Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged ≥18 Years

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00719043
• Collaborator: (none)
• Enrollment: 841
• Locations: 13
• Arms: 7
• Duration (Months): 31.3
• Patients Per Site: 64.7
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether GSK's avian flu vaccine GSK 1557484A is immunogenic and safe when given to adults aged >=18 years.

This Protocol Posting has been updated following Amendments 1-3 of the Protocol, Dec 2009. The impacted sections are study design and outcome measures.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Biological: A/turkey H5N1 vaccine; Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia); Biological: Placebo	Phase 2

Detailed Description

All subjects will receive 3 doses of study vaccine, including 2 doses of active vaccine and 1 dose of placebo. All subjects will attend formal study center visits for safety and immunogenicity assessments on Days 0, 10, 42, 182, 192, 224, 549, 559, 591, and 729. A telephone contact to assess safety will be made at Day 364 and Day 909.

Study Design

• Study Type: Interventional
• Actual Enrollment: 841 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: A Trial to Evaluate the Safety and Immunogenicity of Monovalent H5N1 Vaccine in Adults >=18 Yrs of Age
• Study Start Date: Jul 11, 2008
• Actual Primary Completion Date: Apr 22, 2010
• Actual Study Completion Date: Feb 18, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A/Indonesia primed-A/turkey Influenza (H5N1)-F1-Placebo Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Biological: A/turkey H5N1 vaccine; Administered as an intramuscular (IM) injection; Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia); Administered as an intramuscular (IM) injection; Biological: Placebo; Administered as an intramuscular (IM) injection
Experimental: A/Indonesia primed-A/turkey Influenza (H5N1)-F2-Placebo Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Biological: A/turkey H5N1 vaccine; Administered as an intramuscular (IM) injection; Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia); Administered as an intramuscular (IM) injection; Biological: Placebo; Administered as an intramuscular (IM) injection
Experimental: A/Indonesia primed-A/turkey Influenza (H5N1)-F3-Placebo Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Biological: A/turkey H5N1 vaccine; Administered as an intramuscular (IM) injection; Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia); Administered as an intramuscular (IM) injection; Biological: Placebo; Administered as an intramuscular (IM) injection
Experimental: A/Indonesia primed-Placebo-A/turkey Influenza (H5N1)-F1-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Biological: A/turkey H5N1 vaccine; Administered as an intramuscular (IM) injection; Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia); Administered as an intramuscular (IM) injection; Biological: Placebo; Administered as an intramuscular (IM) injection
Experimental: A/Indonesia primed-Placebo-A/turkey Influenza (H5N1)-F4-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Biological: A/turkey H5N1 vaccine; Administered as an intramuscular (IM) injection; Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia); Administered as an intramuscular (IM) injection; Biological: Placebo; Administered as an intramuscular (IM) injection
Experimental: A/Indonesia primed-Placebo-A/turkey Influenza (H5N1)-F2-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Biological: A/turkey H5N1 vaccine; Administered as an intramuscular (IM) injection; Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia); Administered as an intramuscular (IM) injection; Biological: Placebo; Administered as an intramuscular (IM) injection
Placebo Comparator: Naïve Placebo-A/turkey Influenza (H5N1)-F3-Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.	Biological: A/turkey H5N1 vaccine; Administered as an intramuscular (IM) injection; Biological: Placebo; Administered as an intramuscular (IM) injection

Outcome Measures

Primary Outcome Measures

1. Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. [At Day 559]

   A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.

2. Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. [At Day 192]

   A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group

3. Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. [At Days 549 and 559]

   HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.

4. Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. [At Days 182 and 192]

   HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.

5. Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. [At Days 549 and 559]

   A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.

6. Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. [At Days 182 and 192]

   A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.

7. Number of Subjects With Solicited Local Symptoms [Within the 7-day (Days 0-6) post vaccination periods]

   Assessed solicited local symptoms were pain, redness and swelling. Any was defined as an occurrence of the specified solicited local symptom regardless of its intensity.

8. Number of Subjects With Solicited General Symptoms [Within the 7-day (Days 0-6) post vaccination periods]

   Solicited general symptoms assessed were fatigue, headache, joint pain at other locations (joint pain), muscle aches, shivering, sweating and fever. Any was defined as an occurrence of the specified solicited general symptom, irrespective of its intensity or relationship to vaccination. Any fever was defined as oral temperature higher than or equal to (≥) 38.0 degrees Celsius (°C).

9. Number of Subjects With Medically-attended Adverse Events (MAEs) [From Day 0 to Day 909]

   MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).

