Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ASCLIN/01/2009
Study information
Scientific title
Phase II/III immunogenicity and safety clinical trial of a Meningococcus B Brazilian vaccine
Acronym
MenB-Bio
Study hypothesis
Bio-Manguinhos meningococcus B vaccine (Men-B-Bio) is safe and immunogenic in children.
Ethics approval
National Ethics Committee approved on the 19th January 2009
Study design
Randomised open label four arm clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Meningococcus B disease
Intervention
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 best dose for the Brazilian vaccine.
Total duration: 20 months
Total duration of follow up: 20 months
Blood samples: before 1st dose, before 3rd dose and 1 month after 3rd dose
The second (25 µg) and third (50 µg) concentration groups will start after completion of the first concentration (12.5 µg) evaluation, hence the extension of the study to 20 months of follow up.
Intervention type
Drug
Phase
Not Applicable
Drug names
Bio-Manguinhos meningococcus B vaccine (Men-B-Bio)
Primary outcome measure
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 outcome measures
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.
Overall trial start date
01/05/2009
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Both sexes
2. Aged between 4 years and 12 years
3. Agreement with Free and Informed Consent Form
4. Healthy children
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
240
Participant 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
Recruitment start date
01/05/2009
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Brazil
Trial participating centre
Av. Brasil 4365
Rio de Janeiro
21040-900
Brazil
Sponsor information
Organisation
Bio-Manguinhos/Fiocruz (Brazil)
Sponsor details
c/o Akira Homma
Av. Brasil 4365
Manguinhos
Rio de Janeiro
21040-900
Brazil
Sponsor type
Industry
Website
Funders
Funder type
Government
Funder name
Brazilian Ministry of Science and Technology (MCT) (Brazil) - Financing Agency for Studies and Projects (Financiadora de Estudos e Projetos [FINEP])
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list