Brazilian Meningococcal B Vaccine: Safety and Immunogenicity Study
Completed
- Conditions
- Meningococcal disease serogroup BInfections and Infestations
- Registration Number
- ISRCTN75538667
- Lead Sponsor
- Bio-Manguinhos/Fiocruz (Brazil)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety 30 days after immunization
- Secondary Outcome Measures
Name Time Method Immunogenicity 30 days after immunization