Evaluate Reactogenicity & Immunogenicity of an Influenza Pandemic Candidate Vaccine (GSK1562902A) in Primed Adults

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00506350
• Collaborator: (none)
• Enrollment: 350
• Location: 1
• Arms: 9
• Actual Duration (Months): 26.4
• Patients Per Site Per Month: 13.3

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Influenza	Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose; Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 350 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Oct 12, 2009
• Actual Study Completion Date: Oct 12, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses; 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.
Experimental: 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.	Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses; 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.
Experimental: 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.	Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses; 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.
Experimental: 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.	Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses; 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.
Experimental: 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.	Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose; A single dose of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Experimental: 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.	Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose; A single dose of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Experimental: 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.	Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose; A single dose of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Experimental: GSK1562902A AD Approved F4 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.	Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose; A single dose of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Experimental: 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.	Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses; 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.

Outcome Measures

Primary Outcome Measures

1. Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain [At Day 0]

   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.

2. Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain [At Day 21]

   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.

3. Number of Seroconverted Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain [At Day 21]

   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.

4. Seroconversion Factor (SCF) for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain [At Day 21]

   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.

5. Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain [At Day 0]

   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.

6. Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain [At Day 21]

   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.

7. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [During the 7-day (Days 0-6) post-vaccination period following each dose and across doses]

   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.

8. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [During the 7-day (Days 0-6) post-vaccination period following each dose and across doses]

   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.

9. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [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]

   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.

10. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [During the 30-day (Days 0-29) follow-up period after the first vaccination]

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any 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.

11. Number of Subjects With Serious Adverse Events (SAEs) [During the entire study period (From Day 0 up to Month 24)]

    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Secondary Outcome Measures

1. Titers for Serum Neutralizing HI Antibodies Against A/Indonesia/05/2005 Strain [At Days 0, 21 (post-vaccination one) and 42 (post-vaccination two)]

   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.

2. Titers for Serum Neutralizing HI Antibodies Against A/Indonesia/05/2005 Stain [At Months 6, 12, 18 and 24]

   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.

3. Titers for Serum H5N1 Haemaglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain [At Days 0, 7, 14, 21, 28, 35 and 42]

   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.

4. Titers for Serum H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain [At Months 6, 12, 18 and 24]

   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.

5. Number of Seroconverted (SCR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain [At Days 7,14, 21, 35 and 42]

   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.

6. Number of Seroconverted (SCR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain [At Months 6, 12, 18 and 24]

   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.

7. Number of Seroconverted (SCR) Subjects for Neutralizing HI Antibodies Against the A/Indonesia/05/2005 Strain [At Days 21 (post-vaccination one) and 42 (post-vaccination two)]

   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.

8. Number of Seroconverted (SCR) Subjects for Neutralizing HI Antibodies Against the A/Indonesia/05/2005 Strain [At Months 6, 12, 18 and 24]

   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.

9. Seroconversion Factor (SCF) for H5N1 Haemagglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain [At Days 7, 14, 21, 35 and 42]

   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.

10. Seroconversion Factor (SCF) for H5N1 Haemagglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain [At Months 6, 12, 18 and 24]

    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.

11. Number of Seroprotected (SPR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain [At Days 0, 7, 14, 21, 28, 35 and 42]

    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).

12. Number of Seroprotected (SPR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain [At Months 6, 12, 18 and 24]

    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).

13. Frequency of Antigen-specific CD4/CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines [At Days 0 and 21]

    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.

14. Frequency of Antigen-specific CD4/CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines [At Months 6, 12, 18 and 24]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 61 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Gent		Belgium	9000

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00506350
• Other Study ID Numbers: 109817
• First Posted: Jul 25, 2007
• Last Update Posted: Oct 4, 2017
• Last Verified: Sep 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Influenza, Human; Vaccines

Study Results

Participant Flow

Arm/Group Title	GSK1562902A Non-AD F1 Primed Group	GSK1562902A Non-AD F2 Primed Group	GSK1562902A Non-AD F3 Primed Group	GSK1562902A Non-AD F4 Primed Group	Control Group	GSK1562902A AD F1 Primed Group	GSK1562902A AD F2 Primed Group	GSK1562902A AD F3 Primed Group	GSK1562902A AD Approved F Primed Group
Arm/Group Description	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.	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, 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.	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.
Period Title: Overall Study
STARTED	36	40	37	36	50	40	35	41	35
COMPLETED	33	37	31	34	40	38	33	36	30
NOT COMPLETED	3	3	6	2	10	2	2	5	5

Baseline Characteristics

Arm/Group Title	GSK1562902A Non-AD F1 Primed Group	GSK1562902A Non-AD F2 Primed Group	GSK1562902A Non-AD F3 Primed Group	GSK1562902A Non-AD F4 Primed Group	Control Group	GSK1562902A AD F1 Primed Group	GSK1562902A AD F2 Primed Group	GSK1562902A AD F3 Primed Group	GSK1562902A AD Approved F Primed Group	Total
Arm/Group Description	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.	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, 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.	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.	Total of all reporting groups
Overall Participants	36	40	37	36	50	40	35	41	35	350
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	36.3 (12.80)	36.3 (12.36)	36.8 (12.87)	39.5 (13.27)	32.1 (9.96)	38.5 (13.43)	38.3 (14.61)	34.8 (14.57)	35.9 (12.78)	36.32 (12.97)
Sex: Female, Male (Count of Participants)
Female	18 50%	19 47.5%	16 43.2%	21 58.3%	34 68%	27 67.5%	18 51.4%	23 56.1%	18 51.4%	194 55.4%
Male	18 50%	21 52.5%	21 56.8%	15 41.7%	16 32%	13 32.5%	17 48.6%	18 43.9%	17 48.6%	156 44.6%
Race/Ethnicity, Customized (Count of Participants)
White - Arabic / North African heritage	0 0%	0 0%	0 0%	0 0%	1 2%	0 0%	0 0%	0 0%	0 0%	1 0.3%
White - Caucasian / European heritage	36 100%	38 95%	37 100%	36 100%	48 96%	40 100%	34 97.1%	41 100%	35 100%	345 98.6%
Other	0 0%	2 5%	0 0%	0 0%	1 2%	0 0%	1 2.9%	0 0%	0 0%	4 1.1%

Outcome Measures

1. Primary Outcome

Title	Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Description	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.
Time Frame	At Day 0

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK1562902A AD F1 Primed Group	GSK1562902A AD F2 Primed Group	GSK1562902A AD F3 Primed Group	GSK1562902A AD Approved F Primed Group
Arm/Group Description	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.
Measure Participants	39	33	38	32
Geometric Mean (95% Confidence Interval) [Titers]	5.1	5.6	5.3	5.2

2. Primary Outcome

Title	Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Description	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.
Time Frame	At Day 21

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK1562902A AD F1 Primed Group	GSK1562902A AD F2 Primed Group	GSK1562902A AD F3 Primed Group	GSK1562902A AD Approved F Primed Group
Arm/Group Description	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.
Measure Participants	39	33	38	33
Geometric Mean (95% Confidence Interval) [Titers]	406.8	429.5	208.4	347.9

3. Primary Outcome

Title	Number of Seroconverted Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
Description	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.
Time Frame	At Day 21

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK1562902A AD F1 Primed Group	GSK1562902A AD F2 Primed Group	GSK1562902A AD F3 Primed Group	GSK1562902A AD Approved F Primed Group
Arm/Group Description	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.
Measure Participants	39	33	38	32
Count of Participants [Participants]	36 100%	33 82.5%	34 91.9%	31 86.1%

4. Primary Outcome

Title	Seroconversion Factor (SCF) for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
Description	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.
Time Frame	At Day 21

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK1562902A AD F1 Primed Group	GSK1562902A AD F2 Primed Group	GSK1562902A AD F3 Primed Group	GSK1562902A AD Approved F Primed Group
Arm/Group Description	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.
Measure Participants	39	33	38	32
Geometric Mean (95% Confidence Interval) [Fold increase]	79.9	76.5	39.1	76.9

5. Primary Outcome

Title	Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
Description	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.
Time Frame	At Day 0

