Safety and Immunogenicity of H1N1 Vaccine With Trivalent Inactivated Seasonal Influenza Vaccine in Adults

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00985673
• Collaborator: (none)
• Enrollment: 611
• Locations: 7
• Arms: 6
• Duration (Months): 14.9
• Patients Per Site: 87.3
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief Summary

The purpose of this study is to characterize the safety and immunogenicity of the H1N1 (swine) flu vaccines GSK2340274A and GSK2340273A when co-administered with the seasonal flu vaccine in adults 19 to 40 years of age.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Biological: GSK2340274A; Biological: GSK2340273A; Biological: Seasonal trivalent influenza vaccine (TIV); Biological: Saline placebo	Phase 2

Detailed Description

Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority

Study Design

• Study Type: Interventional
• Actual Enrollment: 611 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Study to Evaluate the Safety and Immunogenicity of an A/California/7/2009 (H1N1)V-like Vaccine GSK2340274A or GSK2340273A Co-administered With Trivalent Inactivated Seasonal Influenza Vaccine in Adults 19 to 40 Years of Age
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Dec 28, 2009
• Actual Study Completion Date: Dec 29, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Flulaval/placebo/unadjuvanted Arepanrix Group subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	Biological: GSK2340273A; Two intramuscular injections; Biological: Seasonal trivalent influenza vaccine (TIV); Single intramuscular injection; Biological: Saline placebo; Single intramuscular injection
Experimental: Flulaval/placebo/Arepanrix Group subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	Biological: GSK2340274A; Two intramuscular injections; Biological: Seasonal trivalent influenza vaccine (TIV); Single intramuscular injection; Biological: Saline placebo; Single intramuscular injection
Experimental: Flulaval/unadjuvanted Arepanrix/placebo Group subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	Biological: GSK2340273A; Two intramuscular injections; Biological: Seasonal trivalent influenza vaccine (TIV); Single intramuscular injection; Biological: Saline placebo; Single intramuscular injection
Experimental: Flulaval/Arepanrix/placebo Group subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	Biological: GSK2340274A; Two intramuscular injections; Biological: Seasonal trivalent influenza vaccine (TIV); Single intramuscular injection; Biological: Saline placebo; Single intramuscular injection
Experimental: Unadjuvanted Arepanrix/placebo/Flulaval Group subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	Biological: GSK2340273A; Two intramuscular injections; Biological: Seasonal trivalent influenza vaccine (TIV); Single intramuscular injection; Biological: Saline placebo; Single intramuscular injection
Experimental: Arepanrix/placebo/Flulaval Group subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	Biological: GSK2340274A; Two intramuscular injections; Biological: Seasonal trivalent influenza vaccine (TIV); Single intramuscular injection; Biological: Saline placebo; Single intramuscular injection

Outcome Measures

Primary Outcome Measures

1. Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain. [21 days after the second dose of Arepanrix vaccine (at Day 42).]

   The A/California vaccine virus-homologous antibody response was measured in subjects having received Flulaval vaccine co-administered with the first dose of Arepanrix vaccine, and in subjects having received two doses of Arepanrix vaccine alone. Titers were expressed as geometric mean antibody titers (GMTs).

2. Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain. [21 days after the second dose of the unadjuvanted formulation of Arepanrix vaccine (at Day 42)]

   The A/California vaccine virus-homologous antibody response was measured in subjects having received Flulaval vaccine co-administered with the first dose of the unadjuvanted formulation of Arepanrix vaccine, and in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine alone. Titers were expressed as geometric mean antibody titers (GMTs).

Secondary Outcome Measures

1. Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α). [On Days 0, 7, 21, 28, 42, 63 and 182]

   Influenza-specific CD4 T-Cells were stimulated in vitro with A/California virus and seasonal Influenza viruses, related antigens or derived peptides. Stimulating antigens were A/Brisbane, A/California, pool peptides H1N1 and pool FLU.

2. Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α). [On Days 0, 7, 21, 28, 42, 63 and 182]

   Influenza-specific CD8 T-Cells were stimulated in vitro with A/California virus and seasonal Influenza viruses, related antigens or derived peptides. Stimulating antigens were A/Brisbane, A/California, pool peptides H1N1 and pool FLU.

3. Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed [On Days 0, 7, 21, 28, 42, 63 and 182]

   Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatase (AP), bilirubin (BIL) (total (T)), basophils (BAS). For each parameter and for each range it was assessed whether the values of the subjects were in unkown, above, below or within the range.

4. Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed [On Days 0, 7, 21, 28, 42, 63 and 182]

   Laboratory parameters assessed were creatinine (CREA), bilirubin (BIL) (direct (D)), eosinophils (EOS), hemoglobin (Hgb), hematocrit (Hct). For each parameter and for each range it was assessed whether the values of the subjects were unknown, in above, below or within the range.

5. Number of Subjects Reporting Solicited Local Symptoms. [During a 7-day follow-up period (Days 0-6) post-vaccination period]

   Solicited local symptoms assessed were pain, redness and swelling

6. Number of Subjects Reporting Solicited General Symptoms. [During a 7-day follow-up period (Days 0-6) post-vaccination period]

   Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature. Temperature is defined as an axillary temperature equal to or above 38.0 degrees Celsius (°C).

7. Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed [On Days 0, 7, 21, 28, 42, 63 and 182]

   Laboratory parameters assessed were serum urea nitrogen (SUN), white blood cells (WBC), red blood cells (RBC). For each parameter and for each range it was assessed whether the values of the subjects were unknown, above, below or within the range.

8. Number of Subjects Reporting Unsolicited Adverse Events (AEs). [Within the 84-day (Days 0-83) post-vaccination period.]

   An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.

9. Number of Subjects Reporting Medically Attended Visits (MAEs). [During the entire study period (Days 0-368).]

   The day 368 was the last contact day for the last subject reporting the event. For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.

10. Number of Subjects Reporting Potential Immune Diseases (pIMDs). [During the entire study period (Days 0-406).]

    The day 406 was the last contact day with the subjects reporting the event. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.

11. Number of Subjects Reporting Serious Adverse Events (SAEs). [During the entire study period (Days 0-329).]

    The day 329 was the last contact day with the subjects reporting serious adverse events. SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

12. Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed [On Days 0, 7, 21, 28, 42, 63 and 182]

    Laboratory parameters assessed were neutrophils (NEU), lymphocytes (LYM), monocytes (MON) and platelets (PLA). For each parameter and for each range it was assessed whether the values of the subjects were unknown, in above, below or within the range.

13. Microneutralization Antibody Titers Against A/California/7/2009 (H1N1) Strain. [On Days 0, 21, 42, 63 and 182]

    Titers were expressed as geometric mean titers (GMTs) and measured by microneutralization. Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1). Microneutralization testing was cancelled.

14. Number of Subjects With a Microneutralization Titer Greater Than or Equal to 1:28 for Antibodies Against A/California/7/2009 (H1N1) Strain. [On Days 0, 21, 42, 63 and 182]

    Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1). The antibody cut-off value assessed was a titer of 1:10 and this value was considered as seropositivity. Seronegative subject is a subject whose antibody titer is below the cut-off value, a seropositive subject is a subject whose antibody titer is greater than or equal to the cut-off value. Microneutralization titers < 1:28 were considered below the cut-off. Microneutralization testing was cancelled.

15. Vaccine Response Rates (VRR) for Microneutralization Antibody Titers Against A/California/7/2009 (H1N1) Strain. [On Days 0, 21, 42, 63 and 182]

    Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1). Vaccine Response Rate for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. Microneutralization testing was cancelled.

16. Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain. [21 days after the second dose of Arepanrix vaccine (Day 63 for Flulaval/placebo/Arepanrix Group and Day 42 for Arepanrix/placebo/Flulaval Group)]

    The A/California vaccine virus-homologous antibody response was measured in subjects having received two doses of Arepanrix vaccine, with prior treatment with Flulaval vaccine 21 days before the first dose and in subjects having received two doses of Arepanrix vaccine alone. Titers were expressed as geometric mean antibody titers (GMTs).

17. Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain. [21 days after the second dose of the unadjuvanted formulation of Arepanrix vaccine (Day 63 for Flulaval/placebo/unadjuvanted Arepanrix Group and Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group)]

    The A/California vaccine virus-homologous antibody response was measured in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine, with prior treatment with Flulaval vaccine 21 days before the first dose and in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine alone. Titers were expressed as geometric mean antibody titers (GMTs).

18. Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain. [21 days after the second dose of the pandemic vaccine (at Day 63)]

    The A/California vaccine virus-homologous antibody response was measured in subjects pre-treated with Flulaval who subsequently received two doses of the unadjuvanted formulation of Arepanrix vaccine compared to subjects pre-treated with Flulaval vaccine who subsequently received two doses of Arepanrix vaccine. Titers were expressed as geometric mean antibody titers (GMTs).

19. Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. [21 days after the Flulaval vaccination (at Day 21).]

    The antibody response against each of the three Flulaval vaccine components in subjects exposed to co-administration of Flulaval vaccine with the first of two doses of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine. Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs).

20. Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. [21 days after the Flulaval vaccination (at Day 21).]

    The antibody response against each of the three Flulaval vaccine components in subjects exposed to co-administration of Flulaval vaccine with the first of two doses of the unadjuvanted formulation of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine. Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs).

21. Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. [21 days after the Flulaval vaccination (Day 63 for Arepanrix/placebo/Flulaval Group and Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups)]

    The antibody response against each of the three Flulaval vaccine components in subjects exposed to pre-treatment with two doses of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine. Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs).

22. Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains. [21 days after the Flulaval vaccination (Day 63 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups)]

    The antibody response against each of the three Flulaval vaccine components in subjects exposed to pre-treatment with two doses of the unadjuvanted formulation of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine. Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs).

23. Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. [On Days 0, 21, 42 and 63]

    Titers were expressed as geometric mean antibody titers (GMTs).

24. Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain. [At Day 182]

    Titers were expressed as geometric mean antibody titers (GMTs).

25. Number of Seroconverted Subjects for Antibodies Against A/ California Strain. [At Day 63 from Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 from Day 0 for the 4 other groups]

    Seroconversion rate was defined as the incidence rate of vaccinees who had either a pre-vaccination titer recorded as < 1:10 and a post-vaccination reciprocal titer ≥ 40 or a pre-vaccination reciprocal titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer. Seroconversion defined as: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer

26. Number of Seroprotected Subjects for Antibodies Against A/California Strain. [At Day 63 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 for the 4 other groups.]

    Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.

27. Seroconversion Factor for Antibodies Against A/California Strain. [At Day 63 from Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 from Day 0 for the 4 other groups]

    Seroconversion factor was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the prevaccination reciprocal HI titer.

28. Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains. [At Day 21 from Day 0 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 from Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group]

    Seroconversion defined as: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008. For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled.

29. Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains [At Day 21 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group]

    Seroprotection was defined as the proportion of subjects with H1N1 reciprocal Hemagglutination Inhibition (HI) titers ≥ 1:40 against the tested vaccine virus. Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008. For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled.

30. Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. [At Day 21 from Day 0 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 from Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group]

    Seroconversion factor was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal Hemagglutination Inhibition (HI) titer to the prevaccination reciprocal HI titer. Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008. For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled.

31. Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains [on Days 21 and 63 from Day 0 for the first 4 groups; on Days 42 and 63 from Day 0 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups]

    Seroconversion defined as: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.

32. Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains [At Day 182 from Day 0]

    Seroconversion defined as: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.

33. Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. [before vaccination and on days 21 and 63 for the first 4 groups and before vaccination and on days 42 and 63 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups]

    Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus. Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.

34. Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains. [At Day 182 after the first dose]

    Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus. Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.

35. Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. [On Days 21 and 63 from Day 0 for the first 4 groups and on Days 42 and 63 from Day 0 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups]

    Seroconversion factor of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.

36. Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains. [At Day 182 from Day 0]

    Seroconversion factor of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.

37. Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. [On Days 0, 21 and 63 for the first 4 groups and on Days 0, 42 and 63 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups]

    Titers were expressed as geometric mean titers (GMTs). Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.

38. Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains. [At Day 182 after dose 1 vaccination]

    Titers were expressed as geometric mean titers (GMTs). Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 40 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.

• Written informed consent obtained from the subject.

• Male or female adults, 19-40 years of age at the time of the first vaccination.

• Safety laboratory tests results within the parameters specified in the protocol.

• Satisfactory baseline medical assessment by physical examination.

• Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits as documented by signature on the informed consent document.

• Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user device.

• Female subjects of non-childbearing potential may be enrolled in the study.

• Female subjects of childbearing potential may be enrolled in the study, if the subject:

• has practiced adequate contraception for 30 days prior to vaccination, and

• has a negative pregnancy test on the day of first vaccination, and

• has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

• Previous vaccination with an H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-like virus.

