Immunogenicity and safety of a Meningococcus B Brazilian vaccine

ISRCTN ISRCTN15065741
DOI https://doi.org/10.1186/ISRCTN15065741
Secondary identifying numbers ASCLIN/01/2009
Submission date
05/03/2009
Registration date
27/03/2009
Last edited
27/03/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Reinaldo de Menezes Martins
Scientific

Av. Brasil 4365
Manguinhos
Rio de Janeiro
21040-900
Brazil

Study information

Study designRandomised open label four arm clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titlePhase II/III immunogenicity and safety clinical trial of a Meningococcus B Brazilian vaccine
Study acronymMenB-Bio
Study objectivesBio-Manguinhos meningococcus B vaccine (Men-B-Bio) is safe and immunogenic in children.
Ethics approval(s)National Ethics Committee approved on the 19th January 2009
Health condition(s) or problem(s) studiedMeningococcus B disease
InterventionRandomised 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Bio-Manguinhos meningococcus B vaccine (Men-B-Bio)
Primary outcome measureSeroconversion (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 measuresReactogenicity 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 study start date01/05/2009
Completion date31/12/2010

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit4 Years
Upper age limit12 Years
SexBoth
Target number of participants240
Key inclusion criteria1. Both sexes
2. Aged between 4 years and 12 years
3. Agreement with Free and Informed Consent Form
4. Healthy children
Key exclusion criteria1. 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
Date of first enrolment01/05/2009
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • Brazil

Study participating centre

Av. Brasil 4365
Rio de Janeiro
21040-900
Brazil

Sponsor information

Bio-Manguinhos/Fiocruz (Brazil)
Industry

c/o Akira Homma
Av. Brasil 4365
Manguinhos
Rio de Janeiro
21040-900
Brazil

Website http://www.bio.fiocruz.br
ROR logo "ROR" https://ror.org/05gj5j117

Funders

Funder type

Government

Brazilian Ministry of Science and Technology (MCT) (Brazil) - Financing Agency for Studies and Projects (Financiadora de Estudos e Projetos [FINEP])

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan