Meningococcus B disease Infections and Infestations Meningococcal infection
Conditions
Interventions
Randomised open-label study with four arms:
1. Men-B-Bio 12.5 µg
2. Men-B-Bio 25 µg
3. Men-B-Bio 50 µg
4. Similar Cuban vaccine (reference vaccine)
At the end of the study we expect to choose the be
Sponsors
Bio-Manguinhos/Fiocruz (Brazil)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both sexes 2. Aged between 4 years and 12 years 3. Agreement with Free and Informed Consent Form 4. Healthy children
Exclusion criteria
Exclusion criteria: 1. Personal history of meningitis or meningococcus B vaccine 2. Immunosupression 3. Use of blood products in the last 12 months 4. Use of penicillin in the last 30 days 5. Personal history of serious adverse event to any vaccination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroconversion (bactericidal titre from seronegative to greater than or equal to 1/4 or four-fold increase in titre). Timepoints at the point of blood collection; before 1st dose, before 3rd dose and 1 month after 3rd dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reactogenicity similar to the reference vaccine, measured 1 month of follow up after each dose for solicited events and for the entire study duration for all other events. | — |
Countries
Brazil
Outcome results
None listed