• Prior receipt at any time of any seasonal influenza vaccine.

• Planned administration of any vaccine not foreseen by the study protocol between Day 0 and the Day 63 phlebotomy.

• Administration of any licensed vaccine within 4 weeks before the first study vaccine dose.

• Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.

• Receipt of systemic glucocorticoids within one month prior to study enrolment, or any other cytotoxic or immunosuppressive drug within six months of study enrolment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed.

• Receipt of any immunoglobulins and/or any blood products within three months of study enrolment or planned administration of any of these products during the study period.

• Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.

• Presence of a temperature >= 38.0ºC (>=100.4ºF), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.

• Diagnosed with cancer, or treatment for cancer, within 3 years.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

• Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.

• An acute evolving neurological disorder or history of Guillain-Barré syndrome within six weeks of receipt of seasonal influenza vaccine.

• Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.

• Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to first vaccination.

• Lactating or nursing women.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Stockbridge	Georgia	United States	30281
2	GSK Investigational Site	Raleigh	North Carolina	United States	27612
3	GSK Investigational Site	Austin	Texas	United States	78705
4	GSK Investigational Site	Fort Worth	Texas	United States	76135
5	GSK Investigational Site	Halifax	Nova Scotia	Canada	B3K 6R8
6	GSK Investigational Site	Montreal	Quebec	Canada	H2K 4L5
7	GSK Investigational Site	Sherbrooke	Quebec	Canada	J1H 4J6

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: NCT00985673
• Other Study ID Numbers: 113536
• First Posted: Sep 28, 2009
• Last Update Posted: Aug 1, 2018
• Last Verified: Sep 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: GSK Bio's influenza vaccine GSK2340274A; influenza infection; GSK Bio's influenza vaccine GSK2340273A
• Additional relevant MeSH terms: Influenza, Human

Study Results

Participant Flow

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Period Title: Overall Study
STARTED	102	104	102	100	101	102
COMPLETED	95	93	90	88	93	96
NOT COMPLETED	7	11	12	12	8	6

Baseline Characteristics

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group	Total
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	Total of all reporting groups
Overall Participants	102	104	102	100	101	102	611
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	29.7 (6.20)	28.6 (6.24)	28.2 (6.32)	29.2 (6.12)	29.3 (6.47)	28.1 (6.08)	28.9 (6.2)
Sex: Female, Male (Count of Participants)
Female	53 52%	62 59.6%	54 52.9%	48 48%	60 59.4%	58 56.9%	335 54.8%
Male	49 48%	42 40.4%	48 47.1%	52 52%	41 40.6%	44 43.1%	276 45.2%

Outcome Measures

1. Primary Outcome

Title	Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.
Description	The A/California vaccine virus-homologous antibody response was measured in subjects having received Flulaval vaccine co-administered with the first dose of Arepanrix vaccine, and in subjects having received two doses of Arepanrix vaccine alone. Titers were expressed as geometric mean antibody titers (GMTs).
Time Frame	21 days after the second dose of Arepanrix vaccine (at Day 42).

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	0	0	0	89	0	91
Geometric Mean (95% Confidence Interval) [Titers]	589.8	933.1

2. Primary Outcome

Title	Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.
Description	The A/California vaccine virus-homologous antibody response was measured in subjects having received Flulaval vaccine co-administered with the first dose of the unadjuvanted formulation of Arepanrix vaccine, and in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine alone. Titers were expressed as geometric mean antibody titers (GMTs).
Time Frame	21 days after the second dose of the unadjuvanted formulation of Arepanrix vaccine (at Day 42)

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	0	0	92	0	91	0
Geometric Mean (95% Confidence Interval) [Titers]	271.2	387.1

3. Secondary Outcome

Title	Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Description	Influenza-specific CD4 T-Cells were stimulated in vitro with A/California virus and seasonal Influenza viruses, related antigens or derived peptides. Stimulating antigens were A/Brisbane, A/California, pool peptides H1N1 and pool FLU.
Time Frame	On Days 0, 7, 21, 28, 42, 63 and 182

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at day 182.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	27	27	27	27	25	28
A/Brisbane [D0] (N=25,25,24,25,25,26)	2533.40 (1225.90)	2604.64 (1435.48)	3521.33 (1922.24)	2612.56 (1256.47)	2644.40 (1219.04)	2016.31 (822.34)
A/Brisbane [D7] (N=24,27,24,23,24,26)	4437.33 (1930.30)	4595.26 (2058.76)	5560.33 (3301.90)	6242.30 (2773.60)	4269.96 (1744.37)	4674.88 (2325.77)
A/Brisbane [D21] (N=26,25,27,24,24,26)	3561.00 (1502.24)	3756.72 (1379.69)	5581.78 (3123.38)	6069.67 (3306.79)	3894.54 (1596.44)	5590.23 (2407.32)
A/Brisbane [D28] (N=27,27,27,26,25,27)	3500.22 (1615.89)	4269.11 (1482.01)	5102.78 (2856.77)	6989.15 (3950.45)	3816.20 (1290.25)	7083.19 (3227.04)
A/Brisbane [D42] (N=27,26,27,27,24,28)	3595.11 (1268.17)	5246.88 (2407.94)	4791.41 (2706.43)	5607.96 (2773.17)	3872.67 (1270.26)	6200.64 (2733.75)
A/Brisbane [D63] (N=26,26,25,25,24,26)	3407.62 (1114.62)	6444.50 (2681.50)	4169.32 (2216.49)	5020.88 (2346.39)	4074.38 (1639.45)	5757.04 (3131.86)
A/Brisbane [D182] (N=26,24,26,26,25,25)	3190.31 (1086.38)	4631.00 (1834.57)	4132.81 (1816.70)	3988.04 (1606.16)	3672.16 (1191.85)	4568.16 (2043.61)
A/California [D0] (N=25,25,24,25,25,26)	2176.28 (1226.08)	1988.24 (1072.73)	2804.63 (1912.94)	2055.44 (1053.95)	2109.52 (828.11)	1641.04 (799.39)
A/California [D7] (N=24,27,24,23,24,26)	4089.25 (2131.69)	3852.44 (1970.35)	4780.21 (2828.25)	5265.74 (2008.41)	3224.42 (1238.08)	3590.08 (1912.94)
A/California [D21] (N=26,25,27,24,24,26)	3144.62 (1723.51)	3032.52 (1342.30)	4455.00 (2768.12)	4986.71 (2398.42)	2975.38 (1058.31)	4793.35 (2194.74)
A/California [D28] (N=27,27,27,26,25,27)	3061.63 (1632.58)	3770.44 (1460.62)	4058.63 (2349.19)	5979.12 (3448.84)	2875.52 (837.73)	6689.44 (3501.59)
A/California [D42] (N=27,27,27,27,24,28)	2931.04 (1276.42)	4381.48 (2053.51)	3720.07 (2261.08)	4658.07 (1939.82)	2838.00 (1008.20)	5622.14 (2870.26)
A/California [D63] (N=26,26,25,25,24,26)	2768.15 (1109.96)	5328.19 (2436.59)	3149.00 (1844.25)	3967.12 (1655.09)	3246.71 (1379.49)	5151.62 (3008.33)
A/California [D182] (N=26,24,26,26,25,25)	1461.88 (735.77)	2333.88 (925.38)	1838.96 (842.26)	2068.73 (939.92)	1630.40 (592.23)	2513.48 (1232.20)
Pool peptides H1 [D0] (N=25,24,24,25,23,25)	349.64 (336.13)	428.00 (296.76)	356.79 (206.44)	320.52 (216.19)	443.35 (356.02)	271.76 (180.44)
Pool peptides H1 [D7] (N=24,27,24,23,24,25)	596.42 (500.15)	581.63 (527.07)	708.96 (518.87)	857.04 (474.48)	692.29 (454.48)	718.76 (663.81)
Pool peptides H1 [D21] (N=26,24,27,24,24,26)	465.42 (352.18)	589.79 (459.57)	728.15 (623.89)	974.67 (579.23)	619.50 (391.47)	1022.38 (572.50)
Pool peptides H1 [D28] (N=26,27,27,26,25,27)	480.42 (392.81)	704.59 (518.63)	528.78 (322.10)	1345.69 (1536.94)	642.00 (379.90)	1251.07 (695.04)
Pool peptides H1 [D42] (N=27,27,27,27,24,28)	467.70 (302.91)	1049.96 (865.58)	514.78 (296.67)	1080.93 (669.26)	600.04 (496.71)	1228.25 (637.35)
Pool peptides H1 [D63] (N=26,26,25,25,24,26)	504.92 (321.17)	1248.54 (1175.35)	460.28 (267.85)	815.24 (634.45)	508.58 (316.75)	910.81 (482.86)
Pool peptides H1 [D182] (N=26,24,26,26,25,25)	554.65 (439.30)	824.17 (565.53)	531.73 (481.91)	648.69 (557.34)	552.52 (528.46)	757.68 (638.40)
Pool Flu [D0] (N=24,25,24,25,25,24)	3286.63 (1710.00)	3531.36 (1972.37)	4315.71 (2499.77)	3056.80 (1096.38)	3308.08 (1124.49)	2775.50 (1214.18)
Pool Flu [D7] (N=24,27,24,23,24,25)	6574.50 (3399.35)	6921.85 (4366.14)	7096.46 (3777.79)	7682.43 (2951.47)	4668.17 (1675.47)	4713.28 (2161.14)
Pool Flu [D21] (N=25,25,27,24,24,25)	5234.16 (2513.78)	5124.60 (2268.53)	6579.26 (3489.20)	6949.96 (3006.25)	4329.96 (1672.20)	5691.08 (2047.10)
Pool Flu [D28] (N=25,27,27,26,25,26)	4767.36 (2217.82)	5256.07 (2292.16)	6090.00 (3336.49)	7265.23 (3520.63)	4047.92 (1219.00)	6804.42 (2824.80)
Pool Flu [D42] (N=26,27,27,26,24,27)	4734.42 (1823.28)	5881.78 (2641.14)	5721.70 (3058.63)	6239.38 (2542.17)	4167.63 (1351.74)	6215.93 (2389.59)
Pool Flu [D63] (N=25,26,25,25,24,24)	4405.96 (1586.42)	6639.92 (3131.66)	4893.88 (2322.10)	5323.84 (2132.52)	4900.17 (2016.61)	6455.25 (2694.48)
Pool Flu [D182] (N=26,24,26,26,25,25)	3304.50 (1393.44)	4325.63 (1541.34)	4006.46 (1836.30)	3937.67 (1413.94)	3918.28 (1284.32)	4277.76 (1655.16)

4. Secondary Outcome

Title	Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Description	Influenza-specific CD8 T-Cells were stimulated in vitro with A/California virus and seasonal Influenza viruses, related antigens or derived peptides. Stimulating antigens were A/Brisbane, A/California, pool peptides H1N1 and pool FLU.
Time Frame	On Days 0, 7, 21, 28, 42, 63 and 182

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at day 182.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	27	27	27	27	25	28
A/Brisbane [D0] (N=25,25,24,25,25,26)	515.36 (1191.10)	382.84 (595.58)	489.08 (520.30)	183.96 (226.54)	1222.40 (4485.04)	119.46 (113.79)
A/Brisbane [D7] (N=24,27,24,23,24,26)	772.96 (716.40)	884.81 (1225.90)	1115.96 (1545.07)	725.39 (585.98)	1611.96 (4894.45)	529.73 (416.76)
A/Brisbane [D21] (N=26,25,27,24,24,26)	601.31 (1154.73)	517.44 (799.20)	655.22 (1327.00)	319.17 (315.86)	1184.17 (4146.13)	501.08 (1319.91)
A/Brisbane [D28] (N=27,27,27,26,25,27)	629.22 (964.11)	642.22 (850.79)	498.33 (730.34)	508.88 (540.73)	1466.76 (5768.96)	1735.48 (5219.43)
A/Brisbane [D42] (N=27,26,27,27,24,28)	666.67 (1180.05)	551.88 (911.02)	525.07 (938.18)	209.07 (171.21)	1737.50 (6861.67)	501.54 (1329.90)
A/Brisbane [D63] (N=26,26,25,25,24,26)	620.00 (1393.77)	420.50 (486.62)	428.92 (687.17)	230.84 (226.10)	1493.46 (5828.76)	529.81 (1383.73)
A/Brisbane [D182] (N=26,24,26,26,25,25)	550.27 (1948.06)	436.79 (653.50)	377.65 (426.59)	86.81 (99.38)	1474.56 (6012.19)	370.64 (955.57)
A/California [D0] (N=25,25,24,25,25,26)	357.40 (800.46)	189.28 (197.92)	271.58 (192.68)	365.72 (985.87)	482.64 (1286.27)	93.50 (114.90)
A/California [D7] (N=24,27,24,23,24,26)	610.29 (744.70)	466.93 (573.69)	716.88 (1251.20)	553.78 (639.15)	834.50 (2063.34)	348.69 (326.74)
A/California [D21] (N=26,25,27,24,24,26)	332.00 (539.48)	275.04 (334.83)	324.37 (668.77)	183.00 (146.43)	428.92 (1071.57)	351.69 (713.52)
A/California [D28] (N=27,27,27,26,25,27)	470.33 (655.02)	452.93 (547.61)	332.63 (553.07)	344.54 (288.96)	973.96 (3644.93)	497.67 (612.95)
A/California [D42] (N=27,27,27,27,24,28)	314.89 (289.95)	304.00 (255.38)	247.89 (459.58)	157.67 (192.15)	702.50 (2209.62)	291.96 (654.16)
A/California [D63] (N=26,2625,25,24,26)	203.62 (197.89)	260.54 (359.88)	242.36 (357.21)	114.24 (165.15)	853.83 (3236.11)	194.73 (453.09)
A/California [D182] (N=26,24,26,26,25,25)	214.85 (326.43)	220.71 (330.88)	225.50 (366.51)	139.50 (273.43)	598.92 (2344.64)	138.52 (245.14)
Pool peptides H1 [D0] (N=25,24,24,25,23,25)	110.48 (140.31)	180.38 (359.58)	101.04 (158.31)	150.08 (215.56)	111.26 (162.75)	70.92 (113.24)
Pool peptides H1 [D7] (N=24,27,24,23,24,25)	205.33 (288.67)	185.15 (243.88)	202.13 (293.11)	254.65 (417.53)	243.46 (382.39)	173.48 (202.67)
Pool peptides H1 [D21] (N=26,24,27,24,24,26)	103.81 (160.76)	194.92 (384.18)	101.30 (148.62)	140.75 (155.63)	211.96 (482.54)	173.77 (432.74)
Pool peptides H1 [D28] (N=26,27,27,26,25,27)	100.08 (132.13)	170.04 (385.99)	124.56 (181.86)	277.77 (329.71)	160.80 (216.87)	187.37 (361.53)
Pool peptides H1 [D42] (N=27,27,27,27,24,28)	143.67 (189.28)	157.41 (350.83)	87.41 (115.12)	103.89 (139.95)	266.75 (481.50)	145.96 (261.67)
Pool peptides H1 [D63] (N=26,26,25,25,24,26)	85.96 (97.66)	173.88 (244.91)	113.20 (193.78)	88.28 (162.10)	210.33 (403.19)	88.19 (206.24)
Pool peptides H1 [D182] (N=26,24,26,26,25,25)	287.31 (511.19)	265.63 (343.36)	306.04 (630.16)	241.42 (353.02)	255.44 (425.71)	198.44 (561.99)
Pool Flu [D0] (N=24,25,24,25,25,24)	351.38 (467.93)	224.60 (251.59)	478.42 (463.43)	344.60 (641.98)	761.68 (2411.00)	157.63 (166.45)
Pool Flu [D7] (N=24,27,24,23,24,25)	986.92 (863.16)	843.44 (826.65)	1042.17 (1237.44)	788.78 (947.53)	1094.96 (3111.41)	522.84 (514.35)
Pool Flu [D21] (N=25,25,27,24,24,25)	586.32 (876.08)	268.24 (324.48)	609.07 (997.10)	266.63 (252.28)	693.88 (2082.82)	406.28 (620.10)
Pool Flu [D28] (N=25,27,27,26,25,26)	484.48 (587.46)	508.11 (559.97)	505.33 (595.15)	458.12 (496.69)	963.20 (3548.16)	423.62 (430.29)
Pool Flu [D42] (N=26,27,27,26,24,27)	506.35 (560.83)	356.41 (392.23)	471.30 (610.38)	344.77 (709.66)	996.67 (3648.68)	391.11 (755.53)
Pool Flu [D63] (N=25,26,25,25,24,24)	461.20 (698.48)	325.12 (270.84)	402.24 (418.89)	296.08 (624.75)	1123.13 (4008.27)	432.08 (1145.71)
Pool Flu [D182] (N=26,24,26,26,25,25)	404.77 (981.01)	315.75 (441.50)	334.23 (447.12)	291.73 (790.15)	926.40 (3463.27)	234.92 (398.06)

5. Secondary Outcome

Title	Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Description	Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatase (AP), bilirubin (BIL) (total (T)), basophils (BAS). For each parameter and for each range it was assessed whether the values of the subjects were in unkown, above, below or within the range.
Time Frame	On Days 0, 7, 21, 28, 42, 63 and 182

Outcome Measure Data

Analysis Population Description

The Total Vaccinated Cohort included all vaccinated subjects.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	102	104	102	100	101	102
ALAT [D0] Below (N=102,101,102,100,101,102)	0	0	0	0	0	0
ALAT [D0] Within (N=102,101,102,100,101,102)	100	101	99	95	100	99
ALAT [D0] Above (N=102,101,102,100,101,102)	2	3	2	4	0	3
ALAT [D7] Below (N=102,101,100,99,100,99)	0	0	0	0	0	0
ALAT [D7] Within (N=102,101,100,99,100,99)	100	96	99	97	100	98
ALAT [D7] Above (N=102,101,100,99,100,99)	2	5	1	2	0	1
ALAT [D21] Below (N=101,100,97,97,99,99)	0	0	0	0	0	0
ALAT [D21] Within (N=101,100,97,97,99,99)	96	97	96	96	96	97
ALAT [D21] Above (N=101,100,97,97,99,99)	5	3	1	1	3	1
ALAT [D28] Below (N=101,98,96,98,98,97)	0	0	0	0	0	0
ALAT [D28] Within (N=101,98,96,98,98,97)	96	96	94	93	96	92
ALAT [D28] Above (N=101,98,96,98,98,97)	4	2	2	4	2	4
ALAT [D42] Below (N=101,97,95,95,96,97)	0	0	0	0	0	0
ALAT [D42] Within (N=101,97,95,95,96,97)	97	94	93	94	92	95
ALAT [D42] Above (N=101,97,95,95,96,97)	4	3	1	1	2	2
ALAT [D63] Below (N=100,95,95,95,97,97)	0	0	0	0	0	0
ALAT [D63] Within (N=100,95,95,95,97,97)	93	89	93	95	93	92
ALAT [D63] Above (N=100,95,95,95,97,97)	6	5	1	0	3	3
ALAT [D182] Below (N=99,91,88,91,93,97)	0	0	0	0	0	0
ALAT [D182] Within (N=99,91,88,91,93,97)	97	89	88	90	91	95
ALAT [D182] Above (N=99,91,88,91,93,97)	2	1	0	1	1	2
AP [D0] Below (N=102,104, 102,100,101,102)	0	0	0	0	0	0
AP [D0] Within (N=102,104, 102,100,101,102)	102	104	100	98	99	101
AP [D0] Above (N=102,104, 102,100,101,102)	0	0	1	1	1	1
AP [D7] Below (N=102,101,100,99,100,99)	0	0	0	0	0	0
AP [D7] Within (N=102,101,100,99,100,99)	101	101	100	98	99	98
AP [D7] Above (N=102,101,100,99,100,99)	1	0	0	1	1	1
AP [D21] Below (N=101,100,97,97,99,99)	0	0	0	0	0	0
AP [D21] Within (N=101,100,97,97,99,99)	101	100	96	96	97	97
AP [D21] Above (N=101,100,97,97,99,99)	0	0	1	1	2	1
AP [D28] Below (N=101,98,96,98,98,97)	0	0	0	0	0	0
AP [D28] Within (N=101,98,96,98,98,97)	99	97	95	95	98	96
AP [D28] Above (N=101,98,96,98,98,97)	1	1	1	2	0	0
AP [D42] Below (N=101,97, 95,95,96,97)	0	0	0	0	0	0
AP [D42] Within (N=101,97, 95,95,96,97)	99	97	94	92	93	96
AP [D42] Above (N=101,97, 95,95,96,97)	2	0	0	3	1	1
AP [D63] Below (N=100,95,95,95,97,97)	0	0	0	0	0	0
AP [D63] Within (N=100,95,95,95,97,97)	99	94	93	92	95	94
AP [D63] Above (N=100,95,95,95,97,97)	0	0	1	3	1	1
AP [D182] Below (N=99,91,88,91,93,97)	0	0	0	0	0	0
AP [D182] Within (N=99,91,88,91,93,97)	98	90	88	90	89	97
AP [D182] Above (N=99,91,88,91,93,97)	1	0	0	1	3	0
ASAT [D0] Below (N=102,104,102,100,101,102)	0	0	0	0	0	0
ASAT [D0] Within (N=102,104,102,100,101,102)	101	102	100	98	99	101
ASAT [D0] Above (N=102,104,102,100,101,102)	1	2	1	1	1	1
ASAT [D7] Below (N=102,101,100,99,100,99)	0	0	0	0	0	0
ASAT [D7] Within (N=102,101,100,99,100,99)	99	99	97	99	99	97
ASAT [D7] Above (N=102,101,100,99,100,99)	3	2	2	0	1	2
ASAT [D21] Below (N=101,100,97,97,99,99)	0	0	0	0	0	0
ASAT [D21] Within (N=101,100,97,97,99,99)	99	99	97	97	98	97
ASAT [D21] Above (N=101,100,97,97,99,99)	2	1	0	0	1	1
ASAT [D28] Below (N=101,98,96,98,98,97)	0	0	0	0	0	0
ASAT [D28] Within (N=101,98,96,98,98,97)	96	97	93	95	98	93
ASAT [D28] Above (N=101,98,96,98,98,97)	4	1	3	2	0	3
ASAT [D42] Below (N=101,97,95,95,96,97)	0	0	0	0	0	0
ASAT [D42] Within (N=101,97,95,95,96,97)	95	95	93	95	94	97
ASAT [D42] Above (N=101,97,95,95,96,97)	6	2	1	0	0	0
ASAT [D63] Below (N=100,95,95,95,97,97)	0	0	0	0	0	0
ASAT [D63] Within (N=100,95,95,95,97,97)	98	94	92	94	95	93
ASAT [D63] Above (N=100,95,95,95,97,97)	1	0	1	1	0	2
ASAT [D182] Below (N=99,91,88,91,93,97)	0	0	0	0	0	0
ASAT [D182] Within (N=99,91,88,91,93,97)	96	86	87	88	91	97
ASAT [D182] Above (N=99,91,88,91,93,97)	2	4	0	3	1	0
BAS [D0] Below (N=102,104,102,100,101,102)	0	0	0	0	0	0
BAS [D0] Within (N=102,104,102,100,101,102)	100	104	102	98	101	102
BAS [D0] Above (N=102,104,102,100,101,102)	0	0	0	0	0	0
BAS [D7] Below (N=102,101,100,99,100,99)	0	0	0	0	0	0
BAS [D7] Within (N=102,101,100,99,100,99)	102	100	100	98	100	99
BAS [D7] Above (N=102,101,100,99,100,99)	0	0	0	0	0	0
BAS [D21] Below (N=101,100,97,97,99,99)	0	0	0	0	0	0
BAS [D21] Within (N=101,100,97,97,99,99)	101	99	94	96	97	95
BAS [D21] Above (N=101,100,97,97,99,99)	0	0	0	0	0	0
BAS [D28] Below (N=101,98,96,98,98,97)	0	0	0	0	0	0
BAS [D28] Within (N=101,98,96,98,98,97)	99	96	96	96	97	94
BAS [D28] Above (N=101,98,96,98,98,97)	0	0	0	0	0	0
BAS [D42] Below (N=101,97,95,95,96,97)	0	0	0	0	0	0
BAS [D42] Within (N=101,97,95,95,96,97)	101	97	95	95	96	97
BAS [D42] Above (N=101,97,95,95,96,97)	0	0	0	0	0	0
BAS [D63] Below (N=100,95,95,95,97,97)	0	0	0	0	0	0
BAS [D63] Within (N=100,95,95,95,97,97)	100	95	95	95	97	97
BAS [D63] Above (N=100,95,95,95,97,97)	0	0	0	0	0	0
BAS [D182] Below (N=99,91,88,91,93,97)	0	0	0	0	0	0
BAS [D182] Within (N=99,91,88,91,93,97)	99	91	88	89	93	96
BAS [D182] Above (N=99,91,88,91,93,97)	0	0	0	0	0	0
BIL T [D0] Below (N=102,104,102,100,101,102)	0	0	0	0	0	0
BIL T [D0] Within (N=102,104,102,100,101,102)	101	102	100	98	99	101
BIL T [D0] Above (N=102,104,102,100,101,102)	1	2	1	1	1	1
BIL T [D7] Below (N=102,101,100,99,100,99)	0	0	0	0	0	0
BIL T [D7] Within (N=102,101,100,99,100,99)	101	100	97	98	99	97
BIL T [D7] Above (N=102,101,100,99,100,99)	1	1	3	1	1	2
BIL T [D21] Below (N=101,100,97,97,99,99)	0	0	0	0	0	0
BIL T [D21] Within (N=101,100,97,97,99,99)	99	97	95	96	97	97
BIL T [D21] Above (N=101,100,97,97,99,99)	2	3	2	1	2	1
BIL T [D28] Below (N=101,98,96,98,98,97)	0	0	0	0	0	0
BIL T [D28] Within (N=101,98,96,98,98,97)	99	96	94	95	97	95
BIL T [D28] Above (N=101,98,96,98,98,97)	1	2	2	2	1	1
BIL T [D42] Below (N=101,97,95,95,96,97)	0	0	0	0	0	0
BIL T [D42] Within (N=101,97,95,95,96,97)	98	93	92	91	93	95
BIL T [D42] Above (N=101,97,95,95,96,97)	3	4	2	4	1	2
BIL T [D63] Below (N=100,95,95,95,97,97)	0	0	0	0	0	0
BIL T [D63] Within (N=100,95,95,95,97,97)	98	92	92	94	93	94
BIL T [D63] Above (N=100,95,95,95,97,97)	1	2	2	1	3	1
BIL T [D182] Below (N=99,91,88,91,93,97)	0	0	0	0	0	0
BIL T [D182] Within (N=99,91,88,91,93,97)	99	87	86	89	90	96
BIL T [D182] Above (N=99,91,88,91,93,97)	0	3	2	2	2	1
ALAT [D0] Unknown (N=102,101,102,100,101,102)	0	0	1	1	1	0
ALAT [D7] Unknown (N=102,101,100,99,100,99)	0	0	0	0	0	0
ALAT [D21] Unknown (N=101,100,97,97,99,99)	0	0	0	0	0	1
ALAT [D28] Unknown (N=101,98,96,98,98,97)	1	0	0	1	0	1
ALAT [D42] Unknown (N=101,97,95,95,96,97)	0	0	1	0	2	0
ALAT [D63] Unknown (N=100,95,95,95,97,97)	1	1	1	0	1	2
ALAT [D182] Unknown (N=99,91,88,91,93,97)	0	1	0	0	1	0
AP [D0] Unknown (N=102,104, 102,100,101,102)	0	0	1	1	1	0
AP [D7] Unknown (N=102,101,100,99,100,99)	0	0	0	0	0	0
AP [D21] Unknown (N=101,100,97,97,99,99)	0	0	0	0	0	1
AP [D28] Unknown (N=101,98,96,98,98,97)	1	0	0	1	0	1
AP [D42] Unknown (N=101,97, 95,95,96,97)	0	0	1	0	2	0
AP [D63] Unknown (N=100,95,95,95,97,97)	1	1	1	0	1	2
AP [D182] Unknown (N=99,91,88,91,93,97)	0	1	0	0	1	0
ASAT [D0] Unknown (N=102,104,102,100,101,102)	0	0	1	1	1	0
ASAT [D7] Unknown (N=102,101,100,99,100,99)	0	0	1	0	0	0
ASAT [D21] Unknown (N=101,100,97,97,99,99)	0	0	0	0	0	1
ASAT [D28] Unknown (N=101,98,96,98,98,97)	1	0	0	1	0	1
ASAT [D42] Unknown (N=101,97,95,95,96,97)	0	0	1	0	2	0
ASAT [D63] Unknown (N=100,95,95,95,97,97)	1	1	2	0	2	2
ASAT [D182] Unknown (N=99,91,88,91,93,97)	1	1	1	0	1	0
BAS [D0] Unknown (N=102,104,102,100,101,102)	2	0	0	2	0	0
BAS [D7] Unknown (N=102,101,100,99,100,99)	0	1	0	1	0	0
BAS [D21] Unknown (N=101,100,97,97,99,99)	0	1	3	1	2	4
BAS [D28] Unknown (N=101,98,96,98,98,97)	2	2	0	2	1	3
BAS [D42] Unknown (N=101,97,95,95,96,97)	0	0	0	0	0	0
BAS [D63] Unknown (N=100,95,95,95,97,97)	0	0	0	0	0	0
BAS [D182] Unknown (N=99,91,88,91,93,97)	0	0	0	2	0	1
BIL T [D0] Unknown (N=102,104,102,100,101,102)	0	0	1	1	1	0
BIL T [D7] Unknown (N=102,101,100,99,100,99)	0	0	0	0	0	0
BIL T [D21] Unknown (N=101,100,97,97,99,99)	0	0	0	0	0	1
BIL T [D28] Unknown (N=101,98,96,98,98,97)	1	0	0	1	0	1
BIL T [D42] Unknown (N=101,97,95,95,96,97)	0	0	1	0	2	0
BIL T [D63] Unknown (N=100,95,95,95,97,97)	1	1	1	0	1	2
BIL T [D182] Unknown (N=99,91,88,91,93,97)	0	1	0	0	1	0

