| 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. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. | Posted | | Count of Participants | | Participants | | One month after the last dose (at Month 4) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
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| hSBA-MenA | - ParticipantsOG000132
- ParticipantsOG001138
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| 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. | | | | | Percentage of subjects with hSBA titers | 88.4 | | | 2-Sided | 95 | 81.9 | 93.2 | | | Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 80%. | | Superiority | | |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | One month after the first dose (at Month 1) | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Count of Participants | | Participants | | At Month 1 (for GSK 134612 2 doses Group only) and Month 4 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | 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). | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 1 (for GSK 134612 2 doses Group only) and Month 4 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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). | Posted | | Count of Participants | | Participants | | At Month 1 (for GSK 134612 2 doses Group only) and Month 4 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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). | Posted | | Count of Participants | | Participants | | At Month 1 (GSK 134612 2 doses Group only) and Month 4 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | 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). | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 1 (GSK 134612 2 doses Group only) and Month 4 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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). | 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). | Posted | | Count of Participants | | Participants | | At Month 1 (GSK 134612 2 doses Group only) and Month 4 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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). | 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). | Posted | | Count of Participants | | Participants | | At Month 1 (GSK 134612 s doses Group only) and Month 4 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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). | 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). | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | At Month 1 (GSK 134612 2 doses Group only) and Month 4 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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). | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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). | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | | Count of Participants | | Participants | | Up to 1 month post-vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | | Count of Participants | | Participants | | Up to study end (Month 9) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Subjects With New Onset Chronic Ilnesses (NOCI) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | | Count of Participants | | Participants | | Up to study end (Month 9) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Subjects Reporting Rash | Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | | Count of Participants | | Participants | | Up to study end (Month 9) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | | Count of Participants | | Participants | | Up to study end (Month 9) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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