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| ID | Type | Description | Link |
|---|---|---|---|
| 102252 | Other Identifier | GSK | |
| 102253 | Other Identifier | GSK | |
| 102254 | Other Identifier | GSK |
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The purpose of this study is to evaluate the safety, reactogenicity, immunogenicity and persistence up to three years after administration of one dose of the MenACWY conjugate vaccine when given to young adults aged 18-25 years.
Administration of the candidate vaccine or of the active control (Mencevaxâ„¢ ACWY) will be done in an open manner. The study consists of a vaccination phase during which subjects receive one vaccine dose (GSK's MenACWY conjugate vaccine or Mencevaxâ„¢ ACWY vaccine) and 3 years of follow-up. There are in total 7 visits to the doctor: before and 2, 7 and 30 days after vaccination (vaccination phase) as well as 12, 24 and 36 months after vaccination (follow-up phase). 7 blood samples are taken: one at each visit.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal (vaccine) | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of any grade 3 solicited symptoms within 8 days (day 0-7) following vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Sol (d 0-7, local&general), unsol (d 0-30) symptoms. SAEs. Routine blood & urine examination before, 2&7 d post vacc. % SBA-MenA C W Y responders 1m post vacc. Antibodies to MenA C W Y before, 1, 12, 24&36m post vacc & tetanus before, 1m post vacc |
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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 | Gosselies | 6041 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18834910 | Background | Ostergaard L, Lebacq E, Poolman J, Maechler G, Boutriau D. Immunogenicity, reactogenicity and persistence of meningococcal A, C, W-135 and Y-tetanus toxoid candidate conjugate (MenACWY-TT) vaccine formulations in adolescents aged 15-25 years. Vaccine. 2009 Jan 1;27(1):161-8. doi: 10.1016/j.vaccine.2008.08.075. Epub 2008 Oct 1. |
| 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 |
|---|---|---|---|
| 134612/003 | Dataset Specification | 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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| ID | Term |
|---|---|
| D022401 | Meningococcal Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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For additional information about this study please refer to the GSK Clinical Study Register |
| 134612/003 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 134612/003 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 134612/003 are summarised with studies 102252, 102253, and 102254 on the GSK Clinical Study Register. |
| 134612/003 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 134612/003 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 134612/003 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D007239 | Infections |