tetano
Editor, Senior Moderator
Clin Microbiol Infect
. 2026 Jul 11:S1198-743X(26)00365-4.
doi: 10.1016/j.cmi.2026.07.001. Online ahead of print.
Real-world influenza surveillance and vaccine effectiveness in children: a multicentre study of the Italian Federation of Primary Care Paediatricians (FIMP)
M Barretta[SUP] 1 [/SUP], S Ricci[SUP] 2 [/SUP], A Compagnone[SUP] 1 [/SUP], R Indaco[SUP] 1 [/SUP], E Napoleone[SUP] 1 [/SUP], P Giorgi Rossi[SUP] 3 [/SUP], F Leoni[SUP] 4 [/SUP], F Nieddu[SUP] 5 [/SUP], E Ferraro[SUP] 5 [/SUP], M Moriondo[SUP] 5 [/SUP], C Azzari[SUP] 6 [/SUP], A D Avino[SUP] 1 [/SUP]; FIMP vaccination study group
Collaborators, Affiliations
Objectives: Influenza is a significant cause of morbidity among children and a significant factor in primary care consultations. While numerous studies on influenza vaccine effectiveness have been conducted, the majority of the available data comes from hospital settings; the objective of this study is to estimate influenza vaccine effectiveness in children in paediatric primary care settings.
Methods: A multicentre observational study was conducted among family paediatricians working in outpatient clinics in various Italian regions during the 2024/25 influenza season. Children aged 2-7 years with influenza-like illness were enrolled and underwent rapid antigen point-of-care tests (POCT). Children who were positive on POCT underwent molecular RT-PCR tests for influenza in a centralized laboratory. Vaccine effectiveness (VE) was estimated as 1-odds ratio by a test-negative case-control design and as 1-incidence rate ratio by a cohort study, in which the aggregated denominator of the children included in the beneficiary lists of the participant pediatriacians was used to compute the incidence in vaccinated and non-vaccinated.
Results: The circulation of influenza was characterized by a clear seasonal pattern, with sustained activity of the virus throughout the period. 739 ILI cases were tested. The results showed a 79% (95%CI: 70-86) reduction of laboratory-confirmed influenza ILI, i.e vaccine efficacy (1-OR). The results were consistent when sensitivity analysis was performed for different types of influenza vaccine and when results obtained by POCT were compared to results obtained by RT-PCR confirmation. When the results were assessed by the cohort method, vaccination was associated with a marked reduction in incidence of influenza with VE 76% (1-IRR); 95%CI 67-82) and no reduction of ILI that tested negative for influenza virus.
Conclusions: This study shows high VE of the 24-25 influenza vaccines against symptomatic disease in healthy children, demonstrating the feasibility to perform influenza surveillance in a paediatric primary care setting in real-life conditions.
Keywords: Influenza; Influenza-like illness; Paediatric primary care; Point-of-care testing; Real-world study; Surveillance; Vaccine effectiveness.
. 2026 Jul 11:S1198-743X(26)00365-4.
doi: 10.1016/j.cmi.2026.07.001. Online ahead of print.
Real-world influenza surveillance and vaccine effectiveness in children: a multicentre study of the Italian Federation of Primary Care Paediatricians (FIMP)
M Barretta[SUP] 1 [/SUP], S Ricci[SUP] 2 [/SUP], A Compagnone[SUP] 1 [/SUP], R Indaco[SUP] 1 [/SUP], E Napoleone[SUP] 1 [/SUP], P Giorgi Rossi[SUP] 3 [/SUP], F Leoni[SUP] 4 [/SUP], F Nieddu[SUP] 5 [/SUP], E Ferraro[SUP] 5 [/SUP], M Moriondo[SUP] 5 [/SUP], C Azzari[SUP] 6 [/SUP], A D Avino[SUP] 1 [/SUP]; FIMP vaccination study group
Collaborators, Affiliations
- PMID: 42435855
- DOI: 10.1016/j.cmi.2026.07.001
Objectives: Influenza is a significant cause of morbidity among children and a significant factor in primary care consultations. While numerous studies on influenza vaccine effectiveness have been conducted, the majority of the available data comes from hospital settings; the objective of this study is to estimate influenza vaccine effectiveness in children in paediatric primary care settings.
Methods: A multicentre observational study was conducted among family paediatricians working in outpatient clinics in various Italian regions during the 2024/25 influenza season. Children aged 2-7 years with influenza-like illness were enrolled and underwent rapid antigen point-of-care tests (POCT). Children who were positive on POCT underwent molecular RT-PCR tests for influenza in a centralized laboratory. Vaccine effectiveness (VE) was estimated as 1-odds ratio by a test-negative case-control design and as 1-incidence rate ratio by a cohort study, in which the aggregated denominator of the children included in the beneficiary lists of the participant pediatriacians was used to compute the incidence in vaccinated and non-vaccinated.
Results: The circulation of influenza was characterized by a clear seasonal pattern, with sustained activity of the virus throughout the period. 739 ILI cases were tested. The results showed a 79% (95%CI: 70-86) reduction of laboratory-confirmed influenza ILI, i.e vaccine efficacy (1-OR). The results were consistent when sensitivity analysis was performed for different types of influenza vaccine and when results obtained by POCT were compared to results obtained by RT-PCR confirmation. When the results were assessed by the cohort method, vaccination was associated with a marked reduction in incidence of influenza with VE 76% (1-IRR); 95%CI 67-82) and no reduction of ILI that tested negative for influenza virus.
Conclusions: This study shows high VE of the 24-25 influenza vaccines against symptomatic disease in healthy children, demonstrating the feasibility to perform influenza surveillance in a paediatric primary care setting in real-life conditions.
Keywords: Influenza; Influenza-like illness; Paediatric primary care; Point-of-care testing; Real-world study; Surveillance; Vaccine effectiveness.