CompletedNCT00449670Updated Apr 9, 2020Results posted

Assess Consistency of Immunogenicity of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults

A Phase 3 interventional study of H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain) and H5N1 non-adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain) in Influenza and Influenza Vaccines, sponsored by GlaxoSmithKline. Completed at 6 sites in 4 countries. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-09.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 1,206
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study summary

The present study is designed to assess the lot-to-lot consistency of the immunogenicity of a GlaxoSmithKline Biologicals' pandemic influenza candidate vaccine (GSK1562902A) in adults aged between 18 and 60 years.

Read the detailed description

The protocol posting has been updated to reflect changes due to an amendment to the protocol (addition of an exclusion criterion). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions studied

Influenza
Influenza Vaccines

Browse trials for

Influenza, Human 2,214

Keywords

Influenza
Influenza Vaccine

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 1,206 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

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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 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Subjects who the investigator believes that they can and will comply with the requirements of the protocol
A male or female between, and including, 18 and 60 years of age at the time of the first vaccination.
Written informed consent obtained from the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.

Exclusion criteria

Exclusion Criteria:

Administration of any licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
Planned administration of a vaccine not foreseen by the study protocol during the following periods: from Day 0 up to Day 51, 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Month 6; from Month 6 up to Month 6 + 30 days (or Month 6 + 51 days for the control groups).
Previous vaccination with a pandemic candidate vaccine or a vaccine containing the same adjuvant as the study vaccine.
Previous proven contact with H5N1 wild type virus (i.e. contact with an individual with laboratory-confirmed H5N1 infection, or contact with an animal (e.g. poultry) which died as a result of H5N1 infection).
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the candidate vaccines.
Any confirmed or suspected immunosuppressive or immunodeficient condition, or autoimmune diseases such as Guillain Barre Syndrome, based on medical history and physical examination (no laboratory testing required).
History of hypersensitivity to vaccines.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
History of chronic alcohol consumption and/or drug abuse.
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first administration of the candidate vaccine or during the study.
Lactating women.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 1,206 participants (actual)

Study arms

Experimental
H5N1 Adjuvanted Group
Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).
Biological: H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain) · Biological: H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain)
Active comparator
H5N1 Un-adjuvanted Group
Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Biological: H5N1 non-adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain) · Biological: H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain)

Interventions

BiologicalH5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain)
Two doses of the GSK1562902A adjuvanted split virus vaccine, administered intramuscularly into the deltoid region of the non-dominant arm at Day 0 and Day 21.
BiologicalH5N1 non-adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain)
Two doses of the GSK1562902A non-adjuvanted split virus vaccine, administered intramuscularly into the deltoid region of the non-dominant arm at Day 0 and Day 21.
BiologicalH5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain)
Booster administration at Month 6 (and a second booster dose 21 days later for the un-adjuvanted group only) with an adjuvanted split virus pandemic influenza candidate vaccine containing the strain A/Indonesia/5/2005.

What researchers measure

Primary outcomes

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Time frame: Before vaccination (Day 0)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Time frame: Within 21 days following 2-dose primary vaccination (at Day 42)

Secondary outcomes

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Time frame: Within 21 days following the first primary vaccination dose (Day 21)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Time frame: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Time frame: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D) and at Month 12 (M12)
Titers for Serum Neutralizing (SN) Antibodies Against 2 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28.
Time frame: Before vaccination at Day 0 (D0) and within 21 days following 2-dose primary vaccination at Day 42 (D42)
Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Time frame: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Time frame: At Day 0, at Day 21, at Day 42, at Month 6 and at Month 12
Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Time frame: At Month 12
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease
Seroconversion was defined as: for initially seronegative subjects, antibody titer greater than or equal to ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: At Day 21 (D21) and at Day 42 (D42)
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease
Seroconversion was defined as: for initially seronegative subjects, antibody titer greater than or equal to ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Received the Booster Dose at Month 6 - Booster Phase
Seroconversion was defined as: for initially seronegative subjects, antibody titer greater than or equal to ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: Following booster vaccination at Month 6 +21 days (M6+21D) and Month 6 +42 days (M6+42D)
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Received the Booster Dose at Month 6 - Booster Phase
Seroconversion was defined as: for initially seronegative subjects, antibody titer greater than or equal to ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: At Month 12
Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease
Seroconversion was defined as: antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: Within 21 days following 2-dose primary vaccination at Day 42
Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease - Booster Phase
Seroconversion was defined as: for initially seronegative subjects, antibody titer ≥ 1:56 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.
Time frame: Following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Have Not Received Booster at Month 6
Seroconversion defined as: for initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-booster antibody titer.
Time frame: At Day 21, Day 42, Month 6 and Month 12 following primary vaccination
Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6
Seroconversion was defined as: for initially seronegative subjects, antibody titer ≥ 1:56 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.
Time frame: At Month 12
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: At day 21 and Day 42
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: Before booster vaccination at Month 6 (M6) and within 21 days following each booster dose: At Month 6 + 21 days (M6+21D) and, for H5N1 Un-adjuvanted Group only, at Month 6 + 42 days (M6+42D)
Booster Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: Within 21 days following each booster dose: At Month 6 + 21 days (M6+21D) and, for H5N1 Un-adjuvanted Group only, at Month 6 + 42 days (M6+42D)
Booster Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: At Month 12
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: At Day 21, at Day 42, at Month 6 and at Month 12
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: Before primary vaccination at Day 0 and within 21 days following each primary vaccination dose at Day 21 and at Day 42.
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12)
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: At Day 0, Day 21, Day 42, Month 6 and Month 12
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation
The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.
Time frame: Within 21 days of each primary vaccine dose: at Day 21 and at Day 42
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation
The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.
Time frame: Within 21 days of each primary vaccine dose: at Day 21 and at Day 42
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation
The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.
Time frame: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12)
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation
The analyzed cytokines were CD40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.
Time frame: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12)
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6
The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.
Time frame: At Month 6 and Month 12
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6
The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.
Time frame: At Month 6 and at Month 12
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: During the 7-days (Days 0-6) post-primary vaccination period following each dose and overall
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-days (Days 0-6) post-primary vaccination period following each dose and overall
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: During the 7-days (Days 0-6) post-booster vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-days (Days 0-6) post-booster vaccination period
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the primary phase (from Day 0 to Month 6)
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the booster phase (from Month 6 to Month 12)
Number of Subjects With Serious Adverse Events (SAEs).
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the primary phase (from Day 0 to Month 6)
Number of Subjects With Serious Adverse Events (SAEs).
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the booster phase (from Month 6 to Month 12)
Number of Subjects With Serious Adverse Events (SAEs) for Subjects Not Boosted at Month 6
This group consists of the remaining subjects from the GSK1562902A Pooled Group who received a single dose of H5N1 vaccine at Month 12 or 36.
Time frame: From Month 6 to Month 12

Results

Posted Apr 9, 2020

Participant flow

Primary Phase (Study no.109630)

Participant flow — Primary Phase (Study no.109630)
Milestone	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
Started	961	245
Completed	947	243
Not completed	14	2
Withdrew: Serious adverse event	1	0
Withdrew: Non-serious adverse event	4	0
Withdrew: Withdrawal by subject	4	1
Withdrew: Lost to follow-up	5	1

Booster Phase (Study no.109873)

Participant flow — Booster Phase (Study no.109873)
Milestone	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
Started	265	236
Completed	265	233
Not completed	0	3
Withdrew: Migrated/moved from study area	0	1
Withdrew: Other	0	2

Outcome measures

PrimaryTiters for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.

Time frame:: Before vaccination (Day 0)
Reported as:: Geometric mean · Titers

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers	H5N1 Adjuvanted Group - Lot 1	H5N1 Adjuvanted Group - Lot 2	H5N1 Adjuvanted Group - Lot 3	H5N1 Adjuvanted Group - Lot 4	H5N1 Un-adjuvanted Group
A/Vietnam/1194/2004	5.6 (5.3 to 5.9)	5.5 (5.2 to 5.8)	5.6 (5.2 to 5.9)	5.4 (5.2 to 5.7)	5.6 (5.3 to 5.9)
A/Indonesia/5/2005	5.1 (5 to 5.2)	5 (5 to 5.1)	5 (5 to 5.1)	5.1 (5 to 5.1)	5.0 (5.0 to 5.1)

PrimaryTiters for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Time frame:: Within 21 days following 2-dose primary vaccination (at Day 42)
Reported as:: Geometric mean · Titers

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers	H5N1 Adjuvanted Group - Lot 1	H5N1 Adjuvanted Group - Lot 2	H5N1 Adjuvanted Group - Lot 3	H5N1 Adjuvanted Group - Lot 4	H5N1 Un-adjuvanted Group
A/Vietnam/1194/2004	192.7 (164.2 to 226.2)	235.2 (203.1 to 272.5)	225.6 (193.5 to 263)	226.3 (194 to 264)	7.5 (6.7 to 8.3)
A/Indonesia/5/2005	24.3 (20.4 to 29)	27.9 (23.4 to 33.3)	25.5 (21.2 to 30.7)	22.4 (18.6 to 27)	5.2 (5.0 to 5.4)

Statistical analysis

H5N1 Adjuvanted Group - Lot 1 vs H5N1 Adjuvanted Group - Lot 2 · ANCOVA · Adjusted gmt ratio: 0.81 · 95% CI 0.66 to 1.01
H5N1 Adjuvanted Group - Lot 1 vs H5N1 Adjuvanted Group - Lot 3 · ANCOVA · Adjusted gmt ratio: 0.85 · 95% CI 0.69 to 1.06
H5N1 Adjuvanted Group - Lot 1 vs H5N1 Adjuvanted Group - Lot 4 · ANCOVA · Adjusted gmt ratio: 0.85 · 95% CI 0.68 to 1.05
H5N1 Adjuvanted Group - Lot 2 vs H5N1 Adjuvanted Group - Lot 3 · ANCOVA · Adjusted gmt ratio: 1.05 · 95% CI 0.85 to 1.3
H5N1 Adjuvanted Group - Lot 2 vs H5N1 Adjuvanted Group - Lot 4 · ANCOVA · Adjusted gmt ratio: 1.04 · 95% CI 0.84 to 1.29
H5N1 Adjuvanted Group - Lot 3 vs H5N1 Adjuvanted Group - Lot 4 · ANCOVA · Adjusted gmt ratio: 0.99 · 95% CI 0.8 to 1.23

SecondaryTiters for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Time frame:: Within 21 days following the first primary vaccination dose (Day 21)
Reported as:: Geometric mean · Titers

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers	H5N1 Adjuvanted Group - Lot 1	H5N1 Adjuvanted Group - Lot 2	H5N1 Adjuvanted Group - Lot 3	H5N1 Adjuvanted Group - Lot 4	H5N1 Un-adjuvanted Group
A/Vietnam/1194/2004	21.8 (18.1 to 26.2)	25.1 (20.7 to 30.5)	24 (19.6 to 29.3)	20.5 (17 to 24.6)	6.7 (6.0 to 7.4)
A/Indonesia/5/2005	6.3 (5.7 to 6.8)	5.9 (5.6 to 6.3)	5.9 (5.5 to 6.4)	5.1 (5 to 5.1)	5.2 (5.0 to 5.3)

SecondaryTiters for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Time frame:: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)
Reported as:: Geometric mean · Titers

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
A/Vietnam/1194/2004, M6	19.1 (16.5 to 22.2)	5.8 (5.4 to 6.2)
A/Vietnam/1194/2004, M6+21D	397.4 (342.5 to 461.0)	30.1 (24.9 to 36.3)
A/Vietnam/1194/2004, M6+42D	—	76.3 (64.1 to 90.8)
A/Indonesia/5/2005, M6	6.4 (6 to 6.9)	5.1 (5 to 5.1)
A/Indonesia/5/2005, M6+21D	321.3 (274.3 to 376.2)	24.8 (20.5 to 30.0)
A/Indonesia/5/2005, M6+42D	—	96.3 (80.6 to 115.1)

SecondaryTiters for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Time frame:: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D) and at Month 12 (M12)
Reported as:: Geometric mean · Titers

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
A/Vietnam/1194/2004, M6	19.4 (16.6 to 22.5)	5.8 (5.4 to 6.2)
A/Vietnam/1194/2004, M6+21D	395.3 (339.8 to 459.7)	31.0 (25.6 to 37.5)
A/Vietnam/1194/2004, M6+42D	—	78 (65.5 to 92.9)
A/Vietnam/1194/2004, M12	76.1 (62.5 to 92.7)	14.3 (12.2 to 16.8)
A/Indonesia/5/2005, M6	6.5 (6 to 6.9)	5.1 (5 to 5.1)
A/Indonesia/5/2005, M6+21D	319.1 (271.7 to 374.7)	25.5 (21 to 30.9)
A/Indonesia/5/2005, M6+42D	—	98.5 (82.3 to 117.9)
A/Indonesia/5/2005, M12	46.9 (38.3 to 57.4)	14.6 (12.5 to 17.1)

SecondaryTiters for Serum Neutralizing (SN) Antibodies Against 2 Strains of Influenza Disease

Time frame:: Before vaccination at Day 0 (D0) and within 21 days following 2-dose primary vaccination at Day 42 (D42)
Reported as:: Geometric mean · Titers

Titers for Serum Neutralizing (SN) Antibodies Against 2 Strains of Influenza Disease
Titers	H5N1 Adjuvanted Group - Lot 1	H5N1 Adjuvanted Group - Lot 2	H5N1 Adjuvanted Group - Lot 3	H5N1 Adjuvanted Group - Lot 4	H5N1 Un-adjuvanted Group
A/Vietnam/1194/2004, D0	17.8 (15.4 to 20.5)	17.8 (15.7 to 20.2)	18 (15.7 to 20.8)	16.6 (15.3 to 18.1)	17.7 (15.4 to 20.4)
A/Vietnam/1194/2004, D42	274.4 (232.7 to 323.5)	330.6 (281.4 to 388.4)	283.1 (234.2 to 342.3)	350.4 (293.9 to 417.8)	29.0 (23.4 to 35.9)
A/Indonesia/5/2005, D0	14.6 (14 to 15.3)	14.8 (14 to 15.7)	15.3 (13.7 to 17.2)	14.7 (13.9 to 15.5)	15.6 (14.4 to 16.7)
A/Indonesia/5/2005, D42	74.3 (61.9 to 89.3)	100.0 (86 to 116.5)	80.4 (66.7 to 96.9)	82.1 (69.8 to 96.5)	16.2 (14.8 to 17.8)

