The purpose of this Phase 3, observer-blind, placebo-controlled, multi-center study is to characterize the immunogenicity \& safety of the investigation vaccination regimen of GSK 1557484A vaccine given to adults aged ≥18 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
4,561
Two intramuscular injections at Days 0 and 21.
Two intramuscular injections at Days 0 and 21.
Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer \< 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.
Time frame: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
Time frame: At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Number of Subjects With Any Solicited Local Symptoms.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
Number of Subjects With Any Solicited General Symptoms.
Assessed solicited general symptoms were fatigue, headache, joint pain at other locations, muscle aches, shivering, sweating and temperature\[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
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.
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GSK Investigational Site
Huntsville, Alabama, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Anaheim, California, United States
GSK Investigational Site
Jacksonville, Florida, United States
GSK Investigational Site
Melbourne, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Pembroke Pines, Florida, United States
GSK Investigational Site
Stockbridge, Georgia, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
Peoria, Illinois, United States
...and 30 more locations
Time frame: During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)
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: From Day 0 through Day 182 and through Day 379.
Number of Subjects With Medically Attended Events (MAEs)
Time frame: From Day 0 through Day 182 and through Day 364.
Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10
Time frame: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Number of Subjects With A/Indonesia/5/05 Antibody Titers ≥ 1:10
Time frame: At Month 6 (Day 182) post Dose 1
Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer \< 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.
Time frame: At Month 6 (Day 182) after Dose 1
Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)
Time frame: At Month 6 (Day 182) after Dose 1
Titers for Serum HI Antibodies Against A/Indonesia/5/05 (H5N1)
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10.
Time frame: At Month 6 (Day 182) after Dose 1
Number of Subjects With a Vaccine Response to the Vaccine-homologous Virus and Drift Variant H5N1 Virus, as Assessed by Microneutralization Assays.
Virus antibody response rates were defined as the number of subjects with antibody titers at Day 42 ≥ 4-fold the pre-vaccination antibody titers. The 2 strains assessed were Flu A/Indonesia/5/05 and Flu A/Vietnam/1194/04.
Time frame: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1) as Assessed by Microneutralization Assays
Titers were expressed as Geometric Mean Titers (GMTs).
Time frame: At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)