CompletedNCT00771615Updated Sep 21, 2018Results posted

Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged 18-64 Years

A Phase 2 interventional study of GSK A/turkey H5N1 Influenza vaccine in Influenza, sponsored by GlaxoSmithKline. Completed at 10 sites in 2 countries. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-21.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention

Phase: Phase 2
Study type: Interventional
Enrollment: 469
Allocation: Randomized
Ages: 18 Years to 64 Years
Sex: All

Study summary

The purpose of this observer-blind study is to determine whether GSK's avian flu vaccine GSK 1557484A is immunogenic when given to adults aged 18-64 years.

Read the detailed description

All enrolled subjects will receive 1 dose of study vaccine. All subjects will attend formal study center visits for safety and immunogenicity assessments on Days 0, 10, 42, 84, and 182 with a telephone safety contact on Day 364.

This Protocol Posting has been updated according to Protocol amendment, 8 Dec 08

Conditions studied

Influenza

Browse trials for

Influenza, Human 2,214

Keywords

human
Avian
safety
vaccines
influenza
pandemic
immunogenicity
H5N1

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 469 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 64 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Male and female adults 18 to 64 years of age at time of first vaccination, inclusive.
Written informed consent obtained from the subject.
Stable health status as defined by absence of a health event satisfying the definition of a SAE, 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

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.
Presence of an oral temperature >= 37.8ºC, or acute symptoms greater than "mild" severity on the scheduled date of vaccination.
Any confirmed or suspected immunosuppressive or immunodeficiency 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.
An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
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 12 months following test article administration. 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 3 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; 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 vaccination.
Known receipt of analgesic or antipyretic medication with the specific intent of prophylaxis of vaccine reactogenicity on the day of vaccination. Subjects on stable chronic regimens of potentially analgesic or anti-pyretic medications for pre-existing diagnoses are not required to discontinue them.

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 469 participants (actual)

Study arms

Experimental
A/turkey H5N1 influenza Formulation A Group
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: GSK A/turkey H5N1 Influenza vaccine
Experimental
A/turkey H5N1 influenza Formulation B1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: GSK A/turkey H5N1 Influenza vaccine
Experimental
A/turkey H5N1 influenza Formulation B2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: GSK A/turkey H5N1 Influenza vaccine
Experimental
A/turkey H5N1 influenza Formulation C1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: GSK A/turkey H5N1 Influenza vaccine
Experimental
A/turkey H5N1 influenza Formulation C2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: GSK A/turkey H5N1 Influenza vaccine
Experimental
A/turkey H5N1 influenza Formulation D1 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: GSK A/turkey H5N1 Influenza vaccine
Experimental
A/turkey H5N1 influenza Formulation D2 Group
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: GSK A/turkey H5N1 Influenza vaccine
Experimental
A/turkey H5N1 influenza Formulation E1 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: GSK A/turkey H5N1 Influenza vaccine
Experimental
A/turkey H5N1 influenza Formulation E2 Group
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: GSK A/turkey H5N1 Influenza vaccine

Interventions

BiologicalGSK A/turkey H5N1 Influenza vaccine
One dose administered intramuscularly (IM) in the deltoid region. Different formulations are tested.

What researchers measure

Primary outcomes

Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (\<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.
Time frame: At Day 10
Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain
A seroprotected subject against the A/turkey virus strain was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.
Time frame: At Day 10
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
HI antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10.
Time frame: At Day 10

Secondary outcomes

Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (\<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.
Time frame: At Day 0 to Day 42 and at Day 0 to Day 182
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain.
Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10
Time frame: At Day 0, Day 10, Day 42 and Day 182
HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.
Time frame: At Day 0 to Day 10, Day 42 and Day 182
HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain.
Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10
Time frame: At Day 0, Day 10, Day 42 and Day 182
Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.
A seroprotected subject was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.
Time frame: At Day 0, Day 10, Day 42 and Day 182 for A/Indo and at Day 0, Day 42 and Day 182 for A/turkey virus strains.
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
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.
Time frame: At Day 0 to Day 10, Day 42 and Day 182
HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.
Time frame: At Day 10, Day 42 and Day 182
Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
MN antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:28.
Time frame: At Day 0, Day 10, Day 42 and Day 182
Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
A seropositive subject was defined as a vaccinated subject who had a MN antibody titer ≥ the cut-off value of 1:28.
Time frame: At Day 0, Day 10, Day 42 and Day 182
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (\< 1:28, recorded 1:14 if \< 1:28) to ≥ 1:56 in the subjects.
Time frame: At Day 10
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains
VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (\< 1:28, recorded 1:14 if \< 1:28) to ≥ 1:56 in the subjects.
Time frame: At Day 42
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (\< 1:28, recorded 1:14 if \< 1:28) to ≥ 1:56 in the subjects.
Time frame: At Day 182
Number of Subjects Reporting Any and Grade 3 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 (Days 0-6) post vaccination period.
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Solicited general symptoms assessed were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any =occurrence of any solicited general symptoms reported irrespective of intensity grade and relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).
Time frame: Within the 7-day (Days 0-6) post vaccination period.
Number of Subjects With Medically-attended Adverse Events (MAEs).
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 378
Number of Subjects Reporting Any 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."Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time frame: From Day 0 to Day 42
Number of Subjects Reporting Serious Adverse Events (SAEs).
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 occurrence of any symptom regardless of intensity grade or relation to vaccination.
Time frame: From Day 0 to Day 378

Results

Posted Sep 4, 2014

Participant flow

Participant flow — Overall Study
Milestone	A/Turkey H5N1 Influenza Formulation A Group	A/Turkey H5N1 Influenza Formulation B1 Group	A/Turkey H5N1 Influenza Formulation B2 Group	A/Turkey H5N1 Influenza Formulation C1 Group	A/Turkey H5N1 Influenza Formulation C2 Group	A/Turkey H5N1 Influenza Formulation D1 Group	A/Turkey H5N1 Influenza Formulation D2 Group	A/Turkey H5N1 Influenza Formulation E1 Group	A/Turkey H5N1 Influenza Formulation E2 Group
Started	49	72	41	60	40	61	46	59	41
Completed	48	70	40	59	40	60	45	58	41
Not completed	1	2	1	1	0	1	1	1	0
Withdrew: Withdrawal by subject	0	1	0	0	0	0	0	1	0
Withdrew: Lost to follow-up	1	1	1	1	0	1	1	0	0

Outcome measures

PrimaryNumber of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (\<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.

Time frame:: At Day 10
Reported as:: Count of participants · Participants

Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Participants	A/Turkey H5N1 Influenza A Group	A/Turkey H5N1 Influenza B1 + D1 Group	A/Turkey H5N1 Influenza C1 + E1 Group	A/Turkey H5N1 Influenza B2 + D2 Group	A/Turkey H5N1 Influenza C2 + E2 Group	A/Turkey H5N1 Influenza B1 + C1 Group	A/Turkey H5N1 Influenza D1 + E1 Group	A/Turkey H5N1 Influenza B2 + C2 Group	A/Turkey H5N1 Influenza D2 + E2 Group
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.	43	121	109	57	56	122	108	51	62

PrimaryNumber of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain

A seroprotected subject against the A/turkey virus strain was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.

Time frame:: At Day 10
Reported as:: Count of participants · Participants

Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain
Participants	A/Turkey H5N1 Influenza A Group	A/Turkey H5N1 Influenza B1 + D1 Group	A/Turkey H5N1 Influenza C1 + E1 Group	A/Turkey H5N1 Influenza B2 + D2 Group	A/Turkey H5N1 Influenza C2 + E2 Group	A/Turkey H5N1 Influenza B1 + C1 Group	A/Turkey H5N1 Influenza D1 + E1 Group	A/Turkey H5N1 Influenza B2 + C2 Group	A/Turkey H5N1 Influenza D2 + E2 Group
Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain	44	125	113	76	67	127	111	69	74

PrimaryHaemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.

HI antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10.

Time frame:: At Day 10
Reported as:: Geometric mean · Titer

Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Titer	A/Turkey H5N1 Influenza A Group	A/Turkey H5N1 Influenza B1 + D1 Group	A/Turkey H5N1 Influenza C1 + E1 Group	A/Turkey H5N1 Influenza B2 + D2 Group	A/Turkey H5N1 Influenza C2 + E2 Group	A/Turkey H5N1 Influenza B1 + C1 Group	A/Turkey H5N1 Influenza D1 + E1 Group	A/Turkey H5N1 Influenza B2 + C2 Group	A/Turkey H5N1 Influenza D2 + E2 Group
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.	229.6 (148.6 to 354.9)	847.3 (686.1 to 1046.4)	810.5 (666.6 to 985.3)	121.9 (89.7 to 165.7)	86.9 (64.7 to 116.7)	838.5 (703.1 to 1000.1)	819.8 (647.8 to 1037.3)	97.9 (70.3 to 136.4)	108.6 (82.3 to 143.3)

SecondaryNumber of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.

Time frame:: At Day 0 to Day 42 and at Day 0 to Day 182
Reported as:: Count of participants · Participants

Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.
Participants	A/Turkey H5N1 Influenza A Group	A/Turkey H5N1 Influenza B1 + D1 Group	A/Turkey H5N1 Influenza C1 + E1 Group	A/Turkey H5N1 Influenza B2 + D2 Group	A/Turkey H5N1 Influenza C2 + E2 Group	A/Turkey H5N1 Influenza B1 + C1 Group	A/Turkey H5N1 Influenza D1 + E1 Group	A/Turkey H5N1 Influenza B2 + C2 Group	A/Turkey H5N1 Influenza D2 + E2 Group
A/turkey, D 42	41	123	108	55	51	123	108	45	61
A/turkey, D 182	28	105	90	38	38	103	92	31	45

SecondaryHaemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain.

Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10

Time frame:: At Day 0, Day 10, Day 42 and Day 182
Reported as:: Geometric mean · Titer

Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain.
Titer	A/Turkey H5N1 Influenza A Group	A/Turkey H5N1 Influenza B1 + D1 Group	A/Turkey H5N1 Influenza C1 + E1 Group	A/Turkey H5N1 Influenza B2 + D2 Group	A/Turkey H5N1 Influenza C2 + E2 Group	A/Turkey H5N1 Influenza B1 + C1 Group	A/Turkey H5N1 Influenza D1 + E1 Group	A/Turkey H5N1 Influenza B2 + C2 Group	A/Turkey H5N1 Influenza D2 + E2 Group
A/turkey, D 0	6.1 (5.0 to 7.5)	13.5 (11.3 to 16.3)	14.4 (11.6 to 18.0)	14.2 (11.3 to 17.9)	10.9 (8.7 to 13.6)	14.1 (11.6 to 17.2)	13.7 (11.1 to 16.9)	13.2 (10.3 to 17.1)	11.8 (9.6 to 14.5)
A/turkey, D 10	229.6 (148.6 to 354.9)	847.3 (686.1 to 1046.4)	810.5 (666.6 to 985.3)	121.9 (89.7 to 165.7)	86.9 (64.7 to 116.7)	838.5 (703.1 to 1000.1)	819.8 (647.8 to 1037.3)	97.9 (70.3 to 136.4)	108.6 (82.3 to 143.3)
A/turkey, D 42	155.4 (102.1 to 236.3)	652.2 (525.3 to 809.8)	699.5 (561.9 to 870.8)	126.3 (91.6 to 174.1)	81.4 (59.6 to 111.2)	653.9 (545.5 to 783.9)	697.8 (539.2 to 903.2)	90.9 (64.7 to 127.6)	113.6 (84.1 to 153.4)
A/turkey, D 182	40.9 (26.8 to 62.4)	221.5 (172.3 to 284.6)	238.4 (185.1 to 307.0)	62.7 (44.9 to 87.5)	42.9 (31.6 to 58.3)	213.3 (170.5 to 266.9)	249.1 (187.6 to 330.8)	51.1 (37.2 to 70.3)	53.2 (38.3 to 73.8)

SecondaryHI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.

GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.

Time frame:: At Day 0 to Day 10, Day 42 and Day 182
Reported as:: Geometric mean · fold change

HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
fold change	A/Turkey H5N1 Influenza A Group	A/Turkey H5N1 Influenza B1 + D1 Group	A/Turkey H5N1 Influenza C1 + E1 Group	A/Turkey H5N1 Influenza B2 + D2 Group	A/Turkey H5N1 Influenza C2 + E2 Group	A/Turkey H5N1 Influenza B1 + C1 Group	A/Turkey H5N1 Influenza D1 + E1 Group	A/Turkey H5N1 Influenza B2 + C2 Group	A/Turkey H5N1 Influenza D2 + E2 Group
A/turkey, D 10	37.4 (23.3 to 59.9)	61.6 (47.4 to 80.1)	56.3 (43.5 to 72.8)	8.5 (6.0 to 12.1)	8.0 (6.0 to 10.7)	58.4 (45.5 to 74.9)	59.8 (45.5 to 78.6)	7.4 (5.2 to 10.5)	9.1 (6.8 to 12.3)
A/turkey, D 42	25.3 (16.6 to 38.5)	48.2 (37.2 to 62.5)	48.6 (37.5 to 63.0)	8.9 (6.2 to 12.9)	7.5 (5.6 to 10.1)	46.3 (36.2 to 59.2)	50.9 (38.6 to 67.1)	6.9 (4.8 to 9.8)	9.6 (7.1 to 13.1)
A/turkey, D 182	6.7 (4.4 to 10.0)	16.4 (12.4 to 21.5)	16.6 (12.7 to 21.6)	4.4 (3.0 to 6.3)	3.9 (2.9 to 5.2)	15.1 (11.6 to 19.6)	18.2 (13.7 to 24.1)	3.9 (2.7 to 5.4)	4.4 (3.2 to 6.1)

SecondaryHI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain.

Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10

Time frame:: At Day 0, Day 10, Day 42 and Day 182
Reported as:: Geometric mean · Titer

HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain.
Titer	A/Turkey H5N1 Influenza A Group	A/Turkey H5N1 Influenza B1 + D1 Group	A/Turkey H5N1 Influenza C1 + E1 Group	A/Turkey H5N1 Influenza B2 + D2 Group	A/Turkey H5N1 Influenza C2 + E2 Group	A/Turkey H5N1 Influenza B1 + C1 Group	A/Turkey H5N1 Influenza D1 + E1 Group	A/Turkey H5N1 Influenza B2 + C2 Group	A/Turkey H5N1 Influenza D2 + E2 Group
A/Indo, D 0	7.3 (5.6 to 9.4)	26.1 (20.8 to 32.7)	23.8 (18.6 to 30.5)	25.5 (19.3 to 33.7)	18.5 (13.9 to 24.5)	25.5 (20.2 to 32.1)	24.5 (19.2 to 31.1)	22.0 (16.6 to 29.1)	21.7 (16.3 to 28.8)
A/Indo, D 10	286.5 (187.6 to 437.5)	905.0 (743.7 to 1101.4)	888.6 (739.6 to 1067.5)	176.7 (131.9 to 236.8)	113.6 (83.2 to 155.1)	873.5 (738.5 to 1033.3)	924.9 (745.0 to 1148.1)	124.6 (89.4 to 173.8)	161.3 (122.3 to 212.8)
A/Indo, D 42	192.3 (129.3 to 286.1)	740.8 (604.7 to 907.4)	798.1 (656.6 to 970.1)	168.7 (123.5 to 230.5)	108.8 (77.7 to 152.4)	728.1 (613.5 to 864.1)	814.6 (646.3 to 1026.8)	107.8 (75.6 to 153.8)	169.3 (126.1 to 227.2)
A/Indo, D182	34.8 (22.6 to 53.6)	213.8 (166.4 to 274.6)	224.2 (174.4 to 288.3)	58.7 (41.2 to 83.6)	38.6 (28.0 to 53.3)	197.3 (156.0 to 249.5)	246.0 (188.0 to 321.9)	42.7 (30.4 to 60.0)	53.4 (37.9 to 75.2)

SecondaryNumber of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.

A seroprotected subject was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.

Time frame:: At Day 0, Day 10, Day 42 and Day 182 for A/Indo and at Day 0, Day 42 and Day 182 for A/turkey virus strains.
Reported as:: Count of participants · Participants

Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.
Participants	A/Turkey H5N1 Influenza A Group	A/Turkey H5N1 Influenza B1 + D1 Group	A/Turkey H5N1 Influenza C1 + E1 Group	A/Turkey H5N1 Influenza B2 + D2 Group	A/Turkey H5N1 Influenza C2 + E2 Group	A/Turkey H5N1 Influenza B1 + C1 Group	A/Turkey H5N1 Influenza D1 + E1 Group	A/Turkey H5N1 Influenza B2 + C2 Group	A/Turkey H5N1 Influenza D2 + E2 Group
A/Indo, D 0	5	70	56	44	31	68	58	34	41
A/Indo, D 10	44	125	113	79	68	127	111	69	78
A/Indo, D 42	44	126	113	78	67	129	110	66	79
A/Indo, D 182	28	116	106	58	47	121	101	48	57
A/turkey, D 0	3	32	35	25	16	36	31	23	18
A/turkey, D 42	41	126	113	74	62	129	110	64	72
A/turkey, D 182	31	119	106	58	53	122	103	54	57

SecondaryNumber of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.

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.

Time frame:: At Day 0 to Day 10, Day 42 and Day 182
Reported as:: Count of participants · Participants

Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
Participants	A/Turkey H5N1 Influenza A Group	A/Turkey H5N1 Influenza B1 + D1 Group	A/Turkey H5N1 Influenza C1 + E1 Group	A/Turkey H5N1 Influenza B2 + D2 Group	A/Turkey H5N1 Influenza C2 + E2 Group	A/Turkey H5N1 Influenza B1 + C1 Group	A/Turkey H5N1 Influenza D1 + E1 Group	A/Turkey H5N1 Influenza B2 + C2 Group	A/Turkey H5N1 Influenza D2 + E2 Group
A/Indo, D 10	42	122	108	50	44	122	108	41	53
A/Indo, D 42	42	120	105	48	43	121	104	38	53
A/Indo, D 182	25	91	84	24	22	96	79	20	26

SecondaryHI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.

GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.

Time frame:: At Day 10, Day 42 and Day 182
Reported as:: Geometric mean · fold change

HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
fold change	A/Turkey H5N1 Influenza A Group	A/Turkey H5N1 Influenza B1 + D1 Group	A/Turkey H5N1 Influenza C1 + E1 Group	A/Turkey H5N1 Influenza B2 + D2 Group	A/Turkey H5N1 Influenza C2 + E2 Group	A/Turkey H5N1 Influenza B1 + C1 Group	A/Turkey H5N1 Influenza D1 + E1 Group	A/Turkey H5N1 Influenza B2 + C2 Group	A/Turkey H5N1 Influenza D2 + E2 Group
A/Indo, D 10	39.3 (24.8 to 62.4)	34.7 (26.8 to 44.8)	37.3 (28.5 to 48.8)	6.8 (4.9 to 9.5)	6.1 (4.5 to 8.3)	34.3 (26.8 to 43.8)	37.8 (28.5 to 50.2)	5.7 (4.1 to 7.9)	7.3 (5.4 to 10.0)
A/Indo, D 42	26.4 (17.2 to 40.5)	28.4 (22.0 to 36.7)	33.5 (25.4 to 44.3)	6.6 (4.7 to 9.4)	5.9 (4.3 to 8.1)	28.6 (22.3 to 36.6)	33.3 (24.9 to 44.5)	4.9 (3.4 to 7.0)	7.8 (5.7 to 10.7)
A/Indo, D 182	4.8 (3.1 to 7.4)	8.2 (6.3 to 10.7)	9.4 (7.2 to 12.3)	2.3 (1.6 to 3.3)	2.1 (1.6 to 2.8)	7.7 (6.0 to 9.9)	10.1 (7.6 to 13.4)	1.9 (1.4 to 2.7)	2.5 (1.8 to 3.4)

SecondaryMicroneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.

MN antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:28.

Time frame:: At Day 0, Day 10, Day 42 and Day 182
Reported as:: Geometric mean · Titer

Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
Titer	A/Turkey H5N1 Influenza A Group	A/Turkey H5N1 Influenza B1 + D1 Group	A/Turkey H5N1 Influenza C1 + E1 Group	A/Turkey H5N1 Influenza B2 + D2 Group	A/Turkey H5N1 Influenza C2 + E2 Group	A/Turkey H5N1 Influenza B1 + C1 Group	A/Turkey H5N1 Influenza D1 + E1 Group	A/Turkey H5N1 Influenza B2 + C2 Group	A/Turkey H5N1 Influenza D2 + E2 Group
A/turkey, D 0	27.5 (20.6 to 36.7)	115.4 (92.7 to 143.7)	114.6 (91.0 to 144.4)	102.9 (82.4 to 128.4)	94.9 (71.0 to 126.9)	115.0 (92.4 to 143.2)	115.1 (91.3 to 145.0)	95.9 (73.8 to 124.6)	101.9 (79.2 to 130.9)
A/turkey, D 10	2211.5 (1579.1 to 3097.1)	5367.7 (4604.3 to 6257.6)	5191.4 (4403.4 to 6120.5)	1276.2 (962.5 to 1692.1)	976.0 (740.6 to 1286.1)	5670.5 (4958.4 to 6484.8)	4876.8 (4057.3 to 5861.7)	1026.9 (756.6 to 1393.9)	1213.4 (939.3 to 1567.5)
A/turkey, D 42	1582.9 (1080.4 to 2319.0)	4777.7 (4037.3 to 5654.0)	4649.4 (3884.9 to 5564.3)	1261.2 (950.0 to 1674.2)	906.0 (673.6 to 1218.6)	4915.6 (4212.6 to 5735.8)	4498.4 (3699.9 to 5469.2)	935.7 (688.9 to 1271.0)	1223.9 (929.0 to 1612.3)
A/turkey, D 182	349.7 (246.2 to 496.7)	1509.9 (1230.5 to 1852.8)	1484.8 (1181.6 to 1865.8)	471.5 (352.2 to 631.3)	342.2 (254.8 to 459.7)	1375.0 (1123.6 to 1682.7)	1653.6 (1313.4 to 2081.9)	332.3 (245.2 to 450.3)	484.8 (365.7 to 642.8)
A/Indo, D 0	72.8 (52.0 to 101.9)	326.0 (280.2 to 379.3)	300.2 (256.7 to 351.1)	343.4 (288.8 to 408.2)	262.0 (220.9 to 310.9)	308.1 (263.0 to 361.0)	320.1 (276.3 to 371.0)	288.1 (238.3 to 348.3)	313.7 (267.3 to 368.2)
A/Indo, D 10	2311.5 (1708.9 to 3126.5)	5807.1 (5144.8 to 6554.7)	5680.0 (4943.7 to 6525.9)	1516.5 (1194.5 to 1925.3)	1250.0 (1002.6 to 1558.5)	6011.0 (5424.1 to 6661.5)	5460.9 (4670.2 to 6385.4)	1240.9 (966.2 to 1593.7)	1523.4 (1233.4 to 1881.5)
A/Indo, D 42	1622.0 (1105.2 to 2380.4)	5080.1 (4412.0 to 5849.3)	5054.1 (4276.6 to 5972.8)	1537.2 (1192.0 to 1982.3)	1194.5 (940.0 to 1517.9)	5157.1 (4518.4 to 5886.0)	4967.0 (4163.2 to 5926.0)	1178.0 (916.6 to 1514.0)	1552.4 (1216.5 to 1981.0)
A/Indo, D 182	380.8 (267.5 to 542.1)	1482.3 (1223.3 to 1796.1)	1556.0 (1265.4 to 1913.3)	535.5 (416.8 to 688.0)	378.4 (288.7 to 496.1)	1358.2 (1130.0 to 1632.5)	1721.5 (1390.0 to 2132.1)	379.4 (287.9 to 500.0)	534.2 (417.9 to 682.8)
A/Vie, D 0	181.3 (138.5 to 237.4)	210.1 (177.0 to 249.4)	249.0 (217.8 to 284.7)	197.3 (159.0 to 244.9)	205.5 (161.8 to 261.1)	237.5 (206.4 to 273.2)	216.5 (181.6 to 258.2)	198.7 (155.2 to 254.3)	203.7 (165.2 to 251.0)
A/Vie, D 10	662.5 (526.4 to 833.9)	1564.1 (1312.0 to 1864.7)	1350.1 (1142.2 to 1595.8)	552.0 (447.8 to 680.4)	430.5 (351.8 to 527.0)	1485.0 (1250.8 to 1763.1)	1430.0 (1202.3 to 1700.8)	509.3 (408.1 to 635.6)	470.8 (387.7 to 571.8)
A/Vie, D 42	529.3 (426.2 to 657.2)	1213.8 (1004.5 to 1466.6)	1249.3 (1033.4 to 1510.3)	589.4 (469.5 to 739.9)	377.8 (311.3 to 458.5)	1168.1 (969.8 to 1407.1)	1306.0 (1076.8 to 1584.1)	481.8 (382.4 to 607.0)	469.0 (381.8 to 576.2)
A/Vie, D 182	112.5 (84.5 to 149.8)	432.5 (366.6 to 510.2)	324.9 (260.0 to 406.1)	172.7 (137.9 to 216.3)	144.1 (119.9 to 173.3)	371.4 (309.2 to 446.1)	386.3 (313.8 to 475.5)	151.7 (120.5 to 191.0)	164.5 (136.7 to 198.1)

SecondaryNumber of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.

A seropositive subject was defined as a vaccinated subject who had a MN antibody titer ≥ the cut-off value of 1:28.

Time frame:: At Day 0, Day 10, Day 42 and Day 182
Reported as:: Count of participants · Participants

Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
Participants	A/Turkey H5N1 Influenza A Group	A/Turkey H5N1 Influenza B1 + D1 Group	A/Turkey H5N1 Influenza C1 + E1 Group	A/Turkey H5N1 Influenza B2 + D2 Group	A/Turkey H5N1 Influenza C2 + E2 Group	A/Turkey H5N1 Influenza B1 + C1 Group	A/Turkey H5N1 Influenza D1 + E1 Group	A/Turkey H5N1 Influenza B2 + C2 Group	A/Turkey H5N1 Influenza D2 + E2 Group
A/turkey, D 0	20	116	102	80	68	114	104	71	77
A/turkey, D 10	47	126	113	84	80	127	112	79	85
A/turkey, D 42	47	128	113	85	79	129	112	79	85
A/turkey, D 182	46	128	111	82	77	127	112	75	84
A/Indo, D 0	36	126	112	85	79	127	111	78	86
A/Indo, D 10	47	126	113	84	80	127	112	79	85
A/Indo, D 42	46	128	113	85	80	129	112	79	86
A/Indo, D 182	46	128	112	83	78	128	112	78	83
A/Vie, D 0	46	120	112	80	76	126	106	73	83
A/Vie, D10	47	126	113	84	80	127	112	79	85
A/Vie, D 42	47	128	112	85	80	128	112	79	86
A/Vie, D 182	44	126	106	80	77	124	108	74	83

SecondaryVaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.

VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (\< 1:28, recorded 1:14 if \< 1:28) to ≥ 1:56 in the subjects.

Time frame:: At Day 10
Reported as:: Count of participants · Participants

Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
Participants	A/Turkey H5N1 Influenza A Group	A/Turkey H5N1 Influenza B1 + D1 Group	A/Turkey H5N1 Influenza C1 + E1 Group	A/Turkey H5N1 Influenza B2 + D2 Group	A/Turkey H5N1 Influenza C2 + E2 Group	A/Turkey H5N1 Influenza B1 + C1 Group	A/Turkey H5N1 Influenza D1 + E1 Group	A/Turkey H5N1 Influenza B2 + C2 Group	A/Turkey H5N1 Influenza D2 + E2 Group
A/turkey, Day 10	46	122	112	66	56	124	110	55	67
A/Indo, Day 10	45	121	105	36	40	122	104	32	44
A/Vie, Day 10	19	84	64	29	18	75	73	24	23

SecondaryVaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains

VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (\< 1:28, recorded 1:14 if \< 1:28) to ≥ 1:56 in the subjects.

Time frame:: At Day 42
Reported as:: Count of participants · Participants

Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains
Participants	A/Turkey H5N1 Influenza A Group	A/Turkey H5N1 Influenza B1 + D1 Group	A/Turkey H5N1 Influenza C1 + E1 Group	A/Turkey H5N1 Influenza B2 + D2 Group	A/Turkey H5N1 Influenza C2 + E2 Group	A/Turkey H5N1 Influenza B1 + C1 Group	A/Turkey H5N1 Influenza D1 + E1 Group	A/Turkey H5N1 Influenza B2 + C2 Group	A/Turkey H5N1 Influenza D2 + E2 Group
A/turkey, Day 42	46	121	110	67	58	122	109	56	69
A/Indo, D 42	41	118	103	39	38	119	102	31	46
A/Vie, D 42	15	73	65	32	15	71	67	25	22

SecondaryVaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.

VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (\< 1:28, recorded 1:14 if \< 1:28) to ≥ 1:56 in the subjects.

Time frame:: At Day 182
Reported as:: Count of participants · Participants

Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
Participants	A/Turkey H5N1 Influenza A Group	A/Turkey H5N1 Influenza B1 + D1 Group	A/Turkey H5N1 Influenza C1 + E1 Group	A/Turkey H5N1 Influenza B2 + D2 Group	A/Turkey H5N1 Influenza C2 + E2 Group	A/Turkey H5N1 Influenza B1 + C1 Group	A/Turkey H5N1 Influenza D1 + E1 Group	A/Turkey H5N1 Influenza B2 + C2 Group	A/Turkey H5N1 Influenza D2 + E2 Group
A/turkey, Day 182	34	103	89	43	36	102	90	35	44
A/Indo, Day 182	28	68	72	15	17	71	69	13	19
A/Vie, Day 182	5	32	22	11	5	24	30	7	9

SecondaryNumber of Subjects Reporting Any and Grade 3 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 (Days 0-6) post vaccination period.
Reported as:: Count of participants · Participants

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Participants	A/Turkey H5N1 Influenza Formulation A Group	A/Turkey H5N1 Influenza Formulation B1 Group	A/Turkey H5N1 Influenza Formulation B2 Group	A/Turkey H5N1 Influenza Formulation C1 Group	A/Turkey H5N1 Influenza Formulation C2 Group	A/Turkey H5N1 Influenza Formulation D1 Group	A/Turkey H5N1 Influenza Formulation D2 Group	A/Turkey H5N1 Influenza Formulation E1 Group	A/Turkey H5N1 Influenza Formulation E2 Group
Any Pain	41	59	9	53	10	48	13	46	6
Any Redness	1	3	0	4	0	4	0	1	0
Any Swelling	6	2	0	4	0	5	1	2	0

SecondaryNumber of Subjects Reporting Any and Grade 3 Solicited General Symptoms.

Solicited general symptoms assessed were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any =occurrence of any solicited general symptoms reported irrespective of intensity grade and relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).

Time frame:: Within the 7-day (Days 0-6) post vaccination period.
Reported as:: Count of participants · Participants

Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Participants	A/Turkey H5N1 Influenza Formulation A Group	A/Turkey H5N1 Influenza Formulation B1 Group	A/Turkey H5N1 Influenza Formulation B2 Group	A/Turkey H5N1 Influenza Formulation C1 Group	A/Turkey H5N1 Influenza Formulation C2 Group	A/Turkey H5N1 Influenza Formulation D1 Group	A/Turkey H5N1 Influenza Formulation D2 Group	A/Turkey H5N1 Influenza Formulation E1 Group	A/Turkey H5N1 Influenza Formulation E2 Group
Any Fatigue	10	18	3	20	6	18	4	23	11
Any Headache	11	22	4	25	5	17	8	17	10
Any Joint pain	5	16	1	10	4	12	2	19	4
Any Muscle aches	10	29	3	17	7	21	8	28	8
Any Shivering	3	9	1	8	0	7	1	9	2
Any Sweating	4	4	0	5	0	3	1	6	2
Any Fever	0	1	0	0	0	4	0	4	0

SecondaryNumber of Subjects With Medically-attended Adverse Events (MAEs).

