Infections, Meningococcal
Conditions
Keywords
Neisseria meningitidis;, Humans;, Meningococcal vaccines;, Safety, Vaccines, conjugate;, Toddlers;, Immunogenicity;
Brief summary
The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK134612 vaccine at 12 months of age and of GSK134612 vaccine administered as 2 doses at 9 and 12 months of age.
Detailed description
The protocol posting has been amended to reflect changes as a consequence of an amendment to the protocol and also to comply with the FDA amendment Act, Sep 2007. Sections impacted are Brief Title, Official Title of the study, Brief Summary, Key Inclusion & Exclusion criteria.
Interventions
BIOLOGICALMeningococcal vaccine GSK134612
One or 2 intramuscular injections.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Months to 9 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol * A male or female of 9 months of age (has not attained 10 months of age) at the time of enrollment. * Up to date on vaccinations based on ACIP recommendations and the standard practice at the investigational site. * Written informed consent obtained from parents/guardian of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding enrollment, 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 vaccine dose. * Planned administration/ administration of a vaccine not foreseen by the study protocol within 1 month of a dose of study vaccine(s), with the exception of influenza vaccine. * Planned administration of a tetanus toxoid (TT) containing vaccine throughout the active phase of the study (through one month after the last vaccination). * Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C W and/or Y. * History of meningococcal diseases. * Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing is required). * A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. * History of reactions or allergic disease 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 enrollment. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the active phase of the study (through one month after the last dose of study vaccine).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | One month after the last dose (at Month 4) | The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | At Month 1 (for GSK 134612 2 doses Group only) and Month 4 | Antibody titers were presented as geometric mean titers (GMTs). |
| Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | At Month 1 (for GSK 134612 2 doses Group only) and Month 4 | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. |
| Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value | At Month 1 (GSK 134612 2 doses Group only) and Month 4 | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128. |
| rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | At Month 1 (GSK 134612 2 doses Group only) and Month 4 | Antibody titers were presented as geometric mean titers (GMTs). |
| Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | At Month 1 (GSK 134612 2 doses Group only) and Month 4 | The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL). |
| Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value | At Month 1 (GSK 134612 s doses Group only) and Month 4 | The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 2.0 micrograms per milliliter (μg/mL). |
| Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations | At Month 1 (GSK 134612 2 doses Group only) and Month 4 | Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). |
| Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | One month after the first dose (at Month 1) | The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination | Assessed solicited general symptoms were drowsiness, fever \[defined as axillary, oral, tympanic or rectal temperature equal to or above (≥) 38 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (\>) 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | Up to 1 month post-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) | Up to study end (Month 9) | 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 New Onset Chronic Ilnesses (NOCI) | Up to study end (Month 9) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. |
| Number of Subjects Reporting Rash | Up to study end (Month 9) | Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae. |
| Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | Up to study end (Month 9) | Among AEs prompting emergency room visits were: infections, injuries, skin diseases and respiratory diseases. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. |
Countries
United States
Participant flow
Recruitment details
A total of 196 subjects were enrolled and randomized in the GSK 134612 1 dose Group at the study start but 36 subjects were not vaccinated, due to the 3-month period between enrollment and vaccination.
Pre-assignment details
The majority of subjects withdrawn in the active Phase were still contacted for the safety follow-up, therefore the subjects listed as withdrawn were not necessarily the same individuals in the two phases (Active Phase and Extended Safety Follow-Up).
