GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.

Per protocol, GMTs were assessed only in part of the According-To-Protocol (ATP) cohort for immunogenicity (children aged 6 months to < 5 years).

Seroconverted subjects are defined as subjects with either a pre-vaccination HI titer <1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer.

Data are presented for all 3 viral strains comprised in the vaccine.

As per protocol, seroconversion was assessed in part of the ATP cohort for immunogenicity: children aged 6 months to < 5 years for whom post-vaccination results were available.

Rare serious event is defined as any untoward medical event with an occurrence rate of ≥1/300 that:

• resulted in death,
• was life-threatening,
• required hospitalization or prolongation of existing hospitalization,
• resulted in disability/incapacity, or
• was a congenital anomaly/birth defect in the offspring of a study subject.

Seroprotected subjects are defined as vaccinees with a serum HI titer ≥ 1:40. Data are presented for all 3 viral strains comprised in the vaccine.

As per protocol, seroprotection was assessed in part of the ATP cohort for immunogenicity: children aged 6 months to < 5 years for whom results were available.

Initially unprotected subjects are subjects with a baseline HI titer < 1:40. Data are presented for all 3 viral strains comprised in the vaccine.

As per protocol, only subjects from the ATP cohort for immunogenicity aged 6 months to < 5 years and with a baseline titre < 1:40 were analysed for this Outcome Measure.

Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, loss of appetite, arthralgia, fatigue, headache, muscle aches, and shivering.

Data across doses are presented. Any = at least one symptom irrespective of intensity/relationship to vaccination; Grade 3: symptom that prevented normal everyday activities; Related: considered by the investigator as related to the study vaccination.

Analysis was performed on vaccinated subjects with available data.

• Pain, redness, swelling and fever were assessed in all age cohorts.
• Drowsiness, irritability and loss of appetite were assessed in the 6 months to < 5 years cohort only.
• Arthralgia, fatigue, headache, muscle aches and shivering were assessed in the 5 to < 18 years cohort only.

An Adverse Event is 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.

Any = at least one symptom irrespective of intensity and relationship to vaccination; Grade 3 = preventing normal activity; Related = considered by the investigator to be causally related to the study vaccination.

SAE: any untoward medical occurrence that

• resulted in death,
• was life-threatening,
• required hospitalization or prolongation of existing hospitalization,
• resulted in disability/incapacity, or
• was a congenital anomaly/birth defect in the offspring of a study subject.

Examples of possible new onset chronic illnesses include but are not limited to diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders.