The purpose of the study is to evaluate the safety of GSK Biologicals' influenza vaccine. Elderly subjects were randomized in the primary study (NCT00760617) and will now receive the same vaccine for the third time. For this study the masking is "observer-blind" for elderly subjects and "open" for young adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
370
Single dose, intramuscular injection
Single dose, intramuscular injection
GSK Investigational Site
Güglingen, Baden-Wurttemberg, Germany
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 ecchymosis, redness and swelling was ≥ 100 millimeter (mm) and grade 3 pain was considerable pain at rest, that prevented normal everyday activities.
Time frame: Day 0-6
Duration of Solicited Local AEs
Duration was defined as number of days with any grade of local symptoms.
Time frame: Day 0-6
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any fever was defined as oral temperature ≥ 38.0 degree centigrade (°C), grade 3 fever was oral temperature ≥ 39.0°C-≤ 40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade, grade 3 was defined as general symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.
Time frame: Day 0-6
Duration of Solicited General AEs
Duration was defined as number of days with any grade of general symptoms.
Time frame: Day 0-6
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Unsolicited AE covers any AE 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, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by the investigator as causally related to the study vaccination.
Time frame: Day 0-20
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit
For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.
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GSK Investigational Site
Mannheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Rudersberg, Baden-Wurttemberg, Germany
GSK Investigational Site
Weinheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Augsburg, Bavaria, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, Germany
GSK Investigational Site
Rhaunen, Rhineland-Palatinate, Germany
GSK Investigational Site
Dresden, Saxony, Germany
...and 14 more locations
Time frame: Day 0-179
Number of Subjects Reporting AEs of Specific Interest (AESI)
AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.
Time frame: Day 0-179
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) up to Day 180
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.
Time frame: Up to Day 180
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) After Day 180
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.
Time frame: After Day 180
Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21
Antibody titers were expressed as Geometric mean titers (GMTs) against separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Time frame: Day 0 and Day 21
HI Antibody Titers at Day 180
Antibody titers were expressed as GMTs against separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Time frame: Day 180
The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21
Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.
Time frame: Day 0 and Day 21
The Number of Subjects Seropositive to HI Antibodies at Day 180
Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.
Time frame: Day 180
The Number of Subjects Seroconverted to HI Antibodies at Day 21
A seroconverted subject was defined as a subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
Time frame: Day 21
The Number of Subjects Seroconverted to HI Antibodies at Day 180
A seroconverted subject was defined as a subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
Time frame: Day 180
HI Antibody Seroconversion Factors (SCF) at Day 21
SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
Time frame: At Day 21
HI Antibody SCF at Day 180
SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
Time frame: At Day 180
The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21
A seroprotected subject was defined as a subject with a serum HI titer ≥ to 1:40 that usually is accepted as indicating protection.
Time frame: At Day 0 and Day 21
The Number of Subjects Seroprotected to HI Antibodies at Day 180
A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection.
Time frame: At Day 180
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21
The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin 2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ) and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Time frame: At Day 0 and Day 21
The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180
The markers assessed were CD40L, IL-2, TNF-α and IFN-γ and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Time frame: At Day 180