Portugal meningococcal B vaccine (menB) effectiveness study

Phase 4

Completed

• Conditions: eisseria meningitidis; Nervous System Diseases

• Registration Number: ISRCTN10901628
• Lead Sponsor: Sociedade Portuguese de Pediatria

Brief Summary

2020 results in https://doi.org/10.1001/jama.2020.20449 (added 02/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-21
• Study Completion: 2019-09-01
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Case participant inclusion criteria:
1. Age > 2 months and 14 days and < 18 years
2. Meningococcal invasive disease confirmed by culture or PCR in a normally-sterile biological sample (blood, CSF, pleural fluid, joint fluid, other)
3. Resident in Portugal at time of presentation
4. Eligible to have received and responded to 4CMenB (age at least 2 months and 14 days, absence of vaccine contraindication)
5. Available information about vaccine status for 4CMenB, MenC and MenACWY from central immunisation records database.

Control participant inclusion criteria:
6. Born within specified time period of matched case participant. If case is less than < 2 years old, controls have to have been born +/- 14 days (minimum age of 2 months and 14 days); if cases are aged 2-5 years, controls have to have been born +/- 60 days, if cases are aged >= 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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified