Last updated: 09/03/2026 15:30:46
A database study of the impact and effectiveness of 4CMenB vaccination against serogroup B invasive meningococcal disease (IMD) in New Zealand
GSK study ID
300590
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Planned
Planned
Trial overview
Official title: Bexsero impact and effectiveness against invasive meningococcal disease in the New Zealand population (BEXSIEmen)
Trial description: The purpose of this database study is to assess the impact and effectiveness of 4CMenB vaccination against serogroup B IMD among individuals resident in New Zealand during the study period from 01 January 2017 to 31 March 2026.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Population-level impact of 4CMenB vaccination on serogroup B IMD incidence in infants and children
Timeframe: From 01 January 2017 to 31 March 2026
Real-world effectiveness of 4CMenB vaccination against serogroup B IMD in fully vaccinated infants and children
Timeframe: From 01 March 2023 to 31 March 2026
Secondary outcomes:
Descriptive assessment of time to serogroup B IMD by vaccination status
Timeframe: From 01 January 2017 to 31 March 2026
Real-world effectiveness of 4CMenB vaccination against serogroup B IMD in fully vaccinated infants and children, assessed separately
Timeframe: From 01 March 2023 to 31 March 2026
Real-world effectiveness of 4CMenB vaccination against serogroup B IMD in partially vaccinated infants and children
Timeframe: From 01 March 2023 to 31 March 2026
Real-world effectiveness of 4CMenB vaccination against severe serogroup B IMD in fully vaccinated infants and children
Timeframe: From 01 March 2023 to 31 March 2026
Real-world effectiveness of 4CMenB vaccination against serogroup B IMD in the combined population of fully vaccinated infants, children, adolescents, and young adults
Timeframe: From 01 March 2023 to 31 March 2026
Interventions:
Not applicable
Enrollment:
Not applicable
Observational study model:
Case-Control
Primary completion date:
2027-29-10
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Infections, Meningococcal
Product
Not applicable
Collaborators
Waipapa Taumata Rau, University of Auckland
Study date(s)
September 2026 to November 2027
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
6 Weeks - 25 Years
Accepts healthy volunteers
Yes
- Residency: Be resident in New Zealand during the study period.
- Data linkability: Have a valid, encrypted National Health Index number enabling data linkage.
- Individuals who have been absent from New Zealand for more than two consecutive quarters during the study period.
Inclusion and exclusion criteria
Inclusion criteria:
- Data linkability: Have a valid, encrypted National Health Index number enabling data linkage.
Residency: Be resident in New Zealand during the study period.
Exclusion criteria:
Individuals who have been absent from New Zealand for more than two consecutive quarters during the study period.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Planned
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website