Infections, Meningococcal
Conditions
Keywords
Safety, Meningococcal vaccine, Dose selection, Toddlers, Immunogenicity, Conjugate vaccine, Reactogenicity, Children
Brief summary
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12-14 months and 3-5 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
The study will enrol subjects of 12 to 14 months of age and subjects of 3 to 5 years of age. 3 formulations of GSK's MenACWY conjugate vaccine will be administered in a double-blind manner, while the 4th one will be single-blinded. Administration of the candidate vaccine or the active controls (MenC-CRM197 or Mencevax™ ACWY) will be done in an open manner. The study will be conducted in two stages: The primary vaccination phase (Study Stage 1) of the study will include all subjects; the second (booster/persistence) phase of the study (Study Stage 2) will include subjects in the active control groups and in the group which was primed with the selected MenACWY formulation. The study will be conducted in a double-blind manner for groups receiving formulations A, B, C and in single blind manner with respect to the group receiving formulation D. The control vaccines will be administered in an open manner with respect to the investigational vaccination regimens. Each group will have one blood sample prior to and one blood sample one month after the first vaccine dose.
Interventions
One intramuscular dose during the primary vaccination
BIOLOGICALDTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only
BIOLOGICALDTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
BIOLOGICALMeningitec™
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age
BIOLOGICALMencevax™ACWY
One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (Group E) and intramuscular administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (Groups A and E)
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
12 Months to 60 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including 12 and 14 months or 3 and 5 years of age at the time of the first vaccination. * Written informed consent obtained from the parent or guardian of the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Previously completed routine childhood vaccinations to the best of his/her parents'/guardians' knowledge. For pertussis vaccination, the children aged 12-14 months should have been vaccinated with an acellular pertussis vaccine.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the first dose of vaccine and up to one month after administration of each study vaccine dose with the exception of oral polio vaccine (OPV). * Previous vaccination against meningococcal serogroup A, C, W-135 or Y disease. * Administration of a H. influenzae type b, diphtheria or tetanus vaccine within 3 months before the first dose of vaccine. * For subjects aged 12-14 months at enrolment: * For Austria: DTPa-HBV-IPV/Hib booster vaccination in the second year of life: these booster vaccines will be given at Visit 2. * For Greece: DTPa-IPV/Hib booster vaccination in the second year of life: these booster vaccines will be given at Visit 2. * History of meningococcal serogroup A, C, W-135 or Y disease. * Known exposure to meningococcal serogroup A, C, W-135 or Y disease within the previous year. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. * A family history of congenital or hereditary immunodeficiency. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures. * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With an Immune Response to Different Meningococcal Serogroups | One month after the first vaccine dose (Month 1) | A responder to serum bactericidal assay meningococcal serogroups A, C, W and Y, using rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) was defined as follows: -for initially seronegative subjects (antibody titers \< 1:8 for rSBA-Men), a subject achieving a post-vaccination rSBA-Men antibody titer of ≥ 1:32; - for initially seropositive subjects (antibody titers ≥ 1:8 for rSBA-Men), a subject having a ≥ 4-fold increase in rSBA-Men antibody titer from pre to post vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | Prior to (Month 0) and one month after (Month 1) after the first vaccine dose | A seropositive subject for meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Y assessed, was defined as having antibody titers greater than or equal to (≥) 1:128. |
| Antibody Titers Against Different Meningococcal Serogroups | Prior to (Month 0) and one month after (Month 1) the first vaccine dose | Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs). |
| Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Prior to (Month 0) and one month after (Month 1) the first vaccine dose | A seropositive subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the cut-off value of 0.3 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA). |
| Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Prior to (Month 0) and one month after (Month 1) the first vaccine dose | A seroprotected subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the value of 2.0 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA). |
| Antibody Concentrations Against Different Meningococcal Polysaccharides | Prior to (Month 0) and one month after (Month 1) the first vaccine dose | The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). |
| Number of Seropositive Subjects for Anti-tetanus (Anti-T) | Prior to (Month 0) and one month after (Month 1) the first vaccine dose | A seropositive subject for anti-tetanus was defined as having antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units per milliliter (IU/mL). Antibody titers were determined by enzyme-linked immunosorbent assay (ELISA). |
| Antibody Concentrations Against Tetanus (Anti-T) | Prior to (Month 0) and one month after (Month 1) the first vaccine dose | Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) method, presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). |
| Number of Toddlers With Any Solicited Local Symptoms | During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose | The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. |
| Number of Children With Any Solicited Local Symptoms | During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose | The children subgroup received one dose of the meningococcal vaccine. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. |
| Number of Toddlers With Any Solicited General Symptoms | During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose | The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine. Assessed solicited general symptoms included drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination. |
| Number of Seroprotected Subjects Against Different Meningococcal Serogroups | Prior to (Month 0) and one month after (Month 1) the first vaccine dose | A seroprotected subject against meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY assessed, was defined as having antibody titers greater than or equal to (≥) 1:8. |
| Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination | A seropositive subject for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY was defined as a vaccinated subject with antibody titers greater than or equal to (≥) 1:128, while for a seroprotected subject, titers were ≥1:8. |
| Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination | A seropositive subject for anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY was defined as a vaccinated subject with antibody concentrations greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL), while for a seroprotected subject, antibody concentrations were ≥ 2.0 μg/mL. |
| Number of Subjects With Any Solicited Local Symptoms | During the 8-day (Days 0-7) post-vaccination period following booster dose | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. |
| Number of Subjects With Any Solicited General Symptoms | During the 8-day (Days 0-7) post-vaccination period following booster dose | Assessed solicited general symptoms were drowsiness, fever \[defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)\], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination | Within 31 days (Days 0-30) after the primary meningococcal vaccination | 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. |
| Number of Subjects With Any Unsolicited AEs During the Primary Vaccination | Within 31 days (Days 0-30) post-vaccination with diphteria, tetanus and acellular pertusis-containing vaccine, during the primary vaccination | 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. |
| Number of Subjects With Any Unsolicited AEs | Within 31 days (Days 0-30) after the booster vaccination | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the primary vaccination study (from Month 0 up to Month 2) | 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. |
| Number of Subjects With SAEs | Since the last study contact in the primary study up to the end of the booster study (from Month 2 up to Month 13) | 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. |
| Number of Children With Any Solicited General Symptoms | During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose | The children subgroup received one primary meningococcal vaccine dose. Assessed solicited general symptoms included drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination. |
Countries
Austria, Greece
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| GSK134612A Form1 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination. | 39 |
| GSK134612A Form2 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination. | 41 |
| GSK134612A Form3 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination. | 41 |
| GSK134612A Form4 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination. | 40 |
| Control (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination. | 40 |
| GSK134612A Form1 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). | 54 |
| GSK134612A Form2 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). | 50 |
| GSK134612A Form3 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). | 52 |
| GSK134612A Form4 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). | 52 |
| Control (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533). | 52 |
| GSK134612A Form1 (T), Booster Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534). | 33 |
| Control (T), Booster Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534). | 32 |
| GSK134612A Form1 (C), Booster Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination. | 45 |
| Control (C), Booster Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, did not receive any booster vaccination. | 43 |
| Total | 614 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Booster Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 0 |
| Booster Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Primary Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Primary Study | Migrated from study area | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Primary Study | Other | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Primary Study | Protocol Violation | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Primary Study | Withdrawal by Subject | 1 | 0 | 1 | 1 | 2 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | GSK134612A Form1 (T), Primary Group | GSK134612A Form2 (T), Primary Group | GSK134612A Form3 (T), Primary Group | GSK134612A Form4 (T), Primary Group | Control (T), Primary Group | GSK134612A Form1 (C), Primary Group | GSK134612A Form2 (C), Primary Group | GSK134612A Form3 (C), Primary Group | GSK134612A Form4 (C), Primary Group | Control (C), Primary Group | GSK134612A Form1 (T), Booster Group | Control (T), Booster Group | GSK134612A Form1 (C), Booster Group | Control (C), Booster Group | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | NA Months | NA Months | NA Months | NA Months | NA Months | NA Months | NA Months | NA Months | NA Months | NA Months | 24.9 Months STANDARD_DEVIATION 1.24 | 24.9 Months STANDARD_DEVIATION 1.27 | 60.8 Months STANDARD_DEVIATION 7.23 | 60.0 Months STANDARD_DEVIATION 7.36 | 45.32 Months STANDARD_DEVIATION 18.47 |
| Race/Ethnicity, Customized Arabic/ north african | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants |
| Race/Ethnicity, Customized Arabic/north African | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | NA Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants |
| Race/Ethnicity, Customized East/ south east asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants |
| Race/Ethnicity, Customized White/Caucasian | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | 32 Participants | 31 Participants | 44 Participants | 43 Participants | NA Participants |
| Race/Ethnicity, Customized White/ Caucasian | 38 Participants | 40 Participants | 40 Participants | 38 Participants | 39 Participants | 53 Participants | 50 Participants | 50 Participants | 50 Participants | 51 Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Female | 15 Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | 11 Participants | 15 Participants | 16 Participants | 23 Participants | NA Participants |
| Sex: Female, Male Male | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants | 22 Participants | 17 Participants | 29 Participants | 20 Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 41 | 0 / 41 | 0 / 40 | 0 / 40 | 0 / 54 | 0 / 50 | 0 / 52 | 0 / 52 | 0 / 52 | 0 / 33 | 0 / 32 | 0 / 45 | 0 / 43 |
| other Total, other adverse events | 20 / 39 | 27 / 41 | 23 / 41 | 24 / 40 | 25 / 40 | 10 / 54 | 11 / 50 | 10 / 52 | 11 / 52 | 13 / 52 | 5 / 33 | 5 / 32 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 1 / 39 | 1 / 41 | 1 / 41 | 1 / 40 | 1 / 40 | 0 / 54 | 0 / 50 | 0 / 52 | 0 / 52 | 0 / 52 | 0 / 33 | 0 / 32 | 0 / 45 | 0 / 43 |
Outcome results
Primary
Number of Subjects With an Immune Response to Different Meningococcal Serogroups
A responder to serum bactericidal assay meningococcal serogroups A, C, W and Y, using rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) was defined as follows: -for initially seronegative subjects (antibody titers \< 1:8 for rSBA-Men), a subject achieving a post-vaccination rSBA-Men antibody titer of ≥ 1:32; - for initially seropositive subjects (antibody titers ≥ 1:8 for rSBA-Men), a subject having a ≥ 4-fold increase in rSBA-Men antibody titer from pre to post vaccination.
Time frame: One month after the first vaccine dose (Month 1)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenA | 30 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenC | 30 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenW-135 | 34 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenY | 33 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenC | 32 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenA | 32 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenY | 34 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenW-135 | 36 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenC | 26 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenA | 26 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenW-135 | 27 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenY | 26 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenA | 27 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenC | 33 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenW-135 | 35 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenY | 34 Participants |
| Control (T), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenW-135 | 3 Participants |
| Control (T), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenC | 30 Participants |
| Control (T), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenY | 3 Participants |
| Control (T), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenA | 6 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenW-135 | 46 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenC | 45 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenA | 41 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenY | 46 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenC | 44 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenW-135 | 44 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenY | 47 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenA | 38 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenA | 41 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenY | 45 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenC | 44 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenW-135 | 46 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenY | 47 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenA | 42 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenW-135 | 48 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenC | 46 Participants |
| Control (C), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenW-135 | 36 Participants |
| Control (C), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenA | 36 Participants |
| Control (C), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenY | 34 Participants |
| Control (C), Primary Group | Number of Subjects With an Immune Response to Different Meningococcal Serogroups | rSBA-MenC | 34 Participants |
Secondary
Antibody Concentrations Against Different Meningococcal Polysaccharides
The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Time frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 0.15 μg/mL |
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 0 | 0.16 μg/mL |
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 10.86 μg/mL |
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 0 | 0.16 μg/mL |
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 10.67 μg/mL |
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 7.52 μg/mL |
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 30.65 μg/mL |
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 0 | 0.16 μg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 0 | 0.16 μg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 6.71 μg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 3.12 μg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 0.15 μg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 11.23 μg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 0 | 0.16 μg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 22.09 μg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 0 | 0.15 μg/mL |
| GSK134612A Form3 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 0 | 0.15 μg/mL |
| GSK134612A Form3 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 3.62 μg/mL |
| GSK134612A Form3 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 0 | 0.16 μg/mL |
| GSK134612A Form3 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 6.01 μg/mL |
| GSK134612A Form3 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 0 | 0.15 μg/mL |
| GSK134612A Form3 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 34.68 μg/mL |
| GSK134612A Form3 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 12.91 μg/mL |
| GSK134612A Form3 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 0.16 μg/mL |
| GSK134612A Form4 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 0 | 0.16 μg/mL |
| GSK134612A Form4 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 0 | 0.16 μg/mL |
| GSK134612A Form4 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 0.15 μg/mL |
| GSK134612A Form4 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 7.09 μg/mL |
| GSK134612A Form4 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 10.74 μg/mL |
| GSK134612A Form4 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 0 | 0.15 μg/mL |
| GSK134612A Form4 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 4.03 μg/mL |
| GSK134612A Form4 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 13.38 μg/mL |
| Control (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 0 | 0.15 μg/mL |
| Control (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 0.16 μg/mL |
| Control (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 0 | 0.15 μg/mL |
| Control (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 0.17 μg/mL |
| Control (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 0 | 0.16 μg/mL |
| Control (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 11.99 μg/mL |
| Control (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 0.15 μg/mL |
| Control (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 0.15 μg/mL |
| GSK134612A Form1 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 20.01 μg/mL |
| GSK134612A Form1 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 0 | 0.18 μg/mL |
