Neisseria meningitidis Nervous System Diseases
Conditions
Interventions
All children and adolescents diagnosed with invasive meningococcal disease in Portugal between October 2014 and March 2019 inclusive will be eligible for inclusion. For each case, 2-4 age and location
Sponsors
Sociedade Portuguese de Pediatria
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Case participant inclusion criteria: 1. Age > 2 months and 14 days and = 5 years or more, controls have to have been born +/-90 days 7. Eligible to have received and responded to 4CMenB (aged at least = 2 months and 14 days, absence of vaccine contraindication) 8. Living in the same district as the case 9. Same gender as the case 10. Presenting to the same hospital, within the same week of the case (up to 14 days before or after the day when the case was observed), with an illness that was clearly not invasive meningococcal disease (i.e. not meningitis, septicaemia or pyrexia of unknown origin) 11. Available information about vaccine status for 4CMenB, MenC and MenACWY from central immunisation records database Vaccination status: For the primary analysis, children who have received the appropriate number of vaccine doses for their age will be considered vaccinated – i.e. those aged 4 to 15 months who have had 2 or more vaccine doses with the second dose at least 14 days before presentation and those aged 16 months or more who have had either 2 or 3 doses before 1 year of age and one dose after 1 year of age (with the booster dose at least 14 days before presentation) or who have had at least 2 vaccine doses after the first birthday (with the second dose at least 14 days before presentation). All children who have received fewer than the appropriate number of doses as defined above will be considered unvaccinated. Children too young to have received two priming doses with the second at least 14 days before presentation (i.e. less than 4 months and 14 days old) will not be included in this analysis.
Exclusion criteria
Exclusion criteria: 1. Unknown vaccine status from centralised immunisation records database 2. Belonging to a risk group for meningococcal invasive disease: asplenia, immunodeficiency including but not restricted to complement deficiency or on treatment with Eculizumab 3. History of invasive meningococcal disease 4. Recent known or suspected contact with a case of meningococcal invasive disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of the 4CMenB vaccine for protection against invasive meningococcal disease caused by group B Nm in Portugal (partially immunized children considered unvaccinated). Data are extracted from the medical records of cases and matched controls including immunisation history. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Effectiveness of the 4CMenB vaccine for protection against invasive meningococcal disease caused by group B Nm in Portugal when partially vaccinated children are excluded from analysis. 2. Effectiveness of one or more doses of 4CMenB vaccine for protection against invasive meningococcal disease caused by group B Nm in Portugal (i.e. partially vaccinated children included in analysis but considered to be vaccinated). 3. Effectiveness of the 4CMenB vaccine, using the 3 approaches summarized above, for protection against all-cause invasive meningococcal disease in Portugal. Standardised data are extracted from the medical records of cases and matched controls including immunisation history. | — |
Countries
Portugal
Outcome results
None listed