A Trial to Test the Response to Different Vaccination Regimens With an H5N1 Vaccine With AS03 in Adults Aged 18-64

A Trial to Evaluate the Immunogenicity of Accelerated Primary Vaccination With Monovalent A/Indonesia/5/05 (H5N1) Vaccine Antigen in Association With AS03 Adjuvant in Adults Aged 18-64

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00695669

Enrollment

312

Registered

2008-06-12

Start date

2008-06-05

Completion date

2009-01-08

Last updated

2018-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

H5N1, immunogenicity, influenza, Avian, pandemic, vaccines, human, safety

Brief summary

The purpose of the study is to characterize the immunogenicity & safety of 2 doses of GSK's avian flu vaccine GSK 1557484A given according to different regimens to adults aged 18 to 64 years

Detailed description

A Phase 2, open-label, randomized, parallel group, multi-centered study designed to evaluate the immunogenicity and safety of a 2-dose series of avian influenza vaccine plus AS03 adjuvant according to different regimens, in adults aged 18-64 years. All subjects will receive active study vaccine; no subjects are to receive placebo. A total of 312 subjects will be enrolled in this study at approximately 3 study centers in Canada. All subjects will attend formal study center visits for safety and immunogenicity assessments on Days 0, 21, 42, and 182. Additional formal study center visits will be scheduled at additional timepoints for subjects in particular dose groups. In addition, a telephone call will be conducted for all subjects on Day 51

Interventions

BIOLOGICALInfluenza A (H5N1) Virus Monovalent Vaccine

Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

Inclusion criteria

* A male or female 18-64 years old at the time of the first vaccination. * Written informed consent obtained from the subject. * Good general health as established by medical history and clinical examination before entering into the study. * Access to a consistent means of telephone contact. * Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits. * Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study

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 be enrolled, but other histological types of skin cancer are exclusionary. * Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may be enrolled. * 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 within 1 month of 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 study enrollment or during the 30 days following the last test article dose. Subjects who receive such immunizations on an emergent basis after enrollment will be followed per protocol and included in the Total Vaccinated Cohort (TVC), but excluded from the According to Protocol (ATP) Cohort for both safety and immunogenicity. * 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 182 days 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 either 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. Note: all women will have urine pregnancy tests regardless of their status. * Known receipt of analgesic or antipyretic medication on the day of treatment with 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

Design outcomes

Primary

Measure	Time frame	Description
Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	At Day 14 post Dose 2	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal hemagglutination inhibition (HI) titer less than (\<) 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	At Day 0 and at Day 14 post Dose 2	Titers are presented as geometric mean titers (GMTs). The Confidence Interval for this outcome was 98.75%.
Number of Seroprotected Subjects Against 3 Strains the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	At Day 0 and at Day 14 post Dose 2	A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.

Secondary

Measure	Time frame	Description
Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	At Day 182	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal hemagglutination inhibition (HI) titer \< 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer ≥ 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.
Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	At Days 0, 42 and 182.	The GMFR is presented as the GMT ratio between GMTs at Day 42/182 and at Day 0.
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	At Days 0, 21, 28, 35, 42 and 182.	Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.
Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	At 7, 14 and 21 days after the second dose	Subjects with a vaccine response were defined as vaccinated subjects who had either a pre-vaccination titer \< 1:28 and a post vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer.
Number of Subjects With a Vaccine Response of MN Assessed Antibodies for the Flu A/Turkey/Turkey/1/2005 (TURK) Strain of Influenza Disease.	At Day 182	Subjects with vaccine response were defined as vaccinated subjects who had either a pre-vaccination titer \< 1:28 and a post vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	At Days 0, 21, 28, 35, 42 and 182.	Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.
Number of Subjects With Solicited General Symptoms	Within the 7-day follow-up period (Days 0-6) after any vaccination	Assessed solicited general symptoms were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Fever was defined as oral temperature ≥ 38 degrees Celsius (°C). Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination.
Number of Subjects With Medically Attended Adverse Events (MAEs).	From Day 0 to 182	A MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.
Number of Subjects With Unsolicited Adverse Events (AEs)	Within the 51-day follow-up period (Days 0-50) after first vaccination.	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.
Number of Subjects With Any Serious Adverse Events (SAEs)	From Day 0 to 182	A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject.
Number of Subjects With Solicited Local Symptoms	Within the 7-day follow-up period (Days 0-6) after any vaccination	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	At Days 0, 21, 28, 35, 42 and 182.	Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.
Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	At Day 42	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer \< 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer ≥ 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.

