Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

Geometric mean titers (GMT) to influenza vaccine A antigens were determined in randomized and vaccinated participants, per-protocol population. The GMT data for antigen A/Victoria/210/2009 and A/California/07/2009 were pooled for participants vaccinated with either 2010-2011 TIV or the investigational TIV. Data presented in column for Group 1.

Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

Seroconversion was defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥four-fold increase in post-vaccination

Seroconversion with respect to influenza vaccine B antigens were determined in randomized and vaccinated participants, per-protocol population

Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

Geometric mean titers to influenza vaccine B antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigen.

Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

Geometric mean titers to influenza vaccine B antigens (cross-reactive antibody) were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigen.

Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil)

Seroprotection against influenza vaccine antigens was determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.

Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

Seroconversion was defined as either a pre vaccination HAI titer <1:10 and a post vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and a four-fold increase in post-vaccination.

Seroconversion with respect to vaccine antigens (cross-reactive antibody) were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.

Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 6 months to less than 36 months with valid serology results for the particular antigen.

Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

Seroconversion was defined as either a pre vaccination HAI titer <1:10 and a post vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and a four-fold increase in post-vaccination.

Seroconversion with respect to influenza vaccine B antigens (cross-reactive antibody) was determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigens.

Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil).

Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 6 months to less than 36 months with valid serology results for the particular antigen.

Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil).

Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 3 years to less than 9 years with valid serology results for the particular antigen.

Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil).

Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.

Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil).

Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.

Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 3 years to less than 9 Years with valid serology results for the particular antigen.

Solicited injection site reactions (Age 6-23 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability.

Grade 3: Tenderness: cries when injected limb is moved; Erythema and Swelling ≥ 50 mm; Fever: >103.1°F; Vomiting: ≥6 episodes/24 hours; Abnormal crying: >3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals or most feeds/meals; Irritability: inconsolable.

Solicited Injection site reactions (Age 24 Months to < 36 months): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.

Grade 3: Pain: Incapacitating, unable to perform usual activities; Redness and Swelling: ≥ 50 mm; Fever: ≥102.1°F; Headache, Malaise and Myalgia: Significant, prevents daily activity.

Safety profile were assessed in all randomized and vaccinated participants, safety population. Values presented for participants aged 6 months to <36 months with available data for the relevant endpoint.

Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (Temperature); Headache, Malaise and Myalgia Grade 3 Pain: incapacitating, unable to perform usual activities; Redness and Swelling: ≥ 50 mm; Fever: ≥ 102.1°F; Headache, Malaise and Myalgia: Significant, prevents daily activity, respectively.

Safety profile were assessed in all randomized and vaccinated participants, safety population. Values presented for participants aged 3 years to <9 years with available data for the relevant endpoint.