| GSK134612A Form1 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 0.15 μg/mL |
| GSK134612A Form1 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 0 | 0.2 μg/mL |
| GSK134612A Form1 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 9.41 μg/mL |
| GSK134612A Form1 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 6.33 μg/mL |
| GSK134612A Form1 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 4.76 μg/mL |
| GSK134612A Form1 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 0 | 0.16 μg/mL |
| GSK134612A Form2 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 6.59 μg/mL |
| GSK134612A Form2 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 0.17 μg/mL |
| GSK134612A Form2 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 0 | 0.17 μg/mL |
| GSK134612A Form2 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 0 | 0.18 μg/mL |
| GSK134612A Form2 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 3.2 μg/mL |
| GSK134612A Form2 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 12.62 μg/mL |
| GSK134612A Form2 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 0 | 0.19 μg/mL |
| GSK134612A Form2 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 7.76 μg/mL |
| GSK134612A Form3 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 0.16 μg/mL |
| GSK134612A Form3 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 7.71 μg/mL |
| GSK134612A Form3 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 0 | 0.17 μg/mL |
| GSK134612A Form3 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 5.75 μg/mL |
| GSK134612A Form3 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 0 | 0.16 μg/mL |
| GSK134612A Form3 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 3.85 μg/mL |
| GSK134612A Form3 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 24.69 μg/mL |
| GSK134612A Form3 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 0 | 0.16 μg/mL |
| GSK134612A Form4 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 0 | 0.21 μg/mL |
| GSK134612A Form4 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 4.99 μg/mL |
| GSK134612A Form4 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 0.15 μg/mL |
| GSK134612A Form4 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 11.7 μg/mL |
| GSK134612A Form4 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 3.63 μg/mL |
| GSK134612A Form4 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 0 | 0.15 μg/mL |
| GSK134612A Form4 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 7.78 μg/mL |
| GSK134612A Form4 (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 0 | 0.15 μg/mL |
| Control (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 7.93 μg/mL |
| Control (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 13.79 μg/mL |
| Control (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 18.96 μg/mL |
| Control (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 0 | 0.18 μg/mL |
| Control (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 0 | 0.15 μg/mL |
| Control (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 14.44 μg/mL |
| Control (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 0 | 0.25 μg/mL |
| Control (C), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 0.16 μg/mL |
Secondary
Antibody Concentrations Against Different Meningococcal Polysaccharides
The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Time frame: At one month (M1) and 12 months (M12) post-primary vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 32.72 µg/mL |
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 6.65 µg/mL |
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 12 | 0.39 µg/mL |
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 10.37 µg/mL |
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 12 | 2.36 µg/mL |
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 12 | 1.36 µg/mL |
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 12 | 1.25 µg/mL |
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 11.25 µg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 12.43 µg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 12 | 0.21 µg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 12 | 0.21 µg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 0.15 µg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 0.17 µg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 0.16 µg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 12 | 0.17 µg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 12 | 0.54 µg/mL |
| GSK134612A Form3 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 18.29 µg/mL |
| GSK134612A Form3 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 12 | 1.84 µg/mL |
| GSK134612A Form3 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 12 | 0.28 µg/mL |
| GSK134612A Form3 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 12 | 1.32 µg/mL |
| GSK134612A Form3 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 5.64 µg/mL |
| GSK134612A Form3 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 4.23 µg/mL |
| GSK134612A Form3 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 12 | 1.11 µg/mL |
| GSK134612A Form3 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 8.07 µg/mL |
| GSK134612A Form4 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 12 | 6.9 µg/mL |
| GSK134612A Form4 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 13 µg/mL |
| GSK134612A Form4 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 12 | 4.43 µg/mL |
| GSK134612A Form4 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 14.5 µg/mL |
| GSK134612A Form4 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 8.17 µg/mL |
| GSK134612A Form4 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 18.12 µg/mL |
| GSK134612A Form4 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 12 | 2.9 µg/mL |
| GSK134612A Form4 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 12 | 3.16 µg/mL |
Secondary
Antibody Concentrations Against Different Meningococcal Polysaccharides
The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Time frame: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for immune memory, which included subjects in the Toddlers subgroup from the ATP cohort for persistence, for whom assay results were available for antibodies against at least one study vaccine antigen component for the post-booster dose blood sampling.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, PRE | 0.98 μg/mL |
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, PRE | 1.33 μg/mL |
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, PRE | 25.67 μg/mL |
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, PRE | 56.94 μg/mL |
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 13 | 0.32 μg/mL |
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 13 | 2.34 μg/mL |
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 13 | 11.63 μg/mL |
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 13 | 79.03 μg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, Month 13 | 4.19 μg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, PRE | 0.16 μg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSA, Month 13 | 0.5 μg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, PRE | 0.19 μg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 13 | 15.23 μg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSW-135, PRE | 3.1 μg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSC, Month 13 | 0.19 μg/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Different Meningococcal Polysaccharides | Anti-PSY, PRE | 1.34 μg/mL |
Secondary
Antibody Concentrations Against Tetanus (Anti-T)
Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) method, presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Time frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Tetanus (Anti-T) | Anti-T, Month 1 | 7.559 IU/mL |
| GSK134612A Form1 (T), Primary Group | Antibody Concentrations Against Tetanus (Anti-T) | Anti-T, Month 0 | 1.007 IU/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Tetanus (Anti-T) | Anti-T, Month 0 | 1.159 IU/mL |
| GSK134612A Form2 (T), Primary Group | Antibody Concentrations Against Tetanus (Anti-T) | Anti-T, Month 1 | 5.353 IU/mL |
| GSK134612A Form3 (T), Primary Group | Antibody Concentrations Against Tetanus (Anti-T) | Anti-T, Month 1 | 8.094 IU/mL |
| GSK134612A Form3 (T), Primary Group | Antibody Concentrations Against Tetanus (Anti-T) | Anti-T, Month 0 | 1.203 IU/mL |
| GSK134612A Form4 (T), Primary Group | Antibody Concentrations Against Tetanus (Anti-T) | Anti-T, Month 0 | 1.293 IU/mL |
| GSK134612A Form4 (T), Primary Group | Antibody Concentrations Against Tetanus (Anti-T) | Anti-T, Month 1 | 7.675 IU/mL |
| Control (T), Primary Group | Antibody Concentrations Against Tetanus (Anti-T) | Anti-T, Month 0 | 0.792 IU/mL |
| Control (T), Primary Group | Antibody Concentrations Against Tetanus (Anti-T) | Anti-T, Month 1 | 0.696 IU/mL |
| GSK134612A Form1 (C), Primary Group | Antibody Concentrations Against Tetanus (Anti-T) | Anti-T, Month 0 | 1.426 IU/mL |
| GSK134612A Form1 (C), Primary Group | Antibody Concentrations Against Tetanus (Anti-T) | Anti-T, Month 1 | 17.284 IU/mL |
| GSK134612A Form2 (C), Primary Group | Antibody Concentrations Against Tetanus (Anti-T) | Anti-T, Month 0 | 1.312 IU/mL |
| GSK134612A Form2 (C), Primary Group | Antibody Concentrations Against Tetanus (Anti-T) | Anti-T, Month 1 | 15.823 IU/mL |
| GSK134612A Form3 (C), Primary Group | Antibody Concentrations Against Tetanus (Anti-T) | Anti-T, Month 0 | 1.232 IU/mL |
| GSK134612A Form3 (C), Primary Group | Antibody Concentrations Against Tetanus (Anti-T) | Anti-T, Month 1 | 19.369 IU/mL |
| GSK134612A Form4 (C), Primary Group | Antibody Concentrations Against Tetanus (Anti-T) | Anti-T, Month 0 | 1.18 IU/mL |
| GSK134612A Form4 (C), Primary Group | Antibody Concentrations Against Tetanus (Anti-T) | Anti-T, Month 1 | 15.957 IU/mL |
| Control (C), Primary Group | Antibody Concentrations Against Tetanus (Anti-T) | Anti-T, Month 1 | 1.231 IU/mL |
| Control (C), Primary Group | Antibody Concentrations Against Tetanus (Anti-T) | Anti-T, Month 0 | 1.083 IU/mL |
Secondary
Antibody Titers Against Different Meningococcal Serogroups
Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).
Time frame: At one month (M1) and 12 months (M12) post-primary vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 6577.8 Titers |
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 660.4 Titers |
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 2523.5 Titers |
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 2483.9 Titers |
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 12 | 2369.1 Titers |
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 12 | 110.2 Titers |
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 12 | 541.8 Titers |
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 12 | 740.3 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 12 | 122 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 12 | 179.3 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 440.2 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 12 | 110.6 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 12 | 18.9 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 57.7 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 17.2 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 84.9 Titers |
| GSK134612A Form3 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 12 | 1322.2 Titers |
| GSK134612A Form3 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 3893.6 Titers |
| GSK134612A Form3 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 4808.5 Titers |
| GSK134612A Form3 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 12 | 2356.7 Titers |
| GSK134612A Form3 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 12 | 172.5 Titers |
| GSK134612A Form3 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 12 | 1400.8 Titers |
| GSK134612A Form3 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 6565.3 Titers |
| GSK134612A Form3 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 893.6 Titers |
| GSK134612A Form4 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 1004.4 Titers |
| GSK134612A Form4 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 1641.1 Titers |
| GSK134612A Form4 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 416.2 Titers |
| GSK134612A Form4 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 4649.5 Titers |
| GSK134612A Form4 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 12 | 1134.3 Titers |
| GSK134612A Form4 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 12 | 347.2 Titers |
| GSK134612A Form4 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 12 | 181.7 Titers |
| GSK134612A Form4 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 12 | 41.7 Titers |
Secondary
Antibody Titers Against Different Meningococcal Serogroups
Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).
Time frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 0 | 6.9 Titers |
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 6648 Titers |
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 0 | 84.2 Titers |
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 656.4 Titers |
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 0 | 19.8 Titers |
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 2781.4 Titers |
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 0 | 57.7 Titers |
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 2599.9 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 3447.5 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 0 | 21.1 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 2150.9 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 0 | 4.5 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 0 | 77.3 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 5406.8 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 0 | 24.4 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 495.7 Titers |
| GSK134612A Form3 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 6225.2 Titers |
| GSK134612A Form3 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 1920.9 Titers |
| GSK134612A Form3 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 0 | 32.4 Titers |
| GSK134612A Form3 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 2545 Titers |
| GSK134612A Form3 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 477.2 Titers |
| GSK134612A Form3 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 0 | 4.6 Titers |
| GSK134612A Form3 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 0 | 14.5 Titers |
| GSK134612A Form3 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 0 | 68.4 Titers |
| GSK134612A Form4 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 0 | 32.9 Titers |
| GSK134612A Form4 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 0 | 12.1 Titers |
| GSK134612A Form4 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 3928.6 Titers |
| GSK134612A Form4 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 3544.7 Titers |
| GSK134612A Form4 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 0 | 76 Titers |
| GSK134612A Form4 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 3260.8 Titers |
| GSK134612A Form4 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 464.3 Titers |
| GSK134612A Form4 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 0 | 6.6 Titers |
| Control (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 75.6 Titers |
| Control (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 125.9 Titers |
| Control (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 0 | 52.8 Titers |
| Control (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 0 | 69.1 Titers |
| Control (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 0 | 5.3 Titers |
| Control (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 404.5 Titers |
| Control (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 0 | 18 Titers |
| Control (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 21.7 Titers |
| GSK134612A Form1 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 967.6 Titers |
| GSK134612A Form1 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 5249.1 Titers |
| GSK134612A Form1 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 0 | 12.5 Titers |
| GSK134612A Form1 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 4317.4 Titers |
| GSK134612A Form1 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 0 | 45.8 Titers |
| GSK134612A Form1 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 0 | 359.7 Titers |
| GSK134612A Form1 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 7469.5 Titers |
| GSK134612A Form1 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 0 | 98.7 Titers |
| GSK134612A Form2 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 5150.5 Titers |
| GSK134612A Form2 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 0 | 181.9 Titers |
| GSK134612A Form2 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 0 | 7.4 Titers |
| GSK134612A Form2 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 0 | 367.2 Titers |
| GSK134612A Form2 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 7569.7 Titers |
| GSK134612A Form2 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 1115 Titers |
| GSK134612A Form2 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 0 | 22.3 Titers |
| GSK134612A Form2 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 3856.5 Titers |
| GSK134612A Form3 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 0 | 375.9 Titers |
| GSK134612A Form3 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 13668.3 Titers |
| GSK134612A Form3 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 0 | 11.8 Titers |
| GSK134612A Form3 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 1738.8 Titers |
| GSK134612A Form3 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 0 | 23.7 Titers |
| GSK134612A Form3 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 5896.3 Titers |
| GSK134612A Form3 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 5262.1 Titers |
| GSK134612A Form3 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 0 | 146.8 Titers |
| GSK134612A Form4 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 0 | 140.6 Titers |
| GSK134612A Form4 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 1197.6 Titers |
| GSK134612A Form4 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 4556.1 Titers |
| GSK134612A Form4 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 0 | 8.9 Titers |
| GSK134612A Form4 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 0 | 465.2 Titers |
| GSK134612A Form4 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 4878 Titers |
| GSK134612A Form4 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 0 | 44.6 Titers |
| GSK134612A Form4 (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 7548.4 Titers |
| Control (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 378.3 Titers |
| Control (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 0 | 31.5 Titers |
| Control (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 0 | 123.6 Titers |
| Control (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 1527.3 Titers |
| Control (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 912.7 Titers |
| Control (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 0 | 11.9 Titers |
| Control (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 4556.8 Titers |
| Control (C), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 0 | 427.4 Titers |
Secondary
Antibody Titers Against Different Meningococcal Serogroups
Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).