Countries

Canada

Participant flow

Participants by arm

Arm	Count
Influenza A (H5N1) 1 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	78
Influenza A (H5N1) 2 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	78
Influenza A (H5N1) 3 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	78
Influenza A (H5N1) 4 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.	78
Total	312

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Adverse Event	0	0	2	0
Overall Study	Lost to Follow-up	4	4	1	4

Baseline characteristics

Characteristic	Influenza A (H5N1) 1 Group	Influenza A (H5N1) 2 Group	Influenza A (H5N1) 3 Group	Influenza A (H5N1) 4 Group	Total
Age, Continuous	40.2 Years STANDARD_DEVIATION 13.88	39.7 Years STANDARD_DEVIATION 13.81	40.8 Years STANDARD_DEVIATION 13.87	40.7 Years STANDARD_DEVIATION 13.22	40.3 Years STANDARD_DEVIATION 13.64
Sex: Female, Male Female	39 Participants	36 Participants	43 Participants	48 Participants	166 Participants
Sex: Female, Male Male	39 Participants	42 Participants	35 Participants	30 Participants	146 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	66 / 78	67 / 78	68 / 78	67 / 78
serious Total, serious adverse events	1 / 78	0 / 78	3 / 78	1 / 78

Outcome results

Primary

Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal hemagglutination inhibition (HI) titer less than (\<) 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.

Time frame: At Day 14 post Dose 2

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.

Arm	Measure	Value (NUMBER)
Influenza A (H5N1) 1 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	63 Subjects
Influenza A (H5N1) 2 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	64 Subjects
Influenza A (H5N1) 3 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	53 Subjects
Influenza A (H5N1) 4 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	54 Subjects

Primary

Number of Seroprotected Subjects Against 3 Strains the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.

Time frame: At Day 0 and at Day 14 post Dose 2

Arm	Measure	Group	Value (NUMBER)
Influenza A (H5N1) 1 Group	Number of Seroprotected Subjects Against 3 Strains the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 0	2 Subjects
Influenza A (H5N1) 1 Group	Number of Seroprotected Subjects Against 3 Strains the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 14 post Dose 2	63 Subjects
Influenza A (H5N1) 2 Group	Number of Seroprotected Subjects Against 3 Strains the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 14 post Dose 2	64 Subjects
Influenza A (H5N1) 2 Group	Number of Seroprotected Subjects Against 3 Strains the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 0	1 Subjects
Influenza A (H5N1) 3 Group	Number of Seroprotected Subjects Against 3 Strains the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 0	2 Subjects
Influenza A (H5N1) 3 Group	Number of Seroprotected Subjects Against 3 Strains the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 14 post Dose 2	55 Subjects
Influenza A (H5N1) 4 Group	Number of Seroprotected Subjects Against 3 Strains the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 0	3 Subjects
Influenza A (H5N1) 4 Group	Number of Seroprotected Subjects Against 3 Strains the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 14 post Dose 2	56 Subjects

Primary

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

Titers are presented as geometric mean titers (GMTs). The Confidence Interval for this outcome was 98.75%.

