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| ID | Type | Description | Link |
|---|---|---|---|
| 108596 | Other Identifier | GSK | |
| 108598 | Other Identifier | GSK |
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This study will investigate the long-term protection offered by GSK Biologicals' meningococcal vaccine 134612 up to 3.5 years after vaccination. Subjects were vaccinated at 15 to 19 years of age. This extension phase starts 18 months after vaccination and part of the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled. This protocol posting deals with objectives & outcome measures of the extension phase 18, 30 and 42 months after vaccination. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00126945). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
Subjects were previously vaccinated at 15 to 19 years of age with GSK Biologicals' meningococcal vaccine 134612 or with Mencevax™ ACWY. This extension phase starts 18 months after vaccination and part of the subjects will be enrolled in this extension phase. No additional vaccines will be administered during this study and no new subjects will be enrolled. The subjects will have three blood samples taken: at 18, 30 and 42 months after vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Subjects previously primed with meningococcal vaccine 134612. |
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| Group B | Active Comparator | Subjects previously primed with Mencevax™ ACWY. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal vaccine 134612 | Biological | One intramuscular dose during the primary study |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Meningococcal rSBA titres. | At the start of this persistence study and 12 and 24 months later. | |
| Anti-meningococcal polysaccharide concentrations | At the start of this persistence study and 12 and 24 months later. | |
| Occurrence of serious adverse events related to vaccination, adverse events related to lack of vaccine efficacy or study participation. | From the last study contact of the primary vaccination study to the end of this persistence study. |
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Inclusion Criteria:
Exclusion Criteria:
• Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since the last visit of the primary vaccination study.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Aarhus N | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23246368 | Background | Ostergaard L, Van der Wielen M, Bianco V, Miller JM. Persistence of antibodies for 42 months following vaccination of adolescents with a meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine (MenACWY-TT). Int J Infect Dis. 2013 Mar;17(3):e173-6. doi: 10.1016/j.ijid.2012.10.001. Epub 2012 Dec 13. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 108595 Mth18 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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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| Mencevax™ ACWY |
| Biological |
One subcutaneous dose during the primary study |
|
For additional information about this study please refer to the GSK Clinical Study Register |
| 108595 Mth18 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108595 Mth18 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108595 Mth18 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108595 Mth18 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108595 Mth18 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D007239 | Infections |