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The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of 3 doses of the meningococcal serogroup B vaccine when given, using either a 0-2-4 month or a 0-1-6 month schedule, to healthy adolescents aged 12-18 years; a control group will receive 2 doses of Havrixâ„¢ (0-6 months) and Meningitecâ„¢ (month 1).
The study is open; however, vaccines given to study group at 0-1-6 months and to control group will be administered in an observer-blind manner. 3 blood samplings for antibody testing: before vaccination and one month after the second and third vaccine doses.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal serogroup B vaccine | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Meningococcal serogroup B (MenB) immune response (i.e. at least a 4-fold increase in serum bactericidal activity [SBA] from pre-vaccination titer) at 1 month postvaccination for each MenB strain assayed |
| Measure | Description | Time Frame |
|---|---|---|
| For each MenB strain assayed, pre and 1m post dose 2 and 3: SBA seropositivity, titer and immune response (post dose 2 only) | ||
| After each vaccination: grade 3 and any solicited symptoms (Day 0-14), unsolicited symptoms (Day 0-30) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17065257 | Derived | Boutriau D, Poolman J, Borrow R, Findlow J, Domingo JD, Puig-Barbera J, Baldo JM, Planelles V, Jubert A, Colomer J, Gil A, Levie K, Kervyn AD, Weynants V, Dominguez F, Barbera R, Sotolongo F. Immunogenicity and safety of three doses of a bivalent (B:4:p1.19,15 and B:4:p1.7-2,4) meningococcal outer membrane vesicle vaccine in healthy adolescents. Clin Vaccine Immunol. 2007 Jan;14(1):65-73. doi: 10.1128/CVI.00230-06. Epub 2006 Oct 25. |
| 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 |
|---|---|---|---|
| 710158/002 | Individual Participant Data Set | 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 |
|---|---|
| C570015 | 4CMenB vaccine |
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| Serious adverse events [SAEs] (whole study) |
For additional information about this study please refer to the GSK Clinical Study Register |
| 710158/002 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 710158/002 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 710158/002 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 710158/002 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D007239 | Infections |