Titers were expressed as geometric mean antibody titers and were calculated on all subjects from both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.

The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.

Vaccine response was defined as a rSBA titer of at least 1:32 in initially seronegative subjects (<1:8) and as 4-fold increase in titer in initially seropositive subjects (≥1:8). A seronegative subject had antibody titer below 1:8 prior to vaccination and a seropositive subject had antibody titer equal to or above 1:8 prior to vaccination. Vaccine response was assessed for subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.

The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.

Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine and on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort).

The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.

Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.

The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.

Seroconversion was defined as the percentage of 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, for each vaccine strain.

Seroconversion was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.

The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.

Conversion factor defined as the fold increase in serum HI Geometric Mean Titers 1 month after vaccination compared to pre-vaccination, for each vaccine strain. Conversion factor was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.

The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.

Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually is accepted as indicating protection. Seroprotection was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.

The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.

Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects of both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.

The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.

Titers were expressed as geometric mean antibody titers and were calculated on all subjects of both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.

The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.

Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort) and on subjects receiving 1 dose of Mencevax ACWY vaccine (in the Flu vaccine cohort).

The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.

Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort) and on subjects receiving 1 dose of Mencevax ACWY vaccine (in the Flu vaccine cohort).

The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.

Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.

The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.

Titers were expressed as geometric mean antibody titers and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.

The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.

Vaccine response was defined as a rSBA titer of at least 1:32 in initially seronegative subjects (<1:8) and as 4-fold increase in titer in initially seropositive subjects (≥ 1:8). A seronegative subject had antibody titer >1:8 and a seropositive subject had antibody titer ≥1:8 prior to vaccination. Vaccine response was assessed for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).

The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.

Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.

The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.

Concentrations were expressed in geometric mean concentrations in International unit per milliliter (IU/mL) and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.

The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.

Blood samples were taken on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).

The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.

Concentrations were expressed in geometric mean concentrations in International unit per milliliter (IU/mL) and were calculated on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).

The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.

Meningococcal polysaccharide serogroups, A, C, W-135 and Y = PSA, PSC, PSW-135 & PSY. Assay cut-off values assessed were ≥ 0.3 microgram per milliliter (µg/mL) and ≥ 2.0 µg/mL. Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.

The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.

Concentrations were expressed in geometric mean concentrations in microgram per milliliter (µg/mL) and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.

The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.

Assay cut-off values assessed were ≥ 0.3 microgram per milliliter (µg/mL) and ≥ 2.0 µg/mL. Blood samples were taken on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).

The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.

Concentrations were expressed in geometric mean concentrations in microgram per milliliter (µg/mL) and were calculated on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).

The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.

Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.

The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.

Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).

The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.

Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine after the Fluarix vaccine administration.

The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.

Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever (= axillary temperature ≥ 37.5 degrees Celsius). Any = occurrence of any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activities. Grade 3 fever = axillary temperature > 39.5°C. Symptoms were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.

The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.

Solicited general symptoms = fatigue, gastrointestinal symptoms, headache and fever (= axillary temperature ≥ 37.5°C). Any = occurrence of any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activities. Grade 3 fever = > 39.5°C. Symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).

The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.

Rash assessed were hives, idiopathic thrombocytopenic purpura and petechiae and were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.

The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.

NOCIs assessed were autoimmune disorders, asthma, type I diabetes and allergies and were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.

The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.

AEs resulting in ER visits were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.

The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.

Rash assessed were hives, idiopathic thrombocytopenic purpura and petechiae and were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).

The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.

NOCIs assessed were autoimmune disorders, asthma, type I diabetes and allergies and were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).

The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.

AEs resulting in ER visits were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).

The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.

An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. Unsolicited AEs were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, B and C) or the Mencevax ACWY vaccine.

The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. SAEs were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.

The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.

An unsolicited AE = any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. AEs were collected for subjects receiving Nimenrix vaccine lot A+Fluarix vaccine, Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and Mencevax ACWY vaccine (in the Flu vaccine cohort).

The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. SAEs were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).

The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.