SecondaryTiters for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease

Time frame:: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)
Reported as:: Geometric mean · Titers

Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease
Titers	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
A/Vietnam/1194/2004, M6	170.5 (154.6 to 188.0)	29.4 (23 to 37.6)
A/Vietnam/1194/2004, M6+21D	1660.1 (1435.9 to 1919.4)	248.1 (187 to 329)
A/Vietnam/1194/2004, M6+42D	—	447.1 (331.9 to 602.1)
A/Indonesia/5/2005, M6	183.6 (167 to 201.8)	30.3 (22.8 to 40.1)
A/Indonesia/5/2005, M6+21D	2917.5 (2490.8 to 3417.3)	451.9 (357.5 to 571.3)
A/Indonesia/5/2005, M6+42D	—	1075.8 (834.7 to 1386.6)

SecondaryTiters for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6

Time frame:: At Day 0, at Day 21, at Day 42, at Month 6 and at Month 12
Reported as:: Geometric mean · Titers

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6
Titers	H5N1 Adjuvanted Group
A/Vietnam/1194/2004, D0	5.6 (5.4 to 5.7)
A/Vietnam/1194/2004, D21	23.3 (20.8 to 26.1)
A/Vietnam/1194/2004, D42	215.7 (197.4 to 235.7)
A/Vietnam/1194/2004, M6	18.5 (17 to 20.3)
A/Vietnam/1194/2004, M12	11.4 (10.4 to 12.5)
A/Indonesia/5/2005, D0	5.1 (5 to 5.1)
A/Indonesia/5/2005, D21	6.1 (5.8 to 6.3)
A/Indonesia/5/2005, D42	24.8 (22.3 to 27.5)
A/Indonesia/5/2005, M6	6.3 (6 to 6.5)
A/Indonesia/5/2005, M12	6.2 (5.9 to 6.5)

SecondaryTiters for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6

Time frame:: At Month 12
Reported as:: Geometric mean · Titers

Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6
Titers	H5N1 Adjuvanted Group
A/Vietnam/1194/2004	215.5 (191.4 to 242.7)
A/Indonesia/5/2005	57.9 (50.5 to 66.4)

SecondaryNumber of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease

Seroconversion was defined as: for initially seronegative subjects, antibody titer greater than or equal to ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

Time frame:: At Day 21 (D21) and at Day 42 (D42)
Reported as:: Count of participants · Participants

Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease
Participants	H5N1 Adjuvanted Group - Lot 1	H5N1 Adjuvanted Group - Lot 2	H5N1 Adjuvanted Group - Lot 3	H5N1 Adjuvanted Group - Lot 4	H5N1 Un-adjuvanted Group
A/Vietnam/1194/2004, D21	97	103	97	96	8
A/Vietnam/1194/2004, D42	213	220	214	219	13
A/Indonesia/5/2005, D21	9	4	5	6	0
A/Indonesia/5/2005, D42	108	128	118	110	1

SecondaryNumber of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease

Time frame:: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)
Reported as:: Count of participants · Participants

Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease
Participants	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
A/Vietnam/1194/2004, M6	96	2
A/Vietnam/1194/2004, M6+21D	244	110
A/Vietnam/1194/2004, M6+42D	0	174
A/Indonesia/5/2005, M6	9	0
A/Indonesia/5/2005, M6+21D	241	105
A/Indonesia/5/2005, M6+42D	0	188

SecondaryNumber of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Received the Booster Dose at Month 6 - Booster Phase

Time frame:: Following booster vaccination at Month 6 +21 days (M6+21D) and Month 6 +42 days (M6+42D)
Reported as:: Count of participants · Participants

Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Received the Booster Dose at Month 6 - Booster Phase
Participants	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
A/Vietnam/1194/2004, M6+21D	233	112
A/Vietnam/1194/2004, M6+42D	0	173
A/Indonesia/5/2005, M6+21D	241	106
A/Indonesia/5/2005, M6+42D	0	189

SecondaryNumber of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Received the Booster Dose at Month 6 - Booster Phase

Time frame:: At Month 12
Reported as:: Count of participants · Participants

Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Received the Booster Dose at Month 6 - Booster Phase
Participants	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
A/Vietnam/1194/2004	93	57
A/Indonesia/5/2005	140	67

SecondaryNumber of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease

Seroconversion was defined as: antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

Time frame:: Within 21 days following 2-dose primary vaccination at Day 42
Reported as:: Count of participants · Participants

Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease
Participants	H5N1 Adjuvanted Group - Lot 1	H5N1 Adjuvanted Group - Lot 2	H5N1 Adjuvanted Group - Lot 3	H5N1 Adjuvanted Group - Lot 4	H5N1 Un-adjuvanted Group
A/Vietnam/1194/2004	64	70	64	68	23
A/Indonesia/5/2005	61	70	61	63	4

SecondaryNumber of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease - Booster Phase

Seroconversion was defined as: for initially seronegative subjects, antibody titer ≥ 1:56 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.

Time frame:: Following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)
Reported as:: Count of participants · Participants

Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease - Booster Phase
Participants	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
A/Vietnam/1194/2004, M6+21D	140	36
A/Vietnam/1194/2004, M6+42D	0	41
A/Indonesia/5/2005, M6+21D	165	41
A/Indonesia/5/2005, M6+42D	0	45

SecondaryNumber of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Have Not Received Booster at Month 6

Seroconversion defined as: for initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-booster antibody titer.

Time frame:: At Day 21, Day 42, Month 6 and Month 12 following primary vaccination
Reported as:: Count of participants · Participants

Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Have Not Received Booster at Month 6
Participants	H5N1 Adjuvanted Group
A/Vietnam/1194/2004, D21	293
A/Vietnam/1194/2004, D42	620
A/Vietnam/1194/2004, M6	228
A/Vietnam/1194/2004, M12	108
A/Indonesia/5/2005, D21	18
A/Indonesia/5/2005, D42	328
A/Indonesia/5/2005, M6	11
A/Indonesia/5/2005, M12	25

SecondaryNumber of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6

Time frame:: At Month 12
Reported as:: Count of participants · Participants

Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6
Participants	H5N1 Adjuvanted Group
A/Vietnam/1194/2004, M12	20
A/Indonesia/5/2005, M12	15

SecondarySeroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

Time frame:: At day 21 and Day 42
Reported as:: Number · Fold change

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Fold change	H5N1 Adjuvanted Group - Lot 1	H5N1 Adjuvanted Group - Lot 2	H5N1 Adjuvanted Group - Lot 3	H5N1 Adjuvanted Group - Lot 4	H5N1 Un-adjuvanted Group
A/Vietnam/1194/2004, D21	3.9 (3.3 to 4.6)	4.6 (3.8 to 5.6)	4.3 (3.5 to 5.2)	3.8 (3.2 to 4.5)	1.2 (1.1 to 1.3)
A/Vietnam/1194/2004, D42	34.4 (29.2 to 40.5)	43.2 (37 to 50.5)	40.5 (34.6 to 47.5)	41.6 (35.6 to 48.5)	1.3 (1.2 to 1.5)
A/Indonesia/5/2005, D21	1.2 (1.1 to 1.3)	1.2 (1.1 to 1.3)	1.2 (1.1 to 1.3)	1.2 (1.1 to 1.3)	1.0 (1.0 to 1.0)
A/Indonesia/5/2005, D42	4.8 (4 to 5.7)	5.6 (4.6 to 6.6)	5.1 (4.2 to 6.1)	4.4 (3.7 to 5.3)	1.0 (1.0 to 1.1)

SecondarySeroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Time frame:: Before booster vaccination at Month 6 (M6) and within 21 days following each booster dose: At Month 6 + 21 days (M6+21D) and, for H5N1 Un-adjuvanted Group only, at Month 6 + 42 days (M6+42D)
Reported as:: Number · Fold change

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Fold change	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
A/Vietnam/1194/2004, M6	3.6 (3.1 to 4.1)	1 (1 to 1.1)
A/Vietnam/1194/2004, M6+21D	74 (63.1 to 86.7)	5.3 (4.4 to 6.4)
A/Vietnam/1194/2004, M6+42D	—	13.4 (11.2 to 16.0)
A/Indonesia/5/2005, M6	1.3 (1.2 to 1.4)	1 (1 to 1)
A/Indonesia/5/2005, M6+21D	63.8 (54.4 to 74.9)	4.9 (4 to 5.9)
A/Indonesia/5/2005, M6+42D	—	18.9 (15.8 to 22.6)

SecondaryBooster Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Time frame:: Within 21 days following each booster dose: At Month 6 + 21 days (M6+21D) and, for H5N1 Un-adjuvanted Group only, at Month 6 + 42 days (M6+42D)
Reported as:: Number · Fold change

Booster Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Fold change	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
A/Vietnam/1194/2004, M6+21D	20.8 (17.3 to 24.9)	5.2 (4.3 to 6.2)
A/Vietnam/1194/2004, M6+42D	—	13.2 (11.1 to 15.8)
A/Indonesia/5/2005, M6+21D	50 (42.5 to 58.8)	4.9 (4.1 to 5.9)
A/Indonesia/5/2005, M6+42D	—	19 (15.9 to 22.7)

SecondaryBooster Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Time frame:: At Month 12
Reported as:: Number · Fold change

Booster Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Fold change	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
A/Vietnam/1194/2004	3.7 (3.1 to 4.5)	2.5 (2.1 to 2.9)
A/Indonesia/5/2005	7.2 (5.9 to 8.8)	2.9 (2.5 to 3.4)

SecondarySeroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6

Time frame:: At Day 21, at Day 42, at Month 6 and at Month 12
Reported as:: Number · Fold change

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6
Fold change	H5N1 Adjuvanted Group
A/Vietnam/1194/2004, D21	4.2 (3.8 to 4.7)
A/Vietnam/1194/2004, D42	38.8 (35.4 to 42.5)
A/Vietnam/1194/2004, M6	3.3 (3.1 to 3.6)
A/Vietnam/1194/2004, M12	2 (1.9 to 2.2)
A/Indonesia/5/2005, D21	1.2 (1.2 to 1.3)
A/Indonesia/5/2005, D42	4.9 (4.4 to 5.4)
A/Indonesia/5/2005, M6	1.2 (1.2 to 1.3)
A/Indonesia/5/2005, M12	1.2 (1.2 to 1.3)

SecondaryNumber of Subjects Seroprotected Against 2 Strains of Influenza Disease

A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

Time frame:: Before primary vaccination at Day 0 and within 21 days following each primary vaccination dose at Day 21 and at Day 42.
Reported as:: Count of participants · Participants

Number of Subjects Seroprotected Against 2 Strains of Influenza Disease
Participants	H5N1 Adjuvanted Group - Lot 1	H5N1 Adjuvanted Group - Lot 2	H5N1 Adjuvanted Group - Lot 3	H5N1 Adjuvanted Group - Lot 4	H5N1 Un-adjuvanted Group
A/Vietnam/1194/2004, PRE	4	3	5	3	5
A/Vietnam/1194/2004, D21	102	108	102	100	16
A/Vietnam/1194/2004, D42	213	223	215	220	24
A/Indonesia/5/2005, PRE	1	0	0	0	0
A/Indonesia/5/2005, D21	10	4	6	7	0
A/Indonesia/5/2005, D42	108	128	118	110	1

SecondaryNumber of Subjects Seroprotected Against 2 Strains of Influenza Disease

Time frame:: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)
Reported as:: Count of participants · Participants

Number of Subjects Seroprotected Against 2 Strains of Influenza Disease
Participants	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
A/Vietnam/1194/2004, M6	103	4
A/Vietnam/1194/2004, M6+21D	247	121
A/Vietnam/1194/2004, M6+42D	0	180
A/Indonesia/5/2005, M6	9	0
RA/Indonesia/5/2005, M6+21D	243	106
A/Indonesia/5/2005, M6+42D	0	189

SecondaryNumber of Seroprotected Subjects Against 2 Strains of Influenza Disease

Time frame:: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12)
Reported as:: Count of participants · Participants

Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
Participants	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
A/Vietnam/1194/2004, M6	103	4
A/Vietnam/1194/2004, M6+21D	242	120
A/Vietnam/1194/2004, M6+42D	0	177
A/Vietnam/1194/2004, M12	178	65
A/Indonesia/5/2005, M6	9	0
A/Indonesia/5/2005, M6+21D	238	105
A/Indonesia/5/2005, M6+42D	0	186
A/Indonesia/5/2005, M12	151	67

SecondaryNumber of Subjects Seroprotected Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6

Time frame:: At Day 0, Day 21, Day 42, Month 6 and Month 12
Reported as:: Count of participants · Participants

Number of Subjects Seroprotected Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6
Participants	H5N1 Adjuvanted Group
A/Vietnam/1194/2004, PRE	11
A/Vietnam/1194/2004, D21	307
A/Vietnam/1194/2004, D42	623
A/Vietnam/1194/2004, M6	247
A/Vietnam/1194/2004, M12	131
A/Indonesia/5/2005, PRE	1
A/Indonesia/5/2005, D21	21
A/Indonesia/5/2005, D42	328
A/Indonesia/5/2005, M6	13
A/Indonesia/5/2005, M12	26

SecondaryFrequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation

The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.

Time frame:: Within 21 days of each primary vaccine dose: at Day 21 and at Day 42
Reported as:: Mean · T-cells per million T-cells

Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation
T-cells per million T-cells	H5N1 Adjuvanted Group - Lot 1	H5N1 Adjuvanted Group - Lot 2	H5N1 Adjuvanted Group - Lot 3	H5N1 Adjuvanted Group - Lot 4	H5N1 Un-Adjuvanted Group - Lot 1	H5N1 Un-Adjuvanted Group - Lot 2
A/Vietnam/1194/2004, min. 2 cytokines, D21	2602.17 ± 1369.03	5627.00 ± 3064.90	3632.00 ± 1884.23	4060.75 ± 1566.75	1037.5 ± 290.62	1440.5 ± 593.01
A/Vietnam/1194/2004, min. 2 cytokines, D42	4578.2 ± 848.69	5425.57 ± 2176.77	4917.67 ± 1787.62	3862.00 ± 1024.44	1024.5 ± 547.92	1492.6 ± 442.25
A/Vietnam/1194/2004, min. CD40L+1 cytokine, D21	2516.33 ± 1390.64	5460.33 ± 3093.55	3606.00 ± 1871.46	3828.00 ± 1332.47	893 ± 298.4	1429.75 ± 603.52
A/Vietnam/1194/2004, min. CD40L+1 cytokine, D42	4367.00 ± 858.47	5307.29 ± 2255.72	4863.50 ± 1767.69	3769.75 ± 980.19	1046.75 ± 550.36	1496.4 ± 416.88
A/Vietnam/1194/2004, min.IL-2+1 cytokine, D21	2405.50 ± 1357.76	5345.00 ± 2828.98	3385.17 ± 1752.85	3708.75 ± 1542.48	925 ± 272.94	1412.5 ± 631.94
A/Vietnam/1194/2004, min.IL-2+1 cytokine, D42	3981.40 ± 611.95	5008.14 ± 1938.05	4447.17 ± 1591.81	3461.25 ± 973.71	864 ± 428.27	1422.4 ± 432.38
A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, D21	1459.00 ± 947.19	2799.00 ± 2049.50	1636.33 ± 822.50	1741.50 ± 817.26	667.5 ± 144.96	951 ± 439.73
A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, D42	2570.60 ± 874.72	2573.71 ± 1258.22	2313.17 ± 956.59	1706.00 ± 298.05	667.5 ± 477.67	913.2 ± 262.45
A/Vietnam/1194/2004, min.TNF-α+1 cytokine, D21	1835.33 ± 1124.45	3822.67 ± 3294.28	2683.00 ± 1560.15	1995.50 ± 736.97	447.5 ± 258.09	890.75 ± 169.87
A/Vietnam/1194/2004, min.TNF-α+1 cytokine, D42	2813.40 ± 1327.05	4047.71 ± 2556.46	3670.00 ± 1922.75	2493.25 ± 1000.61	603 ± 590.71	733.8 ± 378.22

SecondaryFrequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation

The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.

Time frame:: Within 21 days of each primary vaccine dose: at Day 21 and at Day 42
Reported as:: Mean · T-cells per million cells

Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation
T-cells per million cells	H5N1 Adjuvanted Group - Lot 1	H5N1 Adjuvanted Group - Lot 2	H5N1 Adjuvanted Group - Lot 3	H5N1 Adjuvanted Group - Lot 4	H5N1 Un-Adjuvanted Group - Lot 1	H5N1 Un-Adjuvanted Group - Lot 2
A/Vietnam/1194/2004,min. 2 cytokines, D21	166.0 ± 182.34	236.33 ± 177.38	76.67 ± 116	127 ± 122.34	289.5 ± 225.57	785.5 ± 1531.24
A/Vietnam/1194/2004, min. 2 cytokines, D42	161 ± 128.26	176.43 ± 204.71	69.17 ± 67.19	32.5 ± 32.3	147 ± 125.63	172 ± 305.46
A/Vietnam/1194/2004, min. CD40L+1 cytokine, D21	25.33 ± 30.73	1.00 ± 0	18.50 ± 20.74	1 ± 0	1 ± 0	78 ± 136.59
A/Vietnam/1194/2004, min. CD40L+1 cytokine, D42	15.20 ± 31.75	12.71 ± 30.99	13.50 ± 19.49	10.25 ± 11.06	1 ± 0	47.8 ± 33.69
A/Vietnam/1194/2004, min.IL-2+1 cytokine, D21	144.33 ± 165.58	131.67 ± 70.81	66.17 ± 104.61	120.75 ± 153.51	198 ± 278.6	341.5 ± 663.12
A/Vietnam/1194/2004, min.IL-2+1 cytokine, D42	140.00 ± 148.92	108.71 ± 114.78	80.83 ± 73.51	30.00 ± 22.77	139 ± 103.58	138.6 ± 205.65
A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, D21	163.50 ± 187.70	245.33 ± 170.81	59.83 ± 89.57	104.75 ± 136.03	335 ± 229.1	765.25 ± 1510.55
A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, D42	166.60 ± 131.04	161.29 ± 201.37	34.50 ± 43.63	23.75 ± 26.30	128.75 ± 138.81	159.8 ± 319.18
A/Vietnam/1194/2004, min.TNF-α+1 cytokine, D21	75.83 ± 135.65	175.33 ± 195.41	45.83 ± 74.25	95.25 ± 32.26	208.5 ± 12.02	804 ± 1485.55
A/Vietnam/1194/2004, min.TNF-α+1 cytokine, D42	89.20 ± 64.10	164.14 ± 194.30	72.50 ± 100.04	29.75 ± 34.98	79.5 ± 127.03	110 ± 227.33

SecondaryFrequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation

The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.

Time frame:: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12)
Reported as:: Mean · T-cells per million T-cells

Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation
T-cells per million T-cells	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
A/Vietnam/1194/2004, min. 2 cytokines, M6	1773.0 ± 748.95	681.00 ± 243.30
A/Vietnam/1194/2004, min. 2 cytokines, M6+21D	7049.60 ± 3832.18	3898.00 ± 1133.03
A/Vietnam/1194/2004, min. 2 cytokines, M6+42D	—	4472.75 ± 2352.87
A/Vietnam/1194/2004, min. 2 cytokines, M12	3197.29 ± 1428.81	2141.57 ± 617.49
A/Vietnam/1194/2004, min. CD40L+1 cytokine, M6	1720.00 ± 765.05	666 ± 187.51
A/Vietnam/1194/2004, min. CD40L+1 cytokine, M6+21D	6849.60 ± 3814.40	3885.60 ± 1116.51
A/Vietnam/1194/2004, min. CD40L+1 cytokine, M6+42D	—	4330.88 ± 2255.37
A/Vietnam/1194/2004, min. CD40L+1 cytokine, M12	3164.43 ± 1419.03	2148.57 ± 617.94
A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M6	921.00 ± 489.49	409.00 ± 227.75
A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M6+21D	3585.40 ± 2106.34	1665.60 ± 659.04
A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M6+42D	—	2332.25 ± 1640.24
A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M12	1592.57 ± 781.64	1016.86 ± 509.21
A/Vietnam/1194/2004, min.IL-2+1 cytokine, M6	1653.33 ± 608.11	688.33 ± 212.18
A/Vietnam/1194/2004, min.IL-2+1 cytokine, M6+21D	6526.40 ± 3484.66	3674.00 ± 1062.72
A/Vietnam/1194/2004, min.IL-2+1 cytokine, M6+42D	—	4177.25 ± 2092.28
A/Vietnam/1194/2004, min.IL-2+1 cytokine, M12	3043.86 ± 1386.80	2098.86 ± 558.63
A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M6	1443.00 ± 554.28	538.33 ± 224.38
A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M6+21D	5544.20 ± 3219.20	2671.00 ± 863.72
A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M6+42D	—	3296.25 ± 2060.05
A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M12	2501.43 ± 1190.18	1649.14 ± 504.41

SecondaryFrequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation

The analyzed cytokines were CD40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.