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK1562902A AD F1 Primed Group	GSK1562902A AD F2 Primed Group	GSK1562902A AD F3 Primed Group	GSK1562902A AD Approved F Primed Group
Arm/Group Description	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.
Measure Participants	39	33	38	32
Count of Participants [Participants]	0 0%	1 2.5%	0 0%	0 0%

6. Primary Outcome

Title	Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
Description	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.
Time Frame	At Day 21

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK1562902A AD F1 Primed Group	GSK1562902A AD F2 Primed Group	GSK1562902A AD F3 Primed Group	GSK1562902A AD Approved F Primed Group
Arm/Group Description	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.
Measure Participants	39	33	38	33
Count of Participants [Participants]	36 100%	33 82.5%	34 91.9%	31 86.1%

7. Primary Outcome

Title	Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description	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.
Time Frame	During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK1562902A Non-AD F1 Primed Group	GSK1562902A Non-AD F2 Primed Group	GSK1562902A Non-AD F3 Primed Group	GSK1562902A Non-AD F4 Primed Group	Control Group	GSK1562902A AD F1 Primed Group	GSK1562902A AD F2 Primed Group	GSK1562902A AD F3 Primed Group	GSK1562902A AD Approved F Primed Group
Arm/Group Description	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.	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, 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.	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.
Measure Participants	36	40	36	36	50	40	35	41	35
Any Ecchymosis, Dose 1	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 3 Ecchymosis, Dose 1	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Induration, Dose 1	5 13.9%	1 2.5%	3 8.1%	2 5.6%	2 4%	2 5%	3 8.6%	3 7.3%	4 11.4%
Grade 3 Induration, Dose 1	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Pain, Dose 1	33 91.7%	35 87.5%	32 86.5%	34 94.4%	45 90%	38 95%	34 97.1%	39 95.1%	31 88.6%
Grade 3 Pain, Dose 1	2 5.6%	0 0%	0 0%	2 5.6%	1 2%	1 2.5%	1 2.9%	1 2.4%	0 0%
Any Redness, Dose 1	0 0%	1 2.5%	0 0%	0 0%	1 2%	1 2.5%	3 8.6%	1 2.4%	1 2.9%
Grade 3 Redness, Dose 1	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Swelling, Dose 1	4 11.1%	2 5%	4 10.8%	4 11.1%	3 6%	2 5%	2 5.7%	3 7.3%	2 5.7%
Grade 3 Swelling, Dose 1	0 0%	0 0%	0 0%	0 0%	1 2%	0 0%	0 0%	0 0%	0 0%
Any Ecchymosis, Dose 2	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 3 Ecchymosis, Dose 2	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Induration, Dose 2	1 2.8%	5 12.5%	3 8.1%	1 2.8%	4 8%	1 2.5%	0 0%	0 0%
Grade 3 Induration, Dose 2	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Pain, Dose 2	28 77.8%	30 75%	24 64.9%	28 77.8%	42 84%	1 2.5%	1 2.9%	1 2.4%
Grade 3 Pain, Dose 2	0 0%	0 0%	0 0%	0 0%	2 4%	0 0%	0 0%	0 0%
Any Redness, Dose 2	0 0%	1 2.5%	0 0%	0 0%	2 4%	1 2.5%	0 0%	0 0%
Grade 3 Redness, Dose 2	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Swelling, Dose 2	3 8.3%	0 0%	2 5.4%	5 13.9%	5 10%	1 2.5%	0 0%	0 0%
Grade 3 Swelling, Dose 2	0 0%	0 0%	0 0%	0 0%	1 2%	0 0%	0 0%	0 0%
Any Ecchymosis, Across doses	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 3 Ecchymosis, Across doses	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Induration, Across doses	6 16.7%	5 12.5%	5 13.5%	2 5.6%	6 12%	2 5%	4 11.4%	3 7.3%	4 11.4%
Grade 3 Induration, Across doses	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Pain, Across doses	34 94.4%	36 90%	32 86.5%	35 97.2%	47 94%	38 95%	34 97.1%	39 95.1%	31 88.6%
Grade 3 Pain, Across doses	2 5.6%	0 0%	0 0%	2 5.6%	3 6%	1 2.5%	1 2.9%	1 2.4%	0 0%
Any Redness, Across doses	0 0%	1 2.5%	0 0%	0 0%	3 6%	1 2.5%	4 11.4%	1 2.4%	1 2.9%
Grade 3 Redness, Across doses	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Swelling, Across doses	5 13.9%	2 5%	5 13.5%	6 16.7%	6 12%	2 5%	3 8.6%	3 7.3%	2 5.7%
Grade 3 Swelling, Across doses	0 0%	0 0%	0 0%	0 0%	1 2%	0 0%	0 0%	0 0%	0 0%