Participants by arm
| Arm | Count |
|---|---|
| GSK 134612 1 Dose Group Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh. | 160 |
| GSK 134612 2 Doses Group Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh. | 189 |
| Total | 349 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Active Phase | Lost health plan/insurance | 1 | 8 |
| Active Phase | Lost to Follow-up | 0 | 1 |
| Active Phase | Protocol Violation | 1 | 1 |
| Active Phase | Withdrawal by Subject | 0 | 3 |
| Extended Safety Follow-Up | Lost to Follow-up | 1 | 8 |
| Extended Safety Follow-Up | Missing confirmed | 0 | 1 |
| Extended Safety Follow-Up | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | GSK 134612 1 Dose Group | GSK 134612 2 Doses Group | Total |
|---|---|---|---|
| Age, Continuous | 9 Months STANDARD_DEVIATION 0.08 | 9 Months STANDARD_DEVIATION 0 | 9 Months STANDARD_DEVIATION 0.05 |
| Sex: Female, Male Female | 77 Participants | 101 Participants | 178 Participants |
| Sex: Female, Male Male | 83 Participants | 88 Participants | 171 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 160 | 0 / 189 |
| other Total, other adverse events | 124 / 160 | 172 / 189 |
| serious Total, serious adverse events | 5 / 160 | 2 / 189 |
Outcome results
Primary
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
Time frame: One month after the last dose (at Month 4)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK 134612 1 Dose Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA | 105 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC | 123 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 | 60 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY | 74 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY | 145 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA | 122 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 | 142 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC | 137 Participants |
Comparison: To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup A.95% CI: [81.9, 93.2]
Comparison: To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup C.95% CI: [97.3, 100]
Comparison: To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup W-135.95% CI: [96.2, 100]
Comparison: To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup Y.95% CI: [96.2, 100]
Secondary
Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Time frame: At Month 1 (GSK 134612 2 doses Group only) and Month 4
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK 134612 1 Dose Group | Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations | Anti-PSA, Month 4 | 35.92 μg/mL |
| GSK 134612 1 Dose Group | Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations | Anti-PSC, Month 4 | 10.91 μg/mL |
| GSK 134612 1 Dose Group | Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations | Anti-PSY, Month 4 | 8.19 μg/mL |
| GSK 134612 1 Dose Group | Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations | Anti-PSW-135, Month 4 | 7.37 μg/mL |
| GSK 134612 2 Doses Group | Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations | Anti-PSW-135, Month 1 | 4.42 μg/mL |
| GSK 134612 2 Doses Group | Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations | Anti-PSW-135, Month 4 | 13.47 μg/mL |
| GSK 134612 2 Doses Group | Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations | Anti-PSY, Month 1 | 3.40 μg/mL |
| GSK 134612 2 Doses Group | Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations | Anti-PSA, Month 1 | 12.39 μg/mL |
| GSK 134612 2 Doses Group | Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations | Anti-PSY, Month 4 | 12.43 μg/mL |
| GSK 134612 2 Doses Group | Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations | Anti-PSA, Month 4 | 5.59 μg/mL |
| GSK 134612 2 Doses Group | Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations | Anti-PSC, Month 1 | 8.15 μg/mL |
| GSK 134612 2 Doses Group | Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations | Anti-PSC, Month 4 | 3.42 μg/mL |
Secondary
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: At Month 1 (for GSK 134612 2 doses Group only) and Month 4
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK 134612 1 Dose Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenC, Month 4 | 161.5 Titers |
| GSK 134612 1 Dose Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenW-135, Month 4 | 11.6 Titers |
| GSK 134612 1 Dose Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenY, Month 4 | 15.7 Titers |
| GSK 134612 1 Dose Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenA, Month 4 | 24.9 Titers |
| GSK 134612 2 Doses Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenC, Month 4 | 1105.5 Titers |
| GSK 134612 2 Doses Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenW-135, Month 1 | 3.5 Titers |
| GSK 134612 2 Doses Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenW-135, Month 4 | 1062.9 Titers |
| GSK 134612 2 Doses Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenY, Month 1 | 7.0 Titers |
| GSK 134612 2 Doses Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenY, Month 4 | 475.2 Titers |
| GSK 134612 2 Doses Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenA, Month 4 | 50.8 Titers |
| GSK 134612 2 Doses Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenC, Month 1 | 83.7 Titers |
| GSK 134612 2 Doses Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenA, Month 1 | 13.6 Titers |
Secondary
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
Among AEs prompting emergency room visits were: infections, injuries, skin diseases and respiratory diseases.
Time frame: Up to study end (Month 9)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK 134612 1 Dose Group | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | 17 Participants |
| GSK 134612 2 Doses Group | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | 32 Participants |
Secondary
Number of Subjects Reporting Rash
Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae.
Time frame: Up to study end (Month 9)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK 134612 1 Dose Group | Number of Subjects Reporting Rash | 16 Participants |
| GSK 134612 2 Doses Group | Number of Subjects Reporting Rash | 61 Participants |
Secondary
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value
The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).
