Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years

Vaccine response for serum bactericidal assay using rabbit complement (rSBA) antibodies against Neisseria meningitides serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) was defined as: for initially seronegative subjects \[rSBA titer below (\<) 1:8\], post-vaccination rSBA titer greater than or equal to (≥) 1: 32; for initially seropositive subjects with rSBA titer between 1:8 and 1:128, at least four-fold increase in rSBA titer from pre to post vaccination; and for initially seropositive subjects with rSBA titer ≥1:128, at least two-fold increase in rSBA titer from pre to post vaccination.

Time frame: One month after vaccination (Month 1)

Population: The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (μg/mL).

Time frame: At Day 0 and Month 1

Population: The primary analysis was performed on a subset of of the 2 treatment groups and 2 age strata of the According-to-protocol (ATP) cohort for immunogenicity, 50% of subjects were tested for anti-PSA and anti-PSC and the other 50% of subjects were tested for anti-PSW-135 and anti-PSY.

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

Time frame: At Day 0 and Month 1

Population: The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).

Time frame: At Day 0 and Month 1

Population: The primary analysis was performed on a subset of of the 2 treatment groups and 2 age strata of the According-to-protocol (ATP) cohort for immunogenicity, 50% of subjects were tested for anti-PSA and anti-PSC and the other 50% of subjects were tested for anti-PSW-135 and anti-PSY.

The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 2.0 micrograms per milliliter (μg/mL).

Time frame: At Day 0 and Month 1

Population: The primary analysis was performed on a subset of of the 2 treatment groups and 2 age strata of the According-to-protocol (ATP) cohort for immunogenicity, 50% of subjects were tested for anti-PSA and anti-PSC and the other 50% of subjects were tested for anti-PSW-135 and anti-PSY.

The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).

Time frame: At Day 0 and Month 1

Population: The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest or pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.

Time frame: Within 4 days (Day 0 to 3) post-vaccination

Population: The primary analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with vaccine administration documented, who had filled in their symptom sheets.

Assessed solicited general symptoms were fatigue,gastrointestinal symptoms, headache and temperature \[defined as orally temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature above (\>) 39.5 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.

Time frame: Within 4 days (Day 0 to 3) post-vaccination

Population: The primary analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with vaccine administration documented, who had filled in their symptom sheets.

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.

Time frame: Within 31 days (Day 0 to 30) after vaccination

Population: The primary analysis was performed on the Total Vaccinated cohort (TVC), which cohort included all subjects with vaccine administration documented.

NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

Time frame: Within 31 days (Day 0 to 30) after vaccination

Population: The primary analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with vaccine administration documented.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.

Time frame: At Day 0 and Month 1

Population: The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128.

Time frame: At Day 0 and Month 1

Population: The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Time frame: Within 31 days (Day 0 to 30) after vaccination

Population: The primary analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with vaccine administration documented.

Antibody titers were presented as geometric mean titers (GMTs).

Time frame: At Day 0 and Month 1

Population: The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.