6. Secondary Outcome

Title	Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Description	Laboratory parameters assessed were creatinine (CREA), bilirubin (BIL) (direct (D)), eosinophils (EOS), hemoglobin (Hgb), hematocrit (Hct). For each parameter and for each range it was assessed whether the values of the subjects were unknown, in above, below or within the range.
Time Frame	On Days 0, 7, 21, 28, 42, 63 and 182

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort included all vaccinated subjects

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	102	104	102	100	101	102
BIL D [D0] Below (N=102,104,102,100,101,102)	0	0	0	0	0	0
BIL D [D0] Within (N=102,104,102,100,101,102)	101	104	101	99	100	102
BIL D [D0] Above (N=102,104,102,100,101,102)	0	0	0	0	0	0
BIL D [D0] Unknown (N=102,104,102,100,101,102)	1	0	1	1	1	0
BIL D [D7] Below (N=102,101,100,99,100,99)	0	0	0	0	0	0
BIL D [D7] Within (N=102,101,100,99,100,99)	102	101	100	99	100	99
BIL D [D7] Above (N=102,101,100,99,100,99)	0	0	0	0	0	0
BIL D [D7] Unknown(N=102,101,100,99,100,99)	0	0	0	0	0	0
BIL D [D21] Below (N=101,100,97,97,99,99)	0	0	0	0	0	0
BIL D [D21] Within (N=101,100,97,97,99,99)	101	100	97	97	99	98
BIL D [D21] Above (N=101,100,97,97,99,99)	0	0	0	0	0	0
BIL D [D21] Unknown (N=101,100,97,97,99,99)	0	0	0	0	0	1
BIL D [D28] Below (N=101,98,96,98,98,97)	0	0	0	0	0	0
BIL D [D28] Within (N=101,98,96,98,98,97)	100	98	96	97	98	96
BIL D [D28] Above (N=101,98,96,98,98,97)	0	0	0	0	0	0
BIL D [D28] Unknown (N=101,98,96,98,98,97)	1	0	0	1	0	1
BIL D [D42] Below (N=101,97,95,95,96,97)	0	0	0	0	0	0
BIL D [D42] Within (N=101,97,95,95,96,97)	101	97	94	95	94	97
BIL D [D42] Above (N=101,97,95,95,96,97)	0	0	0	0	0	0
BIL D [D42] Unknown (N=101,97,95,95,96,97)	0	0	1	0	2	0
BIL D [D63] Below (N=100,95,95,95,97,97)	0	0	0	0	0	0
BIL D [D63] Within (N=100,95,95,95,97,97)	99	94	94	95	96	95
BIL D [D63] Above (N=100,95,95,95,97,97)	0	0	0	0	0	0
BIL D [D63] Unknown (N=100,95,95,95,97,97)	1	1	1	0	1	2
BIL D [D182] Below (N=99,91,88,91,93,97)	0	0	0	0	0	0
BIL D [D182] Within (N=99,91,88,91,93,97)	99	90	88	91	92	96
BIL D [D182] Above (N=99,91,88,91,93,97)	0	0	0	0	0	1
BIL D [D182] Unknown (N=99,91,88,91,93,97)	0	1	0	0	1	0
CREA [D0] Below (N=102,104,102,100,101,102)	8	6	6	9	8	9
CREA [D0] Within (N=102,104,102,100,101,102)	93	97	94	88	92	92
CREA [D0] Above (N=102,104,102,100,101,102)	1	1	1	2	0	1
CREA [D0] Unknown (N=102,104,102,100,101,102)	0	0	1	1	1	0
CREA [D7] Below (N=102,101,100,99,100,99)	8	6	9	17	7	8
CREA [D7] Within (N=102,101,100,99,100,99)	94	93	91	81	93	90
CREA [D7] Above (N=102,101,100,99,100,99)	0	2	0	1	0	1
CREA [D7] Unknown (N=102,101,100,99,100,99)	0	0	0	0	0	0
CREA [D21] Below (N=101,100,97,97,99,99)	12	6	5	16	10	9
CREA [D21] Within (N=101,100,97,97,99,99)	88	92	92	81	89	87
CREA [D21] Above (N=101,100,97,97,99,99)	1	2	0	0	0	2
CREA [D21] Unknown (N=101,100,97,97,99,99)	0	0	0	0	0	1
CREA [D28] Below (N=101,98,96,98,98,97)	5	8	6	15	7	7
CREA [D28] Within (N=101,98,96,98,98,97)	95	90	89	81	91	89
CREA [D28] Above (N=101,98,96,98,98,97)	0	0	1	1	0	0
CREA [D28] Unknown (N=101,98,96,98,98,97)	1	0	0	1	0	1
CREA [D42] Below (N=101,97,95,95,96,97)	6	5	5	10	9	11
CREA [D42] Within (N=101,97,95,95,96,97)	95	90	88	84	85	86
CREA [D42] Above (N=101,97,95,95,96,97)	0	2	1	1	0	0
CREA [D42] Unknown (N=101,97,95,95,96,97)	0	0	1	0	2	0
CREA [D63] Below (N=100,95,95,95,97,97)	7	7	7	14	7	9
CREA [D63] Within (N=100,95,95,95,97,97)	92	86	87	78	89	85
CREA [D63] Above (N=100,95,95,95,97,97)	0	1	0	3	0	1
CREA [D63] Unknown (N=100,95,95,95,97,97)	1	1	1	0	1	2
CREA [D182] Below (N=99,91,88,91,93,97)	14	7	7	10	6	14
CREA [D182] Within (N=99,91,88,91,93,97)	84	82	80	81	86	83
CREA [D182] Above (N=99,91,88,91,93,97)	1	1	1	0	0	0
CREA [D182] Unknown (N=99,91,88,91,93,97)	0	1	0	0	1	0
EOS [D0] Below (N=102,104,102,100,101,102)	2	6	7	5	9	5
EOS [D0] Within (N=102,104,102,100,101,102)	97	96	93	92	90	97
EOS [D0] Above (N=102,104,102,100,101,102)	1	2	2	1	2	0
EOS [D0] Unknown (N=102,104,102,100,101,102)	2	0	0	2	0	0
EOS [D7] Below (N=102,101,100,99,100,99)	7	4	7	1	5	8
EOS [D7] Within (N=102,101,100,99,100,99)	93	93	91	95	92	89
EOS [D7] Above (N=102,101,100,99,100,99)	2	3	2	2	3	2
EOS [D7] Unknown (N=102,101,100,99,100,99)	0	1	0	1	0	0
EOS [D21] Below (N=101,100,97,97,99,99)	2	8	9	8	9	3
EOS [D21] Within (N=101,100,97,97,99,99)	97	87	85	87	85	92
EOS [D21] Above (N=101,100,97,97,99,99)	2	4	0	1	3	0
EOS [D21] Unknown (N=101,100,97,97,99,99)	0	1	3	1	2	4
EOS [D28] Below (N=101,98,96,98,98,97)	4	4	7	2	7	5
EOS [D28] Within (N=101,98,96,98,98,97)	94	90	89	93	90	87
EOS [D28] Above (N=101,98,96,98,98,97)	1	2	0	1	0	2
EOS [D28] Unknown (N=101,98,96,98,98,97)	2	2	0	2	1	3
EOS [D42] Below (N=101,97,95,95,96,97)	4	9	6	5	8	9
EOS [D42] Within (N=101,97,95,95,96,97)	96	86	89	89	85	88
EOS [D42] Above (N=101,97,95,95,96,97)	1	2	0	1	3	0
EOS [D42] Unknown (N=101,97,95,95,96,97)	0	0	0	0	0	0
EOS [D63] Below (N=100,95,95,95,97,97)	2	9	8	4	8	10
EOS [D63] Within (N=100,95,95,95,97,97)	97	82	85	90	88	86
EOS [D63] Above (N=100,95,95,95,97,97)	1	4	2	1	1	1
EOS [D63] Unknown (N=100,95,95,95,97,97)	0	0	0	0	0	0
EOS [D182] Below (N=99,91,88,91,93,97)	3	4	9	3	6	5
EOS [D182] Within (N=99,91,88,91,93,97)	94	86	78	83	84	89
EOS [D182] Above (N=99,91,88,91,93,97)	2	1	1	3	3	2
EOS [D182] Unknown (N=99,91,88,91,93,97)	0	0	0	2	0	1
Hct [D0] Below (N=102,104,102,100,101,102)	4	2	4	3	3	5
Hct [D0] Within (N=102,104,102,100,101,102)	94	99	95	92	97	97
Hct [D0] Above (N=102,104,102,100,101,102)	2	3	3	3	1	0
Hct [D0] Unknown (N=102,104,102,100,101,102)	2	0	0	2	0	0
Hct [D7] Below (N=102,101,100,99,100,99)	7	7	4	4	3	6
Hct [D7] Within (N=102,101,100,99,100,99)	93	91	95	92	97	92
Hct [D7] Above (N=102,101,100,99,100,99)	2	2	1	2	0	1
Hct [D7] Unknown (N=102,101,100,99,100,99)	0	1	0	1	0	0
Hct [D21] Below (N=101,100,97,97,99,99)	8	4	5	8	6	4
Hct [D21] Within (N=101,100,97,97,99,99)	92	94	88	88	91	91
Hct [D21] Above (N=101,100,97,97,99,99)	1	1	1	0	0	1
Hct [D21] Unknown (N=101,100,97,97,99,99)	0	1	3	1	2	3
Hct [D28] Below (N=101,98,96,98,98,97)	10	6	8	9	5	9
Hct [D28] Within (N=101,98,96,98,98,97)	89	88	86	88	92	84
Hct [D28] Above (N=101,98,96,98,98,97)	1	2	2	0	0	1
Hct [D28] Unknown (N=101,98,96,98,98,97)	1	2	0	1	1	3
Hct [D42] Below (N=101,97,95,95,96,97)	11	9	9	7	10	14
Hct [D42] Within (N=101,97,95,95,96,97)	90	86	86	88	86	83
Hct [D42] Above (N=101,97,95,95,96,97)	0	2	0	0	0	0
Hct [D42] Unknown (N=101,97,95,95,96,97)	0	0	0	0	0	0
Hct [D63] Below (N=100,95,95,95,97,97)	8	10	11	6	10	10
Hct [D63] Within (N=100,95,95,95,97,97)	92	84	84	89	87	87
Hct [D63] Above (N=100,95,95,95,97,97)	0	1	0	0	0	0
Hct [D63] Unknown (N=100,95,95,95,97,97)	0	0	0	0	0	0
Hct [D182] Below (N=99,91,88,91,93,97)	4	6	4	3	7	10
Hct [D182] Within (N=99,91,88,91,93,97)	93	84	82	85	86	86
Hct [D182] Above (N=99,91,88,91,93,97)	2	1	2	1	0	1
Hct [D182] Unknown (N=99,91,88,91,93,97)	0	0	0	2	0	0
Hgb [D0] Below (N=102,104,102,100,101,102)	2	6	5	1	4	5
Hgb [D0] Within (N=102,104,102,100,101,102)	97	97	95	97	97	97
Hgb [D0] Above (N=102,104,102,100,101,102)	1	1	2	0	0	0
Hgb [D0] Unknown (N=102,104,102,100,101,102)	2	0	0	2	0	0
Hgb [D7] Below (N=102,101,100,99,100,99)	6	7	5	2	4	3
Hgb [D7] Within (N=102,101,100,99,100,99)	94	91	94	96	96	95
Hgb [D7] Above (N=102,101,100,99,100,99)	2	2	1	0	0	1
Hgb [D7] Unknown (N=102,101,100,99,100,99)	0	1	0	1	0	0
Hgb [D21] Below (N=101,100,97,97,99,99)	6	5	3	6	5	4
Hgb [D21] Within (N=101,100,97,97,99,99)	93	94	90	90	92	91
Hgb [D21] Above (N=101,100,97,97,99,99)	2	0	1	0	0	1
Hgb [D21] Unknown (N=101,100,97,97,99,99)	0	1	3	1	2	3
Hgb [D28] Below (N=101,98,96,98,98,97)	10	7	5	8	1	4
Hgb [D28] Within (N=101,98,96,98,98,97)	90	88	89	89	96	90
Hgb [D28] Above (N=101,98,96,98,98,97)	0	1	2	0	0	0
Hgb [D28] Unknown (N=101,98,96,98,98,97)	1	2	0	1	1	3
Hgb [D42] Below (N=101,97,95,95,96,97)	7	8	6	3	6	11
Hgb [D42] Within (N=101,97,95,95,96,97)	94	87	89	92	90	86
Hgb [D42] Above (N=101,97,95,95,96,97)	0	2	0	0	0	0
Hgb [D42] Unknown (N=101,97,95,95,96,97)	0	0	0	0	0	0
Hgb [D63] Below (N=100,95,95,95,97,97)	8	10	6	4	9	10
Hgb [D63] Within (N=100,95,95,95,97,97)	92	83	89	91	88	87
Hgb [D63] Above (N=100,95,95,95,97,97)	0	2	0	0	0	0
Hgb [D63] Unknown (N=100,95,95,95,97,97)	0	0	0	0	0	0
Hgb [D182] Below (N=99,91,88,91,93,97)	9	6	5	5	6	9
Hgb [D182] Within (N=99,91,88,91,93,97)	89	84	81	84	87	87
Hgb [D182] Above (N=99,91,88,91,93,97)	1	1	2	0	0	1
Hgb [D182] Unknown (N=99,91,88,91,93,97)	0	0	0	2	0	0

7. Secondary Outcome

Title	Number of Subjects Reporting Solicited Local Symptoms.
Description	Solicited local symptoms assessed were pain, redness and swelling
Time Frame	During a 7-day follow-up period (Days 0-6) post-vaccination period

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort included all vaccinated subjects

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	102	100	100	99	101	100
Pain	75	89	66	94	69	95
Redness	2	6	1	5	1	11
Swelling	2	15	2	9	0	16

8. Secondary Outcome

Title	Number of Subjects Reporting Solicited General Symptoms.
Description	Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature. Temperature is defined as an axillary temperature equal to or above 38.0 degrees Celsius (°C).
Time Frame	During a 7-day follow-up period (Days 0-6) post-vaccination period

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort included all vaccinated subjects

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	102	100	100	99	101	100
Fatigue	54	62	41	58	57	56
Headache	52	58	51	51	49	54
Joint pain at other location	24	34	24	28	26	23
Muscle aches	38	52	39	53	43	54
Shivering	21	30	19	24	21	25
Sweating	22	21	21	17	12	25
Temperature (axillary) >=38°C	3	9	3	2	1	4

9. Secondary Outcome

Title	Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Description	Laboratory parameters assessed were serum urea nitrogen (SUN), white blood cells (WBC), red blood cells (RBC). For each parameter and for each range it was assessed whether the values of the subjects were unknown, above, below or within the range.
Time Frame	On Days 0, 7, 21, 28, 42, 63 and 182

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort included all vaccinated subjects

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	102	104	102	100	101	102
RBC [D0] Below (N=102,104,102,100101,102)	4	2	7	3	2	4
RBC [D0] Within (N=102,104,102,100101,102)	96	100	95	93	99	98
RBC [D0] Above (N=102,104,102,100101,102)	0	2	0	2	0	0
RBC [D0] Unknown (N=102,104,102,100101,102)	2	0	0	2	0	0
RBC [D7] Below (N=102,101,100,99,100,99)	3	5	5	4	5	3
RBC [D7] Within (N=102,101,100,99,100,99)	99	94	95	93	95	96
RBC [D7] Above (N=102,101,100,99,100,99)	0	1	0	1	0	0
RBC [D7] Unknown (N=102,101,100,99,100,99)	0	1	0	1	0	0
RBC [D21] Below (N=101,100,97,97,99,99)	5	7	5	6	3	6
RBC [D21] Within (N=101,100,97,97,99,99)	96	92	89	90	94	90
RBC [D21] Above (N=101,100,97,97,99,99)	0	0	0	0	0	0
RBC [D21] Unknown (N=101,100,97,97,99,99)	0	1	3	1	2	3
RBC [D28] Below (N=101,98,96,98,98,97)	5	8	8	7	2	8
RBC [D28] Within (N=101,98,96,98,98,97)	95	87	88	89	95	86
RBC [D28] Above (N=101,98,96,98,98,97)	0	1	0	1	0	0
RBC [D28] Unknown (N=101,98,96,98,98,97)	1	2	0	1	1	3
RBC [D42] Below (N=101,97,95,95,96,97)	2	9	9	6	7	12
RBC [D42] Within (N=101,97,95,95,96,97)	99	87	86	89	89	85
RBC [D42] Above (N=101,97,95,95,96,97)	0	1	0	0	0	0
RBC [D42] Unknown (N=101,97,95,95,96,97)	0	0	0	0	0	0
RBC [D63] Below (N=100,95,95,95,97,97)	6	8	5	5	6	12
RBC [D63] Within (N=100,95,95,95,97,97)	94	86	90	89	91	85
RBC [D63] Above (N=100,95,95,95,97,97)	0	1	0	1	0	0
RBC [D63] Unknown (N=100,95,95,95,97,97)	0	0	0	0	0	0
RBC [D182] Below (N=99,91,88,91,93,97)	6	6	9	4	5	10
RBC [D182] Within (N=99,91,88,91,93,97)	92	85	77	84	88	87
RBC [D182] Above (N=99,91,88,91,93,97)	1	0	2	1	0	0
RBC [D182] Unknown (N=99,91,88,91,93,97)	0	0	0	2	0	0
SUN [D0] Below (N=102,104,102,100101,102)	1	0	1	1	1	2
SUN [D0] Within (N=102,104,102,100101,102)	100	104	100	98	98	99
SUN [D0] Above (N=102,104,102,100101,102)	1	0	0	0	1	1
SUN [D0] Unknown (N=102,104,102,100101,102)	0	0	1	1	1	0
SUN [D7] Below (N=102,101,100,99,100,99)	2	1	4	1	0	0
SUN [D7] Within (N=102,101,100,99,100,99)	100	99	96	98	99	99
SUN [D7] Above (N=102,101,100,99,100,99)	0	1	0	0	1	0
SUN [D7] Unknown (N=102,101,100,99,100,99)	0	0	0	0	0	0
SUN [D21] Below (N=101,100,97,97,99,99)	1	1	0	2	1	3
SUN [D21] Within (N=101,100,97,97,99,99)	100	99	96	95	98	95
SUN [D21] Above (N=101,100,97,97,99,99)	0	0	1	0	0	0
SUN [D21] Unknown (N=101,100,97,97,99,99)	0	0	0	0	0	1
SUN [D28] Below (N=101,98,96,98,98,97)	2	1	0	0	0	4
SUN [D28] Within (N=101,98,96,98,98,97)	98	97	96	97	98	91
SUN [D28] Above (N=101,98,96,98,98,97)	0	0	0	0	0	1
SUN [D28] Unknown (N=101,98,96,98,98,97)	1	0	0	1	0	1
SUN [D42] Below (N=101,97,95,95,96,97)	1	1	2	1	2	2
SUN [D42] Within (N=101,97,95,95,96,97)	100	96	91	94	92	95
SUN [D42] Above (N=101,97,95,95,96,97)	0	0	1	0	0	0
SUN [D42] Unknown (N=101,97,95,95,96,97)	0	0	1	0	2	0
SUN [D63] Below (N=100,95,95,95,97,97)	1	0	1	2	0	1
SUN [D63] Within (N=100,95,95,95,97,97)	98	94	93	93	96	94
SUN [D63] Above (N=100,95,95,95,97,97)	0	0	0	0	0	0
SUN [D63] Unknown (N=100,95,95,95,97,97)	1	1	1	0	1	2
SUN [D182] Below (N=99,91,88,91,93,97)	0	2	1	1	1	3
SUN [D182] Within (N=99,91,88,91,93,97)	99	88	87	90	91	94
SUN [D182] Above (N=99,91,88,91,93,97)	0	0	0	0	0	0
SUN [D182] Unknown (N=99,91,88,91,93,97)	0	1	0	0	1	0
WBC [D0] Below (N=102,104,102,100,101,102)	1	2	5	3	2	2
WBC [D0] Within (N=102,104,102,100,101,102)	95	100	94	93	95	95
WBC [D0] Above (N=102,104,102,100,101,102)	4	2	3	2	4	5
WBC [D0] Unknown (N=102,104,102,100,101,102)	2	0	0	2	0	0
WBC [D7] Below (N=102,101,100,99,100,99)	3	0	2	1	3	2
WBC [D7] Within (N=102,101,100,99,100,99)	99	97	98	92	94	94
WBC [D7] Above (N=102,101,100,99,100,99)	0	3	0	5	3	3
WBC [D7] Unknown (N=102,101,100,99,100,99)	0	1	0	1	0	0
WBC [D21] Below (N=101,100,97,97,99,99)	1	4	2	2	3	2
WBC [D21] Within (N=101,100,97,97,99,99)	98	94	90	93	91	90
WBC [D21] Above (N=101,100,97,97,99,99)	2	1	2	1	3	3
WBC [D21] Unknown (N=101,100,97,97,99,99)	0	1	3	1	2	4
WBC [D28] Below (N=101,98,96,98,98,97)	0	1	3	3	2	0
WBC [D28] Within (N=101,98,96,98,98,97)	98	92	92	92	93	91
WBC [D28] Above (N=101,98,96,98,98,97)	1	3	1	1	2	3
WBC [D28] Unknown (N=101,98,96,98,98,97)	2	2	0	2	1	3
WBC [D42] Below (N=101,97,95,95,96,97)	0	4	2	3	3	3
WBC [D42] Within (N=101,97,95,95,96,97)	100	91	92	90	92	91
WBC [D42] Above (N=101,97,95,95,96,97)	1	2	1	2	1	3
WBC [D42] Unknown (N=101,97,95,95,96,97)	0	0	0	0	0	0
WBC [D63] Below (N=100,95,95,95,97,97)	1	2	1	2	3	3
WBC [D63] Within (N=100,95,95,95,97,97)	98	92	93	89	91	91
WBC [D63] Above (N=100,95,95,95,97,97)	1	1	1	4	3	3
WBC [D63] Unknown (N=100,95,95,95,97,97)	0	0	0	0	0	0
WBC [D182] Below (N=99,91,88,91,93,97)	2	2	4	3	2	4
WBC [D182] Within (N=99,91,88,91,93,97)	93	87	82	84	88	91
WBC [D182] Above (N=99,91,88,91,93,97)	4	2	2	2	3	1
WBC [D182] Unknown (N=99,91,88,91,93,97)	0	0	0	2	0	1

10. Secondary Outcome

Title	Number of Subjects Reporting Unsolicited Adverse Events (AEs).
Description	An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.
Time Frame	Within the 84-day (Days 0-83) post-vaccination period.

Outcome Measure Data

Analysis Population Description

The Total Vaccinated Cohort included all vaccinated subjects.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	102	104	102	100	101	102
Number [Subjects]	68	65	57	57	62	63

11. Secondary Outcome

Title	Number of Subjects Reporting Medically Attended Visits (MAEs).
Description	The day 368 was the last contact day for the last subject reporting the event. For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.
Time Frame	During the entire study period (Days 0-368).

Outcome Measure Data

Analysis Population Description

The Total Vaccinated Cohort included all vaccinated subjects.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	102	104	102	100	101	102
Number [Subjects]	51	42	40	42	38	45

12. Secondary Outcome

Title	Number of Subjects Reporting Potential Immune Diseases (pIMDs).
Description	The day 406 was the last contact day with the subjects reporting the event. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Time Frame	During the entire study period (Days 0-406).

Outcome Measure Data

Analysis Population Description

The Total Vaccinated Cohort included all vaccinated subjects.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	102	104	102	100	101	102
Number [Subjects]	0	0	0	0	0	1

13. Secondary Outcome

Title	Number of Subjects Reporting Serious Adverse Events (SAEs).
Description	The day 329 was the last contact day with the subjects reporting serious adverse events. SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time Frame	During the entire study period (Days 0-329).

Outcome Measure Data

Analysis Population Description

The Total Vaccinated Cohort included all vaccinated subjects.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	102	104	102	100	101	102
Number [Subjects]	3	1	1	2	1	3

14. Secondary Outcome

Title	Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Description	Laboratory parameters assessed were neutrophils (NEU), lymphocytes (LYM), monocytes (MON) and platelets (PLA). For each parameter and for each range it was assessed whether the values of the subjects were unknown, in above, below or within the range.
Time Frame	On Days 0, 7, 21, 28, 42, 63 and 182

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort included all vaccinated subjects

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	102	104	102	100	101	102
LYM [D0] Below (N=102,104,102,100,101,102)	0	2	0	0	0	0
LYM [D0] Within (N=102,104,102,100,101,102)	100	101	102	98	101	101
LYM [D0] Above (N=102,104,102,100,101,102)	0	1	0	0	0	1
LYM [D0] Unknown (N=102,104,102,100,101,102)	2	0	0	2	0	0
LYM [D7] Below (N=102,101,100,99,100,99)	1	0	1	0	0	1
LYM [D7] Within (N=102,101,100,99,100,99)	100	100	99	98	100	98
LYM [D7] Above (N=102,101,100,99,100,99)	1	0	0	0	0	0
LYM [D7] Unknown (N=102,101,100,99,100,99)	0	1	0	1	0	0
LYM [D21] Below (N=101,100,97,97,99,99)	0	1	0	0	0	0
LYM [D21] Within (N=101,100,97,97,99,99)	101	98	94	95	97	94
LYM [D21] Above (N=101,100,97,97,99,99)	0	0	0	1	0	1
LYM [D21] Unknown (N=101,100,97,97,99,99)	0	1	3	1	2	4
LYM [D28] Below (N=101,98,96,98,98,97)	0	0	0	0	0	0
LYM [D28] Within (N=101,98,96,98,98,97)	99	96	95	96	97	93
LYM [D28] Above (N=101,98,96,98,98,97)	0	0	1	0	0	1
LYM [D28] Unknown (N=101,98,96,98,98,97)	2	2	0	2	1	3
LYM [D42] Below (N=101,97,95,95,96,97)	0	2	0	0	3	0
LYM [D42] Within (N=101,97,95,95,96,97)	101	95	95	94	93	97
LYM [D42] Above (N=101,97,95,95,96,97)	0	0	0	1	0	0
LYM [D42] Unknown (N=101,97,95,95,96,97)	0	0	0	0	0	0
LYM [D63] Below (N=100,95,95,95,97,97)	0	0	0	0	1	0
LYM [D63] Within (N=100,95,95,95,97,97)	100	95	95	95	96	96
LYM [D63] Above (N=100,95,95,95,97,97)	0	0	0	0	0	1
LYM [D63] Unknown (N=100,95,95,95,97,97)	0	0	0	0	0	0
LYM [D182] Below (N=99,91,88,91,93,97)	0	1	0	0	1	0
LYM [D182] Within (N=99,91,88,91,93,97)	98	90	88	89	91	95
LYM [D182] Above (N=99,91,88,91,93,97)	1	0	0	0	1	1
LYM [D182] Unknown (N=99,91,88,91,93,97)	0	0	0	2	0	1
MON [D0] Below (N=102,104,102,100,101,102)	11	18	26	18	13	23
MON [D0] Within (N=102,104,102,100,101,102)	89	86	75	79	88	79
MON [D0] Above (N=102,104,102,100,101,102)	0	0	1	1	0	0
MON [D0] Unknown (N=102,104,102,100,101,102)	2	0	0	2	0	0
MON [D7] Below (N=102,101,100,99,100,99)	20	14	22	12	13	22
MON [D7] Within (N=102,101,100,99,100,99)	82	86	78	86	87	77
MON [D7] Above (N=102,101,100,99,100,99)	0	0	0	0	0	0
MON [D7] Unknown (N=102,101,100,99,100,99)	0	1	0	1	0	0
MON [D21] Below (N=101,100,97,97,99,99)	25	20	20	12	18	20
MON [D21] Within (N=101,100,97,97,99,99)	76	79	74	84	79	75
MON [D21] Above (N=101,100,97,97,99,99)	0	0	0	0	0	0
MON [D21] Unknown (N=101,100,97,97,99,99)	0	1	3	1	2	4
MON [D28] Below (N=101,98,96,98,98,97)	17	19	26	26	17	19
MON [D28] Within (N=101,98,96,98,98,97)	82	77	70	70	80	75
MON [D28] Above (N=101,98,96,98,98,97)	0	0	0	0	0	0
MON [D28] Unknown (N=101,98,96,98,98,97)	2	2	0	2	1	3
MON [D42] Below (N=101,97,95,95,96,97)	16	19	20	25	20	20
MON [D42] Within (N=101,97,95,95,96,97)	85	78	75	70	76	77
MON [D42] Above (N=101,97,95,95,96,97)	0	0	0	0	0	0
MON [D42] Unknown (N=101,97,95,95,96,97)	0	0	0	0	0	0
MON [D63] Below (N=100,95,95,95,97,97)	17	20	21	19	15	18
MON [D63] Within (N=100,95,95,95,97,97)	82	75	73	76	82	79
MON [D63] Above (N=100,95,95,95,97,97)	1	0	1	0	0	0
MON [D63] Unknown (N=100,95,95,95,97,97)	0	0	0	0	0	0
MON [D182] Below (N=99,91,88,91,93,97)	17	20	20	21	20	23
MON [D182] Within (N=99,91,88,91,93,97)	82	71	68	68	73	73
MON [D182] Above (N=99,91,88,91,93,97)	0	0	0	0	0	0
MON [D182] Unknown (N=99,91,88,91,93,97)	0	0	0	2	0	1
NEU [D0] Below (N=102,104,102,100,101,102)	1	4	4	4	0	4
NEU [D0] Within (N=102,104,102,100,101,102)	98	98	97	92	98	93
NEU [D0] Above (N=102,104,102,100,101,102)	1	2	1	2	3	5
NEU [D0] Unknown (N=102,104,102,100,101,102)	2	0	0	2	0	0
NEU [D7] Below (N=101,100,98,97,97,97)	2	2	2	2	1	3
NEU [D7] Within (N=101,100,98,97,97,97)	96	94	94	90	93	91
NEU [D7] Above (N=101,100,98,97,97,97)	3	3	2	4	3	3
NEU [D7] Unknown (N=101,100,98,97,97,97)	0	1	0	1	0	0
NEU [D21] Below (N=101,100,97,97,99,99)	3	5	2	2	2	4
NEU [D21] Within (N=101,100,97,97,99,99)	97	92	91	93	92	88
NEU [D21] Above (N=101,100,97,97,99,99)	1	2	1	1	3	3
NEU [D21] Unknown (N=101,100,97,97,99,99)	0	1	3	1	2	4
NEU [D28] Below (N=101,98,96,98,98,97)	1	5	3	2	3	2
NEU [D28] Within (N=101,98,96,98,98,97)	98	89	92	93	93	91
NEU [D28] Above (N=101,98,96,98,98,97)	0	2	1	1	1	1
NEU [D28] Unknown (N=101,98,96,98,98,97)	2	2	0	2	1	3
NEU [D42] Below (N=101,97,95,95,96,97)	3	4	1	1	1	2
NEU [D42] Within (N=101,97,95,95,96,97)	98	91	94	92	93	93
NEU [D42] Above (N=101,97,95,95,96,97)	0	2	0	2	2	2
NEU [D42] Unknown (N=101,97,95,95,96,97)	0	0	0	0	0	0
NEU [D63] Below (N=100,95,95,95,97,97)	1	1	1	1	3	5
NEU [D63] Within (N=100,95,95,95,97,97)	98	93	94	92	92	88
NEU [D63] Above (N=100,95,95,95,97,97)	1	1	0	2	2	4
NEU [D63] Unknown (N=100,95,95,95,97,97)	0	0	0	0	0	0
NEU [D182] Below (N=99,91,88,91,93,97)	3	3	4	2	1	6
NEU [D182] Within (N=99,91,88,91,93,97)	93	86	83	86	89	89
NEU [D182] Above (N=99,91,88,91,93,97)	3	2	1	1	3	1
NEU [D182] Unknown (N=99,91,88,91,93,97)	0	0	0	2	0	1
PLA [D0] Below (N=102,104,102,100,101,102)	0	0	0	1	1	1
PLA [D0] Within (N=102,104,102,100,101,102)	100	104	102	97	98	101
PLA [D0] Above (N=102,104,102,100,101,102)	0	0	0	0	2	0
PLA [D0] Unknown (N=102,104,102,100,101,102)	2	0	0	2	0	0
PLA [D7] Below (N=102,101,100,99,100,99)	1	0	0	0	0	0
PLA [D7] Within (N=102,101,100,99,100,99)	101	100	100	97	99	99
PLA [D7] Above (N=102,101,100,99,100,99)	0	0	0	0	1	0
PLA [D7] Unknown (N=102,101,100,99,100,99)	0	1	0	2	0	0
PLA [D21] Below (N=101,100,97,97,99,99)	1	0	1	0	0	0
PLA [D21] Within (N=101,100,97,97,99,99)	100	99	93	96	97	96
PLA [D21] Above (N=101,100,97,97,99,99)	0	0	0	0	0	0
PLA [D21] Unknown (N=101,100,97,97,99,99)	0	1	3	1	2	3
PLA [D28] Below (N=101,98,96,98,98,97)	2	0	0	1	0	0
PLA [D28] Within (N=101,98,96,98,98,97)	98	96	96	96	95	94
PLA [D28] Above (N=101,98,96,98,98,97)	0	0	0	0	1	0
PLA [D28] Unknown (N=101,98,96,98,98,97)	1	2	0	1	2	3
PLA [D42] Below (N=101,97,95,95,96,97)	1	1	0	0	1	0
PLA [D42] Within (N=101,97,95,95,96,97)	100	96	93	95	93	97
PLA [D42] Above (N=101,97,95,95,96,97)	0	0	1	0	0	0
PLA [D42] Unknown (N=101,97,95,95,96,97)	0	0	1	0	2	0
PLA [D63] Below (N=100,95,95,95,97,97)	0	1	1	1	0	1
PLA [D63] Within (N=100,95,95,95,97,97)	100	94	94	93	96	96
PLA [D63] Above (N=100,95,95,95,97,97)	0	0	0	1	1	0
PLA [D63] Unknown (N=100,95,95,95,97,97)	0	0	0	0	0	0
PLA [D182] Below (N=99,91,88,91,93,97)	2	1	1	0	1	1
PLA [D182] Within (N=99,91,88,91,93,97)	97	90	87	87	91	95
PLA [D182] Above (N=99,91,88,91,93,97)	0	0	0	1	1	1
PLA [D182] Unknown (N=99,91,88,91,93,97)	0	0	0	3	0	0