Time frame: At Day 0 and at Day 14 post Dose 2

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 0	5.4 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 14 post Dose 2	640.0 titers
Influenza A (H5N1) 2 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 14 post Dose 2	345.0 titers
Influenza A (H5N1) 2 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 0	5.3 titers
Influenza A (H5N1) 3 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 0	5.5 titers
Influenza A (H5N1) 3 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 14 post Dose 2	77.7 titers
Influenza A (H5N1) 4 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 0	5.8 titers
Influenza A (H5N1) 4 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 14 post Dose 2	67.4 titers

Secondary

Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

The GMFR is presented as the GMT ratio between GMTs at Day 42/182 and at Day 0.

Time frame: At Days 0, 42 and 182.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Influenza A (H5N1) 1 Group	Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 42 [N=62,68,73,74]	21.7 Fold increase
Influenza A (H5N1) 1 Group	Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	H5N1 at Day 182 [N=65,68,71,73]	9.5 Fold increase
Influenza A (H5N1) 1 Group	Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	H5N1 at Day 42 [N=62,68,73,74]	97.3 Fold increase
Influenza A (H5N1) 1 Group	Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 42 [N=62,68,73,74]	9.1 Fold increase
Influenza A (H5N1) 1 Group	Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 182 [N=65,68,71,73]	3.4 Fold increase
Influenza A (H5N1) 2 Group	Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 42 [N=62,68,73,74]	4.3 Fold increase
Influenza A (H5N1) 2 Group	Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	H5N1 at Day 42 [N=62,68,73,74]	49.4 Fold increase
Influenza A (H5N1) 2 Group	Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 42 [N=62,68,73,74]	9.6 Fold increase
Influenza A (H5N1) 2 Group	Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	H5N1 at Day 182 [N=65,68,71,73]	6.9 Fold increase
Influenza A (H5N1) 2 Group	Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 182 [N=65,68,71,73]	2.7 Fold increase
Influenza A (H5N1) 3 Group	Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 42 [N=62,68,73,74]	4.8 Fold increase
Influenza A (H5N1) 3 Group	Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 182 [N=65,68,71,73]	1.9 Fold increase
Influenza A (H5N1) 3 Group	Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	H5N1 at Day 182 [N=65,68,71,73]	3.9 Fold increase
Influenza A (H5N1) 3 Group	Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 42 [N=62,68,73,74]	2.5 Fold increase
Influenza A (H5N1) 3 Group	Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	H5N1 at Day 42 [N=62,68,73,74]	14.8 Fold increase
Influenza A (H5N1) 4 Group	Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 182 [N=65,68,71,73]	2.1 Fold increase
Influenza A (H5N1) 4 Group	Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	H5N1 at Day 182 [N=65,68,71,73]	4.8 Fold increase
Influenza A (H5N1) 4 Group	Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 42 [N=62,68,73,74]	2.7 Fold increase
Influenza A (H5N1) 4 Group	Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 42 [N=62,68,73,74]	4.6 Fold increase
Influenza A (H5N1) 4 Group	Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	H5N1 at Day 42 [N=62,68,73,74]	13.5 Fold increase

Secondary

Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 4 Group.

Time frame: At Days 0, 7, 14, 21, 42 and 182.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 0 [N=75]	36.1 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 7 [N=74]	62.8 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 14 [N=75]	135.6 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 21 [N=74]	109.3 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 42 [N=74]	93.7 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 0 [N=75]	24.3 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 7 [N=74]	36.5 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 14 [N=75]	97.2 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 21 [N=74]	97.5 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 42 [N=74]	132.1 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 182 [N=73]	147.3 titers

Secondary

Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 3 Group.

Time frame: At Days 0, 7, 14, 21, 28, 42 and 182.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 0 [N=74]	32.9 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 7 [N=74]	42.2 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 14 [N=73]	125.5 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 21 [N=74]	133.8 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 28 [N=72]	119.4 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 42 [N=73]	114.5 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 0 [N=74]	23.4 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 7 [N=74]	25.1 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 14 [N=73]	83.6 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 21 [N=74]	105.8 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 28 [N=72]	115.5 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 42 [N=73]	146.7 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 182 [N=71]	138.7 titers

Secondary

Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 2 Group.

