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The purpose of this study is to evaluate that the vaccine produced with the new process and administered as a single dose is at least as good as the existing Mencevaxâ„¢ ACWY vaccine in terms of immunogenicity, safety and reactogenicity, in healthy subjects aged 2-30 years.
"Randomized study with four groups to receive one of the following vaccination regimens: - One of the 3 lots of GSK Biologicals' Mencevaxâ„¢ ACWY vaccine manufactured by the new process (3 different groups) - GSK Biologicals' already existing Mencevaxâ„¢ ACWY
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mencevax ACWY | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| 1 month after vaccination, measurement of serum bactericidal titers against meningococcal serogroups A, C, W135 and Y (SBA-MenA; SBA-MenC; SBA-MenW135 and SBA-MenY) |
| Measure | Description | Time Frame |
|---|---|---|
| Immuno : the same immuno evaluation performed 1 month after vaccination will also be performed before vaccination; also vaccine response at Post-dose 1. | ||
| Safety : Solicited symptoms during day 0-3, unsol. symptoms during day 0-30 & SAEs during entire study. |
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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 | Beirut | 1107-2020 | Lebanon |
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| 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 |
|---|---|---|---|
| 102394 | Informed Consent Form | 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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For additional information about this study please refer to the GSK Clinical Study Register |
| 102394 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102394 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102394 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102394 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102394 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000610192 | PsACWY vaccine |
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