15. Secondary Outcome

Title	Microneutralization Antibody Titers Against A/California/7/2009 (H1N1) Strain.
Description	Titers were expressed as geometric mean titers (GMTs) and measured by microneutralization. Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1). Microneutralization testing was cancelled.
Time Frame	On Days 0, 21, 42, 63 and 182

Outcome Measure Data

Analysis Population Description

Microneutralization testing was cancelled.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	0	0	0	0	0	0

16. Secondary Outcome

Title	Number of Subjects With a Microneutralization Titer Greater Than or Equal to 1:28 for Antibodies Against A/California/7/2009 (H1N1) Strain.
Description	Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1). The antibody cut-off value assessed was a titer of 1:10 and this value was considered as seropositivity. Seronegative subject is a subject whose antibody titer is below the cut-off value, a seropositive subject is a subject whose antibody titer is greater than or equal to the cut-off value. Microneutralization titers < 1:28 were considered below the cut-off. Microneutralization testing was cancelled.
Time Frame	On Days 0, 21, 42, 63 and 182

Outcome Measure Data

Analysis Population Description

Microneutralization testing was cancelled.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	0	0	0	0	0	0

17. Secondary Outcome

Title	Vaccine Response Rates (VRR) for Microneutralization Antibody Titers Against A/California/7/2009 (H1N1) Strain.
Description	Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1). Vaccine Response Rate for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. Microneutralization testing was cancelled.
Time Frame	On Days 0, 21, 42, 63 and 182

Outcome Measure Data

Analysis Population Description

Microneutralization testing was cancelled.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	0	0	0	0	0	0

18. Secondary Outcome

Title	Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.
Description	The A/California vaccine virus-homologous antibody response was measured in subjects having received two doses of Arepanrix vaccine, with prior treatment with Flulaval vaccine 21 days before the first dose and in subjects having received two doses of Arepanrix vaccine alone. Titers were expressed as geometric mean antibody titers (GMTs).
Time Frame	21 days after the second dose of Arepanrix vaccine (Day 63 for Flulaval/placebo/Arepanrix Group and Day 42 for Arepanrix/placebo/Flulaval Group)

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	0	86	0	0	0	91
Geometric Mean (95% Confidence Interval) [Titers]	645.2	933.1

19. Secondary Outcome

Title	Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.
Description	The A/California vaccine virus-homologous antibody response was measured in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine, with prior treatment with Flulaval vaccine 21 days before the first dose and in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine alone. Titers were expressed as geometric mean antibody titers (GMTs).
Time Frame	21 days after the second dose of the unadjuvanted formulation of Arepanrix vaccine (Day 63 for Flulaval/placebo/unadjuvanted Arepanrix Group and Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group)

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	92	0	0	0	91	0
Geometric Mean (95% Confidence Interval) [Titers]	254.2	387.1

20. Secondary Outcome

Title	Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.
Description	The A/California vaccine virus-homologous antibody response was measured in subjects pre-treated with Flulaval who subsequently received two doses of the unadjuvanted formulation of Arepanrix vaccine compared to subjects pre-treated with Flulaval vaccine who subsequently received two doses of Arepanrix vaccine. Titers were expressed as geometric mean antibody titers (GMTs).
Time Frame	21 days after the second dose of the pandemic vaccine (at Day 63)

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	92	86	0	0	0	0
Geometric Mean (95% Confidence Interval) [Titers]	254.2	645.2

21. Secondary Outcome

Title	Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.
Description	The antibody response against each of the three Flulaval vaccine components in subjects exposed to co-administration of Flulaval vaccine with the first of two doses of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine. Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs).
Time Frame	21 days after the Flulaval vaccination (at Day 21).

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	92	86	0	89	0	0
Flu A/BRI/59/07 H1N1	145.1	215.7	158.7
Flu A/Uru/716/07 H3N2	175.7	183.5	191.4
Flu B/Bri/60/08	662.1	658.3	576.1

22. Secondary Outcome

Title	Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.
Description	The antibody response against each of the three Flulaval vaccine components in subjects exposed to co-administration of Flulaval vaccine with the first of two doses of the unadjuvanted formulation of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine. Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs).
Time Frame	21 days after the Flulaval vaccination (at Day 21).

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	92	86	92	0	0	0
Flu A/Brisbane/59/07 H1N1	145.1	215.7	226.3
Flu A/Uru/716/07 H3N2	175.7	183.5	181.7
Flu B/Brisbane/60/08	662.1	658.3	478.8

23. Secondary Outcome

Title	Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.
Description	The antibody response against each of the three Flulaval vaccine components in subjects exposed to pre-treatment with two doses of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine. Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs).
Time Frame	21 days after the Flulaval vaccination (Day 63 for Arepanrix/placebo/Flulaval Group and Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups)

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	92	86	0	0	0	91
Flu A/BRI/59/07 H1N1	145.1	215.7	166.9
Flu A/Uru/716/07 H3N2	175.7	183.5	221.9
Flu B/Bri/60/08	662.1	658.3	688.1

24. Secondary Outcome

Title	Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.
Description	The antibody response against each of the three Flulaval vaccine components in subjects exposed to pre-treatment with two doses of the unadjuvanted formulation of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine. Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs).
Time Frame	21 days after the Flulaval vaccination (Day 63 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups)

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	92	86	0	0	91	0
Flu A/Bri/59/07 H1N1	145.1	215.7	137.4
Flu A/Uru/716/07 H3N2	175.7	183.5	216.1
Flu B/Bri/60/08	662.1	658.3	644.9

25. Secondary Outcome

Title	Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain.
Description	Titers were expressed as geometric mean antibody titers (GMTs).
Time Frame	On Days 0, 21, 42 and 63

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	92	86	92	89	91	91
Flu A/Cal H1N1 [at Day 0] (N=92;86;92;88;91;91)	14.6	10.9	13.0	10.7	9.3	10.1
Flu A/Cal H1N1 [at Day 21] (N=92;86;92;89;91;91)	31.1	26.3	277.3	361.0	358.7	659.8
Flu A/Cal H1N1 [at Day 42] (N=92;86;92;89;91;91)	238.6	396.2	271.2	589.8	387.1	933.1
Flu A/Cal H1N1 [at Day 63] (N=92;86;92;89;91;91)	254.2	645.2	245.0	426.9	345.3	704.0

26. Secondary Outcome

Title	Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain.
Description	Titers were expressed as geometric mean antibody titers (GMTs).
Time Frame	At Day 182

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	92	89	85	89	89	91
Geometric Mean (95% Confidence Interval) [Titers]	136.6	206.9	151.7	171.7	218.5	323.6

27. Secondary Outcome

Title	Number of Seroconverted Subjects for Antibodies Against A/ California Strain.
Description	Seroconversion rate was defined as the incidence rate of vaccinees who had either a pre-vaccination titer recorded as < 1:10 and a post-vaccination reciprocal titer ≥ 40 or a pre-vaccination reciprocal titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer. Seroconversion defined as: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer
Time Frame	At Day 63 from Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 from Day 0 for the 4 other groups

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	92	86	92	88	91	91
Number [Subjects]	66	77	84	85	88	90

28. Secondary Outcome

Title	Number of Seroprotected Subjects for Antibodies Against A/California Strain.
Description	Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.
Time Frame	At Day 63 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 for the 4 other groups.

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	92	86	92	89	91	91
Number [Subjects]	90	86	92	89	91	91

29. Secondary Outcome

Title	Seroconversion Factor for Antibodies Against A/California Strain.
Description	Seroconversion factor was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the prevaccination reciprocal HI titer.
Time Frame	At Day 63 from Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 from Day 0 for the 4 other groups

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	92	86	92	88	91	91
Mean (95% Confidence Interval) [Fold]	8.2	24.6	20.9	54.9	41.5	92.4

30. Secondary Outcome

Title	Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains.
Description	Seroconversion defined as: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008. For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled.
Time Frame	At Day 21 from Day 0 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 from Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group	Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	0	0	92	88	91	91	178
Flu A/Bri/59/07 H1N1	76	70	50	33	145
Flu A/Uru/716/07 H3N2	72	76	73	72	145
Flu B/Bri/60/08	74	78	71	57	152

31. Secondary Outcome

Title	Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains
Description	Seroprotection was defined as the proportion of subjects with H1N1 reciprocal Hemagglutination Inhibition (HI) titers ≥ 1:40 against the tested vaccine virus. Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008. For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled.
Time Frame	At Day 21 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group	Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	0	0	92	89	91	91	178
Flu A/Bri/59/07 H1N1	89	82	81	87	170
Flu A/Uru/716/07 H3N2	77	79	81	83	155
Flu B/Bri/60/08	90	89	91	91	176

32. Secondary Outcome

Title	Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.
Description	Seroconversion factor was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal Hemagglutination Inhibition (HI) titer to the prevaccination reciprocal HI titer. Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008. For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled.
Time Frame	At Day 21 from Day 0 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 from Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group	Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	0	0	92	88	91	91	178
Flu A/Bri/59/07 H1N1	12.0	9.6	4.2	3.1	10.3
Flu A/Uru/716/07 H3N2	20.6	19.3	17.3	11.6	16.5
Flu B/Bri/60/08	10.5	14.3	8.6	4.9	13.2

33. Secondary Outcome

Title	Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains
Description	Seroconversion defined as: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
Time Frame	on Days 21 and 63 from Day 0 for the first 4 groups; on Days 42 and 63 from Day 0 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	92	86	92	88	91	91
Flu A/Bri/59/07 H1N1 [Day 21 or 42 after dose 1]	71	74	76	70	17	28
Flu A/Bri/59/07 H1N1 [Day 63 after dose 1]	63	76	69	64	71	76
Flu A/Uru/716/07 H3N2 [Day 21 or 42 after dose 1]	72	73	72	76	3	6
Flu A/Uru/716/07 H3N2 [Day 63 after dose 1]	71	69	69	69	75	78
Flu B/Bri/60/08 [Day 21 or 42 after dose 1]	76	76	74	78	6	24
Flu B/Bri/60/08 [Day 63 after dose 1]	73	73	67	73	78	76

34. Secondary Outcome

Title	Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains
Description	Seroconversion defined as: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
Time Frame	At Day 182 from Day 0

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	92	89	85	88	89	91
Flu A/Bri/59/07 H1N1	45	57	45	38	46	54
Flu A/Uru/716/07 H3N2	58	56	54	56	60	61
Flu B/Bri/60/08 Victoria	68	54	48	64	67	62