10. Number of Subjects With Unsolicited Adverse Events (AEs) [Within the 43-day (Days 0-42) post-vaccination periods]

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

11. Number of Subjects With Serious Adverse Events (SAEs) [From Day 0 to Day 909]

    A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as an occurrence of an SAE, regardless its relationship to vaccination.

Secondary Outcome Measures

1. Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. [At Day 192]

   A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.

2. Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey Virus Strain. [At Days 182 and 192]

   HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.

3. Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. [At Days 182 and 192]

   A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.

4. Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. [At Day 224]

   A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.

5. Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. [At Day 591]

   A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.

6. Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain [At Days 192 and 224]

   GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.

7. Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain [At Day 559]

   GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 549. This outcome measure solely concerns subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.

8. Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. [At Day 591]

   A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.

9. Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. [At Day 224]

   A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.

10. Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. [At Days 0, 182,192, 224, 549 and 729]

    HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.

11. Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. [At Days 0, 182, 549, 559, 591 and 729]

    HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.

12. Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. [At Days 0, 182, 192, 224, 549, 559, 591 and 729]

    HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.

13. Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain. [At Days 0, 182,192, 224, 549 and 729]

    A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.

14. Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain [At Days 0, 182, 549, 559, 591 and 729]

    A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.

15. Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain [At Days 0, 182, 192, 224, 549, 559, 591 and 729]

    A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.

16. Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. [At Days 0, 10, 42, 182 and 549]

    HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.

17. Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. [At Days 0, 10, 42, 182, 549 and 559]

    HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.

18. Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. [At Day 0, Day 10, Day 42, Day 182 and Day 549]

    A seroprotected subject was defined as a vaccinated subject with HI antibody reciprocal titers against the A/Indo virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.

19. Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. [At Day 0, Day 10, Day 42, Day 182, Day 549, and Day 559]

    A seroprotected subject was defined as a vaccinated subject with HI antibody reciprocal titers against the A/Indo virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.

20. Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain. [At Days 10 and 42]

    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 0. This outcome measure only concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.

21. Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain. [At Days 192 and 224]

    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. This outcome measure only concerns the Naïve Placebo-A/turkey H5N1-Formulation 3 Group, for whom the pre-vaccination time point corresponds to the Day 192 time point.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• A male or female 18 years of age or older at the time of the first vaccination.

• Written informed consent obtained from the subject.

• Stable health status as defined by absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrollment.

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

• Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.

• Subjects who the investigator believes can and will comply with the requirements of the protocol

Exclusion Criteria:

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

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

• Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.

• Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may enroll within 3 years of diagnosis, but other histologic types of skin cancer require a 3 year untreated and disease-free window as above.

• Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may enroll.

• Presence of an oral temperature ≥ 37.8ºC, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.

• Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.

• Receipt of systemic glucocorticoids (prednisone >= 10 mg/day for more than 14 consecutive days) within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.

• Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.

• Administration of any vaccines within 30 days before the first study vaccine dose.

• Previous administration of any H5N1 vaccine.

• Use of any investigational or non-registered product (drug or vaccine) or planned participation in another investigational study within 30 days prior to study enrollment, or during the 18 months following the first test article dose. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial.

• Receipt of any immunoglobulins and/or any blood products within 6 months of study enrollment or planned administration of any of these products during the study period.

• Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins or mercurial preservatives); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.

• Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test result prior to vaccination.

• Lactating or nursing.

• Women of child bearing potential who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments.

• Known receipt of analgesic or antipyretic medication with the specific intent of prophylaxis of vaccine reactogenicity on the day of first or any treatment. Subjects on stable chronic regimens of potentially analgesic or anti-pyretic medications for pre-existing diagnoses are not required to discontinue them (to do so would represent evaluation of combined vaccine reactogenicity AND treatment withdrawal - which is not the intent of the protocol).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Denver	Colorado	United States	80239
2	GSK Investigational Site	Chicago	Illinois	United States	60610
3	GSK Investigational Site	Metairie	Louisiana	United States	70006
4	GSK Investigational Site	Milford	Massachusetts	United States	01757
5	GSK Investigational Site	Kansas City	Missouri	United States	64114
6	GSK Investigational Site	Missoula	Montana	United States	59801
7	GSK Investigational Site	Winston-Salem	North Carolina	United States	27103
8	GSK Investigational Site	Bristol	Tennessee	United States	37620
9	GSK Investigational Site	Austin	Texas	United States	78705
10	GSK Investigational Site	Fort Worth	Texas	United States	76135
11	GSK Investigational Site	Halifax	Nova Scotia	Canada	B3K 6R8
12	GSK Investigational Site	Montreal	Quebec	Canada	H2K 4L5
13	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: NCT00719043
• Other Study ID Numbers: 110624
• First Posted: Jul 21, 2008
• Last Update Posted: Jul 9, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Influenza; H5N1; Avian; Vaccines; Safety; Immunogenicity; Pandemic; Human
• Additional relevant MeSH terms: Influenza, Human; Vaccines

Study Results

Participant Flow

Recruitment Details	Study duration was of approximately 909 days for all subjects.

