Brazilian Meningococcal B Vaccine: Safety and Immunogenicity Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN75538667

Enrollment

Registered

2006-03-16

Start date

2006-01-02

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningococcal disease serogroup B Infections and Infestations Meningococcal disease serogroup B

Interventions

1. Three doses of three different concentrations of Brazilian meningococcal B vaccine 2. Blood, urine, faeces specimens 3. Electrocardiogram (ECG), x-ray

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Safety 30 days after immunization	—

Secondary

Measure	Time frame
Immunogenicity 30 days after immunization	—

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026