Safety and immunogenicity of meningococcus C conjugate vaccine

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2008
INTERVENTION: 1. 30 volunteers will receive meningococcus C vaccine conjugate to tetanus toxoid from Bio‐Manguinhos, single 0.5 ml dose (10 µg) IM (intramuscularly) 2. 30 volunteers will receive a similar commercial vaccine (reference vaccine), same dose and schedule CONDITION: Meningococcus C disease ; Infections and Infestations ; Meningococcal infection PRIMARY OUTCOME: Frequency/intensity of adverse events during 30 days after vaccination. SECONDARY OUTCOME: 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); 2. Titre of antibodies to meningococcus C after immunisation (intensity of immune response); 3. Measurement of antibodies just before and 30 days after vaccination 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
Epistemonikos ID: 79eaddf6e81d058881b29dc6a7e9c2cb3f8c82bb
First added on: Aug 21, 2024