Arm/Group Title	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group	Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Period Title: Overall Study
STARTED	120	121	119	119	122	120	120
COMPLETED	88	96	99	96	95	86	92
NOT COMPLETED	32	25	20	23	27	34	28

Baseline Characteristics

Arm/Group Title	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group	Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group	Total
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.	Total of all reporting groups
Overall Participants	120	121	119	119	122	120	120	841
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	49.8 (18.01)	49.6 (17.93)	50.7 (17.67)	49.2 (17.75)	50.3 (17.77)	50.1 (18.92)	50.0 (18.03)	49.95 (17.99)
Sex: Female, Male (Count of Participants)
Female	80 66.7%	73 60.3%	69 58%	70 58.8%	68 55.7%	70 58.3%	75 62.5%	505 60%
Male	40 33.3%	48 39.7%	50 42%	49 41.2%	54 44.3%	50 41.7%	45 37.5%	336 40%

Outcome Measures

1. Primary Outcome

Title	Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Description	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.
Time Frame	At Day 559

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.

Arm/Group Title	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	83	87	80	72
Number [Subjects]	71	81	73	65

2. Primary Outcome

Title	Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Description	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group
Time Frame	At Day 192

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.

Arm/Group Title	Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	99
Number [Subjects]	44

3. Primary Outcome

Title	Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.
Description	HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.
Time Frame	At Days 549 and 559

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.

Arm/Group Title	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	83	88	81	72
A/turkey, Day 549 (N=83,88,81,72)	11.1	8.3	9.2	11.4
A/turkey, Day 559 (N= 83,88,81,72)	356.7	266.4	446.6	343.9

4. Primary Outcome

Title	Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.
Description	HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.
Time Frame	At Days 182 and 192

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.

Arm/Group Title	Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	100
A/turkey strain, Day 182 (N=100)	10.8
A/turkey strain, Day 192 (N=99)	43.5

5. Primary Outcome

Title	Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Description	A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.
Time Frame	At Days 549 and 559

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.

Arm/Group Title	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	88	87	81	72
A/turkey, Day 549 (N=83,88,81,72)	15	8	10	13
A/turkey, Day 559 (N= 83,87,80,72)	79	83	77	69

6. Primary Outcome

Title	Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Description	A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.
Time Frame	At Days 182 and 192

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.

Arm/Group Title	Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	100
A/turkey strain, Day 182 (N=100)	24
A/turkey strain, Day 192 (N=99)	64

7. Primary Outcome

Title	Number of Subjects With Solicited Local Symptoms
Description	Assessed solicited local symptoms were pain, redness and swelling. Any was defined as an occurrence of the specified solicited local symptom regardless of its intensity.
Time Frame	Within the 7-day (Days 0-6) post vaccination periods

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.

Arm/Group Title	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	120	121	119	119	122	120	120
Any Pain	98	100	101	93	102	90	95
Any Redness	8	4	12	9	14	4	8
Any Swelling	6	7	15	4	16	9	11

8. Primary Outcome

Title	Number of Subjects With Solicited General Symptoms
Description	Solicited general symptoms assessed were fatigue, headache, joint pain at other locations (joint pain), muscle aches, shivering, sweating and fever. Any was defined as an occurrence of the specified solicited general symptom, irrespective of its intensity or relationship to vaccination. Any fever was defined as oral temperature higher than or equal to (≥) 38.0 degrees Celsius (°C).
Time Frame	Within the 7-day (Days 0-6) post vaccination periods

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.

Arm/Group Title	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	120	121	119	119	122	120	120
Any Fatigue	45	50	47	44	42	39	47
Any Headache	44	50	42	44	44	35	47
Any Joint pain	33	37	36	26	28	16	30
Any Muscle aches	54	52	59	49	48	42	55
Any Shivering	12	18	16	8	20	10	18
Any Sweating	15	20	15	11	14	10	11
Any Fever	2	5	6	3	8	2	2

9. Primary Outcome

Title	Number of Subjects With Medically-attended Adverse Events (MAEs)
Description	MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).
Time Frame	From Day 0 to Day 909

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.

Arm/Group Title	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	120	121	119	119	122	120	120
Number [Subjects]	68	66	77	75	62	63	70

10. Primary Outcome

Title	Number of Subjects With Unsolicited Adverse Events (AEs)
Description	An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as any occurrence of an unsolicited AE in a subject, regardless of intensity grade or relation to vaccination.
Time Frame	Within the 43-day (Days 0-42) post-vaccination periods

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.

Arm/Group Title	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	120	121	119	119	122	120	120
Number [Subjects]	70	72	78	68	67	68	75

11. Primary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as an occurrence of an SAE, regardless its relationship to vaccination.
Time Frame	From Day 0 to Day 909

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.

Arm/Group Title	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	120	121	119	119	122	120	120
Number [Subjects]	12	14	11	9	11	15	12

12. Secondary Outcome

Title	Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Description	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.
Time Frame	At Day 192

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.

Arm/Group Title	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	99
Number [Subjects]	44

13. Secondary Outcome

Title	Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey Virus Strain.
Description	HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.
Time Frame	At Days 182 and 192

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.

Arm/Group Title	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	95	92
A/turkey, Day 182 (N=95,92)	17.6	12.2
A/turkey, Day 192 (N=94,86)	308.4	374.4

14. Secondary Outcome

Title	Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Description	A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.
Time Frame	At Days 182 and 192

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.

Arm/Group Title	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	95	92
A/turkey, Day 182 (N=95,92)	30	25
A/turkey, Day 192 (N=94,86)	89	85

15. Secondary Outcome

Title	Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Description	A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.
Time Frame	At Day 224

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.

Arm/Group Title	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	89	86	98
Number [Subjects]	82	82	60

16. Secondary Outcome

Title	Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Description	A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.
Time Frame	At Day 591

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.

Arm/Group Title	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	82	88	80	71
Number [Subjects]	77	83	75	67

17. Secondary Outcome

Title	Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain
Description	GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.
Time Frame	At Days 192 and 224

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.

Arm/Group Title	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	94	86	99
A/turkey, Day 192 (N=94,86,99)	17.8	30.2	4.0
A/turkey, Day 224 (N=89,86,98)	11.2	17.2	4.2

18. Secondary Outcome

Title	Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain
Description	GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 549. This outcome measure solely concerns subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.
Time Frame	At Day 559

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.

Arm/Group Title	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	83	88	80	72	81
A/turkey, Day 559 (N=83,87,80,72,81)	32.0	32.0	48.1	30.1	19.5
A/turkey, Day 591 (N=82,88,80,71,81)	26.7	29.1	35.2	22.0	14.8

19. Secondary Outcome

Title	Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Description	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.
Time Frame	At Day 591

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.

Arm/Group Title	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	82	88	80	71
Number [Subjects]	69	80	70	61

20. Secondary Outcome

Title	Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Description	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.
Time Frame	At Day 224

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.

Arm/Group Title	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	89	86	98
Number [Subjects]	64	75	42

21. Secondary Outcome

Title	Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.
Description	HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.
Time Frame	At Days 0, 182,192, 224, 549 and 729

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.

Arm/Group Title	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	95	92
A/turkey, Day 0 (N= 95,92)	9.2	6.6
A/turkey, Day 182 (N=95,92)	17.6	12.2
A/turkey, Day 192 (N=94,86)	308.4	374.4
A/turkey, Day 224 (N=93,91)	195.0	213.7
A/turkey, Day 549 (N=84,81)	32.7	28.7
A/turkey, Day 729 (N=78,78)	41.8	31.2

22. Secondary Outcome

Title	Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.
Description	HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.
Time Frame	At Days 0, 182, 549, 559, 591 and 729

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.

Arm/Group Title	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	90	96	99	89
A/turkey, Day 0 (N=90,96,99,89)	8.0	7.1	6.6	6.9
A/turkey, Day 182 (N=90,96,99,89)	13.5	10.8	12.8	13.7
A/turkey, Day 549 (N=83,86,81,72)	11.1	8.4	9.2	11.4
A/turkey, Day 559 (N=83,85,80,72)	356.7	266.4	446.6	343.9
A/turkey, Day 591 (N=82,86,80,71)	300.3	242.4	326.9	254.4
A/turkey, Day 729 (N=81,83,79,70)	119.2	96.6	134.8	105.6

23. Secondary Outcome

Title	Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.
Description	HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.
Time Frame	At Days 0, 182, 192, 224, 549, 559, 591 and 729

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.

Arm/Group Title	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	99
A/turkey, Day 0 (N=99)	8.0
A/turkey, Day 182 (N=99)	10.6
A/turkey, Day 192 (N=98)	43.4
A/turkey, Day 224 (N=98)	43.7
A/turkey, Day 549 (N=81)	15.6
A/turkey, Day 559 (N=80)	314.4
A/turkey, Day 591 (N=80)	236.2
A/turkey, Day 729 (N=80)	98.1

24. Secondary Outcome

Title	Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain.
Description	A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.
Time Frame	At Days 0, 182,192, 224, 549 and 729

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.