Time frame: At Days 0, 14, 21, 28, 35, 42 and 182.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 0 [N=69]	34.5 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 14 [N=69]	99.4 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 21 [N=69]	104.3 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 28 [N=69]	146.9 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 35 [N=69]	142.0 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 42 [N=68]	134.5 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 0 [N=69]	24.1 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 14 [N=68]	64.9 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 21 [N=69]	107.0 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 28 [N=69]	224.0 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 35 [N=69]	221.7 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 42 [N=68]	227.8 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 182 [N=68]	230.2 titers

Secondary

Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.

Time frame: At Days 0, 21, 28, 35, 42 and 182.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 0 [N=65]	31.8 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 21 [N=64]	85.0 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 28 [N=65]	99.8 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 35 [N=65]	142.6 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 42 [N=62]	151.3 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 0 [N=65]	26.5 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 21 [N=64]	57.5 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 28 [N=65]	139.9 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 35 [N=65]	442.6 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 42 [N=62]	377.0 titers
Influenza A (H5N1) 1 Group	Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 182 [N=65]	245.5 titers

Secondary

Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal hemagglutination inhibition (HI) titer \< 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer ≥ 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.

Time frame: At Day 182

Arm	Measure	Group	Value (NUMBER)
Influenza A (H5N1) 1 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	H5N1	45 Subjects
Influenza A (H5N1) 1 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK	30 Subjects
Influenza A (H5N1) 2 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK	22 Subjects
Influenza A (H5N1) 2 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	H5N1	42 Subjects
Influenza A (H5N1) 3 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	H5N1	29 Subjects
Influenza A (H5N1) 3 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK	14 Subjects
Influenza A (H5N1) 4 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	H5N1	38 Subjects
Influenza A (H5N1) 4 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK	18 Subjects

Secondary

Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer \< 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer ≥ 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.

Time frame: At Day 42

Arm	Measure	Group	Value (NUMBER)
Influenza A (H5N1) 1 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	H5N1	59 Subjects
Influenza A (H5N1) 1 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK	52 Subjects
Influenza A (H5N1) 1 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET	41 Subjects
Influenza A (H5N1) 2 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	H5N1	63 Subjects
Influenza A (H5N1) 2 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK	51 Subjects
Influenza A (H5N1) 2 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET	35 Subjects
Influenza A (H5N1) 3 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET	16 Subjects
Influenza A (H5N1) 3 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	H5N1	57 Subjects
Influenza A (H5N1) 3 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK	41 Subjects
Influenza A (H5N1) 4 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	H5N1	55 Subjects
Influenza A (H5N1) 4 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK	39 Subjects
Influenza A (H5N1) 4 Group	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET	19 Subjects

Secondary

Number of Subjects With Any Serious Adverse Events (SAEs)

A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject.

Time frame: From Day 0 to 182

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

Arm	Measure	Value (NUMBER)
Influenza A (H5N1) 1 Group	Number of Subjects With Any Serious Adverse Events (SAEs)	1 Subjects
Influenza A (H5N1) 2 Group	Number of Subjects With Any Serious Adverse Events (SAEs)	0 Subjects
Influenza A (H5N1) 3 Group	Number of Subjects With Any Serious Adverse Events (SAEs)	3 Subjects
Influenza A (H5N1) 4 Group	Number of Subjects With Any Serious Adverse Events (SAEs)	1 Subjects

Secondary

Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

Subjects with a vaccine response were defined as vaccinated subjects who had either a pre-vaccination titer \< 1:28 and a post vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer.

