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The purpose of this phase 2 study is to evaluate the safety, tolerability and immunogenicity of two doses of 4 different investigational MenABCWY combination vaccine when administered to healthy adolescents aged 11-18 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I: Investigational MenABCWY Formulation 1 | Experimental |
| |
| Group II: Investigational MenABCWY Formulation 2 | Experimental |
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| Group III: Investigational MenABCWY Formulation 3 | Experimental |
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| Group IV: Investigational MenABCWY Formulation 4 | Experimental |
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| Group V: Active comparator investigational MenB | Active Comparator |
| |
| Group VI: Active comparator MenACWY | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal Vaccine | Biological | MenABCWY combination vaccine containing four different rMenB formulations with MenACWY, intramuscular (IM) administration, vaccination at 0 and 2 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs) | 3 months | |
| Percentage of subjects with seroresponse, and human Serum Bactericidal Activity (hSBA) titer ≥ 1:8 and hSBA titer ≥ 1:4 to Neisseria meningitidis serogroups A, C, W-135 and Y | 3 months | |
| Percentage of subjects with hSBA titer ≥ 1:5 to N. meningitidis serogroup B strains | 3 months | |
| Number of participants with solicited local and systemic reactions | within 7 days after each vaccination | |
| Number of participants with any adverse events (AEs) | 6 months | |
| Number of participants with Serious Adverse Events (SAEs) | 3 months |
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Inclusion Criteria:
Individuals eligible to be enrolled into this study are male and female subjects:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CESFAM Gabriela Mistral | Santiago | Chile | ||||
| Liceo Carmela Carvajal de Prat |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25969894 | Derived | Saez-Llorens X, Aguilera Vaca DC, Abarca K, Maho E, Grana MG, Heijnen E, Smolenov I, Dull PM. Immunogenicity and safety of investigational vaccine formulations against meningococcal serogroups A, B, C, W, and Y in healthy adolescents. Hum Vaccin Immunother. 2015;11(6):1507-17. doi: 10.1080/21645515.2015.1029686. |
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| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| D008585 | Meningitis, Meningococcal |
| 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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| Santiago |
| Chile |
| Pontificia Universidad Católica de Chile | Santiago | Chile |
| CafeSalud M P (Dir. de Investigación y Proyectos Especiales) | Bogotá | Colombia |
| Centro de Atencion e Investigacion Medica - CAIMED | Bogotá | Colombia |
| Centro de Investigaciones CAFAM | Bogotá | Colombia |
| Health Research International | Panama City | Panama |
| Indicasat | Panama City | Panama |
| D007239 | Infections |
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |