Grade 3 ecchymosis, redness and swelling was ≥ 100 millimeter (mm) and grade 3 pain was considerable pain at rest, that prevented normal everyday activities.

The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.

Duration was defined as number of days with any grade of local symptoms.

The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented on subjects who experienced the symptom.

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.

The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.

Duration was defined as number of days with any grade of general symptoms.

The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.

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.

The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

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.

The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

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.

The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

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.

The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

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.

The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

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.

Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.

Antibody titers were expressed as GMTs against separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.

Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.

Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.

Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.

Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.

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.

Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.

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.

Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.

SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.

Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.

SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.

Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.

A seroprotected subject was defined as a subject with a serum HI titer ≥ to 1:40 that usually is accepted as indicating protection.

Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.

A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection.

Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.

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.

Analysis was performed on According-to-Protocol (ATP) cohort for cell mediated immunity (CMI) Day 21 in subjects for whom data concerning immunogenicity were available for at least one test, 21Days after vaccination.

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.

Analysis was performed on According-to-Protocol (ATP) cohort for cell mediated immunity (CMI) Day 180 in subjects for whom data concerning immunogenicity were available for at least one test, 180 Days after vaccination.