ReviewDrugs2014
A multi-component meningococcal serogroup B vaccine (4CMenB): the clinical development program.
Review in Drugs, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05212935 (A Surveillance Study on Timing and Coverage Of Rotavirus and MenB Vaccine Co-administration in Campania Region, Italy), which is not on this map. Cited by 80 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Surveillance Study on Timing and Coverage Of Rotavirus and MenB Vaccine Co-administration in Campania Region, Italy
Who cites it
80 citing papers in PubMed, 2 syntheses or guidelines pooled it, 166 citations in OpenAlex.
- Bacteria-based immunotherapy for cancer: a systematic review of preclinical studies.Frontiers in immunology · 2023Pooled it
- Systematic literature review on the safety and immunogenicity of rotavirus vaccines when co-administered with meningococcal vaccines.Human vaccines & immunotherapeutics · 2020Pooled it
- Safety and immunogenicity of 4CMenB and MenACWY-CRM meningococcal vaccines when administered concomitantly in healthy adolescents: A phase 3b, randomized, observer-blind study.Human vaccines & immunotherapeutics · 2026Trial
- Immunogenicity, Reactogenicity, and Safety of a Pentavalent Meningococcal ABCWY Vaccine in Adolescents and Young Adults Who Had Previously Received a Meningococcal ACWY Vaccine: A Phase 3, Randomized Controlled Clinical Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Trial
- 4CMenB Breadth of Immune Response, Immunogenicity, and Safety: Results From a Phase 3 Randomized, Controlled, Observer Blind Study in Adolescents and Young Adults.Open forum infectious diseases · 2024Trial
- Safety and immunogenicity of a meningococcal B recombinant vaccine when administered with routine vaccines to healthy infants in Taiwan: A phase 3, open-label, randomized study.Human vaccines & immunotherapeutics · 2018Trial
- Safety and immunogenicity of meningococcal ACWY CRM197-conjugate vaccine in children, adolescents and adults in Russia.Human vaccines & immunotherapeutics · 2014Trial
- Targeting Outer Membrane Vesicles ofJournal of microbiology and biotechnology · 2026Review
- Bacterial extracellular membrane vesicles as multifunctional defense systems: Roles in immune evasion, phage interactions, and antimicrobial resistance.Molecular biology reports · 2026Review
- Review
- Post-marketing safety profile of meningococcal group B vaccines: a real-world disproportionality analysis of the VAERS database, 2015Q1-2025Q3.Frontiers in pharmacology · 2026Article
- Isolation and Proteomic Characterization of Outer Membrane Vesicles in Fusobacterium nucleatum.Methods in molecular biology (Clifton, N.J.) · 2026Article
- Structure-based engineering of a nutrient acquisition protein enhances neutralizing antibodies and protection for the development of a gonococcal vaccine.bioRxiv : the preprint server for biology · 2025Article
- Bioengineering Outer-Membrane Vesicles for Vaccine Development: Strategies, Advances, and Perspectives.Vaccines · 2025Review
- Methods to evaluate the performance of a multicomponent meningococcal serogroup B vaccine.mSphere · 2025Review
- Optimization of methods for isolation and purification of outer membrane vesicles (OMVs) from Neisseria lactamica.Applied microbiology and biotechnology · 2025Article
- Bacterial extracellular vesicles for gut microbiome-host communication and drug development.Acta pharmaceutica Sinica. B · 2025Review
- The global state, trajectory and trends of bacterial extracellular vesicles: a bibliometric and visualized analysis.Frontiers in microbiology · 2025Article
- Syphilis vaccine development: Aligning vaccine design with manufacturing requirements.Human vaccines & immunotherapeutics · 2024Article
- 4CMenB journey to the 10-year anniversary and beyond.Human vaccines & immunotherapeutics · 2024Review
20 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Recently approved in Europe and Australia, the multi-component meningococcal B vaccine, 4CMenB (Bexsero®, Novartis Vaccines and Diagnostics), contains three surface-exposed recombinant proteins (fHbp, NadA, and NHBA) and New Zealand strain outer membrane vesicles (NZ OMV) with PorA 1.4 antigenicity. This comprehensive review of the 4CMenB clinical development program covers pivotal phase I/IIb/III studies in over 7,000 adults, adolescents, and infants. The immunological correlate for clinical protection used was human complement-mediated serum bactericidal activity titers ≥4 or 5 against indicator strains for individual antigens. Based on achievement of protective titers, a four-dose schedule (three primary doses and one booster dose) for infants and a two-dose schedule for adolescents provided the best results. Observed increases in injection site pain/tenderness and fever in infants, and injection site pain, malaise, and headache in adolescents compared with routine vaccines, were mostly mild to moderate; frequencies of rare events (Kawasaki disease, juvenile arthritis) were not significantly different from non-vaccinated individuals. 4CMenB is conservatively estimated to provide 66-91 % coverage against meningococcal serogroup B strains worldwide.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.