35. Secondary Outcome

Title	Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.
Description	Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus. Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
Time Frame	before vaccination and on days 21 and 63 for the first 4 groups and before vaccination and on days 42 and 63 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	92	86	92	89	91	91
Flu A/Bri/59/07 H1N1 [at Day 0]	20	18	26	18	23	20
Flu A/Bri/59/07 H1N1 [Days 21 or 42 post dose 1]	86	84	89	82	47	62
Flu A/Bri/59/07 H1N1 [at Day 63 post dose 1]	84	86	85	79	81	87
Flu A/Uru/716/07 H3N2 [at Day 0]	12	16	8	13	15	17
Flu A/Uru/716/07 H3N2 [Days 21 or 42 post dose 1]	78	77	77	79	18	28
Flu A/Uru/716/07 H3N2 [at Day 63 post dose 1]	78	75	73	75	81	83
Flu B/Bri/60/08 [at Day 0]	62	50	56	49	66	62
Flu B/Bri/60/08 [Days 21 or 42 post dose 1]	91	85	90	89	75	89
Flu B/Bri/60/08 [at Day 63 post dose 1]	91	86	91	89	91	91

36. Secondary Outcome

Title	Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.
Description	Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus. Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
Time Frame	At Day 182 after the first dose

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	92	89	85	89	89	91
Flu A/Bri/59/07 H1N1	63	74	66	61	67	71
Flu A/Uru/716/07 H3N2	66	64	60	64	68	70
Flu B/Bri/60/08 Victoria	90	88	79	89	88	91

37. Secondary Outcome

Title	Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.
Description	Seroconversion factor of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
Time Frame	On Days 21 and 63 from Day 0 for the first 4 groups and on Days 42 and 63 from Day 0 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	92	86	92	88	91	91
Flu A/Bri/59/07 H1N1 [Day 21 or 42 post dose 1]	8.4	12.9	12.0	9.6	2.3	3.2
Flu A/Bri/59/07 H1N1 [at Day 63 post dose 1]	6.9	11.2	8.4	7.6	9.4	10.1
Flu A/Uru/716/07 H3N2 [Day 21 or 42 post dose 1]	17.4	15.5	20.6	19.3	1.2	1.7
Flu A/Uru/716/07 H3N2 [at Day 63 post dose 1]	13.3	11.7	15.0	14.6	20.8	19.3
Flu B:Bri/60/08 [Day 21 or 42 post dose 1]	12.6	13.9	10.5	14.3	1.3	2.4
Flu B/Bri/60/08 [at Day 63 post dose 1]	9.6	10.0	7.9	10.8	11.4	11.9

38. Secondary Outcome

Title	Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.
Description	Seroconversion factor of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
Time Frame	At Day 182 from Day 0

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	92	89	85	88	89	91
Flu A/Bri/59/07 H1N1	4.0	5.2	4.7	3.7	4.4	5.0
Flu A/Uru/716/07 H3N2	9.0	7.2	9.7	8.5	9.9	10.6
Flu B/Bri/60/08 Victoria	6.7	5.7	5.5	6.8	6.9	6.4

39. Secondary Outcome

Title	Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.
Description	Titers were expressed as geometric mean titers (GMTs). Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
Time Frame	On Days 0, 21 and 63 for the first 4 groups and on Days 0, 42 and 63 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	92	86	92	89	91	91
Flu A/Bri/59/07 H1N1 [at Day 0]	17.3	16.7	18.8	16.2	14.6	16.6
Flu A/Bri/59/07 H1N1 [at Day 21 or 42]	145.1	215.7	226.3	158.7	32.9	53.2
Flu A/Bri/59/07 H1N1 [at Day 63]	120.2	186.5	157.0	124.3	137.4	166.9
Flu A/Uru/716/07 H3N2 [at Day 0]	10.1	11.8	8.8	10.2	10.4	11.5
Flu A/Uru/716/07 H3N2 [at Day 21 or 42]	175.7	183.5	181.7	191.4	12.5	19.1
Flu A/Uru/716/07 H3N2 [at Day 63]	134.4	138.4	132.0	145.6	216.1	221.9
Flu B/Bri/60/08 [at Day 0]	52.6	47.3	45.4	40.1	56.7	58.0
Flu B/Bri/60/08 [at Day 21 or 42]	662.1	658.3	478.8	576.1	74.7	139.5
Flu B/Bri/60/08 [at Day 63]	506.7	471.2	359.6	433.5	644.9	688.1

40. Secondary Outcome

Title	Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.
Description	Titers were expressed as geometric mean titers (GMTs). Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
Time Frame	At Day 182 after dose 1 vaccination

Outcome Measure Data

Analysis Population Description

The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.

Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group	Flulaval/Placebo/Arepanrix Group	Flulaval/Unadjuvanted Arepanrix/Placebo Group	Flulaval/Arepanrix/Placebo Group	Unadjuvanted Arepanrix/Placebo/Flulaval Group	Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.	subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
Measure Participants	92	89	85	89	89	91
Flu A/Bri/59/07 H1N1	68.5	89.2	87.4	64.6	64.6	83.7
Flu A/Uru/716/07 H3N2	89.5	87.7	87.1	87.8	110.0	127.2
Flu B/Bri/60/08 Victoria	339.9	273.8	245.4	292.6	369.6	378.4

Adverse Events

Time Frame	SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
Adverse Event Reporting Description	SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
Arm/Group Title	Flulaval/Placebo/Unadjuvanted Arepanrix Group		Flulaval/Placebo/Arepanrix Group		Flulaval/Unadjuvanted Arepanrix/Placebo Group		Flulaval/Arepanrix/Placebo Group		Unadjuvanted Arepanrix/Placebo/Flulaval Group		Arepanrix/Placebo/Flulaval Group
Arm/Group Description	subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.		subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.		subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.		subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.		subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.		subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
All Cause Mortality
	Flulaval/Placebo/Unadjuvanted Arepanrix Group		Flulaval/Placebo/Arepanrix Group		Flulaval/Unadjuvanted Arepanrix/Placebo Group		Flulaval/Arepanrix/Placebo Group		Unadjuvanted Arepanrix/Placebo/Flulaval Group		Arepanrix/Placebo/Flulaval 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
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Flulaval/Placebo/Unadjuvanted Arepanrix Group		Flulaval/Placebo/Arepanrix Group		Flulaval/Unadjuvanted Arepanrix/Placebo Group		Flulaval/Arepanrix/Placebo Group		Unadjuvanted Arepanrix/Placebo/Flulaval Group		Arepanrix/Placebo/Flulaval 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
Total	3/102 (2.9%)		1/104 (1%)		1/102 (1%)		2/100 (2%)		1/101 (1%)		3/102 (2.9%)
Cardiac disorders
Sinus bradycardia	1/102 (1%)		0/104 (0%)		0/102 (0%)		0/100 (0%)		0/101 (0%)		0/102 (0%)
Gastrointestinal disorders
Oral disorder	0/102 (0%)		0/104 (0%)		0/102 (0%)		0/100 (0%)		0/101 (0%)		1/102 (1%)
Vomiting	1/102 (1%)		0/104 (0%)		0/102 (0%)		0/100 (0%)		0/101 (0%)		0/102 (0%)
Hepatobiliary disorders
Jaundice	1/102 (1%)		0/104 (0%)		0/102 (0%)		0/100 (0%)		0/101 (0%)		0/102 (0%)
Infections and infestations
Abscess limb	0/102 (0%)		1/104 (1%)		0/102 (0%)		0/100 (0%)		0/101 (0%)		0/102 (0%)
Injury, poisoning and procedural complications
Pelvic fracture	0/102 (0%)		0/104 (0%)		0/102 (0%)		0/100 (0%)		1/101 (1%)		0/102 (0%)
Radius fracture	0/102 (0%)		0/104 (0%)		0/102 (0%)		0/100 (0%)		0/101 (0%)		1/102 (1%)
Scapula fracture	0/102 (0%)		0/104 (0%)		0/102 (0%)		0/100 (0%)		0/101 (0%)		1/102 (1%)
Investigations
Alanine aminotransferase increased	1/102 (1%)		0/104 (0%)		0/102 (0%)		0/100 (0%)		0/101 (0%)		0/102 (0%)
Musculoskeletal and connective tissue disorders
Tenosynovitis	0/102 (0%)		1/104 (1%)		0/102 (0%)		1/100 (1%)		0/101 (0%)		0/102 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seminoma	0/102 (0%)		0/104 (0%)		0/102 (0%)		1/100 (1%)		0/101 (0%)		0/102 (0%)
Nervous system disorders
VIIth nerve paralysis	0/102 (0%)		0/104 (0%)		0/102 (0%)		0/100 (0%)		0/101 (0%)		1/102 (1%)
Pregnancy, puerperium and perinatal conditions
Gestational hypertension	1/102 (1%)		0/104 (0%)		0/102 (0%)		0/100 (0%)		0/101 (0%)		0/102 (0%)
Psychiatric disorders
Suicide attempt	0/102 (0%)		0/104 (0%)		1/102 (1%)		0/100 (0%)		0/101 (0%)		0/102 (0%)
Other (Not Including Serious) Adverse Events
	Flulaval/Placebo/Unadjuvanted Arepanrix Group		Flulaval/Placebo/Arepanrix Group		Flulaval/Unadjuvanted Arepanrix/Placebo Group		Flulaval/Arepanrix/Placebo Group		Unadjuvanted Arepanrix/Placebo/Flulaval Group		Arepanrix/Placebo/Flulaval 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
Total	92/102 (90.2%)		91/104 (87.5%)		86/102 (84.3%)		97/100 (97%)		84/101 (83.2%)		99/102 (97.1%)
Gastrointestinal disorders
Nausea	9/102 (8.8%)		8/104 (7.7%)		0/102 (0%)		0/100 (0%)		0/101 (0%)		0/102 (0%)
General disorders
Pain	75/102 (73.5%)		89/100 (89%)		66/100 (66%)		94/99 (94.9%)		69/101 (68.3%)		95/100 (95%)
Redness	2/102 (2%)		6/100 (6%)		1/100 (1%)		5/99 (5.1%)		1/101 (1%)		11/100 (11%)
Swelling	2/102 (2%)		15/100 (15%)		2/100 (2%)		9/99 (9.1%)		0/101 (0%)		16/100 (16%)
Fatigue	54/102 (52.9%)		62/100 (62%)		41/100 (41%)		58/99 (58.6%)		57/101 (56.4%)		56/100 (56%)
Headache	52/102 (51%)		58/100 (58%)		51/100 (51%)		51/99 (51.5%)		49/101 (48.5%)		54/100 (54%)
Joint pain at other location	24/102 (23.5%)		34/100 (34%)		24/100 (24%)		28/99 (28.3%)		26/101 (25.7%)		23/100 (23%)
Muscle aches	38/102 (37.3%)		52/100 (52%)		39/100 (39%)		53/99 (53.5%)		43/101 (42.6%)		54/100 (54%)
Shivering	21/102 (20.6%)		30/100 (30%)		19/100 (19%)		24/99 (24.2%)		21/101 (20.8%)		25/100 (25%)
Sweating	22/102 (21.6%)		21/100 (21%)		21/100 (21%)		17/99 (17.2%)		12/101 (11.9%)		25/100 (25%)
Temperature	3/102 (2.9%)		9/100 (9%)		3/100 (3%)		2/99 (2%)		1/101 (1%)		4/100 (4%)
Infections and infestations
Upper respiratory tract infection	11/102 (10.8%)		11/104 (10.6%)		11/102 (10.8%)		8/100 (8%)		15/101 (14.9%)		11/102 (10.8%)
Nasopharyngitis	0/102 (0%)		0/104 (0%)		10/102 (9.8%)		0/100 (0%)		7/101 (6.9%)		0/102 (0%)
Nervous system disorders
Dizziness	0/102 (0%)		7/104 (6.7%)		0/102 (0%)		6/100 (6%)		0/101 (0%)		0/102 (0%)
Headache	0/102 (0%)		0/104 (0%)		0/102 (0%)		7/100 (7%)		6/101 (5.9%)		0/102 (0%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	12/102 (11.8%)		17/104 (16.3%)		9/102 (8.8%)		12/100 (12%)		6/101 (5.9%)		10/102 (9.8%)
Cough	9/102 (8.8%)		11/104 (10.6%)		11/102 (10.8%)		6/100 (6%)		11/101 (10.9%)		5/102 (4.9%)
Nasal congestion	7/102 (6.9%)		7/104 (6.7%)		0/102 (0%)		0/100 (0%)		8/101 (7.9%)		5/102 (4.9%)
Rhinorrhoea	0/102 (0%)		0/104 (0%)		0/102 (0%)		0/100 (0%)		0/101 (0%)		8/102 (7.8%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

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.