG00449
Title
Denominators
Categories
A/Indonesia/05/2005, Day 0
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00233
ParticipantsOG00328
ParticipantsOG00449
Title
Measurements
OG0000
OG0010
OG0020
OG003
A/Indonesia/05/2005, Day 7
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00232
ParticipantsOG00328
A/Indonesia/05/2005, Day 14
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00232
ParticipantsOG00328
A/Indonesia/05/2005, Day 21
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00232
ParticipantsOG00328
A/Indonesia/05/2005, Day 28
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00232
ParticipantsOG00328
A/Indonesia/05/2005, Day 35
ParticipantsOG00033
ParticipantsOG00136
ParticipantsOG00232
ParticipantsOG00328
A/Indonesia/05/2005, Day 42
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00232
ParticipantsOG00328
OG002
GSK1562902A Non-AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG003
GSK1562902A Non-AD F4 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG004
Control Group
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
OG005
GSK1562902A AD F1 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG006
GSK1562902A AD F2 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG007
GSK1562902A AD F3 Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
OG008
GSK1562902A AD Approved F Primed Group
Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00035
OG00140
OG00236
OG00335
OG00446
OG00539
OG00633
OG00740
OG00833
Title
Denominators
Categories
A/Indonesia/05/2005, Month 6
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00236
ParticipantsOG00335
ParticipantsOG00446
ParticipantsOG00539
ParticipantsOG00633
ParticipantsOG00740
ParticipantsOG00833
Title
Measurements
OG00012
OG00112
OG00215
OG003
A/Indonesia/05/2005, Month 12
ParticipantsOG00032
ParticipantsOG00139
ParticipantsOG00236
ParticipantsOG00333
A/Indonesia/05/2005, Month 18
ParticipantsOG00031
ParticipantsOG00136
ParticipantsOG00229
ParticipantsOG00330
A/Indonesia/05/2005, Month 24
ParticipantsOG00030
ParticipantsOG00136
ParticipantsOG00229
ParticipantsOG00327
OG002
Control Group
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00032
OG00138
OG00248
Title
Denominators
Categories
CD4 ALL DOUBLES - H5N1 A/Indonesia, Day 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00248
Title
Measurements
OG000743.00(524.00 to 991.00)
OG0011370.00(776.00 to 1599.00)
OG002473.50(277.50 to 757.00)
CD4 ALL DOUBLES - H5N1 A/Indonesia, Day 21
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00246
Title
Measurements
OG000
CD4 ALL DOUBLES - H5N1 A/Vietnam, Day 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00248
Title
Measurements
OG000
CD4 ALL DOUBLES - H5N1 A/Vietnam, Day 21
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00246
Title
Measurements
OG000
CD4 CD40L - H5N1 A/Indonesia, Day 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00248
Title
Measurements
OG000
CD4 CD40L - H5N1 A/Indonesia, Day 21
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00246
Title
Measurements
OG000
CD4 CD40L - H5N1 A/Vietnam, Day 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00248
Title
Measurements
OG000
CD4 CD40L - H5N1 A/Vietnam, Day 21
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00246
Title
Measurements
OG000
CD4 IL-2 - H5N1 A/Indonesia, Day 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00248
Title
Measurements
OG000
CD4 IL-2 - H5N1 A/Indonesia, Day 21
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00246
Title
Measurements
OG000
CD4 IL-2 - H5N1 A/Vietnam, Day 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00248
Title
Measurements
OG000
CD4 IL-2 - H5N1 A/Vietnam, Day 21
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00246
Title
Measurements
OG000
CD4 INF-γ - H5N1 A/Indonesia, Day 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00248
Title
Measurements
OG000
CD4 INF-γ - H5N1 A/Indonesia, Day 21
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00246
Title
Measurements
OG000
CD4 INF-γ - H5N1 A/Vietnam, Day 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00248
Title
Measurements
OG000
CD4 INF-γ - H5N1 A/Vietnam, Day 21
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00246
Title
Measurements
OG000
CD4 TNF-α - H5N1 A/Indonesia, Day 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00248
Title
Measurements
OG000
CD4 TNF-α - H5N1 A/Indonesia, Day 21
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00246
Title
Measurements
OG000
CD4 TNF-α - H5N1 A/Vietnam, Day 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00248
Title
Measurements
OG000
CD4 TNF-α - H5N1 A/Vietnam, Day 21
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00246
Title
Measurements
OG000
CD8 ALL DOUBLES - H5N1 A/Indonesia, Day 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00248
Title
Measurements
OG000
CD8 ALL DOUBLES - H5N1 A/Indonesia, Day 21
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00246
Title
Measurements
OG000
CD8 ALL DOUBLES - H5N1 A/Vietnam, Day 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00248
Title
Measurements
OG000
CD8 ALL DOUBLES - H5N1 A/Vietnam, Day 21
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00246
Title
Measurements
OG000
CD8 CD40L - H5N1 A/Indonesia, Day 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00248
Title
Measurements
OG000
CD8 CD40L - H5N1 A/Indonesia, Day 21
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00246
Title
Measurements
OG000
CD8 CD40L - H5N1 A/Vietnam, Day 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00248
Title
Measurements
OG000
CD8 CD40L - H5N1 A/Vietnam, Day 21
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00246
Title
Measurements
OG000
CD8 IL-2 - H5N1 A/Indonesia, Day 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00248
Title
Measurements
OG000
CD8 IL-2 - H5N1 A/Indonesia, Day 21
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00246
Title
Measurements
OG000
CD8 IL-2 - H5N1 A/Vietnam, Day 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00248
Title
Measurements
OG000
CD8 IL-2 - H5N1 A/Vietnam, Day 21
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00246
Title
Measurements
OG000
CD8 INF-γ - H5N1 A/Indonesia, Day 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00248
Title
Measurements
OG000
CD8 INF-γ - H5N1 A/Indonesia, Day 21
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00246
Title
Measurements
OG000
CD8 INF-γ - H5N1 A/Vietnam, Day 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00248
Title
Measurements
OG000
CD8 INF-γ - H5N1 A/Vietnam, Day 21
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00246
Title
Measurements
OG000
CD8 TNF-α - H5N1 A/Indonesia, Day 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00248
Title
Measurements
OG000
CD8 TNF-α - H5N1 A/Indonesia, Day 21
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00246
Title
Measurements
OG000
CD8 TNF-α - H5N1 A/Vietnam, Day 0
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00248
Title
Measurements
OG000
CD8 TNF-α - H5N1 A/Vietnam, Day 21
ParticipantsOG00032
ParticipantsOG00138
ParticipantsOG00246
Title
Measurements
OG000
OG002
Control Group
Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.