Time frame: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for immune memory, which included subjects in the Toddlers subgroup from the ATP cohort for persistence, for whom assay results were available for antibodies against at least one study vaccine antigen component for the post-booster dose blood sampling.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, PRE | 2163.4 Titers |
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, PRE | 82.5 Titers |
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, PRE | 436 Titers |
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, PRE | 634.5 Titers |
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 13 | 3695.2 Titers |
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 13 | 7067.4 Titers |
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 13 | 5642.4 Titers |
| GSK134612A Form1 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 13 | 3337.7 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, Month 13 | 323.8 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, PRE | 175.7 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenA, Month 13 | 984.6 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, PRE | 102.5 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, PRE | 15.5 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 13 | 255.6 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenC, Month 13 | 9209.3 Titers |
| GSK134612A Form2 (T), Primary Group | Antibody Titers Against Different Meningococcal Serogroups | rSBA-MenY, PRE | 93.6 Titers |
Secondary
Number of Children With Any Solicited General Symptoms
The children subgroup received one primary meningococcal vaccine dose. Assessed solicited general symptoms included drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.
Time frame: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had filled in the symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Number of Children With Any Solicited General Symptoms | Drowsiness | 4 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Children With Any Solicited General Symptoms | Fever (Axillary) | 4 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Children With Any Solicited General Symptoms | Irritability | 2 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Children With Any Solicited General Symptoms | Loss of appetite | 2 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Children With Any Solicited General Symptoms | Drowsiness | 2 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Children With Any Solicited General Symptoms | Loss of appetite | 3 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Children With Any Solicited General Symptoms | Fever (Axillary) | 4 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Children With Any Solicited General Symptoms | Irritability | 4 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Children With Any Solicited General Symptoms | Loss of appetite | 2 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Children With Any Solicited General Symptoms | Fever (Axillary) | 3 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Children With Any Solicited General Symptoms | Irritability | 2 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Children With Any Solicited General Symptoms | Drowsiness | 0 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Children With Any Solicited General Symptoms | Drowsiness | 5 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Children With Any Solicited General Symptoms | Fever (Axillary) | 3 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Children With Any Solicited General Symptoms | Loss of appetite | 6 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Children With Any Solicited General Symptoms | Irritability | 4 Participants |
| Control (T), Primary Group | Number of Children With Any Solicited General Symptoms | Loss of appetite | 3 Participants |
| Control (T), Primary Group | Number of Children With Any Solicited General Symptoms | Irritability | 7 Participants |
| Control (T), Primary Group | Number of Children With Any Solicited General Symptoms | Fever (Axillary) | 3 Participants |
| Control (T), Primary Group | Number of Children With Any Solicited General Symptoms | Drowsiness | 4 Participants |
Secondary
Number of Children With Any Solicited Local Symptoms
The children subgroup received one dose of the meningococcal vaccine. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had filled in the symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Number of Children With Any Solicited Local Symptoms | Swelling | 7 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Children With Any Solicited Local Symptoms | Redness | 9 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Children With Any Solicited Local Symptoms | Pain | 10 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Children With Any Solicited Local Symptoms | Redness | 11 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Children With Any Solicited Local Symptoms | Swelling | 9 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Children With Any Solicited Local Symptoms | Pain | 11 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Children With Any Solicited Local Symptoms | Redness | 10 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Children With Any Solicited Local Symptoms | Pain | 9 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Children With Any Solicited Local Symptoms | Swelling | 8 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Children With Any Solicited Local Symptoms | Pain | 11 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Children With Any Solicited Local Symptoms | Redness | 9 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Children With Any Solicited Local Symptoms | Swelling | 10 Participants |
| Control (T), Primary Group | Number of Children With Any Solicited Local Symptoms | Pain | 13 Participants |
| Control (T), Primary Group | Number of Children With Any Solicited Local Symptoms | Swelling | 4 Participants |
| Control (T), Primary Group | Number of Children With Any Solicited Local Symptoms | Redness | 7 Participants |
Secondary
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides
A seropositive subject for anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY was defined as a vaccinated subject with antibody concentrations greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL), while for a seroprotected subject, antibody concentrations were ≥ 2.0 μg/mL.
Time frame: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for immune memory, which included subjects in the Toddlers subgroup from the ATP cohort for persistence, for whom assay results were available for antibodies against at least one study vaccine antigen component for the post-booster dose blood sampling.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA ≥ 2.0 μg/mL, PRE | 7 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA ≥ 0.3 μg/mL, Month 13 | 26 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY ≥ 0.3 μg/mL, PRE | 24 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC ≥ 0.3 μg/mL, Month 13 | 25 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC ≥ 0.3 μg/mL, PRE | 11 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135 ≥ 0.3 μg/mL, Month 13 | 25 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY ≥ 0.3 μg/mL, Month 13 | 25 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC ≥ 2.0 μg/mL, PRE | 1 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA ≥ 2.0 μg/mL, Month 13 | 25 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA ≥ 0.3 μg/mL, PRE | 19 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC ≥ 2.0 μg/mL, Month 13 | 25 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135 ≥ 2.0 μg/mL, PRE | 5 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135 ≥ 2.0 μg/mL, Month 13 | 24 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135 ≥ 0.3 μg/mL, PRE | 23 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY ≥ 2.0 μg/mL, Month 13 | 24 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY ≥ 2.0 μg/mL, PRE | 14 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY ≥ 2.0 μg/mL, Month 13 | 12 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135 ≥ 0.3 μg/mL, Month 13 | 18 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA ≥ 0.3 μg/mL, PRE | 1 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC ≥ 0.3 μg/mL, PRE | 15 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135 ≥ 0.3 μg/mL, PRE | 2 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA ≥ 2.0 μg/mL, PRE | 0 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC ≥ 2.0 μg/mL, PRE | 3 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135 ≥ 2.0 μg/mL, PRE | 1 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY ≥ 2.0 μg/mL, PRE | 0 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA ≥ 0.3 μg/mL, Month 13 | 19 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC ≥ 0.3 μg/mL, Month 13 | 22 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY ≥ 0.3 μg/mL, Month 13 | 20 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA ≥ 2.0 μg/mL, Month 13 | 13 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC ≥ 2.0 μg/mL, Month 13 | 22 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135 ≥ 2.0 μg/mL, Month 13 | 9 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY ≥ 0.3 μg/mL, PRE | 2 Participants |
Secondary
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups
A seropositive subject for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY was defined as a vaccinated subject with antibody titers greater than or equal to (≥) 1:128, while for a seroprotected subject, titers were ≥1:8.
Time frame: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for immune memory, which included subjects in the Toddlers subgroup from the ATP cohort for persistence, for whom assay results were available for antibodies against at least one study vaccine antigen component for the post-booster dose blood sampling.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA ≥ 1:8, PRE | 20 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC ≥ 1:8, PRE | 25 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135 ≥ 1:8, PRE | 26 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY ≥ 1:8, PRE | 27 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA ≥ 1:128, PRE | 20 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC ≥ 1:128, PRE | 10 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135 ≥ 1:128, PRE | 23 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY ≥ 1:128, PRE | 26 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA ≥ 1:8, Month 13 | 6 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC ≥ 1:8, Month 13 | 25 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135 ≥ 1:8, Month 13 | 25 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY ≥ 1:8, Month 13 | 25 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA ≥ 1:128, Month 13 | 6 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC ≥ 1:128, Month 13 | 24 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135 ≥ 1:128, Month 13 | 25 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY ≥ 1:128, Month 13 | 25 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY ≥ 1:128, Month 13 | 20 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA ≥ 1:8, PRE | 17 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA ≥ 1:8, Month 13 | 19 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC ≥ 1:8, PRE | 20 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA ≥ 1:128, Month 13 | 19 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135 ≥ 1:8, PRE | 9 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC ≥ 1:8, Month 13 | 24 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY ≥ 1:8, PRE | 18 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135 ≥ 1:128, Month 13 | 18 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA ≥ 1:128, PRE | 16 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135 ≥ 1:8, Month 13 | 21 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC ≥ 1:128, PRE | 12 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC ≥ 1:128, Month 13 | 24 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135 ≥ 1:128, PRE | 4 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY ≥ 1:8, Month 13 | 22 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY ≥ 1:128, PRE | 14 Participants |
Secondary
Number of Seropositive Subjects for Anti-tetanus (Anti-T)
A seropositive subject for anti-tetanus was defined as having antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units per milliliter (IU/mL). Antibody titers were determined by enzyme-linked immunosorbent assay (ELISA).
Time frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Anti-tetanus (Anti-T) | Anti-T, Month 0 | 34 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Anti-tetanus (Anti-T) | Anti-T, Month 1 | 36 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Anti-tetanus (Anti-T) | Anti-T, Month 0 | 36 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Anti-tetanus (Anti-T) | Anti-T, Month 1 | 37 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Anti-tetanus (Anti-T) | Anti-T, Month 0 | 30 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Anti-tetanus (Anti-T) | Anti-T, Month 1 | 30 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Anti-tetanus (Anti-T) | Anti-T, Month 0 | 32 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Anti-tetanus (Anti-T) | Anti-T, Month 1 | 35 Participants |
| Control (T), Primary Group | Number of Seropositive Subjects for Anti-tetanus (Anti-T) | Anti-T, Month 1 | 34 Participants |
| Control (T), Primary Group | Number of Seropositive Subjects for Anti-tetanus (Anti-T) | Anti-T, Month 0 | 33 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seropositive Subjects for Anti-tetanus (Anti-T) | Anti-T, Month 1 | 48 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seropositive Subjects for Anti-tetanus (Anti-T) | Anti-T, Month 0 | 49 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seropositive Subjects for Anti-tetanus (Anti-T) | Anti-T, Month 1 | 47 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seropositive Subjects for Anti-tetanus (Anti-T) | Anti-T, Month 0 | 47 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seropositive Subjects for Anti-tetanus (Anti-T) | Anti-T, Month 0 | 46 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seropositive Subjects for Anti-tetanus (Anti-T) | Anti-T, Month 1 | 48 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seropositive Subjects for Anti-tetanus (Anti-T) | Anti-T, Month 0 | 48 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seropositive Subjects for Anti-tetanus (Anti-T) | Anti-T, Month 1 | 50 Participants |
| Control (C), Primary Group | Number of Seropositive Subjects for Anti-tetanus (Anti-T) | Anti-T, Month 0 | 43 Participants |
| Control (C), Primary Group | Number of Seropositive Subjects for Anti-tetanus (Anti-T) | Anti-T, Month 1 | 43 Participants |
Secondary
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides
A seropositive subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the cut-off value of 0.3 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
Time frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 0 | 1 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 1 | 35 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 0 | 1 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 1 | 33 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 1 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 34 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 0 | 2 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 1 | 34 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 36 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 0 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 1 | 37 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 0 | 1 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 0 | 2 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 1 | 36 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 0 | 0 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 1 | 38 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 1 | 30 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 1 | 30 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 0 | 2 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 30 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 1 | 30 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 0 | 0 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 1 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 0 | 0 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 0 | 1 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 1 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 1 | 34 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 1 | 34 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 0 | 1 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 35 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 1 | 35 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 0 | 1 Participants |
| Control (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 1 | 2 Participants |
| Control (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 1 | 2 Participants |
| Control (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 0 | 1 Participants |
| Control (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 0 | 0 Participants |
| Control (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 0 | 1 Participants |
| Control (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 1 | 34 Participants |
| Control (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 0 Participants |
| Control (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 0 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 1 | 49 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 1 | 49 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 0 | 3 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 48 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 1 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 0 | 10 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 1 | 48 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 0 | 2 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 1 | 45 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 0 | 4 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 0 | 4 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 0 | 4 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 1 | 45 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 1 | 45 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 4 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 45 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 0 | 6 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 1 | 48 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 0 | 1 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 1 | 48 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 2 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 1 | 46 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 48 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 0 | 2 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 0 | 1 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 1 | 48 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 48 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 0 | 1 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 0 | 9 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 1 | 48 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 0 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 1 | 48 Participants |
| Control (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 1 | 44 Participants |
| Control (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 1 Participants |
| Control (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 0 | 1 Participants |
| Control (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 1 | 44 Participants |
| Control (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 44 Participants |
| Control (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 0 | 2 Participants |
| Control (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 1 | 44 Participants |
| Control (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 0 | 10 Participants |
Secondary
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides
A seropositive subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the cut-off value of 0.3 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
Time frame: At one month (M1) and 12 months (M12) post-primary vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 1 | 28 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 29 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 12 | 26 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 1 | 30 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 1 | 29 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 12 | 25 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 12 | 22 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 12 | 13 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 1 | 30 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 12 | 3 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 12 | 3 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 1 | 1 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 0 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 1 | 2 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 12 | 2 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 12 | 18 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 41 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 12 | 34 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 12 | 18 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 12 | 34 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 1 | 42 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 1 | 41 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 12 | 34 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 1 | 42 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 12 | 35 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 1 | 37 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 1 | 37 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 37 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSY, Month 1 | 37 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSA, Month 12 | 34 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSC, Month 12 | 36 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides | Anti-PSW-135, Month 12 | 32 Participants |
Secondary
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups
A seropositive subject for meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Y assessed, was defined as having antibody titers greater than or equal to (≥) 1:128.
Time frame: At one month (M1) and 12 months (M12) post-primary vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 12 | 30 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 1 | 31 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 1 | 31 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 1 | 30 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 12 | 23 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 12 | 13 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 12 | 27 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 1 | 30 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 12 | 17 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 1 | 6 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 12 | 19 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 1 | 23 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 1 | 13 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 12 | 6 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 1 | 14 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 12 | 15 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 12 | 41 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 1 | 44 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 12 | 39 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 12 | 40 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 12 | 27 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 1 | 42 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 1 | 43 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 1 | 42 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 12 | 32 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 1 | 36 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 12 | 10 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 1 | 34 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 12 | 27 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 1 | 35 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 1 | 36 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 12 | 32 Participants |
Secondary
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups
A seropositive subject for meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Y assessed, was defined as having antibody titers greater than or equal to (≥) 1:128.
Time frame: Prior to (Month 0) and one month after (Month 1) after the first vaccine dose
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 1 | 35 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 0 | 3 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 1 | 35 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 1 | 35 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 0 | 8 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 1 | 36 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 0 | 19 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 0 | 17 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 0 | 19 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 1 | 38 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 0 | 0 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 1 | 37 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 1 | 34 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 0 | 11 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 1 | 38 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 0 | 9 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 1 | 29 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 1 | 26 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 1 | 29 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 0 | 9 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 1 | 29 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 0 | 4 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 0 | 0 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 0 | 13 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 0 | 4 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 0 | 19 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 0 | 3 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 1 | 31 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 1 | 34 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 0 | 12 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 1 | 34 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 1 | 35 Participants |
| Control (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 1 | 18 Participants |
| Control (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 1 | 9 Participants |
| Control (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 0 | 17 Participants |
| Control (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 1 | 20 Participants |
| Control (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 0 | 1 Participants |
| Control (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 1 | 27 Participants |
| Control (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 0 | 17 Participants |
| Control (T), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 0 | 8 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 0 | 19 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 0 | 9 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 1 | 51 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 0 | 29 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 1 | 49 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 0 | 41 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 1 | 49 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 1 | 50 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 1 | 46 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 1 | 48 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 0 | 4 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 1 | 47 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 0 | 11 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 1 | 48 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 0 | 39 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 0 | 37 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 0 | 9 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 0 | 40 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 1 | 48 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 0 | 5 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 1 | 45 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 1 | 48 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 0 | 32 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 1 | 48 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 1 | 49 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 0 | 15 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 1 | 48 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 1 | 50 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 0 | 33 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 0 | 7 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 1 | 50 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 0 | 46 Participants |
| Control (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 1 | 43 Participants |
| Control (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 1 | 43 Participants |
| Control (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenY, Month 0 | 30 Participants |
| Control (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 1 | 39 Participants |
| Control (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 1 | 42 Participants |
| Control (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenC, Month 0 | 5 Participants |
| Control (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenA, Month 0 | 37 Participants |
| Control (C), Primary Group | Number of Seropositive Subjects for Different Anti-meningococcal Serogroups | rSBA-MenW-135, Month 0 | 12 Participants |
Secondary
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides
A seroprotected subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the value of 2.0 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
Time frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 0 | 0 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 0 | 0 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 35 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 33 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 0 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 33 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 0 | 0 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 34 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 0 | 0 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 37 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 0 | 0 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 34 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 35 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 0 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 27 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 0 | 0 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 0 | 0 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 29 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 23 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 0 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 27 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 0 | 0 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 0 | 0 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 30 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 25 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 0 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 32 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 0 | 0 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 0 | 0 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 33 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 0 | 1 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 34 Participants |
| Control (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 0 | 0 Participants |
| Control (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 0 Participants |
| Control (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 33 Participants |
| Control (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 0 | 0 Participants |
| Control (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 0 | 0 Participants |
| Control (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 0 Participants |
| Control (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 0 Participants |
| Control (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 0 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 41 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 0 | 1 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 48 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 0 | 2 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 46 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 44 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 0 | 1 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 0 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 1 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 0 | 2 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 40 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 45 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 0 | 2 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 0 | 1 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 44 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 31 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 0 | 0 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 47 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 0 | 0 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 45 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 0 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 39 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 41 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 0 | 0 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 0 | 0 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 47 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 39 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 0 | 0 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 0 | 2 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 34 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 0 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 47 Participants |
| Control (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 44 Participants |
| Control (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 0 | 0 Participants |
| Control (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 0 | 0 Participants |
| Control (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 42 Participants |
| Control (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 39 Participants |
| Control (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 0 | 2 Participants |
| Control (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 40 Participants |
| Control (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 0 | 5 Participants |
Secondary
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides
A seroprotected subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the value of 2.0 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
Time frame: At one month (M1) and 12 months (M12) post primary vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 30 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 28 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 28 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 29 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 12 | 10 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 12 | 2 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 12 | 6 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 12 | 15 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 12 | 4 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 12 | 0 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 29 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 12 | 1 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 12 | 2 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 0 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 0 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 0 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 12 | 10 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 34 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 39 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 12 | 12 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 12 | 0 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 12 | 19 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 41 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 37 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 1 | 32 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 1 | 35 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 1 | 37 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 1 | 33 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSA, Month 12 | 22 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSY, Month 12 | 30 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSW-135, Month 12 | 23 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides | Anti-PSC, Month 12 | 24 Participants |
Secondary
Number of Seroprotected Subjects Against Different Meningococcal Serogroups
A seroprotected subject against meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY assessed, was defined as having antibody titers greater than or equal to (≥) 1:8.
Time frame: At one month (M1) and 12 months (M12) post-primary vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 31 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 31 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 30 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 30 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 12 | 23 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 12 | 29 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 12 | 30 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 12 | 31 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 12 | 25 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 12 | 20 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 29 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 12 | 23 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 12 | 11 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 20 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 11 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 18 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 12 | 41 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 43 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 44 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 12 | 39 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 12 | 40 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 12 | 41 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 43 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 43 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 37 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 37 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 36 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 36 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 12 | 33 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 12 | 36 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 12 | 31 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 12 | 22 Participants |
Secondary
Number of Seroprotected Subjects Against Different Meningococcal Serogroups
A seroprotected subject against meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY assessed, was defined as having antibody titers greater than or equal to (≥) 1:8.
Time frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 0 | 5 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 36 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 0 | 23 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 36 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 0 | 17 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 35 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 0 | 23 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 35 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 38 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 0 | 19 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 38 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 0 | 2 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 0 | 22 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 38 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 0 | 17 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 38 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 30 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 29 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 0 | 16 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 30 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 28 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 0 | 2 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 0 | 12 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 0 | 19 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 0 | 19 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 0 | 13 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 34 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 35 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 0 | 21 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 35 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 35 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 0 | 5 Participants |
| Control (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 25 Participants |
| Control (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 23 Participants |
| Control (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 0 | 22 Participants |
| Control (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 0 | 20 Participants |
| Control (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 0 | 3 Participants |
| Control (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 34 Participants |
| Control (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 0 | 15 Participants |
| Control (T), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 15 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 50 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 51 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 0 | 16 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 50 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 0 | 34 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 0 | 41 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 50 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 0 | 37 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 48 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 0 | 42 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 0 | 8 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 0 | 42 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 47 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 47 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 0 | 24 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 48 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 0 | 40 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 48 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 0 | 17 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 47 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 0 | 25 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 48 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 48 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 0 | 39 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 0 | 42 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 49 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 50 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 0 | 12 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 0 | 47 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 50 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 0 | 36 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 50 Participants |
| Control (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 1 | 43 Participants |
| Control (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 0 | 27 Participants |
| Control (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 0 | 36 Participants |
| Control (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenY, Month 1 | 44 Participants |
| Control (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenW-135, Month 1 | 44 Participants |
| Control (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenC, Month 0 | 14 Participants |
| Control (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 1 | 43 Participants |
| Control (C), Primary Group | Number of Seroprotected Subjects Against Different Meningococcal Serogroups | rSBA-MenA, Month 0 | 39 Participants |
Secondary
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever \[defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)\], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.