8. Primary Outcome

Title	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description	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.
Time Frame	During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK1562902A Non-AD F1 Primed Group	GSK1562902A Non-AD F2 Primed Group	GSK1562902A Non-AD F3 Primed Group	GSK1562902A Non-AD F4 Primed Group	Control Group	GSK1562902A AD F1 Primed Group	GSK1562902A AD F2 Primed Group	GSK1562902A AD F3 Primed Group	GSK1562902A AD Approved F Primed Group
Arm/Group Description	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.	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, 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.	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.
Measure Participants	36	40	36	36	50	40	35	41	35
Any Arthralgia, Dose 1	5 13.9%	7 17.5%	2 5.4%	5 13.9%	9 18%	6 15%	5 14.3%	5 12.2%	5 14.3%
Grade 3 Arthralgia, Dose 1	1 2.8%	0 0%	0 0%	1 2.8%	2 4%	0 0%	0 0%	0 0%	0 0%
Related Arthralgia, Dose 1	4 11.1%	5 12.5%	2 5.4%	5 13.9%	7 14%	5 12.5%	5 14.3%	5 12.2%	4 11.4%
Any Fatigue, Dose 1	12 33.3%	15 37.5%	15 40.5%	15 41.7%	24 48%	15 37.5%	10 28.6%	18 43.9%	13 37.1%
Grade 3 Fatigue, Dose 1	1 2.8%	0 0%	0 0%	0 0%	2 4%	1 2.5%	0 0%	1 2.4%	0 0%
Related Fatigue, Dose 1	10 27.8%	12 30%	15 40.5%	13 36.1%	22 44%	15 37.5%	9 25.7%	17 41.5%	12 34.3%
Any Fever, Dose 1	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 3 Fever, Dose 1	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Related Fever, Dose 1	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Headache, Dose 1	14 38.9%	15 37.5%	12 32.4%	11 30.6%	14 28%	19 47.5%	10 28.6%	11 26.8%	9 25.7%
Grade 3 Headache, Dose 1	0 0%	0 0%	0 0%	0 0%	3 6%	0 0%	0 0%	1 2.4%	0 0%
Related Headache, Dose 1	11 30.6%	11 27.5%	11 29.7%	10 27.8%	11 22%	16 40%	9 25.7%	10 24.4%	8 22.9%
Any Myalgia, Dose 1	12 33.3%	17 42.5%	14 37.8%	12 33.3%	18 36%	12 30%	12 34.3%	11 26.8%	10 28.6%
Grade 3 Myalgia, Dose 1	2 5.6%	0 0%	0 0%	1 2.8%	2 4%	0 0%	0 0%	2 4.9%	0 0%
Related Myalgia, Dose 1	12 33.3%	15 37.5%	14 37.8%	10 27.8%	17 34%	11 27.5%	11 31.4%	9 22%	9 25.7%
Any Shivering, Dose 1	4 11.1%	1 2.5%	1 2.7%	5 13.9%	7 14%	9 22.5%	6 17.1%	6 14.6%	3 8.6%
Grade 3 Shivering, Dose 1	1 2.8%	0 0%	0 0%	1 2.8%	2 4%	0 0%	0 0%	0 0%	0 0%
Related Shivering, Dose 1	4 11.1%	1 2.5%	1 2.7%	4 11.1%	6 12%	9 22.5%	6 17.1%	5 12.2%	3 8.6%
Any Sweating, Dose 1	2 5.6%	4 10%	6 16.2%	3 8.3%	10 20%	5 12.5%	6 17.1%	4 9.8%	3 8.6%
Grade 3 Sweating, Dose 1	1 2.8%	0 0%	0 0%	0 0%	0 0%	1 2.5%	0 0%	0 0%	0 0%
Related Sweating, Dose 1	2 5.6%	2 5%	6 16.2%	2 5.6%	6 12%	5 12.5%	6 17.1%	3 7.3%	3 8.6%
Any Arthralgia, Dose 2	9 25%	4 10%	5 13.5%	6 16.7%	10 20%	0 0%	0 0%	0 0%
Grade 3 Arthralgia, Dose 2	1 2.8%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Related Arthralgia, Dose 2	6 16.7%	4 10%	5 13.5%	6 16.7%	10 20%	0 0%	0 0%	0 0%
Any Fatigue, Dose 2	13 36.1%	12 30%	9 24.3%	13 36.1%	25 50%	0 0%	1 2.9%	0 0%
Grade 3 Fatigue, Dose 2	1 2.8%	0 0%	0 0%	0 0%	3 6%	0 0%	0 0%	0 0%
Related Fatigue, Dose 2	12 33.3%	10 25%	6 16.2%	13 36.1%	24 48%	0 0%	1 2.9%	0 0%
Any Fever, Dose 2	1 2.8%	1 2.5%	0 0%	0 0%	4 8%	0 0%	0 0%	0 0%
Grade 3 Fever, Dose 2	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Related Fever, Dose 2	1 2.8%	1 2.5%	0 0%	0 0%	4 8%	0 0%	0 0%	0 0%
Any Headache, Dose 2	14 38.9%	10 25%	12 32.4%	9 25%	23 46%	0 0%	1 2.9%	0 0%
Grade 3 Headache, Dose 2	0 0%	0 0%	0 0%	0 0%	3 6%	0 0%	0 0%	0 0%
Related Headache, Dose 2	12 33.3%	9 22.5%	8 21.6%	9 25%	19 38%	0 0%	1 2.9%	0 0%
Any Myalgia, Dose 2	11 30.6%	9 22.5%	9 24.3%	7 19.4%	24 48%	0 0%	1 2.9%	0 0%
Grade 3 Myalgia, Dose 2	1 2.8%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Related Myalgia, Dose 2	11 30.6%	8 20%	9 24.3%	6 16.7%	22 44%	0 0%	1 2.9%	0 0%
Any Shivering, Dose 2	7 19.4%	3 7.5%	4 10.8%	3 8.3%	14 28%	0 0%	1 2.9%	0 0%
Grade 3 Shivering, Dose 2	0 0%	0 0%	0 0%	0 0%	1 2%	0 0%	0 0%	0 0%
Related Shivering, Dose 2	6 16.7%	3 7.5%	4 10.8%	3 8.3%	14 28%	0 0%	1 2.9%	0 0%
Any Sweating, Dose 2	7 19.4%	2 5%	3 8.1%	2 5.6%	10 20%	0 0%	1 2.9%	0 0%
Grade 3 Sweating, Dose 2	0 0%	0 0%	0 0%	0 0%	1 2%	0 0%	0 0%	0 0%
Related Sweating, Dose 2	5 13.9%	2 5%	3 8.1%	2 5.6%	10 20%	0 0%	1 2.9%	0 0%
Any Arthralgia, Across doses	13 36.1%	8 20%	6 16.2%	10 27.8%	14 28%	6 15%	5 14.3%	5 12.2%	5 14.3%
Grade 3 Arthralgia, Across doses	2 5.6%	0 0%	0 0%	1 2.8%	2 4%	0 0%	0 0%	0 0%	0 0%
Related Arthralgia, Across doses	10 27.8%	6 15%	6 16.2%	10 27.8%	13 26%	5 12.5%	5 14.3%	5 12.2%	4 11.4%
Any Fatigue, Across doses	20 55.6%	21 52.5%	17 45.9%	20 55.6%	30 60%	15 37.5%	10 28.6%	18 43.9%	13 37.1%
Grade 3 Fatigue, Across doses	2 5.6%	0 0%	0 0%	0 0%	5 10%	1 2.5%	0 0%	1 2.4%	0 0%
Related Fatigue, Across doses	17 47.2%	18 45%	17 45.9%	20 55.6%	29 58%	15 37.5%	9 25.7%	17 41.5%	12 34.3%
Any Fever, Across doses	1 2.8%	1 2.5%	0 0%	0 0%	4 8%	0 0%	0 0%	0 0%	0 0%
Grade 3 Fever, Across doses	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Related Fever, Across doses	1 2.8%	1 2.5%	0 0%	0 0%	4 8%	0 0%	0 0%	0 0%	0 0%
Any Headache, Across doses	20 55.6%	17 42.5%	17 45.9%	14 38.9%	28 56%	19 47.5%	10 28.6%	11 26.8%	9 25.7%
Grade 3 Headache, Across doses	0 0%	0 0%	0 0%	0 0%	4 8%	0 0%	0 0%	1 2.4%	0 0%
Related Headache, Across doses	18 50%	16 40%	14 37.8%	14 38.9%	22 44%	16 40%	9 25.7%	10 24.4%	8 22.9%
Any Myalgia, Across doses	17 47.2%	20 50%	15 40.5%	15 41.7%	30 60%	12 30%	12 34.3%	11 26.8%	10 28.6%
Grade 3 Myalgia, Across doses	3 8.3%	0 0%	0 0%	1 2.8%	2 4%	0 0%	0 0%	2 4.9%	0 0%
Related Myalgia, Across doses	17 47.2%	18 45%	15 40.5%	14 38.9%	28 56%	11 27.5%	11 31.4%	9 22%	9 25.7%
Any Shivering, Across doses	10 27.8%	3 7.5%	4 10.8%	7 19.4%	20 40%	9 22.5%	6 17.1%	6 14.6%	3 8.6%
Grade 3 Shivering, Across doses	1 2.8%	0 0%	0 0%	1 2.8%	3 6%	0 0%	0 0%	0 0%	0 0%
Related Shivering, Across doses	9 25%	3 7.5%	4 10.8%	7 19.4%	19 38%	9 22.5%	6 17.1%	5 12.2%	3 8.6%
Any Sweating, Across doses	9 25%	4 10%	6 16.2%	5 13.9%	13 26%	5 12.5%	6 17.1%	4 9.8%	3 8.6%
Grade 3 Sweating, Across doses	1 2.8%	0 0%	0 0%	0 0%	1 2%	1 2.5%	0 0%	0 0%	0 0%
Related Sweating, Across doses	7 19.4%	3 7.5%	6 16.2%	4 11.1%	12 24%	5 12.5%	6 17.1%	3 7.3%	3 8.6%

9. Primary Outcome

Title	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Arm/Group Title	GSK1562902A Non-AD F1 Primed Group	GSK1562902A Non-AD F2 Primed Group	GSK1562902A Non-AD F3 Primed Group	GSK1562902A Non-AD F4 Primed Group	Control Group
Arm/Group Description	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.	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, 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.
Measure Participants	36	40	37	36	50
Any AE(s)	22 61.1%	24 60%	21 56.8%	26 72.2%	33 66%
Grade 3 AE(s)	2 5.6%	4 10%	1 2.7%	3 8.3%	6 12%
Related AE(s)	4 11.1%	1 2.5%	4 10.8%	1 2.8%	8 16%

10. Primary Outcome

Title	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Description	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.
Time Frame	During the 30-day (Days 0-29) follow-up period after the first vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Arm/Group Title	GSK1562902A AD F1 Primed Group	GSK1562902A AD F2 Primed Group	GSK1562902A AD F3 Primed Group	GSK1562902A AD Approved F Primed Group
Arm/Group Description	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.
Measure Participants	40	35	41	35
Any AE(s)	13 36.1%	17 42.5%	17 45.9%	17 47.2%
Grade 3 AE(s)	3 8.3%	2 5%	5 13.5%	2 5.6%
Related AE(s)	5 13.9%	4 10%	4 10.8%	4 11.1%

11. Primary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame	During the entire study period (From Day 0 up to Month 24)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Arm/Group Title	GSK1562902A Non-AD F1 Primed Group	GSK1562902A Non-AD F2 Primed Group	GSK1562902A Non-AD F3 Primed Group	GSK1562902A Non-AD F4 Primed Group	Control Group	GSK1562902A AD F1 Primed Group	GSK1562902A AD F2 Primed Group	GSK1562902A AD F3 Primed Group	GSK1562902A AD Approved F Primed Group
Arm/Group Description	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.	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, 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.	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.
Measure Participants	36	40	37	36	50	40	35	41	35
Day 0 - Month 6	1 2.8%	1 2.5%	1 2.7%	0 0%	3 6%	1 2.5%	0 0%	1 2.4%	0 0%
Month 6 - Month 12	2 5.6%	1 2.5%	0 0%	0 0%	0 0%	0 0%	0 0%	1 2.4%	0 0%
Month 12 - Month 18	1 2.8%	1 2.5%	0 0%	0 0%	0 0%	0 0%	0 0%	1 2.4%	2 5.7%
Month 18 - Month 24	1 2.8%	1 2.5%	1 2.7%	0 0%	0 0%	1 2.5%	0 0%	1 2.4%	2 5.7%

12. Secondary Outcome

Title	Titers for Serum Neutralizing HI Antibodies Against A/Indonesia/05/2005 Strain
Description	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.
Time Frame	At Days 0, 21 (post-vaccination one) and 42 (post-vaccination two)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK1562902A Non-AD F1 Primed Group	GSK1562902A AD F1 Primed Group	Control Group
Arm/Group Description	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 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, 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.
Measure Participants	34	38	49
A/Indonesia/05/2005, Day 0	47.0	157.8	19.9
A/Indonesia/05/2005, Day 21	692.4	307.3
A/Indonesia/05/2005, Day 42	933.1	3708.9	1606.4

13. Secondary Outcome

Title	Titers for Serum Neutralizing HI Antibodies Against A/Indonesia/05/2005 Stain
Description	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.
Time Frame	At Months 6, 12, 18 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK1562902A AD F1 Primed Group	GSK1562902A Non-AD F1 Primed Group	Control Group
Arm/Group Description	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 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, 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.
Measure Participants	37	35	46
A/Indonesia/05/2005, Month 6	1422.2	502.3	751.3
A/Indonesia/05/2005, Month 12	557.6	180.7	274.4
A/Indonesia/05/2005, Month 18	767.5	278.5	569.9
A/Indonesia/05/2005, Month 24	503.2	201.6	295.4

14. Secondary Outcome

Title	Titers for Serum H5N1 Haemaglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Description	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.
Time Frame	At Days 0, 7, 14, 21, 28, 35 and 42

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK1562902A Non-AD F1 Primed Group	GSK1562902A Non-AD F2 Primed Group	GSK1562902A Non-AD F3 Primed Group	GSK1562902A Non-AD F4 Primed Group	Control Group
Arm/Group Description	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.	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, 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.
Measure Participants	34	38	33	28	49
A/Indonesia/05/2005, Day 0	5.1	5.0	5.0	5.0	5.0
A/Indonesia/05/2005, Day 7	22.1	25.3	27.7	37.6	5.0
A/Indonesia/05/2005, Day 14	46.6	66.1	49.1	71.5	13.7
A/Indonesia/05/2005, Day 21	38.0	57.6	42.2	77.1	31.0
A/Indonesia/05/2005, Day 28	48.1	79.3	56.0	128.0	543.9
A/Indonesia/05/2005, Day 35	56.0	119.9	65.8	160.0	563.6
A/Indonesia/05/2005, Day 42	54.3	116.3	63.7	141.4	443.0

15. Secondary Outcome

Title	Titers for Serum H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain
Description	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.
Time Frame	At Months 6, 12, 18 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK1562902A Non-AD F1 Primed Group	GSK1562902A Non-AD F2 Primed Group	GSK1562902A Non-AD F3 Primed Group	GSK1562902A Non-AD F4 Primed Group	Control Group	GSK1562902A AD F1 Primed Group	GSK1562902A AD F2 Primed Group	GSK1562902A AD F3 Primed Group	GSK1562902A AD Approved F Primed Group
Arm/Group Description	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.	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, 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.	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.
Measure Participants	35	40	36	35	46	39	33	40	33
A/Indonesia/05/2005, Month 6	17.6	17.6	18.5	24.3	17.8	81.5	82.5	42.1	47.3
A/Indonesia/05/2005, Month 12	19.6	17.5	22.4	19.0	16.2	100.2	108.0	59.7	64.7
A/Indonesia/05/2005, Month 18	13.1	22.9	20.5	33.3	12.0	55.4	65.3	42.5	55.3
A/Indonesia/05/2005, Month 24	9.9	9.0	9.4	8.7	10.9	38.0	31.2	21.9	22.9

16. Secondary Outcome

Title	Number of Seroconverted (SCR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
Description	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.
Time Frame	At Days 7,14, 21, 35 and 42

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK1562902A Non-AD F1 Primed Group	GSK1562902A Non-AD F2 Primed Group	GSK1562902A Non-AD F3 Primed Group	GSK1562902A Non-AD F4 Primed Group	Control Group
Arm/Group Description	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.	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, 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.
Measure Participants	34	38	33	28	49
A/Indonesia/05/2005, Day 7	12 33.3%	17 42.5%	18 48.6%	17 47.2%	0 0%
A/Indonesia/05/2005, Day 14	22 61.1%	28 70%	19 51.4%	21 58.3%	12 24%
A/Indonesia/05/2005, Day 21	19 52.8%	27 67.5%	19 51.4%	23 63.9%	29 58%
A/Indonesia/05/2005, Day 35	21 58.3%	33 82.5%	23 62.2%	27 75%	49 98%
A/Indonesia/05/2005, Day 42	22 61.1%	34 85%	23 62.2%	27 75%	48 96%

17. Secondary Outcome

Title	Number of Seroconverted (SCR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
Description	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.
Time Frame	At Months 6, 12, 18 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK1562902A Non-AD F1 Primed Group	GSK1562902A Non-AD F2 Primed Group	GSK1562902A Non-AD F3 Primed Group	GSK1562902A Non-AD F4 Primed Group	Control Group	GSK1562902A AD F1 Primed Group	GSK1562902A AD F2 Primed Group	GSK1562902A AD F3 Primed Group	GSK1562902A AD Approved F Primed Group
Arm/Group Description	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.	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, 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.	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.
Measure Participants	35	40	36	35	46	38	32	40	32
A/Indonesia/05/2005, Month 6	12 33.3%	12 30%	15 40.5%	14 38.9%	15 30%	26 65%	24 68.6%	20 48.8%	24 68.6%
A/Indonesia/05/2005, Month 12	12 33.3%	13 32.5%	17 45.9%	13 36.1%	16 32%	27 67.5%	24 68.6%	27 65.9%	23 65.7%
A/Indonesia/05/2005, Month 18	8 22.2%	17 42.5%	15 40.5%	19 52.8%	5 10%	21 52.5%	20 57.1%	22 53.7%	21 60%
A/Indonesia/05/2005, Month 24	7 19.4%	5 12.5%	7 18.9%	3 8.3%	5 10%	18 45%	16 45.7%	16 39%	11 31.4%

18. Secondary Outcome

Title	Number of Seroconverted (SCR) Subjects for Neutralizing HI Antibodies Against the A/Indonesia/05/2005 Strain
Description	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.
Time Frame	At Days 21 (post-vaccination one) and 42 (post-vaccination two)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK1562902A Non-AD F1 Primed Group	GSK1562902A AD F1 Primed Group	Control Group
Arm/Group Description	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 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, 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.
Measure Participants	34	38	49
A/Indonesia/05/2005, Day 21	29 80.6%	44 110%
A/Indonesia/05/2005, Day 42	31 86.1%	35 87.5%	49 132.4%

19. Secondary Outcome

Title	Number of Seroconverted (SCR) Subjects for Neutralizing HI Antibodies Against the A/Indonesia/05/2005 Strain
Description	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.
Time Frame	At Months 6, 12, 18 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK1562902A Non-AD F1 Primed Group	GSK1562902A AD F1 Primed Group	Control Group
Arm/Group Description	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 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, 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.
Measure Participants	37	35	46
A/Indonesia/05/2005, Month 6	29 80.6%	29 72.5%	44 118.9%
A/Indonesia/05/2005, Month 12	17 47.2%	14 35%	41 110.8%
A/Indonesia/05/2005, Month 18	21 58.3%	19 47.5%	35 94.6%
A/Indonesia/05/2005, Month 24	13 36.1%	13 32.5%	29 78.4%