Time frame: At Day 42

Arm	Measure	Group	Value (NUMBER)
Influenza A (H5N1) 1 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK [N=62,68,73,74]	50 Subjects
Influenza A (H5N1) 1 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET [N=62,68,72,74]	33 Subjects
Influenza A (H5N1) 2 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK [N=62,68,73,74]	55 Subjects
Influenza A (H5N1) 2 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET [N=62,68,72,74]	34 Subjects
Influenza A (H5N1) 3 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET [N=62,68,72,74]	30 Subjects
Influenza A (H5N1) 3 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK [N=62,68,73,74]	49 Subjects
Influenza A (H5N1) 4 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK [N=62,68,73,74]	44 Subjects
Influenza A (H5N1) 4 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET [N=62,68,72,74]	24 Subjects

Secondary

Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

Time frame: At 7, 14 and 21 days after the second dose

Arm	Measure	Group	Value (NUMBER)
Influenza A (H5N1) 1 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at 7 days post dose 2 [N=65,69,72,74]	28 Subjects
Influenza A (H5N1) 1 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at 14 days post dose 2 [N=65,69,73,75]	35 Subjects
Influenza A (H5N1) 1 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at 21 days post dose 2 [N=62,69,71,74]	33 Subjects
Influenza A (H5N1) 1 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at 7 days post dose 2 [N=65,69,73,74]	37 Subjects
Influenza A (H5N1) 1 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at 14 days post dose 2 [N=65,69,74,75]	54 Subjects
Influenza A (H5N1) 1 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at 21 days post dose 2 [N=62,69,72,74]	50 Subjects
Influenza A (H5N1) 2 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at 21 days post dose 2 [N=62,69,72,74]	53 Subjects
Influenza A (H5N1) 2 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at 7 days post dose 2 [N=65,69,73,74]	37 Subjects
Influenza A (H5N1) 2 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at 7 days post dose 2 [N=65,69,72,74]	26 Subjects
Influenza A (H5N1) 2 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at 21 days post dose 2 [N=62,69,71,74]	32 Subjects
Influenza A (H5N1) 2 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at 14 days post dose 2 [N=65,69,73,75]	36 Subjects
Influenza A (H5N1) 2 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at 14 days post dose 2 [N=65,69,74,75]	54 Subjects
Influenza A (H5N1) 3 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at 14 days post dose 2 [N=65,69,73,75]	33 Subjects
Influenza A (H5N1) 3 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at 21 days post dose 2 [N=62,69,71,74]	33 Subjects
Influenza A (H5N1) 3 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at 7 days post dose 2 [N=65,69,73,74]	33 Subjects
Influenza A (H5N1) 3 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at 21 days post dose 2 [N=62,69,72,74]	40 Subjects
Influenza A (H5N1) 3 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at 14 days post dose 2 [N=65,69,74,75]	43 Subjects
Influenza A (H5N1) 3 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at 7 days post dose 2 [N=65,69,72,74]	34 Subjects
Influenza A (H5N1) 4 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at 14 days post dose 2 [N=65,69,74,75]	35 Subjects
Influenza A (H5N1) 4 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at 21 days post dose 2 [N=62,69,72,74]	37 Subjects
Influenza A (H5N1) 4 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at 14 days post dose 2 [N=65,69,73,75]	32 Subjects
Influenza A (H5N1) 4 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at 7 days post dose 2 [N=65,69,73,74]	11 Subjects
Influenza A (H5N1) 4 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at 7 days post dose 2 [N=65,69,72,74]	16 Subjects
Influenza A (H5N1) 4 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at 21 days post dose 2 [N=62,69,71,74]	33 Subjects

Secondary

Number of Subjects With a Vaccine Response of MN Assessed Antibodies for the Flu A/Turkey/Turkey/1/2005 (TURK) Strain of Influenza Disease.

Subjects with vaccine response were defined as vaccinated subjects who had either a pre-vaccination titer \< 1:28 and a post vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer.

