Safety and immunogenicity of meningococcus C conjugate vaccine

Safety and immunogenicity of conjugate vaccine for meningococcal C disease: a randomised study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN37262487

Enrollment

Registered

2008-12-10

Start date

2009-01-01

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

Meningococcus C disease Infections and Infestations Meningococcal infection

Interventions

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 commercia

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Frequency/intensity of adverse events during 30 days after vaccination.	—

Secondary

Measure	Time frame
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	—

Countries

Brazil

Outcome results

None listed

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