Arm/Group Title	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	95	92
A/turkey, Day 0 (N= 95,92)	16	7
A/turkey, Day 182 (N=95,92)	30	25
A/turkey, Day 192 (N=94,86)	89	85
A/turkey, Day 224 (N=93,91)	86	87
A/turkey, Day 549 (N=84,81)	42	40
A/turkey, Day 729 (N=78,78)	47	49

25. Secondary Outcome

Title	Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain
Description	A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.
Time Frame	At Days 0, 182, 549, 559, 591 and 729

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.

Arm/Group Title	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	90	96	99	89
A/turkey, Day 0 (N=90,96,99,89)	11	8	8	6
A/turkey, Day 182 (N=90,96,99,89)	25	20	28	31
A/turkey, Day 549 (N=83,86,81,72)	15	8	10	13
A/turkey, Day 559 (N=83,85,80,72)	79	81	77	69
A/turkey, Day 591 (N=82,86,80,71)	77	82	75	67
A/turkey, Day 729 (N=81,83,79,70)	75	73	71	66

26. Secondary Outcome

Title	Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain
Description	A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.
Time Frame	At Days 0, 182, 192, 224, 549, 559, 591 and 729

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.

Arm/Group Title	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	99
A/turkey, Day 0 (N=99)	8
A/turkey, Day 182 (N=99)	23
A/turkey, Day 192 (N=98)	63
A/turkey, Day 224 (N=98)	59
A/turkey, Day 549 (N=81)	21
A/turkey, Day 559 (N=80)	76
A/turkey, Day 591 (N=80)	73
A/turkey, Day 729 (N=80)	70

27. Secondary Outcome

Title	Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain.
Description	HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.
Time Frame	At Days 0, 10, 42, 182 and 549

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.

Arm/Group Title	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	95	92
A/Indo, Day 0 (N=95,92)	6.7	5.9
A/Indo, Day 10 (N=95,92)	32.3	30.7
A/Indo, Day 42 (N=93,88)	44.1	44.8
A/Indo, Day 182 (N=95,92)	22.4	15.7
A/Indo, Day 549 (N=84,81)	24.0	22.7

28. Secondary Outcome

Title	Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain.
Description	HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.
Time Frame	At Days 0, 10, 42, 182, 549 and 559

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.

Arm/Group Title	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	90	96	99	89	99
A/Indo, Day 0 (N=90,96,99,89,99)	5.9	5.7	5.7	5.6	5.9
A/Indo, Day 10 (N=89,95,98,87,97)	27.0	17.2	31.7	26.2	6.3
A/Indo, Day 42 (N=87,94,96,87,97)	37.5	27.3	45.7	36.6	6.2
A/Indo, Day 182 (N=90,96,99,89,99)	16.4	13.7	17.8	16.2	6.7
A/Indo, Day 549 (N=83,86,81,72,81)	8.1	7.9	7.8	9.2	6.2
A/Indo, Day 559 (N=83,85,81,72,80)	304.3	231.9	376.6	289.2	113.1

29. Secondary Outcome

Title	Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain.
Description	A seroprotected subject was defined as a vaccinated subject with HI antibody reciprocal titers against the A/Indo virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.
Time Frame	At Day 0, Day 10, Day 42, Day 182 and Day 549

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.

Arm/Group Title	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	95	92	99
A/Indo, Day 0 (N=95,92)	6	6.7	2
A/Indo, Day 10 (N=95,92)	50	32.3	4
A/Indo, Day 42 (N=93,88)	57	44.1	3
A/Indo, Day 182 (N=95,92)	42	22.4	9
A/Indo, Day 549 (N=84,81)	38	24.0	2

30. Secondary Outcome

Title	Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain.
Description	A seroprotected subject was defined as a vaccinated subject with HI antibody reciprocal titers against the A/Indo virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.
Time Frame	At Day 0, Day 10, Day 42, Day 182, Day 549, and Day 559

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.

Arm/Group Title	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	90	96	99	89	99
A/Indo, Day 0 (N=90,96,99,89,99)	1	0	3	2	2
A/Indo, Day 10 (N=89,95,98,87,97)	41	36	56	44	4
A/Indo, Day 42 (N=87,94,96,87,97)	50	51	68	53	3
A/Indo, Day 182 (N=90,96,99,89,99)	28	29	35	32	9
A/Indo, Day 549 (N=83,86,81,72,81)	9	9	7	11	2
A/Indo, Day 559 (N=83,85,81,72,80)	79	80	77	68	68

31. Secondary Outcome

Title	Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain.
Description	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 0. This outcome measure only concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.
Time Frame	At Days 10 and 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.

Arm/Group Title	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	95	92	89	97	98	87
A/Indo, Day 10 (N=95,92,89,97,98,87)	42	50	38	33	52	40
A/Indo, Day 42 (N=93,88,87,96,96,87)	50	61	49	51	64	51

32. Secondary Outcome

Title	Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain.
Description	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. This outcome measure only concerns the Naïve Placebo-A/turkey H5N1-Formulation 3 Group, for whom the pre-vaccination time point corresponds to the Day 192 time point.
Time Frame	At Days 192 and 224

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.

Arm/Group Title	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Measure Participants	47
A/Indo, Day 192	8
A/Indo, Day 224	3

Adverse Events

Time Frame	Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Arm/Group Title	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group		A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group		A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group		A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group		A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group		A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group		Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Arm/Group Description	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.		Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.		Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.		Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.		Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.		Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.		Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
All Cause Mortality
	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group		A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group		A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group		A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group		A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group		A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group		Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group		A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group		A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group		A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group		A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group		A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group		Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/120 (10%)		14/121 (11.6%)		11/119 (9.2%)		9/119 (7.6%)		11/122 (9%)		15/120 (12.5%)		12/120 (10%)
Blood and lymphatic system disorders
Lymphadenitis	1/120 (0.8%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Cardiac disorders
Bradycardia	0/120 (0%)		0/121 (0%)		1/119 (0.8%)		0/119 (0%)		0/122 (0%)		1/120 (0.8%)		0/120 (0%)
Coronary artery disease	0/120 (0%)		0/121 (0%)		0/119 (0%)		1/119 (0.8%)		0/122 (0%)		0/120 (0%)		1/120 (0.8%)
Angina pectoris	0/120 (0%)		1/121 (0.8%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Arteriosclerosis coronary artery	1/120 (0.8%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Atrial fibrillation	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		1/120 (0.8%)		0/120 (0%)
Cardiac failure congestive	1/120 (0.8%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Coronary artery occlusion	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		1/122 (0.8%)		0/120 (0%)		0/120 (0%)
Endocarditis noninfective	1/120 (0.8%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Mitral valve disease	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		1/120 (0.8%)		0/120 (0%)
Myocardial infarction	0/120 (0%)		0/121 (0%)		0/119 (0%)		1/119 (0.8%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Gastrointestinal disorders
Pancreatitis	0/120 (0%)		0/121 (0%)		1/119 (0.8%)		0/119 (0%)		0/122 (0%)		1/120 (0.8%)		1/120 (0.8%)
Colitis	0/120 (0%)		1/121 (0.8%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Dyspepsia	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		1/120 (0.8%)		0/120 (0%)
Gastrointestinal haemorrhage	0/120 (0%)		1/121 (0.8%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Haemorrhoids	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		1/120 (0.8%)		0/120 (0%)
Pancreatic mass	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		1/120 (0.8%)
Pancreatic pseudocyst	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		1/120 (0.8%)
Small intestinal obstruction	0/120 (0%)		0/121 (0%)		1/119 (0.8%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Small intestinal perforation	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		1/120 (0.8%)
General disorders
Chest discomfort	0/120 (0%)		1/121 (0.8%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		1/120 (0.8%)
Mass	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		1/120 (0.8%)
Pain	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		1/122 (0.8%)		0/120 (0%)		0/120 (0%)
Hepatobiliary disorders
Cholecystitis	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		1/120 (0.8%)		0/120 (0%)
Cholecystitis acute	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		1/120 (0.8%)
Immune system disorders
Anaphylactic shock	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		1/120 (0.8%)
Infections and infestations
Pneumonia	1/120 (0.8%)		1/121 (0.8%)		1/119 (0.8%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		1/120 (0.8%)
Appendicitis	0/120 (0%)		1/121 (0.8%)		0/119 (0%)		1/119 (0.8%)		0/122 (0%)		1/120 (0.8%)		0/120 (0%)
Bronchitis	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		1/122 (0.8%)		0/120 (0%)		1/120 (0.8%)
Cellulitis gangrenous	0/120 (0%)		0/121 (0%)		0/119 (0%)		1/119 (0.8%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Gastroenteritis salmonella	1/120 (0.8%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Meningitis viral	0/120 (0%)		0/121 (0%)		1/119 (0.8%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Post procedural infection	1/120 (0.8%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Septic shock	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		1/120 (0.8%)		0/120 (0%)
Staphylococcal infection	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		1/120 (0.8%)
Urinary tract infection	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		1/120 (0.8%)
Uterine infection	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		1/122 (0.8%)		0/120 (0%)		0/120 (0%)
Injury, poisoning and procedural complications
Ankle fracture	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		1/122 (0.8%)		0/120 (0%)		0/120 (0%)
Head injury	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		1/120 (0.8%)		0/120 (0%)
Lower limb fracture	0/120 (0%)		0/121 (0%)		1/119 (0.8%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Lumbar vertebral fracture	0/120 (0%)		1/121 (0.8%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Multiple fractures	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		1/120 (0.8%)		0/120 (0%)
Overdose	1/120 (0.8%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Patella fracture	1/120 (0.8%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Post procedural complication	0/120 (0%)		0/121 (0%)		1/119 (0.8%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Postoperative ileus	0/120 (0%)		0/121 (0%)		1/119 (0.8%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Subdural haematoma	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		1/120 (0.8%)
Metabolism and nutrition disorders
Dehydration	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		1/120 (0.8%)		0/120 (0%)
Hypoglycaemia	0/120 (0%)		1/121 (0.8%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Musculoskeletal and connective tissue disorders
Exostosis	0/120 (0%)		1/121 (0.8%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Intervertebral disc disorder	0/120 (0%)		1/121 (0.8%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Intervertebral disc protrusion	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		1/122 (0.8%)		0/120 (0%)		0/120 (0%)
Iron deficiency anaemia	1/120 (0.8%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Musculoskeletal pain	0/120 (0%)		0/121 (0%)		0/119 (0%)		1/119 (0.8%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Osteoarthritis	0/120 (0%)		1/121 (0.8%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	1/120 (0.8%)		1/121 (0.8%)		1/119 (0.8%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		1/120 (0.8%)
Bladder transitional cell carcinoma recurrent	0/120 (0%)		0/121 (0%)		0/119 (0%)		1/119 (0.8%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Breast cancer in situ	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		1/122 (0.8%)		0/120 (0%)		0/120 (0%)
Breast cancer recurrent	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		1/122 (0.8%)		0/120 (0%)		0/120 (0%)
Lung adenocarcinoma	0/120 (0%)		0/121 (0%)		0/119 (0%)		1/119 (0.8%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Lung adenocarcinoma metastatic	0/120 (0%)		1/121 (0.8%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Lymphoma	0/120 (0%)		0/121 (0%)		1/119 (0.8%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Malignant melanoma	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		1/122 (0.8%)		0/120 (0%)		0/120 (0%)
Myelodysplastic syndrome	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		1/120 (0.8%)		0/120 (0%)
Non-small cell lung cancer	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		1/120 (0.8%)		0/120 (0%)
Ovarian adenoma	0/120 (0%)		0/121 (0%)		1/119 (0.8%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Parathyroid tumour benign	0/120 (0%)		1/121 (0.8%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Prostate cancer	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		1/120 (0.8%)
Squamous cell carcinoma	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		1/120 (0.8%)		0/120 (0%)
Testis cancer	0/120 (0%)		1/121 (0.8%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Thyroid cancer	1/120 (0.8%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Nervous system disorders
Cerebrovascular accident	2/120 (1.7%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		1/122 (0.8%)		0/120 (0%)		0/120 (0%)
Loss of consciousness	0/120 (0%)		1/121 (0.8%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		1/120 (0.8%)