Time frame: At Day 182

Arm	Measure	Value (NUMBER)
Influenza A (H5N1) 1 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for the Flu A/Turkey/Turkey/1/2005 (TURK) Strain of Influenza Disease.	47 Subjects
Influenza A (H5N1) 2 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for the Flu A/Turkey/Turkey/1/2005 (TURK) Strain of Influenza Disease.	51 Subjects
Influenza A (H5N1) 3 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for the Flu A/Turkey/Turkey/1/2005 (TURK) Strain of Influenza Disease.	45 Subjects
Influenza A (H5N1) 4 Group	Number of Subjects With a Vaccine Response of MN Assessed Antibodies for the Flu A/Turkey/Turkey/1/2005 (TURK) Strain of Influenza Disease.	43 Subjects

Secondary

Number of Subjects With Medically Attended Adverse Events (MAEs).

A MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.

Time frame: From Day 0 to 182

Arm	Measure	Value (NUMBER)
Influenza A (H5N1) 1 Group	Number of Subjects With Medically Attended Adverse Events (MAEs).	18 Subjects
Influenza A (H5N1) 2 Group	Number of Subjects With Medically Attended Adverse Events (MAEs).	19 Subjects
Influenza A (H5N1) 3 Group	Number of Subjects With Medically Attended Adverse Events (MAEs).	15 Subjects
Influenza A (H5N1) 4 Group	Number of Subjects With Medically Attended Adverse Events (MAEs).	21 Subjects

Secondary

Number of Subjects With Solicited General Symptoms

Assessed solicited general symptoms were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Fever was defined as oral temperature ≥ 38 degrees Celsius (°C). Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination.

Time frame: Within the 7-day follow-up period (Days 0-6) after any vaccination

Arm	Measure	Group	Value (NUMBER)
Influenza A (H5N1) 1 Group	Number of Subjects With Solicited General Symptoms	Any Muscle Aches	49 Subjects
Influenza A (H5N1) 1 Group	Number of Subjects With Solicited General Symptoms	Any Joint Pain	20 Subjects
Influenza A (H5N1) 1 Group	Number of Subjects With Solicited General Symptoms	Any Sweating	15 Subjects
Influenza A (H5N1) 1 Group	Number of Subjects With Solicited General Symptoms	Any Shivering	10 Subjects
Influenza A (H5N1) 1 Group	Number of Subjects With Solicited General Symptoms	Any Headache	30 Subjects
Influenza A (H5N1) 1 Group	Number of Subjects With Solicited General Symptoms	Any Fever	2 Subjects
Influenza A (H5N1) 1 Group	Number of Subjects With Solicited General Symptoms	Any Fatigue	23 Subjects
Influenza A (H5N1) 2 Group	Number of Subjects With Solicited General Symptoms	Any Muscle Aches	43 Subjects
Influenza A (H5N1) 2 Group	Number of Subjects With Solicited General Symptoms	Any Fatigue	30 Subjects
Influenza A (H5N1) 2 Group	Number of Subjects With Solicited General Symptoms	Any Headache	28 Subjects
Influenza A (H5N1) 2 Group	Number of Subjects With Solicited General Symptoms	Any Joint Pain	23 Subjects
Influenza A (H5N1) 2 Group	Number of Subjects With Solicited General Symptoms	Any Shivering	13 Subjects
Influenza A (H5N1) 2 Group	Number of Subjects With Solicited General Symptoms	Any Sweating	11 Subjects
Influenza A (H5N1) 2 Group	Number of Subjects With Solicited General Symptoms	Any Fever	4 Subjects
Influenza A (H5N1) 3 Group	Number of Subjects With Solicited General Symptoms	Any Headache	24 Subjects
Influenza A (H5N1) 3 Group	Number of Subjects With Solicited General Symptoms	Any Muscle Aches	40 Subjects
Influenza A (H5N1) 3 Group	Number of Subjects With Solicited General Symptoms	Any Shivering	13 Subjects
Influenza A (H5N1) 3 Group	Number of Subjects With Solicited General Symptoms	Any Fever	1 Subjects
Influenza A (H5N1) 3 Group	Number of Subjects With Solicited General Symptoms	Any Sweating	8 Subjects
Influenza A (H5N1) 3 Group	Number of Subjects With Solicited General Symptoms	Any Fatigue	22 Subjects
Influenza A (H5N1) 3 Group	Number of Subjects With Solicited General Symptoms	Any Joint Pain	22 Subjects
Influenza A (H5N1) 4 Group	Number of Subjects With Solicited General Symptoms	Any Headache	20 Subjects
Influenza A (H5N1) 4 Group	Number of Subjects With Solicited General Symptoms	Any Joint Pain	11 Subjects
Influenza A (H5N1) 4 Group	Number of Subjects With Solicited General Symptoms	Any Muscle Aches	40 Subjects
Influenza A (H5N1) 4 Group	Number of Subjects With Solicited General Symptoms	Any Fever	1 Subjects
Influenza A (H5N1) 4 Group	Number of Subjects With Solicited General Symptoms	Any Sweating	5 Subjects
Influenza A (H5N1) 4 Group	Number of Subjects With Solicited General Symptoms	Any Shivering	10 Subjects
Influenza A (H5N1) 4 Group	Number of Subjects With Solicited General Symptoms	Any Fatigue	27 Subjects