Time frame: During the 8-day (Days 0-7) post-vaccination period following booster dose
Population: The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects who received the booster dose of Mencevax™ ACWY vaccine and had the symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness | 3 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Subjects With Any Solicited General Symptoms | Any Fever (Rectally) | 5 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability | 4 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite | 2 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite | 2 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness | 5 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability | 5 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Subjects With Any Solicited General Symptoms | Any Fever (Rectally) | 3 Participants |
Secondary
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 8-day (Days 0-7) post-vaccination period following booster dose
Population: The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects who received the booster dose of Mencevax™ ACWY vaccine and had the symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 1 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 3 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 1 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 0 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 3 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 1 Participants |
Secondary
Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination
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 (Days 0-30) after the primary meningococcal vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK134612A Form1 (T), Primary Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination | 11 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination | 16 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination | 5 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination | 8 Participants |
| Control (T), Primary Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination | 14 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination | 6 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination | 12 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination | 7 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination | 5 Participants |
| Control (C), Primary Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination | 6 Participants |
Secondary
Number of Subjects With Any Unsolicited AEs
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 (Days 0-30) after the booster vaccination
Population: The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects who received the booster dose of Mencevax™ ACWY vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK134612A Form1 (T), Primary Group | Number of Subjects With Any Unsolicited AEs | 3 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Subjects With Any Unsolicited AEs | 5 Participants |
Secondary
Number of Subjects With Any Unsolicited AEs During the Primary Vaccination
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 (Days 0-30) post-vaccination with diphteria, tetanus and acellular pertusis-containing vaccine, during the primary vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK134612A Form1 (T), Primary Group | Number of Subjects With Any Unsolicited AEs During the Primary Vaccination | 5 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Subjects With Any Unsolicited AEs During the Primary Vaccination | 8 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Subjects With Any Unsolicited AEs During the Primary Vaccination | 5 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Subjects With Any Unsolicited AEs During the Primary Vaccination | 5 Participants |
| Control (T), Primary Group | Number of Subjects With Any Unsolicited AEs During the Primary Vaccination | 7 Participants |
Secondary
Number of Subjects With SAEs
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: Since the last study contact in the primary study up to the end of the booster study (from Month 2 up to Month 13)
Population: The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects who received the booster dose of Mencevax™ ACWY vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK134612A Form1 (T), Primary Group | Number of Subjects With SAEs | 0 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Subjects With SAEs | 0 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Subjects With SAEs | 0 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Subjects With SAEs | 0 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
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: During the primary vaccination study (from Month 0 up to Month 2)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK134612A Form1 (T), Primary Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| Control (T), Primary Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| GSK134612A Form1 (C), Primary Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| GSK134612A Form2 (C), Primary Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| GSK134612A Form3 (C), Primary Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| GSK134612A Form4 (C), Primary Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Control (C), Primary Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Number of Toddlers With Any Solicited General Symptoms
The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine. Assessed solicited general symptoms included drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.
Time frame: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had filled in the symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Fever (Axillary), Dose 2 | 4 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Irritability, Dose 1 | 4 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Drowsiness, Dose 1 | 1 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Loss of appetite, Dose 2 | 4 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Irritability, Dose 2 | 6 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Drowsiness, Dose 2 | 2 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Loss of appetite, Dose 1 | 1 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Fever (Axillary), Dose 1 | 5 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Irritability, Dose 2 | 7 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Loss of appetite, Dose 2 | 3 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Fever (Axillary), Dose 1 | 8 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Irritability, Dose 1 | 9 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Loss of appetite, Dose 1 | 6 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Drowsiness, Dose 1 | 5 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Drowsiness, Dose 2 | 2 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Fever (Axillary), Dose 2 | 5 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Drowsiness, Dose 1 | 4 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Loss of appetite, Dose 1 | 5 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Irritability, Dose 2 | 3 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Drowsiness, Dose 2 | 3 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Fever (Axillary), Dose 1 | 8 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Fever (Axillary), Dose 2 | 5 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Irritability, Dose 1 | 6 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Loss of appetite, Dose 2 | 2 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Irritability, Dose 1 | 5 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Fever (Axillary), Dose 2 | 5 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Loss of appetite, Dose 1 | 3 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Drowsiness, Dose 1 | 4 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Irritability, Dose 2 | 9 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Drowsiness, Dose 2 | 7 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Fever (Axillary), Dose 1 | 3 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Loss of appetite, Dose 2 | 6 Participants |
| Control (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Loss of appetite, Dose 2 | 2 Participants |
| Control (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Drowsiness, Dose 1 | 5 Participants |
| Control (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Fever (Axillary), Dose 1 | 5 Participants |
| Control (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Loss of appetite, Dose 1 | 6 Participants |
| Control (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Drowsiness, Dose 2 | 3 Participants |
| Control (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Fever (Axillary), Dose 2 | 8 Participants |
| Control (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Irritability, Dose 2 | 5 Participants |
| Control (T), Primary Group | Number of Toddlers With Any Solicited General Symptoms | Irritability, Dose 1 | 5 Participants |
Secondary
Number of Toddlers With Any Solicited Local Symptoms
The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who had filled in the symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK134612A Form1 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Pain, Dose 2 | 3 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Redness, Dose 1 | 9 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Pain, Dose 1 | 4 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Swelling, Dose 2 | 3 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Swelling, Dose 1 | 1 Participants |
| GSK134612A Form1 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Redness, Dose 2 | 7 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Swelling, Dose 2 | 7 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Redness, Dose 2 | 13 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Pain, Dose 2 | 10 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Redness, Dose 1 | 12 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Swelling, Dose 1 | 6 Participants |
| GSK134612A Form2 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Pain, Dose 1 | 8 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Pain, Dose 1 | 3 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Swelling, Dose 1 | 7 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Swelling, Dose 2 | 9 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Pain, Dose 2 | 6 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Redness, Dose 1 | 10 Participants |
| GSK134612A Form3 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Redness, Dose 2 | 9 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Redness, Dose 2 | 8 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Swelling, Dose 2 | 7 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Redness, Dose 1 | 9 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Swelling, Dose 1 | 6 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Pain, Dose 2 | 7 Participants |
| GSK134612A Form4 (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Pain, Dose 1 | 6 Participants |
| Control (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Swelling, Dose 2 | 3 Participants |
| Control (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Pain, Dose 1 | 4 Participants |
| Control (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Redness, Dose 1 | 11 Participants |
| Control (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Swelling, Dose 1 | 4 Participants |
| Control (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Pain, Dose 2 | 6 Participants |
| Control (T), Primary Group | Number of Toddlers With Any Solicited Local Symptoms | Redness, Dose 2 | 7 Participants |