Safety and immunogenicity of meningococcus C conjugate vaccine

Completed

Conditions: Meningococcus C disease
Infections and Infestations
Meningococcal infection

Registration Number: ISRCTN37262487

Lead Sponsor: Bio-Manguinhos/Fiocruz (Brazil)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

1. Healthy
2. Both sexes
3. Aged between 18 and 50 years
4. Capable of understanding and signing Free and Informed Consent Form
5. Intellectual level which permits filling out records of adverse events at home
6. Capable of understanding risks of the experiment
7. Willing test for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV)
8. Clinical examination without significant abnormalities
9. Laboratorial tests within normal range, or only with clinically non-significant alterations
10. Pre-vaccinal level of antibodies against tetanus below 5 IU/mL
11. Negative pregnancy test

Exclusion Criteria

1. Pregnancy or breastfeeding
2. Personal history of meningitis, any kind
3. Previous serious adverse event to any vaccination
4. Severe adverse event to tetanus toxoids
5. Vaccination against tetanus in the last 2 years
6. Anti-allergic vaccines 14 days or less before vaccination
7. Blood products in the last 12 months
8. Any vaccination 30 days or less before vaccination in test
9. Chronic use of any medication, except trivial ones
10. Previous use of cytotoxic or immunosuppressive therapy
11. Asthma which requires hospital care
12. Serious angioedema or anaphylaxis

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency/intensity of adverse events during 30 days after vaccination.

Secondary Outcome Measures

Name	Time	Method
1. Serological conversion, defined as prevaccinal sera non-reactive to meningococcus C, and post-immunisation sera reactive (titre greater than or equal to 8, reciprocal of dilution)<br>2. Titre of antibodies to meningococcus C after immunisation (intensity of immune response)<br>3. Measurement of antibodies just before and 30 days after vaccination