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Subjects were previously vaccinated at 11 to 17 years of age. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled.
Subjects were previously vaccinated at 11 to 17 months of age with GSK Biologicals' meningococcal vaccine 134612 or with Mencevax™. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new studies will be enrolled. The subjects will have 4 blood samples taken: at 24, 36, 48 and 60 months after vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Subjects who received GSK Biologicals' meningococcal vaccine 134612 in the primary vaccination study 109069. |
|
| Group B | Active Comparator | Subjects who received MencevaxTM ACWY in the primary vaccination study 109069. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Sampling | Procedure | A blood sample will be taken yearly at each long-term follow-up visit (i.e. Year 2 through Year 5) after vaccination during the primary study. No vaccines are administered in the long-term follow-up study |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups | A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the GSK Biologicals' laboratory. | At Month 24 post primary dose |
| Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups | A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory. | At Month 36 post primary dose |
| Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups | A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory. | At Month 48 post primary dose |
| Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups | A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups | A seropositive subject was defined as a subject who had the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:128. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Goā | 403202 | India | |||
| GSK Investigational Site |
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Out of the 697 subjects enrolled in this study, only 689 were vaccinated and hence started the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nimenrix™ Group | Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm. |
| FG001 | Mencevax™ Group | Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nimenrix™ Group | Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups | A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the GSK Biologicals' laboratory. | The analysis was performed on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen. | Posted | Number | Subjects | At Month 24 post primary dose |
|
Serious adverse events (SAEs): up to Month 24, 36, 48 and 60 post primary vaccination.
No information about unsolicited AEs was collected during this study as no product was administered.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nimenrix™ Group | Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm. |
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None reported.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| At Month 60 post primary dose |
| At Months 24, 36, 48 and 60 post primary dose |
| Antibody Titers Against the Vaccine Meningococcal Serogroups | Seropositivity status was defined as the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) titers equal to or above the cut-off value of 1:128. Antibody titers were presented as geometric mean titers (GMTs). The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory. | At Months 24, 36, 48 and 60 post primary dose |
| Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides | Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA). | At Month 24 post primary dose |
| Antibody Concentrations Against the Vaccine Polysaccharides | Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA). | At Month 24 post primary dose |
| Indore |
| 452001 |
| India |
| GSK Investigational Site | New Delhi | 110002 | India |
| GSK Investigational Site | Pune | 411 011 | India |
| GSK Investigational Site | City of Muntinlupa | 1781 | Philippines |
| Mencevax™ Group |
Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Mencevax™ Group | Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm. |
|
|
| Primary | Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups | A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory. | The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen. | Posted | Number | Subjects | At Month 36 post primary dose |
|
|
|
| Primary | Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups | A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory. | The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen. | Posted | Number | Subjects | At Month 48 post primary dose |
|
|
|
| Primary | Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups | A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory. | The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen. | Posted | Number | Subjects | At Month 60 post primary dose |
|
|
|
| Secondary | Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups | A seropositive subject was defined as a subject who had the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:128. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory. | The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen. | Posted | Number | Subjects | At Months 24, 36, 48 and 60 post primary dose |
|
|
|
| Secondary | Antibody Titers Against the Vaccine Meningococcal Serogroups | Seropositivity status was defined as the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) titers equal to or above the cut-off value of 1:128. Antibody titers were presented as geometric mean titers (GMTs). The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory. | The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Months 24, 36, 48 and 60 post primary dose |
|
|
|
| Secondary | Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides | Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA). | The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen. | Posted | Number | Subjects | At Month 24 post primary dose |
|
|
|
| Secondary | Antibody Concentrations Against the Vaccine Polysaccharides | Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA). | The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | At Month 24 post primary dose |
|
|
|
| 0 |
| 521 |
| 0 |
| 521 |
| EG001 | Mencevax™ Group | Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm. | 0 | 168 | 0 | 168 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D007239 | Infections |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| rSBA-MenW-135, PHE laboratory |
|
| rSBA-MenY, PHE laboratory |
|
| rSBA-MenW-135, PHE laboratory [N=390;130] |
|
| rSBA-MenY, PHE laboratory [N=389;130] |
|
| rSBA-MenW-135, PHE laboratory [N=236;86] |
|
| rSBA-MenY, PHE laboratory [N=236;86] |
|
| rSBA-MenA, M48, PHE laboratory [N=391;130] |
|
| rSBA-MenA, M60, PHE laboratory [N=236;86] |
|
| rSBA-MenC, M24, GSK laboratory [N=407;132] |
|
| rSBA-MenC, M36, PHE laboratory [N=449;150] |
|
| rSBA-MenC, M48, PHE laboratory [N=390;130] |
|
| rSBA-MenC, M60, PHE laboratory [N=236;85] |
|
| rSBA-MenW-135, M24, GSK laboratory [N=407;131] |
|
| rSBA-MenW-135, M36, PHE laboratory [N=449;150] |
|
| rSBA-MenW-135, M48, PHE laboratory [N=390;130] |
|
| rSBA-MenW-135, M60, PHE laboratory [N=236;86] |
|
| rSBA-MenY, M24, GSK laboratory [N=407;130] |
|
| rSBA-MenY, M36, PHE laboratory [N=449;150] |
|
| rSBA-MenY, M48, PHE laboratory [N=389;130] |
|
| rSBA-MenY, M60, PHE laboratory [N=236;86] |
|
| rSBA-MenA, M48, PHE laboratory [N=391;130] |
|
| rSBA-MenA, M60, PHE laboratory [N=236;86] |
|
| rSBA-MenC, M24, GSK laboratory [N=407;132] |
|
| rSBA-MenC, M36, PHE laboratory [N=449;150] |
|
| rSBA-MenC, M48, PHE laboratory [N=390;130] |
|
| rSBA-MenC, M60, PHE laboratory [N=236;85] |
|
| rSBA-MenW-135, M24, GSK laboratory [N=407;131] |
|
| rSBA-MenW-135, M36, PHE laboratory [N=449;150] |
|
| rSBA-MenW-135, M48, PHE laboratory [N=390;130] |
|
| rSBA-MenW-135, M60, PHE laboratory [N=236;86] |
|
| rSBA-MenY, M24, GSK laboratory [N=407;130] |
|
| rSBA-MenY, M36, PHE laboratory [N=449;150] |
|
| rSBA-MenY, M48, PHE laboratory [N=389;130] |
|
| rSBA-MenY, M60, PHE laboratory [N=236;86] |
|
| Anti-PSC ≥ 0.3 µg/mL, [N=192; 66] |
|
| Anti-PSC ≥ 2.0 µg/mL, [N=192; 66] |
|
| Anti-PSW-135 ≥ 0.3 µg/mL, [N=198; 62] |
|
| Anti-PSW-135 ≥ 2.0 µg/mL, [N=198; 62] |
|
| Anti-PSY ≥ 0.3 µg/mL, [N=208; 65] |
|
| Anti-PSY ≥ 2.0 µg/mL, [N=208; 65] |
|
| Anti-PSW-135 [N=198;62] |
|
| Anti-PSY [N=208;65] |
|