The objective of the study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
145
GSK Investigational Site
Rednitzhembach, Bavaria, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, Germany
GSK Investigational Site
Freital, Saxony, Germany
GSK Investigational Site
Berlin, Germany
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain
Titers were expressed as GMTs. The Pandemrix vaccine strain was A/Cal/7/09.
Time frame: At Day 42
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain
The Pandemrix vaccine strain was A/Cal/7/09. The cut-off was a titer of 1:10 and this titer was considered as seropositivity.
Time frame: At Day 42
Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain
The Pandemrix vaccine strain was A/Cal/7/09. A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Time frame: At Day 42
Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain
Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination compared to prevaccination (Day 0). The Pandemrix vaccine strain was A/Cal/7/09.
Time frame: At Day 42
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain
The Pandemrix vaccine strain was A/Cal/7/09. A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40.
Time frame: At Day 42
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
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GSK Investigational Site
Hamburg, Germany
GSK Investigational Site
Hamburg, Germany
Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63.
Time frame: Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
The cut-off was a titer of 1:10 and this titer was considered as seropositivity. Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63.
Time frame: At Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12
Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
A seroconverted subject was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63).
Time frame: At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains.
Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
For the definition of seroconversion factor, please refer to the primary outcome measure. Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63).
Time frame: At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains.
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40. Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63.
Time frame: Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12
Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix
Solicited local symptoms were pain, redness and swelling at the injection site. Solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius).
Time frame: During a 7-Day (Day 0-6) follow-up period after each administration of Pandemrix
Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix
Solicited local symptoms were pain, redness and swelling at the injection site. General symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius)
Time frame: During a 7-Day (Day 0-6) follow-up period after each administration of (at Day -21 and at Day 42) placebo or Fluarix
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (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: any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activity Related: unsolicited AE assessed by the investigator as related to the vaccination
Time frame: During 21 days (Day 0-20) after each vaccination
Number of Subjects With Serious Adverse Events (SAEs)
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.
Time frame: During the entire study period (Day 0-364)
Number of Subjects With AEs of Specific Interest
Adverse events of specific interest included auto-immune diseases and other immune mediated disorders.
Time frame: During the entire study period (Day 0-364)