Meningitis C Infections and Infestations Meningitis
Conditions
Interventions
The vaccine under test and the product used by the control group are intramuscular (deltoid muscle of the left arm) at a dose of 0.5 ml in a single application, in accordance with the standards of the
Sponsors
The Immunobiological Technology Institute (Bio-Manguinhos) (Brazil)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have 12 months of age less than 10 years and have not yet been vaccinated against meningitis C or B (Va-Mengoc.BC®) 2. Be accompanied by a parent or other custodian to confirm the ability and willingness to return to the clinic on the dates for the second and third visits 3. Be accompanied by a parent or other legal guardian who can provide the information necessary for the research team contact during follow-up 4. Be accompanied by a parent or other responsible person legally qualified to give informed consent to participate 5. Be users or siblings of children enrolled, in the health unit for routine immunisation or other medical care 6. Keep up with routine vaccines officially recommended for the first year of life in Brazil, except meningitis C vaccine and any type of flu shot within the 28 days preceding the vaccination study 7. Having good health, according to medical history, physical examination (documented as FRC) and review of the research team 8. Are not participating in any other clinical study
Exclusion criteria
Exclusion criteria: Not to be included, children whose legal guardians: 1. Cannot or do not wish to give their informed consent to participate 2. Cannot be contacted by phone (the phone itself or the house or neighbour) by the research team for monitoring adverse events and/or in the event of non-attendance at the second and third visits 3. Unable to complete the log of adverse events, measure and record the child's temperature, measure the largest diameter of any adverse reactions at the injection site, or read and understand instructions or have other difficulties, according to the research team, justify the exclusion from the study 4. Are participating in another clinical study Also not included are children who: 5. Have received another vaccine injections 30 days before the day of vaccination study or shall take such vaccines within 30 days after vaccination in the study. Vaccines programmed and not received before inclusion in this study can be administered after the last blood collection. 6. Have taken at least one dose of vaccine against meningitis C or BC (Cuban vaccine) in the past 7. Have received vaccinations, allergy-free injection in the last 14 days 8. Have had any type of meningitis 9. Have been treated with antibiotics in the last 10 days 10. Have been treated with benzathine penicillin in the last 30 days 11. Have fever on the first visit (greater than 37.5°C in the armpit) or 3 days earlier 12. Suffering from chronic disease 13. Had acute illness in the last 30 days 14. Have a history of anaphylaxis, asthma, urticaria or other allergic reaction to previous vaccinations or who have an allergy or hypersensitivity to vaccine components of the study 15. Have a history of severe asthma hospitalisation 16. Are receiving systemic therapy with high doses of steroids (e.g., 1 mg/kg/day of prednisone or equivalent), or have chronic use of inhaled corticosteroids, high power (e.g., 800 mg per day of fluticasone) 17. Have a diagnosed disorder haemophilia or any other disorder associated with prolonged bleeding 18. Have sickle cell anaemia 19. Have undergone splenectomy 20. Have a history of epilepsy, seizures or neurodevelopmental disorders such as autism 21. Have received blood, blood products or immunoglobulin preparations intravenously 22. Have any disorder, in the opinion of the investigator, may interfere with the evaluation of the objectives of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The immunogenicity of the vaccine under test seroconversion (from seronegative to seropositive) or 4-fold elevation of titres targeted bactericidal for the strain used and/or heterologous strain meningococcal C, compared to pre-vaccination titres. Measured through a blood sampling before vaccination and another 30 days after vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Total antibodies, measured by enzyme-linked immunosorbent assay (ELISA) through a blood sampling before vaccination and another 30 days after vaccination | — |
Countries
Brazil
Outcome results
None listed