Condition category
Infections and Infestations
Date applied
05/03/2009
Date assigned
27/03/2009
Last edited
27/03/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Reinaldo de Menezes Martins

ORCID ID

Contact details

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

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 measures

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

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

http://www.bio.fiocruz.br

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes