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
Scientific
Av. Brasil 4365
Manguinhos
Rio de Janeiro
21040-900
Brazil
Study information
| Study design | Randomised open label four arm clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Phase II/III immunogenicity and safety clinical trial of a Meningococcus B Brazilian vaccine |
| Study acronym | MenB-Bio |
| Study objectives | Bio-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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/05/2009 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 240 |
| Key inclusion criteria | 1. Both sexes 2. Aged between 4 years and 12 years 3. Agreement with Free and Informed Consent Form 4. Healthy children |
| Key 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 |
| Date of first enrolment | 01/05/2009 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Av. Brasil 4365
Rio de Janeiro
21040-900
Brazil
21040-900
Brazil
Sponsor information
Bio-Manguinhos/Fiocruz (Brazil)
Industry
Industry
c/o Akira Homma
Av. Brasil 4365
Manguinhos
Rio de Janeiro
21040-900
Brazil
| Website | http://www.bio.fiocruz.br |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