Syncope	1/120 (0.8%)		0/121 (0%)		1/119 (0.8%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Amnesia	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		1/120 (0.8%)
Carotid artery stenosis	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		1/120 (0.8%)		0/120 (0%)
Presyncope	1/120 (0.8%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	0/120 (0%)		1/121 (0.8%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Abortion spontaneous incomplete	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		1/122 (0.8%)		0/120 (0%)		0/120 (0%)
Psychiatric disorders
Bipolar disorder	0/120 (0%)		0/121 (0%)		0/119 (0%)		1/119 (0.8%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Completed suicide	1/120 (0.8%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Delirium	0/120 (0%)		1/121 (0.8%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Drug abuse	0/120 (0%)		1/121 (0.8%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Renal and urinary disorders
Nephrolithiasis	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		2/122 (1.6%)		0/120 (0%)		0/120 (0%)
Urinary retention	0/120 (0%)		0/121 (0%)		1/119 (0.8%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Reproductive system and breast disorders
Endometriosis	1/120 (0.8%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		1/120 (0.8%)
Ovarian cyst	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		1/120 (0.8%)		0/120 (0%)
Pelvic pain	1/120 (0.8%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Respiratory, thoracic and mediastinal disorders
Respiratory failure	1/120 (0.8%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		1/120 (0.8%)
Acute respiratory failure	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		1/120 (0.8%)
Chronic obstructive pulmonary disease	0/120 (0%)		0/121 (0%)		0/119 (0%)		1/119 (0.8%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Pulmonary embolism	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		1/120 (0.8%)		0/120 (0%)
Vascular disorders
Arteriosclerosis	1/120 (0.8%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		0/120 (0%)		0/120 (0%)
Deep vein thrombosis	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		0/122 (0%)		1/120 (0.8%)		0/120 (0%)
Hypertensive crisis	0/120 (0%)		0/121 (0%)		0/119 (0%)		0/119 (0%)		1/122 (0.8%)		0/120 (0%)		0/120 (0%)
Other (Not Including Serious) Adverse Events
	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group		A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group		A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group		A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group		A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group		A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group		Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	106/120 (88.3%)		109/121 (90.1%)		106/119 (89.1%)		103/119 (86.6%)		106/122 (86.9%)		101/120 (84.2%)		106/120 (88.3%)
Gastrointestinal disorders
Nausea	2/120 (1.7%)		2/121 (1.7%)		10/119 (8.4%)		6/119 (5%)		3/122 (2.5%)		5/120 (4.2%)		5/120 (4.2%)
Diarrhoea	4/120 (3.3%)		4/121 (3.3%)		4/119 (3.4%)		8/119 (6.7%)		4/122 (3.3%)		5/120 (4.2%)		7/120 (5.8%)
General disorders
Pain	98/120 (81.7%)		100/121 (82.6%)		101/119 (84.9%)		93/119 (78.2%)		102/122 (83.6%)		90/120 (75%)		95/120 (79.2%)
Redness	8/120 (6.7%)		4/121 (3.3%)		12/119 (10.1%)		9/119 (7.6%)		14/122 (11.5%)		4/120 (3.3%)		8/120 (6.7%)
Swelling	6/120 (5%)		7/121 (5.8%)		15/119 (12.6%)		4/119 (3.4%)		16/122 (13.1%)		9/120 (7.5%)		11/120 (9.2%)
Fatigue	45/120 (37.5%)		50/121 (41.3%)		47/119 (39.5%)		44/119 (37%)		42/122 (34.4%)		39/120 (32.5%)		47/120 (39.2%)
Headache	44/120 (36.7%)		50/121 (41.3%)		47/119 (39.5%)		44/119 (37%)		44/122 (36.1%)		35/120 (29.2%)		47/120 (39.2%)
Joint pain	33/120 (27.5%)		37/121 (30.6%)		36/119 (30.3%)		44/119 (37%)		42/122 (34.4%)		39/120 (32.5%)		30/120 (25%)
Muscle aches	54/120 (45%)		52/121 (43%)		59/119 (49.6%)		49/119 (41.2%)		48/122 (39.3%)		42/120 (35%)		55/120 (45.8%)
Shivering	12/120 (10%)		18/121 (14.9%)		16/119 (13.4%)		8/119 (6.7%)		20/122 (16.4%)		10/120 (8.3%)		18/120 (15%)
Sweating	15/120 (12.5%)		20/121 (16.5%)		15/119 (12.6%)		11/119 (9.2%)		14/122 (11.5%)		10/120 (8.3%)		18/120 (15%)
Fever	2/120 (1.7%)		5/121 (4.1%)		6/119 (5%)		3/119 (2.5%)		8/122 (6.6%)		2/120 (1.7%)		2/120 (1.7%)
Infections and infestations
Nasopharyngitis	15/120 (12.5%)		9/121 (7.4%)		9/119 (7.6%)		14/119 (11.8%)		12/122 (9.8%)		11/120 (9.2%)		6/120 (5%)
Upper respiratory tract infection	7/120 (5.8%)		5/121 (4.1%)		6/119 (5%)		3/119 (2.5%)		6/122 (4.9%)		3/120 (2.5%)		5/120 (4.2%)
Nervous system disorders
Headache	8/120 (6.7%)		11/121 (9.1%)		4/119 (3.4%)		6/119 (5%)		6/122 (4.9%)		10/120 (8.3%)		5/120 (4.2%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	9/120 (7.5%)		8/121 (6.6%)		9/119 (7.6%)		12/119 (10.1%)		1/122 (0.8%)		10/120 (8.3%)		11/120 (9.2%)
Cough	9/120 (7.5%)		7/121 (5.8%)		6/119 (5%)		5/119 (4.2%)		4/122 (3.3%)		5/120 (4.2%)		5/120 (4.2%)

Limitations/Caveats

[Not Specified]

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

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.