Secondary

Number of Subjects With Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade.

Time frame: Within the 7-day follow-up period (Days 0-6) after any vaccination

Arm	Measure	Group	Value (NUMBER)
Influenza A (H5N1) 1 Group	Number of Subjects With Solicited Local Symptoms	Any Pain	60 Subjects
Influenza A (H5N1) 1 Group	Number of Subjects With Solicited Local Symptoms	Any Swelling	4 Subjects
Influenza A (H5N1) 1 Group	Number of Subjects With Solicited Local Symptoms	Any Redness	2 Subjects
Influenza A (H5N1) 2 Group	Number of Subjects With Solicited Local Symptoms	Any Pain	64 Subjects
Influenza A (H5N1) 2 Group	Number of Subjects With Solicited Local Symptoms	Any Swelling	5 Subjects
Influenza A (H5N1) 2 Group	Number of Subjects With Solicited Local Symptoms	Any Redness	5 Subjects
Influenza A (H5N1) 3 Group	Number of Subjects With Solicited Local Symptoms	Any Redness	5 Subjects
Influenza A (H5N1) 3 Group	Number of Subjects With Solicited Local Symptoms	Any Pain	65 Subjects
Influenza A (H5N1) 3 Group	Number of Subjects With Solicited Local Symptoms	Any Swelling	5 Subjects
Influenza A (H5N1) 4 Group	Number of Subjects With Solicited Local Symptoms	Any Pain	65 Subjects
Influenza A (H5N1) 4 Group	Number of Subjects With Solicited Local Symptoms	Any Swelling	3 Subjects
Influenza A (H5N1) 4 Group	Number of Subjects With Solicited Local Symptoms	Any Redness	4 Subjects

Secondary

Number of Subjects With Unsolicited Adverse Events (AEs)

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

Time frame: Within the 51-day follow-up period (Days 0-50) after first vaccination.

Arm	Measure	Value (NUMBER)
Influenza A (H5N1) 1 Group	Number of Subjects With Unsolicited Adverse Events (AEs)	34 Subjects
Influenza A (H5N1) 2 Group	Number of Subjects With Unsolicited Adverse Events (AEs)	37 Subjects
Influenza A (H5N1) 3 Group	Number of Subjects With Unsolicited Adverse Events (AEs)	41 Subjects
Influenza A (H5N1) 4 Group	Number of Subjects With Unsolicited Adverse Events (AEs)	27 Subjects

Secondary

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 2 Group.

Time frame: At Days 0, 14, 21, 28, 35, 42 and 182.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 0 [N=69]	5.3 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 14 [N=68]	26.8 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 21 [N=69]	99.8 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 28 [N=69]	345.0 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 35 [N=69]	305.9 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 42 [N=68]	262.3 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 182 [N=68]	36.5 titers

Secondary

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.

