Cut-off values assessed were greater than or equal to (≥) 15 milli-international units per milliliter (mIU/mL) in the sera of subjects seronegative before vaccination.

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.

Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.

Antibody concentrations against pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL).

The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.

The immune response was defined, with respect to anti-pneumococcal response rates, as an antibody concentration equal to or above (≥) 0.05 μg/mL.

The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.

Cut-off values assessed were greater than or equal to (≥) 15 mIU/mL in the sera of subjects seronegative before vaccination.

The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.

Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli international units per milliliter (mIU/mL).

The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.

Cut-off values assessed were greater than or equal to (≥) 15 mIU/mL in the sera of subjects seronegative before vaccination.

The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.

Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli international units per milliliter (mIU/mL).

The analysis was performed on the ATP Cohort for Immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.

The vaccine response was defined as:

1. a detectable anti-HAV antibody concentration one month after Dose 2 in subjects who were initially seronegative (antibody concentrations < 15 mIU/mL for anti-HAV); or
2. a 2-fold increase above the pre-vaccination concentration one month after Dose 2 in subjects who were initially seropositive (antibody concentrations ≥ 15 mIU/mL for anti-HAV).

The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented and with the symptoms sheet filled in.

Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.

The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented and with the symptoms sheet filled in.

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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented.

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. NCIs include autoimmune disorders, asthma, type I diabetes, allergies. MSEs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. NCIs include autoimmune disorders, asthma, type I diabetes, allergies. MSEs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

The analysis was performed on the ESFU cohort, which included all vaccinated subjects for whom safety data were available during the extended safety follow-up period (from Day 30 up to 6 months after last vaccine dose).