Adults 18 to 64, any sex, with Influenza. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.Primary· At Day 42
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer less than (\<) 1:10 and a post-vaccination reciprocal HI titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus.
Group
Value
95% CI
Influenza A (H5N1) Group
72
Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease.Primary· At Day 42
MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.
Group
Value
95% CI
Influenza A (H5N1) Group
41.7
32.0 – 54.3
Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.Primary· At Day 42
A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus.
Group
Value
95% CI
Influenza A (H5N1) Group
74
Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.Secondary· At Day 0 and Day 42
A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10.
H5N1 at Day 0
Group
Value
95% CI
Influenza A (H5N1) Group
26
H5N1 at Day 42
Group
Value
95% CI
Influenza A (H5N1) Group
75
Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.Secondary· At Day 0 and Day 42
Titers are presented as geometric mean titers (GMTs).
H5N1 at Day 0
Group
Value
95% CI
Influenza A (H5N1) Group
7.5
6.5 – 8.6
H5N1 at Day 42
Group
Value
95% CI
Influenza A (H5N1) Group
311.3
249.2 – 389.0
Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.Secondary· At Day 0 and Day 182
A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10.
H5N1 at Day 0
Group
Value
95% CI
Influenza A (H5N1) Group
27
H5N1 at Day 182
Group
Value
95% CI
Influenza A (H5N1) Group
73
Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.Secondary· At Day 0 and Day 182
Titers are presented as geometric mean titers (GMTs).
H5N1 at Day 0
Group
Value
95% CI
Influenza A (H5N1) Group
7.8
6.6 – 9.1
H5N1 at Day 182
Group
Value
95% CI
Influenza A (H5N1) Group
56.3
47.0 – 67.5
Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.Secondary· At Day 0 and Day 182
A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus.
H5N1 at Day 0
Group
Value
95% CI
Influenza A (H5N1) Group
3
H5N1 at Day 182
Group
Value
95% CI
Influenza A (H5N1) Group
56
Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.Secondary· At Day 182
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer \< 1:10 and a post-vaccination reciprocal HI titer (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus.
Group
Value
95% CI
Influenza A (H5N1) Group
48
Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease.Secondary· At Day 182
MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.
Group
Value
95% CI
Influenza A (H5N1) Group
7.2
5.8 – 9.0
Number of Subjects With Any and Grade 3 Solicited Local SymptomsSecondary· During the 7-day follow-up period (Days 0-6) after any vaccination
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities. Grade 3 Redness/Swelling = Redness/Swelling \>100 millimeters (mm).
Any Pain
Group
Value
95% CI
Influenza A (H5N1) Group
71
Any Redness
Group
Value
95% CI
Influenza A (H5N1) Group
7
Any Swelling
Group
Value
95% CI
Influenza A (H5N1) Group
12
Grade 3 Pain
Group
Value
95% CI
Influenza A (H5N1) Group
6
Grade 3 Redness
Group
Value
95% CI
Influenza A (H5N1) Group
0
Grade 3 Swelling
Group
Value
95% CI
Influenza A (H5N1) Group
0
Duration of Solicited Local Symptoms After Vaccination.Secondary· During the 7-day (Days 0-6) post-vaccination period following each dose
Assessed solicited local symptoms were pain, redness and swelling. Duration was defined as the number of days with any grade of local symptoms.
Pain, Dose 1
Group
Value
95% CI
Influenza A (H5N1) Group
3.0
2.0 – 4.0
Pain, Dose 2
Group
Value
95% CI
Influenza A (H5N1) Group
3.0
2.0 – 3.0
Redness, Dose1
Group
Value
95% CI
Influenza A (H5N1) Group
2.0
1.0 – 2.0
Redness, Dose 2
Group
Value
95% CI
Influenza A (H5N1) Group
3.0
1.0 – 4.0
Swelling, Dose 1
Group
Value
95% CI
Influenza A (H5N1) Group
2.0
1.0 – 3.0
Swelling, Dose 2
Group
Value
95% CI
Influenza A (H5N1) Group
1.0
1.0 – 2.0
Adverse events — posted to ClinicalTrials.gov
Time frame: Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: From Day 0 to Day 84. SAEs: from Day 0 to Day 385..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Influenza A (H5N1) Group
Serious: 3/78 (4%)
Deaths: —
Serious adverse events (3 terms)
Reaction
System
Influenza A (H5N1) Group
Hernia obstructive
General disorders
—
Pneumonia
Infections and infestations
—
Small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This trial will assess the immunogenicity and safety of GSK Biologicals' vaccine GSK1557484A, prepared from old concentrated monobulk material, in adults aged 18 to 64 years, when administered up to 5 years following production.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 21 September 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01416571.