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 378
Reported as:: Count of participants · Participants

Number of Subjects With Medically-attended Adverse Events (MAEs).
Participants	A/Turkey H5N1 Influenza Formulation A Group	A/Turkey H5N1 Influenza Formulation B1 Group	A/Turkey H5N1 Influenza Formulation B2 Group	A/Turkey H5N1 Influenza Formulation C1 Group	A/Turkey H5N1 Influenza Formulation C2 Group	A/Turkey H5N1 Influenza Formulation D1 Group	A/Turkey H5N1 Influenza Formulation D2 Group	A/Turkey H5N1 Influenza Formulation E1 Group	A/Turkey H5N1 Influenza Formulation E2 Group
Number of Subjects With Medically-attended Adverse Events (MAEs).	17	24	13	18	13	21	16	20	10

SecondaryNumber of Subjects Reporting Any 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."Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

Time frame:: From Day 0 to Day 42
Reported as:: Count of participants · Participants

Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
Participants	A/Turkey H5N1 Influenza Formulation A Group	A/Turkey H5N1 Influenza Formulation B1 Group	A/Turkey H5N1 Influenza Formulation B2 Group	A/Turkey H5N1 Influenza Formulation C1 Group	A/Turkey H5N1 Influenza Formulation C2 Group	A/Turkey H5N1 Influenza Formulation D1 Group	A/Turkey H5N1 Influenza Formulation D2 Group	A/Turkey H5N1 Influenza Formulation E1 Group	A/Turkey H5N1 Influenza Formulation E2 Group
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).	9	27	12	26	11	21	12	23	9

SecondaryNumber of Subjects Reporting Serious Adverse Events (SAEs).

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 occurrence of any symptom regardless of intensity grade or relation to vaccination.

Time frame:: From Day 0 to Day 378
Reported as:: Count of participants · Participants

Number of Subjects Reporting Serious Adverse Events (SAEs).
Participants	A/Turkey H5N1 Influenza Formulation A Group	A/Turkey H5N1 Influenza Formulation B1 Group	A/Turkey H5N1 Influenza Formulation B2 Group	A/Turkey H5N1 Influenza Formulation C1 Group	A/Turkey H5N1 Influenza Formulation C2 Group	A/Turkey H5N1 Influenza Formulation D1 Group	A/Turkey H5N1 Influenza Formulation D2 Group	A/Turkey H5N1 Influenza Formulation E1 Group	A/Turkey H5N1 Influenza Formulation E2 Group
Number of Subjects Reporting Serious Adverse Events (SAEs).	1	0	1	1	3	1	1	0	0

Adverse events

Collected over Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 378; Systematically assessed adverse events (AEs): During the 7-day (Days 0-6) post vaccination period. Non-systematically assessed AE: During Days 0 - 42.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
A/Turkey H5N1 Influenza Formulation A Group	—	1/49 (2%)	45/49 (91.8%)
A/Turkey H5N1 Influenza Formulation B1 Group	—	0/72 (0%)	60/72 (83.3%)
A/Turkey H5N1 Influenza Formulation B2 Group	—	1/41 (2.4%)	15/41 (36.6%)
A/Turkey H5N1 Influenza Formulation C1 Group	—	1/60 (1.7%)	54/60 (90%)
A/Turkey H5N1 Influenza Formulation C2 Group	—	3/40 (7.5%)	19/40 (47.5%)
A/Turkey H5N1 Influenza Formulation D1 Group	—	1/61 (1.6%)	52/61 (85.2%)
A/Turkey H5N1 Influenza Formulation D2 Group	—	1/46 (2.2%)	21/46 (45.7%)
A/Turkey H5N1 Influenza Formulation E1 Group	—	0/59 (0%)	51/59 (86.4%)
A/Turkey H5N1 Influenza Formulation E2 Group	—	0/41 (0%)	21/41 (51.2%)

Most frequent serious events

Most frequent serious events
Event	A/Turkey H5N1 Influenza Formulation A Group	A/Turkey H5N1 Influenza Formulation B1 Group	A/Turkey H5N1 Influenza Formulation B2 Group	A/Turkey H5N1 Influenza Formulation C1 Group	A/Turkey H5N1 Influenza Formulation C2 Group	A/Turkey H5N1 Influenza Formulation D1 Group	A/Turkey H5N1 Influenza Formulation D2 Group	A/Turkey H5N1 Influenza Formulation E1 Group	A/Turkey H5N1 Influenza Formulation E2 Group
AppendicitisInfections and infestations	0/49	0/72	0/41	0/60	2/40	0/61	0/46	0/59	0/41
PneumoniaInfections and infestations	0/49	0/72	0/41	1/60	1/40	0/61	0/46	0/59	0/41
Renal colicRenal and urinary disorders	0/49	0/72	1/41	0/60	0/40	0/61	0/46	0/59	0/41
PsoriasisSkin and subcutaneous tissue disorders	0/49	0/72	0/41	0/60	0/40	0/61	1/46	0/59	0/41
Acute respiratory failureRespiratory, thoracic and mediastinal disorders	1/49	0/72	0/41	0/60	0/40	0/61	0/46	0/59	0/41
Drug abusePsychiatric disorders	1/49	0/72	0/41	0/60	0/40	0/61	0/46	0/59	0/41
Status epilepticusNervous system disorders	1/49	0/72	0/41	0/60	0/40	0/61	0/46	0/59	0/41
Lung cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/49	0/72	0/41	1/60	0/40	0/61	0/46	0/59	0/41
Thyroid cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/49	0/72	0/41	0/60	0/40	1/61	0/46	0/59	0/41

Most frequent other events

Showing 10 of 18

Most frequent other events
Event	A/Turkey H5N1 Influenza Formulation A Group	A/Turkey H5N1 Influenza Formulation B1 Group	A/Turkey H5N1 Influenza Formulation B2 Group	A/Turkey H5N1 Influenza Formulation C1 Group	A/Turkey H5N1 Influenza Formulation C2 Group	A/Turkey H5N1 Influenza Formulation D1 Group	A/Turkey H5N1 Influenza Formulation D2 Group	A/Turkey H5N1 Influenza Formulation E1 Group	A/Turkey H5N1 Influenza Formulation E2 Group
PainGeneral disorders	41/49	59/72	9/40	53/60	10/40	48/60	13/46	46/58	6/41
Muscle achesGeneral disorders	10/49	29/72	3/40	17/60	7/40	21/60	8/46	28/58	8/41
HeadacheGeneral disorders	11/49	22/72	4/40	25/60	5/40	17/60	8/46	17/58	10/41
FatigueGeneral disorders	10/49	18/72	3/40	20/60	6/40	18/60	4/46	23/58	11/41
Joint painInfections and infestations	5/49	16/72	1/40	10/60	4/40	12/60	2/46	19/58	4/41
ShiveringGeneral disorders	3/49	9/72	1/40	8/60	0/40	7/60	1/46	9/58	2/41
SwellingGeneral disorders	6/49	2/72	0/40	4/60	0/40	5/60	1/46	2/58	0/41
SweatingGeneral disorders	4/49	4/72	0/40	5/60	0/40	3/60	1/46	6/58	2/41
HeadacheNervous system disorders	3/49	4/72	0/41	1/60	1/40	6/61	1/46	0/59	2/41
Oropharyngeal painRespiratory, thoracic and mediastinal disorders	0/49	2/72	1/41	1/60	1/40	0/61	0/46	0/59	4/41

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	A/Turkey H5N1 Influenza Formulation A Group	A/Turkey H5N1 Influenza Formulation B1 Group	A/Turkey H5N1 Influenza Formulation B2 Group	A/Turkey H5N1 Influenza Formulation C1 Group	A/Turkey H5N1 Influenza Formulation C2 Group	A/Turkey H5N1 Influenza Formulation D1 Group	A/Turkey H5N1 Influenza Formulation D2 Group	A/Turkey H5N1 Influenza Formulation E1 Group	A/Turkey H5N1 Influenza Formulation E2 Group	Total
Mean	42.3 ± 11.47	40.6 ± 12.02	41.1 ± 11.82	41.2 ± 12.33	41.1 ± 12.46	42.4 ± 11.15	41.2 ± 9.78	40.6 ± 12.01	41.6 ± 11.60	41.3 ± 11.55

Sex: Female, Male
Sex: Female, Male(Participants)	A/Turkey H5N1 Influenza Formulation A Group	A/Turkey H5N1 Influenza Formulation B1 Group	A/Turkey H5N1 Influenza Formulation B2 Group	A/Turkey H5N1 Influenza Formulation C1 Group	A/Turkey H5N1 Influenza Formulation C2 Group	A/Turkey H5N1 Influenza Formulation D1 Group	A/Turkey H5N1 Influenza Formulation D2 Group	A/Turkey H5N1 Influenza Formulation E1 Group	A/Turkey H5N1 Influenza Formulation E2 Group	Total
Female	29	42	20	38	21	40	31	37	19	277
Male	20	30	21	22	19	21	15	22	22	192

Study locations

10 sites

GSK Investigational Site
Huntsville, Alabama 35802, United States
GSK Investigational Site
Anaheim, California 92801, United States
GSK Investigational Site
Miami, Florida 33143, United States
GSK Investigational Site
Stockbridge, Georgia 30281, United States
GSK Investigational Site
Lenexa, Kansas 66219, United States
GSK Investigational Site
Missoula, Montana 59801, United States
GSK Investigational Site
Las Vegas, Nevada 89130, United States
GSK Investigational Site
Halifax, Nova Scotia B3K 6R8, Canada
GSK Investigational Site
Truro, Nova Scotia B2N 1L2, Canada
GSK Investigational Site
Sherbrooke, Quebec J1H 4J6, Canada

References and documents

Publications

Risi G, Frenette L, Langley JM, Li P, Riff D, Sheldon E, Vaughn DW, Fries L. Immunological priming induced by a two-dose series of H5N1 influenza antigen, administered alone or in combination with two different formulations of AS03 adjuvant in adults: results of a randomised single heterologous booster dose study at 15 months. Vaccine. 2011 Aug 26;29(37):6408-18. doi: 10.1016/j.vaccine.2011.04.072. Epub 2011 May 7. Erratum In: Vaccine. 2013 Jan 2;31(2):436-7. doi: 10.1016/j.vaccine.2012.11.002.. Dosage error in article text. PubMed 21554915 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00771615
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Oct 13, 2008
Start date: Oct 16, 2008
Primary completion: May 26, 2009
Completion: Dec 4, 2009
Results posted: Sep 4, 2014
Last update: Sep 21, 2018

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

View the source record on ClinicalTrials.gov ↗

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