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Clinical trial phase I, randomized, double blind, where 30 individuals will receive the experimental vaccine while 30 other volunteers will receive a meningococcal C conjugate vaccine already licensed in Brazil and available in the National Immunization Program for children less than 12 months of age. The primary outcome of the study is to evaluate the safety profile of the vaccine under test, which should allow its application in humans. Secondly, the investigators will study its immunogenicity from the evaluation of the correlates of seroprotection for meningococcal, defined by the World Health Organization (WHO).
Study design - This is a clinical study Phase I, randomized, double blind with 60 individuals. 30 individuals will receive the experimental vaccine by Bio-Manguinhos/Fiocruz and 30 individuals will receive a meningococcal C conjugated vaccine used in the National Immunization Program.
Location of Study - Clinical Trials Unit for Immunobiology by Bio-Manguinhos/Fiocruz.
Primary objective - Evaluate the safety of the meningococcal C vaccine by Bio-Manguinhos/Fiocruz for use in humans.
Secondary objective - To evaluate the immunogenicity of the meningococcal C vaccine by Bio-Manguinhos in young adults.
specific objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MenCC-Bio | Experimental | The experimental group will receive one dose of meningococcal C vaccine adsorbed produced by Bio-Manguinhos. |
|
| MENJUGATE® | Active Comparator | The control group will receive one dose of meningococcal C vaccine adsorbed - MENJUGATE®. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 'MenCC-Bio' | Biological | The experimental group will receive one dose of meningococcal C vaccine adsorbed produced by Bio-Manguinhos. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety of the meningococcal C vaccine by Bio-Manguinhos/Fiocruz for use in humans. | To evaluate the frequency / intensity of adverse events occurring up to 30 days after vaccination. | Adverse events post vaccination will be evaluated on days 1,3, 10 and 15 by phone call and on days 2, 7 and 30 at the research center |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the immunogenicity of the meningococcal C vaccine by Bio-Manguinhos in young adults. | 30 days after vaccination, blood sampling will be conducted which composes for serological analysis of immunogenicity. | Blood collection 30 days after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
- Pregnant or breast-feeding.
Personal history of:
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| Name | Affiliation | Role |
|---|---|---|
| Tatiana Guimarães de Noronha, MsD | The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidade de Ensaios Clínicos para Imunobiológicos | Rio de Janeiro | Rio de janeiro/RJ | 21040-360 | Brazil |
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| MENJUGATE | Biological | The control group will receive one dose of meningococcal C vaccine adsorbed - MENJUGATE. |
|
| ID | Term |
|---|---|
| D008585 | Meningitis, Meningococcal |
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D008589 | Meningococcal Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
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