The study will evaluate the immune response and the tolerability of the influenza vaccine administered in children aged 6-13 years old.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
240
Study influenza vaccine was administered intramuscularly in the non-dominant arm
GSK Investigational Site
Würzburg, Bavaria, Germany
GSK Investigational Site
Bützow, Mecklenburg-Vorpommern, Germany
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
Titers of serum HI antibodies are presented as geometric mean titers (GMTs) against the three influenza strains contained in the trivalent influenza vaccine Influsplit SSW 2005/2006 (GlaxoSmithKline/SSW) after a single versus after two vaccine doses of Influsplit SSW 2005/2006. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Time frame: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
Seroconversion Factor (SCF) for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Time frame: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
A seroconverted subject was defined as a subject who was either seronegative prior to the vaccination and had a protective post-vaccination titer of greater than or equal to (≥) 1:40 or who was seropositive prior to the vaccination and had at least a 4-fold increase in the titer as the outcome of the vaccination. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Time frame: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
Titers of serum HI antibodies are presented as geometric mean titers (GMTs) against the three influenza strains contained in the trivalent influenza vaccine Influsplit SSW 2005/2006 (GlaxoSmithKline/SSW) after a single versus after two vaccine doses of Influsplit SSW 2005/2006. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
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GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany
GSK Investigational Site
Bischofswerda, Saxony, Germany
GSK Investigational Site
Dresden, Saxony, Germany
GSK Investigational Site
Dresden, Saxony, Germany
GSK Investigational Site
Dresden, Saxony, Germany
GSK Investigational Site
Leipzig, Saxony, Germany
GSK Investigational Site
Leipzig, Saxony, Germany
...and 8 more locations
Time frame: 21 days post-vaccination (Day 21)
SCF for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Time frame: 21 days post-vaccination (Day 21)
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
A seroconverted subject was defined as a subject who was either seronegative prior to the vaccination and had a protective post-vaccination titer of greater than or equal to (≥) 1:40 or who was seropositive prior to the vaccination and had at least a 4-fold increase in the titer as the outcome of the vaccination. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Time frame: 21 days post-vaccination (Day 21)
Number of Seroprotected Subjects Who Were Unprotected at Pre-vaccination Against 3 Influenza Strains in Children Aged Between 10 and 13 Years
Seroprotection power (SPP) was defined as the proportion of the subjects unprotected before vaccination (titre \< 40) who were protected after vaccination (titer ≥ 40). The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Time frame: 21 days post-vaccination (Day 21)
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Time frame: 21 days post-vaccination (Day 21)
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Time frame: During the 4-day (Day 0-3) post-vaccination period following each dose and across doses
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were Arthralgia, Fatigue, Fever, Headache, Myalgia, Shivering and Sweating. Any= occurrence of the symptom regardless of intensity grade. Grade 3 fever = Grade 3 symptoms greater than (\>) 39.0 °C. Related = symptoms considered by the investigator to have a causal relationship to study vaccination.
Time frame: During the 4-day (Day 0-3) post-vaccination period following each dose and across doses
Number of Subjects With Unsolicited Adverse Events.
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 31 days after the study vaccine dose (Day 0-30)
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 or result in disability/incapacity.
Time frame: During the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group