Brazilian Meningococcal B Vaccine: Safety and Immunogenicity Study
| ISRCTN | ISRCTN75538667 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75538667 |
| Protocol serial number | 0047.0.009.000-05 |
| Sponsor | Bio-Manguinhos/Fiocruz (Brazil) |
| Funder | Bio-Manguinhos/Fiocruz |
- Submission date
- 17/02/2006
- Registration date
- 16/03/2006
- Last edited
- 17/03/2006
- 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 Andre Perisse
Scientific
Scientific
Av. Brasil 4365
Rio de Janeiro
21040-900
Brazil
| Phone | +55 21 3882 9479 |
|---|---|
| areynaldo@bio.fiocruz.br |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open, phase 1 trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Vaccine adverse events occur in acceptable levels for human use |
| Ethics approval(s) | Approved by the Committee of Evandro Chagas Clinical Research Institute on 28/02/2005, reference number: CAAE-0047.0.009.000-05 |
| Health condition(s) or problem(s) studied | Meningococcal disease serogroup B |
| Intervention | 1. Three doses of three different concentrations of Brazilian meningococcal B vaccine 2. Blood, urine, faeces specimens 3. Electrocardiogram (ECG), x-ray |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Vaccine for meningococcal B disease |
| Primary outcome measure(s) |
Safety 30 days after immunization |
| Key secondary outcome measure(s) |
Immunogenicity 30 days after immunization |
| Completion date | 30/12/2006 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 44 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. 18-44 years of age 2. Willingness to comply with protocol requirements 3. Healthy volunteers 4. Ability to understand informed consent form 5. Human Immunodeficiency Virus (HIV) negative 5. Non-pregnant |
| Key exclusion criteria | 1. Nursing women 2. Use of different substances in the previous 14-60 days such as immunosuppressive therapy and other vaccines 3. Prior history of serious adverse event to vaccines 4. Prior history of chronic diseases such as hypertension and diabetes 5. Autoimmune diseases 6. Alcohol and drug abuse |
| Date of first enrolment | 02/01/2006 |
| Date of final enrolment | 30/12/2006 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Av. Brasil 4365
Rio de Janeiro
21040-900
Brazil
21040-900
Brazil
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