Time frame:: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12)
Reported as:: Mean · T-cells per million T-cells

Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation
T-cells per million T-cells	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
A/Vietnam/1194/2004, min. 2 cytokines, M6	55.00 ± 49.76	306.00 ± 363.19
A/Vietnam/1194/2004, min. 2 cytokines, M6+21D	50.00 ± 47.94	62.60 ± 47.45
A/Vietnam/1194/2004, min. 2 cytokines, M6+42D	—	257.63 ± 484.86
A/Vietnam/1194/2004, min. 2 cytokines, M12	50.86 ± 75.46	232.00 ± 383.34
A/Vietnam/1194/2004, min. CD40L+1 cytokine, M6	3.67 ± 4.62	5.33 ± 7.51
A/Vietnam/1194/2004, min. CD40L+1 cytokine, M6+21D	23.80 ± 24.65	31.20 ± 52.39
A/Vietnam/1194/2004, min. CD40L+1 cytokine, M6+42D	—	5.38 ± 10.85
A/Vietnam/1194/2004, min. CD40L+1 cytokine, M12	12.29 ± 12.11	4.71 ± 9.83
A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M6	44 ± 37.24	331.33 ± 407.67
A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M6+21D	36 ± 30.74	50.60 ± 40.5
A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M6+42D	—	257 ± 485.24
A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M12	53 ± 83.7	211.71 ± 375.25
A/Vietnam/1194/2004, min.IL-2+1 cytokine, M6	22.67 ± 33.29	162.00 ± 229.00
A/Vietnam/1194/2004, min.IL-2+1 cytokine, M6+21D	39.40 ± 38.00	36.60 ± 33.08
A/Vietnam/1194/2004, min.IL-2+1 cytokine, M6+42D	—	147.88 ± 246.47
A/Vietnam/1194/2004, min.IL-2+1 cytokine, M12	38.00 ± 52.50	133.14 ± 168.94
A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M6	58.67 ± 58.52	290 ± 335.72
A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M6+21D	24.6 ± 23.56	219.88 ± 443.7
A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M6+42D	—	219.88 ± 443.7
A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M12	34 ± 63.9	204.43 ± 376.77

SecondaryFrequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6

The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.

Time frame:: At Month 6 and Month 12
Reported as:: Mean · T-cells per million T-cells

Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6
T-cells per million T-cells	H5N1 Adjuvanted Group
A/Vietnam/1194/2004, min. 2 cytokines, M6	2529.54 ± 1063.65
A/Vietnam/1194/2004, min. 2 cytokines, M12	2098.17 ± 1287.49
A/Vietnam/1194/2004, min. CD40L+1 cytokine, M6	2407.31 ± 1009.26
A/Vietnam/1194/2004, min. CD40L+1 cytokine, M12	2004.27 ± 1193.53
A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M6	1387.38 ± 840.81
A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M12	1184.07 ± 992.44
A/Vietnam/1194/2004, min.IL-2+1 cytokine, M6	2341.15 ± 936.20
A/Vietnam/1194/2004, min.IL-2+1 cytokine, M12	1912.60 ± 1130.58
A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M6	1960.62 ± 891.12
A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M12	1599.20 ± 945.88

SecondaryFrequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6

The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.

Time frame:: At Month 6 and at Month 12
Reported as:: Mean · T-cells per million T-cells

Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6
T-cells per million T-cells	H5N1 Adjuvanted Group
A/Vietnam/1194/2004, min. 2 cytokines, M6	82.69 ± 166.59
A/Vietnam/1194/2004, min. 2 cytokines, M12	106.13 ± 173.19
A/Vietnam/1194/2004, min. CD40L+1 cytokine, M6	9.62 ± 13.90
A/Vietnam/1194/2004, min. CD40L+1 cytokine, M12	4.53 ± 8.18
A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M6	67.23 ± 145.99
A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M12	102.93 ± 161.31
A/Vietnam/1194/2004, min.IL-2+1 cytokine, M6	66.00 ± 117.35
A/Vietnam/1194/2004, min.IL-2+1 cytokine, M12	70.90 ± 128.03
A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M6	59.08 ± 111.73
A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M12	89.30 ± 140.96

SecondaryNumber of Subjects With Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Time frame:: During the 7-days (Days 0-6) post-primary vaccination period following each dose and overall
Reported as:: Count of participants · Participants

Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Participants	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
Any Ecchymosis, Dose 1	8	0
Grade 3 Ecchymosis, Dose 1	0	0
Any Induration, Dose 1	54	0
Grade 3 Induration, Dose 1	0	0
Any Pain, Dose 1	779	44
Grade 3 Pain, Dose 1	31	0
Any Redness, Dose 1	36	0
Grade 3 Redness, Dose 1	0	0
Any Swelling, Dose 1	84	0
Grade 3 Swelling, Dose 1	1	0
Any Ecchymosis, Dose 2	3	0
Grade 3 Ecchymosis, Dose 2	0	0
Any Induration, Dose 2	38	0
Grade 3 Induration, Dose 2	0	0
Any Pain, Dose 2	674	38
Grade 3 Pain, Dose 2	21	0
Any Redness, Dose 2	33	1
Grade 3 Redness, Dose 2	1	0
Any Swelling, Dose 2	70	0
Grade 3 Swelling, Dose 2	0	0
Any Ecchymosis, Across doses	10	0
Grade 3 Ecchymosis, Across doses	0	0
Any Induration, Across doses	76	0
Grade 3 Induration, Across doses	0	0
Any Pain, Across doses	830	62
Grade 3 Pain, Across doses	49	0
Any Redness, Across doses	64	1
Grade 3 Redness, Across doses	1	0
Any Swelling, Across doses	114	0
Grade 3 Swelling, Across doses	1	0

SecondaryNumber of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Time frame:: During the 7-days (Days 0-6) post-primary vaccination period following each dose and overall
Reported as:: Count of participants · Participants