Time frame: At Days 0, 21, 28, 35, 42 and 182.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 0 [N=65]	5.4 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 21 [N=64]	40.2 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 28 [N=65]	150.9 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 35 [N=65]	640.0 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 42 [N=62]	523.3 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 182 [N=65]	51.1 titers

Secondary

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 4 Group.

Time frame: At Days 0, 7, 14, 21, 42 and 182.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 0 [N=75]	5.8 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 7 [N=74]	10.8 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 14 [N=75]	67.4 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 21 [N=74]	76.3 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 42 [N=74]	78.9 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 182 [N=73]	28.2 titers

Secondary

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 3 Group.

Time frame: At Days 0, 7, 14, 21, 28, 42 and 182.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 0 [N=74]	5.5 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 7 [N=74]	7.6 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 14 [N=73]	45.1 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 21 [N=74]	77.7 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 28 [N=72]	99.8 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 42 [N=73]	81.1 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	H5N1 at Day 182 [N=71]	21.3 titers

Secondary

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.

Time frame: At Days 0, 21, 28, 35, 42 and 182.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 0 [N=65]	5.3 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 21 [N=64]	9.7 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 28 [N=65]	20.7 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 35 [N=65]	61.6 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 42 [N=62]	48.6 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 0 [N=65]	7.6 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 21 [N=64]	22.5 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 28 [N=65]	46.4 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 35 [N=65]	181.8 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 42 [N=62]	162.7 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at 182 [N=65]	25.8 titers

Secondary

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 2 Group.

Time frame: At Days 0, 14, 21, 28, 35, 42 and 182.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 0 [N=69]	5.4 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 14 [N=68]	9.2 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 21 [N=69]	15.1 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 28 [N=69]	29.9 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 35 [N=69]	26.5 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 42 [N=68]	23.2 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 0 [N=69]	7.1 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 14 [N=68]	17.0 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 21 [N=69]	36.4 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 28 [N=69]	83.7 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 35 [N=69]	74.9 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 42 [N=68]	68.3 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 182 [N=68]	18.5 titers

Secondary

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 3 Group.

Time frame: At Days 0, 7, 14, 21, 28, 42 and 182.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 0 [N=74]	5.3 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 7 [N=74]	6.4 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 14 [N=73]	13.7 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 21 [N=74]	16.1 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 28 [N=72]	15.3 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 42 [N=73]	13.4 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 0 [N=74]	7.2 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 7 [N=74]	8.7 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 14 [N=73]	27.2 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 21 [N=74]	33.5 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 28 [N=72]	34.9 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 42 [N=73]	34.7 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 182 [N=71]	13.7 titers

Secondary

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 4 Group.

Time frame: At Days 0, 7, 14, 21, 42 and 182.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 0 [N=75]	5.8 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 7 [N=74]	7.9 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 14 [N=75]	16.3 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 21 [N=74]	16.2 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	VIET at Day 42 [N=74]	16.0 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 0 [N=75]	7.7 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 7 [N=74]	11.8 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 14 [N=75]	28.9 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 21 [N=74]	31.2 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 42 [N=74]	35.6 titers
Influenza A (H5N1) 1 Group	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.	TURK at Day 182 [N=73]	16.4 titers

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026

A Trial to Test the Response to Different Vaccination Regimens With an H5N1 Vaccine With AS03 in Adults Aged 18-64

Conditions

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Brief summary

Detailed description

Related papers

Interventions

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Study design

Eligibility

Inclusion criteria

Exclusion criteria

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Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

Number of Seroprotected Subjects Against 3 Strains the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

Number of Subjects With Any Serious Adverse Events (SAEs)

Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

Number of Subjects With a Vaccine Response of MN Assessed Antibodies for the Flu A/Turkey/Turkey/1/2005 (TURK) Strain of Influenza Disease.

Number of Subjects With Medically Attended Adverse Events (MAEs).

Number of Subjects With Solicited General Symptoms

Number of Subjects With Solicited Local Symptoms

Number of Subjects With Unsolicited Adverse Events (AEs)

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.