Last updated: 07/03/2025 07:30:13

A Study to Provide a Comprehensive and up-to-date Assessment of 4CMenB Vaccine Effectiveness and Duration of Protection in Infants and Children

GSK study ID
224096
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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 is 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:

Estimation of vaccine effectiveness of 4CMenB in fully vaccinated infants and children through meta-analysis

Timeframe: Up to 10 years

Estimation of Duration of Protection (years) of 4CMenB for fully vaccinated infants and children

Timeframe: Up to 10 years

Secondary outcomes:

Estimation of vaccine effectiveness in partially vaccinated participants and participants vaccinated with at least one dose of 4CMenB

Timeframe: Up to 10 years

Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2025-10-07
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Infections, Meningococcal
Product
Not applicable
Collaborators
Not applicable
Study date(s)
July 2025 to July 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:

    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:
  • Intervention: 4CMenB
  • Outcomes: Vaccine Effectiveness, Vaccine Impact, and Duration of Protection with a focus on Real-World Evidence

    • Population: Infant, children/toddler, adolescents, and young adults up to 25 years.

    • 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.
Exclusion criteria:
  • None

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Will be recruiting
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
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