20. Secondary Outcome

Title	Seroconversion Factor (SCF) for H5N1 Haemagglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Description	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.
Time Frame	At Days 7, 14, 21, 35 and 42

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK1562902A Non-AD F1 Primed Group	GSK1562902A Non-AD F2 Primed Group	GSK1562902A Non-AD F3 Primed Group	GSK1562902A Non-AD F4 Primed Group	Control Group
Arm/Group Description	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.	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, 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.
Measure Participants	34	38	33	28	49
A/Indonesia/05/2005, Day 7	4.3	5.1	5.5	7.5	1.0
A/Indonesia/05/2005, Day 14	9.1	13.2	9.8	14.3	2.7
A/Indonesia/05/2005, Day 21	7.4	11.5	8.4	15.4	6.2
A/Indonesia/05/2005, Day 35	11.0	24.0	13.2	32.0	112.7
A/Indonesia/05/2005, Day 42	10.6	23.3	12.7	28.3	88.6

21. Secondary Outcome

Title	Seroconversion Factor (SCF) for H5N1 Haemagglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain
Description	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.
Time Frame	At Months 6, 12, 18 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK1562902A Non-AD F1 Primed Group	GSK1562902A Non-AD F2 Primed Group	GSK1562902A Non-AD F3 Primed Group	GSK1562902A Non-AD F4 Primed Group	Control Group	GSK1562902A AD F1 Primed Group	GSK1562902A AD F2 Primed Group	GSK1562902A AD F3 Primed Group	GSK1562902A AD Approved F Primed Group
Arm/Group Description	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.	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, 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.	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.
Measure Participants	35	40	36	35	46	38	32	40	32
A/Indonesia/05/2005, Month 6	3.4	3.3	3.7	4.9	3.6	15.0	14.1	7.9	9.8
A/Indonesia/05/2005, Month 12	3.8	3.3	4.5	3.8	3.2	18.3	18.3	11.2	13.6
A/Indonesia/05/2005, Month 18	2.6	4.6	4.1	6.7	2.4	10.1	11.5	7.9	11.6
A/Indonesia/05/2005, Month 24	1.9	1.8	1.9	1.7	2.2	6.9	5.9	4.1	4.7

22. Secondary Outcome

Title	Number of Seroprotected (SPR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
Description	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).
Time Frame	At Days 0, 7, 14, 21, 28, 35 and 42

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK1562902A Non-AD F1 Primed Group	GSK1562902A Non-AD F2 Primed Group	GSK1562902A Non-AD F3 Primed Group	GSK1562902A Non-AD F4 Primed Group	Control Group
Arm/Group Description	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.	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, 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.
Measure Participants	34	38	33	28	49
A/Indonesia/05/2005, Day 0	0 0%	0 0%	0 0%	0 0%	0 0%
A/Indonesia/05/2005, Day 7	12 33.3%	17 42.5%	18 48.6%	17 47.2%	0 0%
A/Indonesia/05/2005, Day 14	22 61.1%	28 70%	19 51.4%	21 58.3%	12 24%
A/Indonesia/05/2005, Day 21	19 52.8%	27 67.5%	19 51.4%	23 63.9%	29 58%
A/Indonesia/05/2005, Day 28	22 61.1%	32 80%	22 59.5%	26 72.2%	49 98%
A/Indonesia/05/2005, Day 35	21 58.3%	33 82.5%	23 62.2%	27 75%	49 98%
A/Indonesia/05/2005, Day 42	22 61.1%	34 85%	23 62.2%	27 75%	48 96%

23. Secondary Outcome

Title	Number of Seroprotected (SPR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain
Description	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).
Time Frame	At Months 6, 12, 18 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK1562902A Non-AD F1 Primed Group	GSK1562902A Non-AD F2 Primed Group	GSK1562902A Non-AD F3 Primed Group	GSK1562902A Non-AD F4 Primed Group	Control Group	GSK1562902A AD F1 Primed Group	GSK1562902A AD F2 Primed Group	GSK1562902A AD F3 Primed Group	GSK1562902A AD Approved F Primed Group
Arm/Group Description	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.	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, 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.	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.
Measure Participants	35	40	36	35	46	39	33	40	33
A/Indonesia/05/2005, Month 6	12 33.3%	12 30%	15 40.5%	14 38.9%	15 30%	27 67.5%	25 71.4%	20 48.8%	24 68.6%
A/Indonesia/05/2005, Month 12	12 33.3%	13 32.5%	17 45.9%	13 36.1%	16 32%	28 70%	25 71.4%	27 65.9%	23 65.7%
A/Indonesia/05/2005, Month 18	8 22.2%	17 42.5%	15 40.5%	19 52.8%	5 10%	22 55%	20 57.1%	22 53.7%	21 60%
A/Indonesia/05/2005, Month 24	7 19.4%	5 12.5%	7 18.9%	3 8.3%	5 10%	19 47.5%	16 45.7%	16 39%	11 31.4%

24. Secondary Outcome

Title	Frequency of Antigen-specific CD4/CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines
Description	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.
Time Frame	At Days 0 and 21

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK1562902A Non-AD F1 Primed Group	GSK1562902A AD F1 Primed Group	Control Group
Arm/Group Description	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 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, 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.
Measure Participants	32	38	48
CD4 ALL DOUBLES - H5N1 A/Indonesia, Day 0	743.00	1370.00	473.50
CD4 ALL DOUBLES - H5N1 A/Indonesia, Day 21	1945.50	2504.00	2721.00
CD4 ALL DOUBLES - H5N1 A/Vietnam, Day 0	682.50	1284.50	540.00
CD4 ALL DOUBLES - H5N1 A/Vietnam, Day 21	1870.00	2640.50	2607.00
CD4 CD40L - H5N1 A/Indonesia, Day 0	709.00	1363.50	457.50
CD4 CD40L - H5N1 A/Indonesia, Day 21	1874.00	2480.00	2633.00
CD4 CD40L - H5N1 A/Vietnam, Day 0	650.00	1288.50	525.50
CD4 CD40L - H5N1 A/Vietnam, Day 21	1842.50	2652.00	2580.50
CD4 IL-2 - H5N1 A/Indonesia, Day 0	641.00	1186.50	433.50
CD4 IL-2 - H5N1 A/Indonesia, Day 21	1616.00	2291.50	2485.00
CD4 IL-2 - H5N1 A/Vietnam, Day 0	599.50	1195.50	473.50
CD4 IL-2 - H5N1 A/Vietnam, Day 21	1607.00	2210.00	2368.50
CD4 INF-γ - H5N1 A/Indonesia, Day 0	407.00	607.00	357.00
CD4 INF-γ - H5N1 A/Indonesia, Day 21	785.50	1304.50	993.50
CD4 INF-γ - H5N1 A/Vietnam, Day 0	470.00	729.50	406.50
CD4 INF-γ - H5N1 A/Vietnam, Day 21	960.50	1105.00	1057.50
CD4 TNF-α - H5N1 A/Indonesia, Day 0	544.00	944.50	294.00
CD4 TNF-α - H5N1 A/Indonesia, Day 21	1187.00	1905.50	1658.50
CD4 TNF-α - H5N1 A/Vietnam, Day 0	490.50	952.50	357.00
CD4 TNF-α - H5N1 A/Vietnam, Day 21	1360.00	1888.00	1616.50
CD8 ALL DOUBLES - H5N1 A/Indonesia, Day 0	71.00	60.50	47.50
CD8 ALL DOUBLES - H5N1 A/Indonesia, Day 21	132.50	75.00	52.00
CD8 ALL DOUBLES - H5N1 A/Vietnam, Day 0	159.00	99.50	90.50
CD8 ALL DOUBLES - H5N1 A/Vietnam, Day 21	166.50	153.00	147.50
CD8 CD40L - H5N1 A/Indonesia, Day 0	1.00	1.00	1.00
CD8 CD40L - H5N1 A/Indonesia, Day 21	1.00	1.00	1.00
CD8 CD40L - H5N1 A/Vietnam, Day 0	1.00	1.00	1.00
CD8 CD40L - H5N1 A/Vietnam, Day 21	1.00	1.00	1.00
CD8 IL-2 - H5N1 A/Indonesia, Day 0	42.50	40.00	30.50
CD8 IL-2 - H5N1 A/Indonesia, Day 21	31.00	39.00	39.00
CD8 IL-2 - H5N1 A/Vietnam, Day 0	59.50	48.50	51.00
CD8 IL-2 - H5N1 A/Vietnam, Day 21	86.00	90.50	86.50
CD8 INF-γ - H5N1 A/Indonesia, Day 0	92.00	40.50	37.50
CD8 INF-γ - H5N1 A/Indonesia, Day 21	132.50	56.50	41.00
CD8 INF-γ - H5N1 A/Vietnam, Day 0	152.50	76.00	97.50
CD8 INF-γ - H5N1 A/Vietnam, Day 21	150.00	127.00	149.00
CD8 TNF-α - H5N1 A/Indonesia, Day 0	80.00	47.00	28.00
CD8 TNF-α - H5N1 A/Indonesia, Day 21	124.50	75.50	36.50
CD8 TNF-α - H5N1 A/Vietnam, Day 0	98.50	83.00	71.00
CD8 TNF-α - H5N1 A/Vietnam, Day 21	115.00	98.00	136.00

25. Secondary Outcome

Title	Frequency of Antigen-specific CD4/CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines
Description	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.
Time Frame	At Months 6, 12, 18 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK1562902A AD F1 Primed Group	GSK1562902A Non-AD F1 Primed Group	Control Group
Arm/Group Description	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 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, 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.
Measure Participants	37	35	45
CD4 ALL DOUBLES - H5N1 A/Indonesia, Month 6	1575.00	1244.00	1817.00
CD4 ALL DOUBLES - H5N1 A/Vietnam, Month 6	1710.00	1138.00	1775.00
CD4 CD40L - H5N1 A/Indonesia, Month 6	1605.00	1190.00	1720.00
CD4 CD40L - H5N1 A/Vietnam, Month 6	1724.00	1124.00	1748.00
CD4 IL-2 - H5N1 A/Indonesia, Month 6	1454.00	1136.00	1736.00
CD4 IL-2 - H5N1 A/Vietnam, Month 6	1481.00	1070.00	1580.00
CD4 INF-γ - H5N1 A/Indonesia, Month 6	794.00	636.00	929.00
CD4 INF-γ - H5N1 A/Vietnam, Month 6	876.00	679.00	885.00
CD4 TNF-α - H5N1 A/Indonesia, Month 6	1152.00	920.00	1467.00
CD4 TNF-α - H5N1 A/Vietnam, Month 6	1279.00	941.00	1292.00
CD4 ALL DOUBLES - H5N1 A/Indonesia, Month 12	1333.00	786.50	1332.50
CD4 ALL DOUBLES - H5N1 A/Vietnam, Month 12	1171.00	796.50	1225.00
CD4 CD40L - H5N1 A/Indonesia, Month 12	1119.00	647.00	1159.00
CD4 CD40L - H5N1 A/Vietnam, Month 12	1090.00	641.00	1134.00
CD4 IL-2 - H5N1 A/Indonesia, Month 12	1290.00	721.00	1219.50
CD4 IL-2 - H5N1 A/Vietnam, Month 12	1183.00	733.00	1100.00
CD4 INF-γ - H5N1 A/Indonesia, Month 12	746.00	432.50	618.00
CD4 INF-γ - H5N1 A/Vietnam, Month 12	670.00	497.50	643.00
CD4 TNF-α - H5N1 A/Indonesia, Month 12	1065.00	551.50	997.50
CD4 TNF-α - H5N1 A/Vietnam, Month 12	945.00	616.50	939.50
CD4 ALL DOUBLES - H5N1 A/Indonesia, Month 18	1421.00	1052.00	1392.00
CD4 ALL DOUBLES - H5N1 A/Vietnam, Month 18	1536.00	1022.00	1367.00
CD4 CD40L - H5N1 A/Indonesia, Month 18	1369.00	1013.00	1330.00
CD4 CD40L - H5N1 A/Vietnam, Month 18	1523.00	1036.00	1288.00
CD4 IL-2 - H5N1 A/Indonesia, Month 18	1316.00	946.00	1170.00
CD4 IL-2 - H5N1 A/Vietnam, Month 18	1346.00	933.00	1062.00
CD4 INF-γ - H5N1 A/Indonesia, Month 18	906.00	729.00	865.00
CD4 INF-γ - H5N1 A/Vietnam, Month 18	1042.00	743.00	965.00
CD4 TNF-α - H5N1 A/Indonesia, Month 18	1173.00	811.00	1035.00
CD4 TNF-α - H5N1 A/Vietnam, Month 18	1074.00	793.00	1079.00
CD4 ALL DOUBLES - H5N1 A/Indonesia, Month 24	1307.00	914.00	1306.00
CD4 ALL DOUBLES - H5N1 A/Vietnam, Month 24	1229.00	850.00	1322.00
CD4 CD40L - H5N1 A/Indonesia, Month 24	1220.00	917.00	1280.00
CD4 CD40L - H5N1 A/Vietnam, Month 24	1195.00	826.00	1356.00
CD4 IL-2 - H5N1 A/Indonesia, Month 24	1146.00	867.00	1105.00
CD4 IL-2 - H5N1 A/Vietnam, Month 24	1101.00	839.00	1253.00
CD4 INF-γ - H5N1 A/Indonesia, Month 24	848.00	654.00	860.00
CD4 INF-γ - H5N1 A/Vietnam, Month 24	838.00	704.00	888.00
CD4 TNF-α - H5N1 A/Indonesia, Month 24	1062.00	773.00	1186.00
CD4 TNF-α - H5N1 A/Vietnam, Month 24	999.00	680.00	1023.00
CD8 ALL DOUBLES - H5N1 A/Indonesia, Month 6	59.00	79.00	89.00
CD8 ALL DOUBLES - H5N1 A/Vietnam, Month 6	85.00	139.00	107.00
CD8 CD40L - H5N1 A/Indonesia, Month 6	1.00	1.00	1.00
CD8 CD40L - H5N1 A/Vietnam, Month 6	1.00	1.00	1.00
CD8 IL-2 - H5N1 A/Indonesia, Month 6	52.00	54.00	53.00
CD8 IL-2 - H5N1 A/Vietnam, Month 6	93.00	77.00	63.00
CD8 INF-γ - H5N1 A/Indonesia, Month 6	29.00	49.00	44.00
CD8 INF-γ - H5N1 A/Vietnam, Month 6	48.00	117.00	61.00
CD8 TNF-α - H5N1 A/Indonesia, Month 6	52.00	71.00	76.00
CD8 TNF-α - H5N1 A/Vietnam, Month 6	73.00	123.00	80.00
CD8 ALL DOUBLES - H5N1 A/Indonesia, Month 12	78.00	73.00	30.50
CD8 ALL DOUBLES - H5N1 A/Vietnam, Month 12	69.00	95.00	31.50
CD8 CD40L - H5N1 A/Indonesia, Month 12	1.00	1.00	1.00
CD8 CD40L - H5N1 A/Vietnam, Month 12	1.00	1.00	1.00
CD8 IL-2 - H5N1 A/Indonesia, Month 12	56.00	54.50	5.50
CD8 IL-2 - H5N1 A/Vietnam, Month 12	55.00	49.50	13.00
CD8 INF-γ - H5N1 A/Indonesia, Month 12	46.00	60.50	1.00
CD8 INF-γ - H5N1 A/Vietnam, Month 12	77.00	54.00	32.00
CD8 TNF-α - H5N1 A/Indonesia, Month 12	54.00	62.00	23.50
CD8 TNF-α - H5N1 A/Vietnam, Month 12	55.00	75.50	31.50
CD8 ALL DOUBLES - H5N1 A/Indonesia, Month 18	35.00	82.00	40.00
CD8 ALL DOUBLES - H5N1 A/Vietnam, Month 18	48.00	66.00	119.00
CD8 CD40L - H5N1 A/Indonesia, Month 18	1.00	1.00	1.00
CD8 CD40L - H5N1 A/Vietnam, Month 18	1.00	1.00	1.00
CD8 IL-2 - H5N1 A/Indonesia, Month 18	1.00	43.00	30.00
CD8 IL-2 - H5N1 A/Vietnam, Month 18	1.00	40.00	47.00
CD8 TNF-α - H5N1 A/Indonesia, Month 18	38.00	82.00	31.00
CD8 INF-γ - H5N1 A/Indonesia, Month 18	48.00	62.00	119.00
CD8 INF-γ - H5N1 A/Vietnam, Month 18	1.00	81.00	42.00
CD8 TNF-α - H5N1 A/Vietnam, Month 18	38.00	65.00	107.00
CD8 ALL DOUBLES - H5N1 A/Indonesia, Month 24	78.00	73.00	65.00
CD8 ALL DOUBLES - H5N1 A/Vietnam, Month 24	29.00	73.00	102.00
CD8 CD40L - H5N1 A/Indonesia, Month 24	26.00	1.00	1.00
CD8 CD40L - H5N1 A/Vietnam, Month 24	1.00	1.00	1.00
CD8 IL-2 - H5N1 A/Indonesia, Month 24	21.00	25.00	32.00
CD8 IL-2 - H5N1 A/Vietnam, Month 24	1.00	26.00	31.00
CD8 INF-γ - H5N1 A/Indonesia, Month 24	64.00	93.00	65.00
CD8 INF-γ - H5N1 A/Vietnam, Month 24	31.00	73.00	102.00
CD8 TNF-α - H5N1 A/Indonesia, Month 24	26.00	57.00	55.00
CD8 TNF-α - H5N1 A/Vietnam, Month 24	37.00	45.00	64.00

Adverse Events

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).
Arm/Group Title	GSK1562902A Non-AD F1 Primed Group		GSK1562902A Non-AD F2 Primed Group		GSK1562902A Non-AD F3 Primed Group		GSK1562902A Non-AD F4 Primed Group		Control Group		GSK1562902A AD F1 Primed Group		GSK1562902A AD F2 Primed Group		GSK1562902A AD F3 Primed Group		GSK1562902A AD Approved F Primed Group
Arm/Group Description	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.		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, 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.		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.
All Cause Mortality
	GSK1562902A Non-AD F1 Primed Group		GSK1562902A Non-AD F2 Primed Group		GSK1562902A Non-AD F3 Primed Group		GSK1562902A Non-AD F4 Primed Group		Control Group		GSK1562902A AD F1 Primed Group		GSK1562902A AD F2 Primed Group		GSK1562902A AD F3 Primed Group		GSK1562902A AD Approved F Primed Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/40 (0%)		0/37 (0%)		0/36 (0%)		0/50 (0%)		0/40 (0%)		0/35 (0%)		1/41 (2.4%)		1/35 (2.9%)
Serious Adverse Events
	GSK1562902A Non-AD F1 Primed Group		GSK1562902A Non-AD F2 Primed Group		GSK1562902A Non-AD F3 Primed Group		GSK1562902A Non-AD F4 Primed Group		Control Group		GSK1562902A AD F1 Primed Group		GSK1562902A AD F2 Primed Group		GSK1562902A AD F3 Primed Group		GSK1562902A AD Approved F Primed Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/36 (11.1%)		3/40 (7.5%)		2/37 (5.4%)		0/36 (0%)		4/50 (8%)		2/40 (5%)		1/35 (2.9%)		4/41 (9.8%)		3/35 (8.6%)
Cardiac disorders
Arrhythmia	0/36 (0%)	0	0/40 (0%)	0	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	1/35 (2.9%)	1
Atrial fibrillation	0/36 (0%)	0	0/40 (0%)	0	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	1/35 (2.9%)	1
Pericarditis	0/36 (0%)	0	1/40 (2.5%)	2	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	0/35 (0%)	0
Gastrointestinal disorders
Abdominal pain upper	0/36 (0%)	0	1/40 (2.5%)	1	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	0/35 (0%)	0
Intestinal obstruction	0/36 (0%)	0	0/40 (0%)	0	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	0/35 (0%)	0	1/41 (2.4%)	1	0/35 (0%)	0
General disorders
Chest pain	0/36 (0%)	0	0/40 (0%)	0	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	1/35 (2.9%)	1
Ill-defined disorder	0/36 (0%)	0	0/40 (0%)	0	0/37 (0%)	0	0/36 (0%)	0	1/50 (2%)	1	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	0/35 (0%)	0
Infections and infestations
Abscess	1/36 (2.8%)	1	0/40 (0%)	0	0/37 (0%)	0	0/36 (0%)	0	1/50 (2%)	1	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	0/35 (0%)	0
Appendicitis	0/36 (0%)	0	0/40 (0%)	0	1/37 (2.7%)	1	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	0/35 (0%)	0
Gastroenteritis	0/36 (0%)	0	0/40 (0%)	0	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	1/40 (2.5%)	1	0/35 (0%)	0	0/41 (0%)	0	0/35 (0%)	0
Pneumonia	0/36 (0%)	0	0/40 (0%)	0	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	0/35 (0%)	0	1/41 (2.4%)	1	0/35 (0%)	0
Injury, poisoning and procedural complications
Jaw fracture	0/36 (0%)	0	1/40 (2.5%)	1	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	0/35 (0%)	0
Multiple injuries	0/36 (0%)	0	0/40 (0%)	0	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	0/35 (0%)	0	1/41 (2.4%)	1	0/35 (0%)	0
Tibia fracture	0/36 (0%)	0	0/40 (0%)	0	0/37 (0%)	0	0/36 (0%)	0	1/50 (2%)	1	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	0/35 (0%)	0
Tooth fracture	0/36 (0%)	0	1/40 (2.5%)	1	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	0/35 (0%)	0
Traumatic fracture	0/36 (0%)	0	1/40 (2.5%)	1	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	0/35 (0%)	0
Wrist fracture	1/36 (2.8%)	1	0/40 (0%)	0	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	0/35 (0%)	0
Musculoskeletal and connective tissue disorders
Foot deformity	1/36 (2.8%)	1	0/40 (0%)	0	1/37 (2.7%)	1	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	0/35 (0%)	0
Intervertebral disc protrusion	0/36 (0%)	0	0/40 (0%)	0	0/37 (0%)	0	0/36 (0%)	0	1/50 (2%)	1	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	0/35 (0%)	0
Osteoarthritis	0/36 (0%)	0	0/40 (0%)	0	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	2/40 (5%)	2	0/35 (0%)	0	0/41 (0%)	0	0/35 (0%)	0
Spinal column stenosis	0/36 (0%)	0	0/40 (0%)	0	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	1/35 (2.9%)	1	0/41 (0%)	0	0/35 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
High grade b-cell lymphoma burkitt-like lymphoma	0/36 (0%)	0	0/40 (0%)	0	0/37 (0%)	0	0/36 (0%)	0	1/50 (2%)	1	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	0/35 (0%)	0
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia	0/36 (0%)	0	0/40 (0%)	0	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	1/35 (2.9%)	1
Psychiatric disorders
Major depression	0/36 (0%)	0	0/40 (0%)	0	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	1/35 (2.9%)	1
Renal and urinary disorders
Nephrolithiasis	1/36 (2.8%)	1	0/40 (0%)	0	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	0/35 (0%)	0
Renal colic	1/36 (2.8%)	1	0/40 (0%)	0	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	0/35 (0%)	0
Vascular disorders
