Evidence map›Paper›PMID 41150418›Full record

ReviewVaccines2025

Safety Profile of the 4CMenB (Bexsero

Ana Belén García Flores, Rafael Ruiz-Montero, María Ángeles Onieva-García, Alexander Batista-Duharte, Estefanía López Cabrera, Mohamed Farouk Allam, Inmaculada Salcedo

Abstract readReview
In one paragraph

Review in Vaccines, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Ana Belén García FloresPreventive Medicine and Public Health Unit, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, 14004 Cordoba, Spain.
Rafael Ruiz-MonteroPreventive Medicine and Public Health Unit, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, 14004 Cordoba, Spain.ORCID 0000-0002-9113-6493
María Ángeles Onieva-GarcíaPreventive Medicine and Public Health Unit, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, 14004 Cordoba, Spain.
Alexander Batista-DuharteDepartment of Cell Biology, Physiology and Immunology, University of Cordoba, 14004 Cordoba, Spain.ORCID 0000-0002-1875-0518
Estefanía López CabreraPreventive Medicine and Public Health Unit, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, 14004 Cordoba, Spain.ORCID 0009-0008-5351-4845
Mohamed Farouk AllamPreventive Medicine and Public Health Unit, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, 14004 Cordoba, Spain.ORCID 0000-0001-5954-8909
Inmaculada SalcedoPreventive Medicine and Public Health Unit, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, 14004 Cordoba, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 4CMenB vaccine (Bexsero

methodsA systematic review and meta-analysis of clinical trials published up to 28 February 2025 were conducted using PubMed, ScienceDirect, and Web of Science. Human studies available in English, Spanish, French, German, or Italian were exclusively included. Adverse events following the first dose of the vaccine were analyzed. Pooled proportions with 95% confidence intervals were calculated, and heterogeneity across studies was assessed using the I

resultsTen clinical trials comprising 13,345 participants were included. The most common adverse event was local pain (occurring in up to 94% of cases), followed by induration, erythema, and edema, with frequencies ranging from 25% to 45%. The most frequently reported systemic events were irritability (up to 75%), fatigue (51-59%), fever (up to 60%), headache (42-49%), and persistent crying (50-65%). Most adverse events were mild and self-limiting.

conclusionsThe 4CMenB (Bexsero) vaccine exhibits a favorable safety profile, characterized by a predominance of mild and transient local adverse events. Although several systemic events were reported, their overall frequency was generally low. These findings support the continued inclusion of Bexsero

Indexed as

4CMenBadverse eventsBexsero®clinical trialsmeta-analysis

Identifiers

PMID41150418
PMCPMC12568221

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

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.