Time frame: At Month 1 (GSK 134612 2 doses Group only) and Month 4
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK 134612 1 Dose Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA, Month 4 | 26 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC, Month 4 | 60 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY, Month 4 | 36 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135, Month 4 | 30 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135, Month 1 | 31 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135, Month 4 | 54 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY, Month 1 | 25 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA, Month 1 | 35 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY, Month 4 | 46 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA, Month 4 | 29 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC, Month 1 | 66 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC, Month 4 | 56 Participants |
Secondary
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value
The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 2.0 micrograms per milliliter (μg/mL).
Time frame: At Month 1 (GSK 134612 s doses Group only) and Month 4
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK 134612 1 Dose Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA, Month 4 | 26 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC, Month 4 | 59 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY, Month 4 | 33 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135, Month 4 | 29 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135, Month 1 | 26 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135, Month 4 | 53 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY, Month 1 | 16 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA, Month 1 | 35 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY, Month 4 | 46 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA, Month 4 | 27 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC, Month 1 | 65 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC, Month 4 | 40 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Time frame: During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in and for whom data were available. Post-Dose 2 data are not available for the GSK 134612 1 dose Group (received a single vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK 134612 1 Dose Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1, Days 0-3 | 28 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1, Days 0-7 | 0 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1, Days 0-7 | 0 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1, Days 0-7 | 28 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1, Days 0-7 | 13 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1, Days 0-3 | 0 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1, Days 0-7 | 1 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1, Days 0-3 | 0 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1, Days 0-3 | 13 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1, Days 0-3 | 34 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1, Days 0-3 | 1 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1, Days 0-7 | 35 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2, Days 0-3 | 37 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2, Days 0-3 | 0 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2, Days 0-3 | 19 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2, Days 0-3 | 0 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1, Days 0-7 | 54 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1, Days 0-7 | 0 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1, Days 0-7 | 27 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2, Days 0-7 | 1 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2, Days 0-7 | 37 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2, Days 0-7 | 0 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2, Days 0-7 | 19 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1, Days 0-7 | 49 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2, Days 0-7 | 0 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1, Days 0-7 | 1 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1, Days 0-7 | 1 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2, Days 0-7 | 42 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1, Days 0-3 | 54 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1, Days 0-3 | 0 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1, Days 0-3 | 49 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1, Days 0-3 | 1 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1, Days 0-3 | 27 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1, Days 0-3 | 1 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2, Days 0-3 | 42 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2, Days 0-3 | 1 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever \[defined as axillary, oral, tympanic or rectal temperature equal to or above (≥) 38 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (\>) 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in and for whom data were available. Post-Dose 2 data are not available for the GSK 134612 1 dose Group (received a single vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1, Days 0-7 | 0 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1, Days 0-3 | 12 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1, Days 0-7 | 7 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1, Days 0-3 | 2 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1, Days 0-7 | 69 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1, Days 0-3 | 42 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1, Days 0-7 | 4 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1, Days 0-3 | 48 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1, Days 0-7 | 48 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1, Days 0-3 | 0 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1, Days 0-7 | 42 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1, Days 0-3 | 34 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1, Days 0-7 | 2 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1, Days 0-3 | 1 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1, Days 0-7 | 22 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1, Days 0-3 | 32 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1, Days 0-7 | 52 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1, Days 0-3 | 19 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1, Days 0-7 | 2 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1, Days 0-3 | 7 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1, Days 0-7 | 37 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1, Days 0-3 | 1 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1, Days 0-7 | 17 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1, Days 0-3 | 63 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2, Days 0-3 | 77 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2, Days 0-3 | 46 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2, Days 0-3 | 0 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2, Days 0-3 | 32 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1, Days 0-7 | 70 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1, Days 0-7 | 0 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1, Days 0-7 | 53 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1, Days 0-7 | 6 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1, Days 0-7 | 0 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1, Days 0-7 | 1 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1, Days 0-7 | 103 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1, Days 0-7 | 5 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1, Days 0-7 | 87 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1, Days 0-7 | 48 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1, Days 0-7 | 2 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1, Days 0-7 | 33 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2, Days 0-7 | 39 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2, Days 0-7 | 16 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2, Days 0-7 | 0 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2, Days 0-7 | 5 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2, Days 0-7 | 84 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2, Days 0-7 | 51 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2, Days 0-7 | 1 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1, Days 0-3 | 42 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2, Days 0-7 | 32 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2, Days 0-3 | 3 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2, Days 0-3 | 59 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2, Days 0-7 | 52 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2, Days 0-7 | 0 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2, Days 0-7 | 5 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2, Days 0-7 | 62 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1, Days 0-3 | 63 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1, Days 0-3 | 0 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1, Days 0-3 | 51 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1, Days 0-3 | 4 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1, Days 0-3 | 0 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1, Days 0-3 | 1 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1, Days 0-3 | 101 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1, Days 0-3 | 4 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1, Days 0-3 | 87 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1, Days 0-3 | 1 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1, Days 0-3 | 31 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2, Days 0-3 | 47 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2, Days 0-3 | 0 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2, Days 0-3 | 36 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2, Days 0-3 | 11 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2, Days 0-3 | 0 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2, Days 0-3 | 4 Participants |
Secondary
Number of Subjects With Any Unsolicited Adverse Events (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: Up to 1 month post-vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK 134612 1 Dose Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 87 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 140 Participants |
Secondary
Number of Subjects With New Onset Chronic Ilnesses (NOCI)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: Up to study end (Month 9)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK 134612 1 Dose Group | Number of Subjects With New Onset Chronic Ilnesses (NOCI) | 19 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With New Onset Chronic Ilnesses (NOCI) | 38 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: Up to study end (Month 9)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK 134612 1 Dose Group | Number of Subjects With Serious Adverse Events (SAEs) | 5 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Participants |
Secondary
Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
Time frame: One month after the first dose (at Month 1)
Population: This analysis was performed on subjects who have received the Month 0 vaccination in the GSK 134612 2 doses Group from the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK 134612 1 Dose Group | Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC | 115 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 | 22 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY | 49 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA | 81 Participants |
Secondary
Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Time frame: At Month 1 (for GSK 134612 2 doses Group only) and Month 4
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK 134612 1 Dose Group | Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135, Month 4 | 63 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC, Month 4 | 123 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY, Month 4 | 79 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA, Month 4 | 115 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA, Month 1 | 90 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135, Month 4 | 142 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY, Month 1 | 52 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA, Month 4 | 122 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY, Month 4 | 145 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC, Month 1 | 115 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC, Month 4 | 137 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135, Month 1 | 24 Participants |
Secondary
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.
Time frame: At Month 1 (for GSK 134612 2 doses Group only) and Month 4
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK 134612 1 Dose Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC, Month 4 | 51 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135, Month 4 | 51 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY, Month 4 | 50 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA, Month 4 | 51 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA, Month 4 | 47 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC, Month 1 | 42 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC, Month 4 | 51 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135, Month 1 | 43 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY, Month 4 | 50 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135, Month 4 | 50 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY, Month 1 | 42 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA, Month 1 | 41 Participants |
Secondary
Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128.
Time frame: At Month 1 (GSK 134612 2 doses Group only) and Month 4
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK 134612 1 Dose Group | Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA, Month 4 | 50 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC, Month 4 | 44 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY, Month 4 | 49 Participants |
| GSK 134612 1 Dose Group | Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135, Month 4 | 51 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135, Month 1 | 43 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135, Month 4 | 50 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY, Month 1 | 42 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA, Month 1 | 41 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY, Month 4 | 50 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA, Month 4 | 47 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC, Month 1 | 35 Participants |
| GSK 134612 2 Doses Group | Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC, Month 4 | 50 Participants |
Secondary
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: At Month 1 (GSK 134612 2 doses Group only) and Month 4
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK 134612 1 Dose Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenA, Month 4 | 1911.5 Titers |
| GSK 134612 1 Dose Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenC, Month 4 | 456.3 Titers |
| GSK 134612 1 Dose Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenY, Month 4 | 1521.0 Titers |
| GSK 134612 1 Dose Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenW-135, Month 4 | 3069.9 Titers |
| GSK 134612 2 Doses Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenW-135, Month 1 | 1412.3 Titers |
| GSK 134612 2 Doses Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenW-135, Month 4 | 1771.6 Titers |
| GSK 134612 2 Doses Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenY, Month 1 | 817.1 Titers |
| GSK 134612 2 Doses Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenA, Month 1 | 1092.6 Titers |
| GSK 134612 2 Doses Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenY, Month 4 | 1125.9 Titers |
| GSK 134612 2 Doses Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenA, Month 4 | 1179.1 Titers |
| GSK 134612 2 Doses Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenC, Month 1 | 229.3 Titers |
| GSK 134612 2 Doses Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenC, Month 4 | 1484.4 Titers |