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Participants	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
Any Arthralgia, Dose 1	118	16
Grade 3 Arthralgia, Dose 1	5	0
Related Arthralgia, Dose 1	109	14
Any Fatigue , Dose 1	411	69
Grade 3 Fatigue , Dose 1	18	0
Related Fatigue , Dose 1	395	65
Any Fever, Dose 1	21	1
Grade 3 Fever, Dose 1	5	0
Related Fever, Dose 1	20	1
Any Headache, Dose 1	238	35
Grade 3 Headache, Dose 1	13	0
Related Headache, Dose 1	215	29
Any Myalgia, Dose 1	478	48
Grade 3 Myalgia, Dose 1	14	0
Related Myalgia, Dose 1	462	43
Any Shivering, Dose 1	44	3
Grade 3 Shivering, Dose 1	2	0
Related Shivering, Dose 1	42	2
Any Sweating, Dose 1	86	19
Grade 3 Sweating, Dose 1	0	0
Related Sweating, Dose 1	78	17
Any Arthralgia, Dose 2	147	14
Grade 3 Arthralgia, Dose 2	4	1
Related Arthralgia, Dose 2	147	13
Any Fatigue , Dose 2	435	53
Grade 3 Fatigue , Dose 2	26	2
Related Fatigue , Dose 2	432	52
Any Fever, Dose 2	27	3
Grade 3 Fever, Dose 2	3	1
Related Fever, Dose 2	27	3
Any Headache, Dose 2	269	29
Grade 3 Headache, Dose 2	16	1
Related Headache, Dose 2	265	27
Any Myalgia, Dose 2	429	34
Grade 3 Myalgia, Dose 2	17	1
Related Myalgia, Dose 2	427	34
Any Shivering, Dose 2	75	4
Grade 3 Shivering, Dose 2	4	1
Related Shivering, Dose 2	74	4
Any Sweating, Dose 2	90	13
Grade 3 Sweating, Dose 2	4	2
Related Sweating, Dose 2	87	13
Any Arthralgia, Across doses	212	24
Grade 3 Arthralgia, Across doses	8	1
Related Arthralgia, Across doses	206	22
Any Fatigue , Across doses	559	91
Grade 3 Fatigue , Across doses	38	2
Related Fatigue , Across doses	550	88
Any Fever, Across doses	45	4
Grade 3 Fever, Across doses	8	1
Related Fever, Across doses	44	4
Any Headache, Across doses	380	52
Grade 3 Headache, Across doses	26	1
Related Headache, Across doses	367	47
Any Myalgia, Across doses	610	65
Grade 3 Myalgia, Across doses	29	1
Related Myalgia, Across doses	599	61
Any Shivering, Across doses	105	7
Grade 3 Shivering, Across doses	6	1
Related Shivering, Across doses	103	6
Any Sweating, Across doses	143	25
Grade 3 Sweating, Across doses	4	2
Related Sweating, Across doses	135	24

SecondaryNumber of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase

Time frame:: During the 7-days (Days 0-6) post-booster vaccination period
Reported as:: Count of participants · Participants

Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase
Participants	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
Any Ecchymosis, Booster dose 1	2	1
Grade 3 Ecchymosis, Booster dose 1	0	0
Any Induration, Booster dose 1	21	14
Grade 3 Induration, Booster dose 1	0	1
Any Pain, Booster dose 1	214	187
Grade 3 Pain, Booster dose 1	14	11
Any Redness, Booster dose 1	16	7
Grade 3 Redness, Booster dose 1	0	0
Any Swelling, Booster dose 1	36	24
Grade 3 Swelling, Booster dose 1	0	0
Any Ecchymosis, Booster dose 2	0	2
Grade 3 Ecchymosis, Booster dose 2	—	0
Any Induration, Booster dose 2	—	14
Grade 3 Induration, Booster dose 2	—	0
Any Pain, Booster dose 2	—	159
Grade 3 Pain, Booster dose 2	—	8
Any Redness, Booster dose 2	—	15
Grade 3 Redness, Booster dose 2	—	0
Any Swelling, Booster dose 2	—	22
Grade 3 Swelling, Booster dose 2	—	0
Any Ecchymosis, Across booster doses	—	2
Grade 3 Ecchymosis, Across booster doses	—	0
Any Induration, Across booster doses	—	21
Grade 3 Induration, Across booster doses	—	1
Any Pain, Across booster doses	—	198
Grade 3 Pain, Across booster doses	—	17
Any Redness, Across booster doses	—	16
Grade 3 Redness, Across booster doses	—	0
Any Swelling, Across booster doses	—	33
Grade 3 Swelling, Across booster doses	—	0

SecondaryNumber of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase

Time frame:: During the 7-days (Days 0-6) post-booster vaccination period
Reported as:: Count of participants · Participants

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase
Participants	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
Any Arthralgia, Booster dose 1	57	33
Grade 3 Arthralgia, Booster dose 1	4	1
Related Arthralgia, Booster dose 1	57	32
Any Fatigue , Booster dose 1	165	96
Grade 3 Fatigue , Booster dose 1	15	3
Related Fatigue , Booster dose 1	164	95
Any Fever, Booster dose 1	16	7
Grade 3 Fever, Booster dose 1	3	0
Related Fever, Booster dose 1	16	7
Any Headache, Booster dose 1	120	66
Grade 3 Headache, Booster dose 1	8	1
Related Headache, Booster dose 1	117	65
Any Myalgia, Booster dose 1	169	126
Grade 3 Myalgia, Booster dose 1	15	4
Related Myalgia, Booster dose 1	168	126
Any Shivering, Booster dose 1	47	18
Grade 3 Shivering, Booster dose 1	5	0
Related Shivering, Booster dose 1	47	18
Any Sweating, Booster dose 1	25	15
Grade 3 Sweating, Booster dose 1	0	0
Related Sweating, Booster dose 1	23	15
Any Arthralgia, Booster dose 2	—	38
Grade 3 Arthralgia, Booster dose 2	—	3
Related Arthralgia, Booster dose 2	—	37
Any Fatigue , Booster dose 2	—	95
Grade 3 Fatigue , Booster dose 2	—	4
Related Fatigue , Booster dose 2	—	94
Any Fever, Booster dose 2	—	9
Grade 3 Fever, Booster dose 2	—	1
Related Fever, Booster dose 2	—	9
Any Headache, Booster dose 2	—	69
Grade 3 Headache, Booster dose 2	—	3
Related Headache, Booster dose 2	—	68
Any Myalgia, Booster dose 2	—	101
Grade 3 Myalgia, Booster dose 2	—	5
Related Myalgia, Booster dose 2	—	100
Any Shivering, Booster dose 2	—	30
Grade 3 Shivering, Booster dose 2	—	2
Related Shivering, Booster dose 2	—	29
Any Sweating, Booster dose 2	—	21
Grade 3 Sweating, Booster dose 2	—	1
Related Sweating, Booster dose 2	—	21
Any Arthralgia, Across booster doses	—	54
Grade 3 Arthralgia, Across booster doses	—	4
Related Arthralgia, Across booster doses	—	52
Any Fatigue , Across booster doses	—	121
Grade 3 Fatigue , Across booster doses	—	6
Related Fatigue , Across booster doses	—	119
Any Fever, Across booster doses	—	14
Grade 3 Fever, Across booster doses	—	1
Related Fever, Across booster doses	—	14
Any Headache, Across booster doses	—	97
Grade 3 Headache, Across booster doses	—	3
Related Headache, Across booster doses	—	96
Any Myalgia, Across booster doses	—	141
Grade 3 Myalgia, Across booster doses	—	9
Related Myalgia, Across booster doses	—	141
Any Shivering, Across booster doses	—	38
Grade 3 Shivering, Across booster doses	—	2
Related Shivering, Across booster doses	—	37
Any Sweating, Across booster doses	—	28
Grade 3 Sweating, Across booster doses	—	1
Related Sweating, Across booster doses	—	28

SecondaryNumber of Subjects With Any Unsolicited Adverse Events (AEs)

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

Time frame:: During the primary phase (from Day 0 to Month 6)
Reported as:: Count of participants · Participants

Number of Subjects With Any Unsolicited Adverse Events (AEs)
Participants	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
Number of Subjects With Any Unsolicited Adverse Events (AEs)	308	75

SecondaryNumber of Subjects With Any Unsolicited Adverse Events (AEs)

Time frame:: During the booster phase (from Month 6 to Month 12)
Reported as:: Count of participants · Participants

Number of Subjects With Any Unsolicited Adverse Events (AEs)
Participants	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
Number of Subjects With Any Unsolicited Adverse Events (AEs)	65	54

SecondaryNumber of Subjects With Serious Adverse Events (SAEs).

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Time frame:: During the primary phase (from Day 0 to Month 6)
Reported as:: Count of participants · Participants

Number of Subjects With Serious Adverse Events (SAEs).
Participants	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
Number of Subjects With Serious Adverse Events (SAEs).	7	0

SecondaryNumber of Subjects With Serious Adverse Events (SAEs).

Time frame:: During the booster phase (from Month 6 to Month 12)
Reported as:: Count of participants · Participants

Number of Subjects With Serious Adverse Events (SAEs).
Participants	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
Number of Subjects With Serious Adverse Events (SAEs).	3	5

SecondaryNumber of Subjects With Serious Adverse Events (SAEs) for Subjects Not Boosted at Month 6

This group consists of the remaining subjects from the GSK1562902A Pooled Group who received a single dose of H5N1 vaccine at Month 12 or 36.

Time frame:: From Month 6 to Month 12
Reported as:: Count of participants · Participants

Number of Subjects With Serious Adverse Events (SAEs) for Subjects Not Boosted at Month 6
Participants	H5N1 Adjuvanted Group
Number of Subjects With Serious Adverse Events (SAEs) for Subjects Not Boosted at Month 6	15

Adverse events

Collected over Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
H5N1 Adjuvanted Group	1/961 (0.1%)	25/961 (2.6%)	904/961 (94.1%)
H5N1 Un-adjuvanted Group	0/245 (0%)	5/245 (2%)	159/245 (64.9%)

Most frequent serious events

Showing 10 of 35

Most frequent serious events
Event	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
Ligament ruptureInjury, poisoning and procedural complications	3/961	1/245
Benign ovarian tumourNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/961	1/245
AnxietyPsychiatric disorders	0/961	1/245
Colonic polypGastrointestinal disorders	0/961	1/245
Helicobacter gastritisInfections and infestations	0/961	1/245
Clavicle fractureInjury, poisoning and procedural complications	0/961	1/245
AppendicitisInfections and infestations	2/961	0/245
Skin lacerationInjury, poisoning and procedural complications	2/961	0/245
Uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	2/961	0/245
ContusionInjury, poisoning and procedural complications	2/961	0/245

Most frequent other events

Showing 10 of 12

Most frequent other events
Event	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group
Injection site painGeneral disorders	830/961	62/245
MyalgiaMusculoskeletal and connective tissue disorders	610/961	65/245
FatigueGeneral disorders	559/961	91/245
HeadacheNervous system disorders	389/961	59/245
Injection site swellingGeneral disorders	365/961	23/245
Injection site erythemaGeneral disorders	321/961	48/245
IndurationGeneral disorders	246/961	11/245
ArthralgiaMusculoskeletal and connective tissue disorders	214/961	24/245
PyrexiaGeneral disorders	185/961	21/245
HyperhidrosisSkin and subcutaneous tissue disorders	143/961	25/245

Baseline characteristics

Age, Continuous
Age, Continuous(years)	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group	Total
Mean	33.75 ± 9.82	32.95 ± 9.18	33.59 ± 9.7

Sex: Female, Male
Sex: Female, Male(Participants)	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group	Total
Female	495	122	617
Male	466	123	589

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	H5N1 Adjuvanted Group	H5N1 Un-adjuvanted Group	Total
Race — Asian - Central/ South Asian Heritage	16	6	22
Race — Asian - East Asian Heritage	589	145	734
Race — Asian - South East Asian Heritage	355	93	448
Race — White - Arabic / North African Heritage	0	1	1
Race — White - Caucasian / European Heritage	1	0	1

Study locations

6 sites

GSK Investigational Site
Hong Kong, Hong Kong
GSK Investigational Site
Singapore, 529889, Singapore
GSK Investigational Site
Singapore, 688846, Singapore
GSK Investigational Site
Taipei, 100, Taiwan
GSK Investigational Site
Taipei, 112, Taiwan
GSK Investigational Site
Bangkok, 10700, Thailand

References and documents

Publications

Chu DW, Hwang SJ, Lim FS, Oh HM, Thongcharoen P, Yang PC, Bock HL, Drame M, Gillard P, Hutagalung Y, Tang H, Teoh YL, Ballou RW; H5N1 Flu Study Group for Hong Kong, Singapore, Taiwan and Thailand. Immunogenicity and tolerability of an AS03(A)-adjuvanted prepandemic influenza vaccine: a phase III study in a large population of Asian adults. Vaccine. 2009 Dec 9;27(52):7428-35. doi: 10.1016/j.vaccine.2009.07.102. Epub 2009 Aug 13. PubMed 19683087 ↗
Chu DW, Kwong AS, Tsui WW, Wang JH, Ngai CK, Wan PK, Ong G, Tang HW, Roman F, Dram M, Bock HL. Cross-clade immunogenicity and safety of an AS03A-adjuvanted prepandemic H5N1 influenza vaccine in Hong Kong. Hong Kong Med J. 2011 Feb;17(1):39-46. PubMed 21282825 ↗
Hwang SJ, Chang SC, Yu CJ, Chan YJ, Chen TJ, Hsieh SL, Lai HY, Lin MH, Liu JY, Ong G, Roman F, Drame M, Bock HL, Yang PC. Immunogenicity and safety of an AS03(A)-adjuvanted H5N1 influenza vaccine in a Taiwanese population. J Formos Med Assoc. 2011 Dec;110(12):780-6. doi: 10.1016/j.jfma.2011.11.009. Epub 2011 Dec 23. PubMed 22248833 ↗
Thongcharoen P, Auewarakul P, Hutagalung Y, Ong G, Gillard P, Drame M, Bock HL. Cross-clade immunogenicity and antigen-sparing with an AS03(A)-adjuvanted prepandemic influenza vaccine in a Thai population. J Med Assoc Thai. 2011 Aug;94(8):916-26. PubMed 21863672 ↗
Gillard P, Chu DW, Hwang SJ, Yang PC, Thongcharoen P, Lim FS, Drame M, Walravens K, Roman F. Long-term booster schedules with AS03A-adjuvanted heterologous H5N1 vaccines induces rapid and broad immune responses in Asian adults. BMC Infect Dis. 2014 Mar 15;14:142. doi: 10.1186/1471-2334-14-142. PubMed 24628789 ↗

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 Apr 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00449670
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Mar 20, 2007
Start date: Mar 24, 2007
Primary completion: Jul 12, 2007
Completion: Jun 10, 2008
Results posted: Apr 9, 2020
Last update: Apr 9, 2020

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

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