Evidence map›Paper›PMID 39040889›Full record

ArticleVaccine: X2024

Safety profile assessment of HPV4 and HPV9 vaccines through the passive surveillance system of the Veneto Region (Italy) between 2008 and 2022: A 15-year retrospective observational study.

Diana Dalla Valle, Roberto Benoni, Nicola Soriolo, Chiara Battistella, Francesca Moretti, Laura Augusta Gonella, Stefano Tardivo, Silvia Colpo, Sara Montresor, Francesca Russo and 4 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Vaccine: X, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–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 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
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

14 authors.

Diana Dalla ValleUniversity of Verona, Diagnostics and Public Health Department, Section of Hygiene and Preventive Medicine, Verona, Italy.
Roberto BenoniUniversity of Verona, Diagnostics and Public Health Department, Section of Hygiene and Preventive Medicine, Verona, Italy.
Nicola SorioloUniversity of Verona, Diagnostics and Public Health Department, Section of Hygiene and Preventive Medicine, Verona, Italy.
Chiara BattistellaUniversity of Verona, Diagnostics and Public Health Department, Section of Hygiene and Preventive Medicine, Verona, Italy.
Francesca MorettiUniversity of Verona, Neurosciences, Biomedicine and Movement Sciences Department, Verona, Italy.
Laura Augusta GonellaUniversity of Verona, Diagnostics and Public Health Department, Section of Pharmacology, Verona, Italy.
Stefano TardivoUniversity of Verona, Diagnostics and Public Health Department, Section of Hygiene and Preventive Medicine, Verona, Italy.
Silvia ColpoUniversity of Verona, Diagnostics and Public Health Department, Section of Hygiene and Preventive Medicine, Verona, Italy.
Sara MontresorUniversity of Verona, Diagnostics and Public Health Department, Section of Hygiene and Preventive Medicine, Verona, Italy.
Francesca RussoDirectorate of Prevention, Food Safety, Veterinary Public Health, Veneto Region, Venice, Italy.
Michele TononDirectorate of Prevention, Food Safety, Veterinary Public Health, Veneto Region, Venice, Italy.
Filippo Da ReDirectorate of Prevention, Food Safety, Veterinary Public Health, Veneto Region, Venice, Italy.
Ugo MorettiUniversity of Verona, Diagnostics and Public Health Department, Section of Pharmacology, Verona, Italy.
Giovanna ZanoniUniversity Hospital of Verona, Pathology and Diagnostics Department, Immunology Unit, Verona, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In Veneto Region, HPV vaccine has been actively offered to 12 year-old females since 2008, and to 12 year-old males since 2015. The study aims to analyze the safety profile of HPV4v and HPV9v vaccines and perform a case-by-case review of conditions of interest. Spontaneous reports related to HPV uploaded to the database of the Regional Pharmacovigilance Center between 2008-2022 were included. HPV vaccine doses administered until April 2022 in the Veneto Region were considered to calculate the reporting rate (RR). Potential "safety concerns" examined as conditions of interest were included through Standardized MedDRA or preferred terms searching queries. The level of diagnostic certainty was evaluated as per the Brighton Collaboration case definition criteria. A total of 637 reports and 1316 Adverse Events Following Immunizations (AEFI) were retrieved: 469 for HPV4v (73.6 %) and 168 for HPV9v (26.4 %). Serious reports were 71 (11.1 %): 49 (10.4 %) for HPV4v and 22 (13.1 %) for HPV9v. The RR for serious events between 2008-2022 was 6.9/100,000 administered doses, with no differences by vaccine type. Females and adults showed higher overall RR compared to males and to children and adolescents (p < 0.001), this result was confirmed by stratifying analysis by vaccine type. One case of Guillain Barré syndrome, anaphylactic shock, thrombocytopenia, Henoch Schoenlein purpura and four generalized seizures were reviewed. Vaccinovigilance data from the Veneto Region reaffirm a good safety profile for HPV vaccination and found no vaccine-related unexpected events. Such a detailed analysis may assist healthcare providers to advocate properly for HPV vaccination.

Indexed as

Adolescent healthAdverse drug eventAdverse drug reaction reporting systemHuman papilloma virus vaccinePostmarketing product surveillancePrimary disease preventionVaccination awarenessVaccine hesitancy

Identifiers

PMID39040889
PMCPMC11260860

What OpenQuestion holds

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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.