Aortic aneurysm rupture	0/36 (0%)	0	0/40 (0%)	0	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	0/35 (0%)	0	1/41 (2.4%)	1	0/35 (0%)	0
Other (Not Including Serious) Adverse Events
	GSK1562902A Non-AD F1 Primed Group		GSK1562902A Non-AD F2 Primed Group		GSK1562902A Non-AD F3 Primed Group		GSK1562902A Non-AD F4 Primed Group		Control Group		GSK1562902A AD F1 Primed Group		GSK1562902A AD F2 Primed Group		GSK1562902A AD F3 Primed Group		GSK1562902A AD Approved F Primed Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	34/36 (94.4%)		40/40 (100%)		33/37 (89.2%)		35/36 (97.2%)		48/50 (96%)		39/40 (97.5%)		34/35 (97.1%)		41/41 (100%)		33/35 (94.3%)
Gastrointestinal disorders
Diarrhoea	2/36 (5.6%)	2	3/40 (7.5%)	3	0/37 (0%)	0	1/36 (2.8%)	1	4/50 (8%)	6	2/40 (5%)	2	2/35 (5.7%)	3	1/41 (2.4%)	1	2/35 (5.7%)	2
Dyspepsia	1/36 (2.8%)	3	3/40 (7.5%)	4	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	1/35 (2.9%)	2	2/41 (4.9%)	3	1/35 (2.9%)	1
Nausea	0/36 (0%)	0	2/40 (5%)	2	2/37 (5.4%)	2	1/36 (2.8%)	1	3/50 (6%)	5	2/40 (5%)	2	2/35 (5.7%)	2	0/41 (0%)	0	0/35 (0%)	0
Vomiting	1/36 (2.8%)	1	1/40 (2.5%)	1	0/37 (0%)	0	0/36 (0%)	0	2/50 (4%)	2	2/40 (5%)	2	0/35 (0%)	0	0/41 (0%)	0	0/35 (0%)	0
General disorders
Chills	10/36 (27.8%)	11	3/40 (7.5%)	4	4/37 (10.8%)	5	7/36 (19.4%)	8	20/50 (40%)	21	9/40 (22.5%)	9	6/35 (17.1%)	6	6/41 (14.6%)	7	3/35 (8.6%)	3
Fatigue	20/36 (55.6%)	25	22/40 (55%)	28	18/37 (48.6%)	25	20/36 (55.6%)	28	30/50 (60%)	51	15/40 (37.5%)	16	10/35 (28.6%)	11	18/41 (43.9%)	19	14/35 (40%)	14
Induration	6/36 (16.7%)	6	5/40 (12.5%)	6	5/37 (13.5%)	6	2/36 (5.6%)	3	6/50 (12%)	6	2/40 (5%)	2	4/35 (11.4%)	4	3/41 (7.3%)	3	4/35 (11.4%)	4
Influenza like illness	1/36 (2.8%)	1	2/40 (5%)	2	0/37 (0%)	0	0/36 (0%)	0	1/50 (2%)	1	0/40 (0%)	0	0/35 (0%)	0	2/41 (4.9%)	2	0/35 (0%)	0
Injection site pruritus	0/36 (0%)	0	1/40 (2.5%)	1	1/37 (2.7%)	2	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	4/35 (11.4%)	4
Injection site reaction	2/36 (5.6%)	3	0/40 (0%)	0	1/37 (2.7%)	1	0/36 (0%)	0	4/50 (8%)	4	1/40 (2.5%)	1	3/35 (8.6%)	3	1/41 (2.4%)	1	0/35 (0%)	0
Pain	34/36 (94.4%)	61	36/40 (90%)	65	32/37 (86.5%)	56	35/36 (97.2%)	62	47/50 (94%)	87	38/40 (95%)	38	34/35 (97.1%)	35	39/41 (95.1%)	40	31/35 (88.6%)	32
Pyrexia	1/36 (2.8%)	1	1/40 (2.5%)	1	1/37 (2.7%)	1	0/36 (0%)	0	4/50 (8%)	4	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	0/35 (0%)	0
Swelling	5/36 (13.9%)	7	2/40 (5%)	2	5/37 (13.5%)	6	6/36 (16.7%)	9	6/50 (12%)	8	2/40 (5%)	2	3/35 (8.6%)	3	3/41 (7.3%)	3	2/35 (5.7%)	2
Infections and infestations
Oral herpes	1/36 (2.8%)	1	1/40 (2.5%)	1	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	3/40 (7.5%)	3	0/35 (0%)	0	0/41 (0%)	0	0/35 (0%)	0
Pharyngitis	0/36 (0%)	0	2/40 (5%)	2	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	0/35 (0%)	0	1/41 (2.4%)	1	1/35 (2.9%)	1
Rhinitis	3/36 (8.3%)	3	3/40 (7.5%)	3	3/37 (8.1%)	3	2/36 (5.6%)	2	5/50 (10%)	6	0/40 (0%)	0	1/35 (2.9%)	1	2/41 (4.9%)	2	6/35 (17.1%)	6
Upper respiratory tract infection	3/36 (8.3%)	3	3/40 (7.5%)	3	3/37 (8.1%)	3	8/36 (22.2%)	9	5/50 (10%)	5	1/40 (2.5%)	1	3/35 (8.6%)	3	0/41 (0%)	0	2/35 (5.7%)	2
Musculoskeletal and connective tissue disorders
Arthralgia	15/36 (41.7%)	16	8/40 (20%)	11	6/37 (16.2%)	7	11/36 (30.6%)	12	15/50 (30%)	20	6/40 (15%)	7	5/35 (14.3%)	5	5/41 (12.2%)	5	5/35 (14.3%)	5
Back pain	2/36 (5.6%)	2	0/40 (0%)	0	0/37 (0%)	0	1/36 (2.8%)	1	2/50 (4%)	2	2/40 (5%)	2	1/35 (2.9%)	1	2/41 (4.9%)	2	0/35 (0%)	0
Musculoskeletal stiffness	2/36 (5.6%)	2	1/40 (2.5%)	1	0/37 (0%)	0	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	0/35 (0%)	0
Myalgia	18/36 (50%)	24	21/40 (52.5%)	27	15/37 (40.5%)	23	15/36 (41.7%)	19	30/50 (60%)	42	12/40 (30%)	12	12/35 (34.3%)	12	11/41 (26.8%)	12	10/35 (28.6%)	10
Neck pain	1/36 (2.8%)	1	0/40 (0%)	0	0/37 (0%)	0	1/36 (2.8%)	1	0/50 (0%)	0	2/40 (5%)	2	0/35 (0%)	0	0/41 (0%)	0	0/35 (0%)	0
Nervous system disorders
Headache	22/36 (61.1%)	33	19/40 (47.5%)	30	18/37 (48.6%)	32	18/36 (50%)	30	31/50 (62%)	49	19/40 (47.5%)	23	12/35 (34.3%)	13	13/41 (31.7%)	15	11/35 (31.4%)	14
Psychiatric disorders
Insomnia	0/36 (0%)	0	0/40 (0%)	0	0/37 (0%)	0	3/36 (8.3%)	4	0/50 (0%)	0	0/40 (0%)	0	0/35 (0%)	0	0/41 (0%)	0	0/35 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cough	0/36 (0%)	0	0/40 (0%)	0	2/37 (5.4%)	2	0/36 (0%)	0	0/50 (0%)	0	0/40 (0%)	0	2/35 (5.7%)	2	1/41 (2.4%)	1	1/35 (2.9%)	1
Oropharyngeal pain	0/36 (0%)	0	5/40 (12.5%)	5	3/37 (8.1%)	4	2/36 (5.6%)	2	7/50 (14%)	8	0/40 (0%)	0	0/35 (0%)	0	1/41 (2.4%)	1	4/35 (11.4%)	4
Productive cough	0/36 (0%)	0	1/40 (2.5%)	1	0/37 (0%)	0	1/36 (2.8%)	1	4/50 (8%)	4	2/40 (5%)	2	0/35 (0%)	0	1/41 (2.4%)	1	2/35 (5.7%)	2
Skin and subcutaneous tissue disorders
Erythema	0/36 (0%)	0	1/40 (2.5%)	2	0/37 (0%)	0	0/36 (0%)	0	3/50 (6%)	3	1/40 (2.5%)	1	4/35 (11.4%)	4	1/41 (2.4%)	1	1/35 (2.9%)	1
Hyperhidrosis	9/36 (25%)	9	4/40 (10%)	6	6/37 (16.2%)	9	5/36 (13.9%)	5	13/50 (26%)	20	5/40 (12.5%)	5	6/35 (17.1%)	6	4/41 (9.8%)	5	3/35 (8.6%)	3
Pruritus	0/36 (0%)	0	0/40 (0%)	0	0/37 (0%)	0	0/36 (0%)	0	2/50 (4%)	2	0/40 (0%)	0	2/35 (5.7%)	2	0/41 (0%)	0	1/35 (2.9%)	1

Limitations/Caveats

[Not Specified]

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Principal Investigators are NOT employed by the organization sponsoring the study.

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.