Last updated: 08/19/2026 10:30:30
A Study to Provide a Comprehensive and up-to-date Assessment of 4CMenB Vaccine Effectiveness (VE) and Duration of Protection (DoP) in Infants and Children
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Quantitative Estimation and Meta-Analysis of 4CMenB Vaccine Effectiveness and Duration of Protection in Infants and Children
Trial description: The aim of this study was to synthesize and meta-analyze the current evidence on real-world effectiveness and duration of protection of 4CMenB vaccine in infants and children.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Overall VE of 4CMenB against MenB-IMD in fully vaccinated infants and children
Timeframe: Up to 10 years
DoP of 4CMenB against MenB-IMD in fully vaccinated infants and children
Timeframe: Up to 10 years
Secondary outcomes:
VE of 4CMenB against MenB-IMD in partially vaccinated infants and children, and in infants and children vaccinated with at least one dose, corresponding to combined partially and fully vaccinated cases
Timeframe: Up to 10 years
DoP of 4CMenB against MenB-IMD in infants and children vaccinated according to age-appropriate local vaccination schedules, including the infancy period
Timeframe: Up to 10 years
Interventions:
Not applicable
Enrollment:
Not applicable
Observational study model:
Other
Primary completion date:
2025-20-08
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Infections, Meningococcal
Product
Not applicable
Collaborators
Not applicable
Study date(s)
July 2025 to August 2025
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
0 Months - 25 Years
Accepts healthy volunteers
Yes
- Studies included in the quantitative estimation and meta-analysis were selected based on a previously conducted systematic literature review (SLR).
- The selection process from the SLR for the current study was based on the following criteria:
- None
Inclusion and exclusion criteria
Inclusion criteria:
- The selection process from the SLR for the current study was based on the following criteria:
- Intervention: 4CMenB
- Outcomes: Vaccine Effectiveness, Vaccine Impact, and Duration of Protection with a focus on Real-World Evidence
- Following a comprehensive feasibility assessment to conduct the meta-analysis and quantitative estimation, based on studies selected through the SLR, the study population comprises infants and children, while the evaluated outcomes include vaccine effectiveness and duration of protection.
Studies included in the quantitative estimation and meta-analysis were selected based on a previously conducted systematic literature review (SLR).
Population: Infant, children/toddler, adolescents, and young adults up to 25 years.
Exclusion criteria:
- None
Trial location(s)
No location data available.
Study documents
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2025-20-08
Actual study completion date
2025-20-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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