Study on the Immunogenicity and Tolerability of Influsplit SSW® 2005/2006 in Children Aged 6 - 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: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.

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)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.

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)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.

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)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.

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)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.

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)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.

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

Population: The analysis was performed on the Total Vaccinated Cohort, included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available and who had a dairy card available.

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

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available and who had a dairy card available. Post Dose 2 results are not available for the 10-13 years Group as these subjects received only one dose.

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

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available and who had a dairy card available. Post Dose 2 results are not available for the 10-13 years Group as these subjects received only one dose.

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)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available and who had a dairy card available.

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)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.

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: 21 days post-vaccination (Day 21)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.