Characteristics of adverse events of inactivated quadrivalent influenza vaccine in healthy populations: a meta-analysis based on randomized controlled trials
Abstract
BackgroundInfluenza constitutes a critical global public health issue, and quadrivalent inactivated influenza vaccine (QIV) is widely used, yet systematic analyses of its adverse events (AEs) remain lacking. This meta-analysis aimed to characterize AEs following QIV vaccination in healthy populations.MethodsWe searched for randomized controlled trials (RCTs) of QIV vaccination in healthy populations, extracted AE data from QIV groups, pooled incidence rates, and compared the risks of AEs between QIV and trivalent influenza vaccine (TIV) using a random-effects model. Subgroup analyses, meta-regression, and sensitivity analyses were applied to explore heterogeneity and result robustness. Publication bias was evaluated utilizing Begg's and Egger's tests.ResultsA total of 29 studies published from 2008 to 2025 were included, involving 28,410 participants with 8,197 reported AEs in total. The overall incidence of AEs after QIV vaccination in healthy populations was 43% (95% CI: 31%−54%), with an incidence of 27% (95% CI: 18%−37%) for local AEs and 20% (95% CI: 14%−26%) for systemic AEs. The incidence of SAEs was 0.96%. The QIV group showed significantly elevated risks of overall and local AEs relative to TIV (P < 0.05), while no significant differences were detected in systemic AEs and SAEs between the two groups (P > 0.05). Heterogeneity was associated with study period, study region, AE collection duration, and vaccine origin. Sensitivity analyses and publication bias analyses confirmed result stability.ConclusionThis study summarizes AE incidence and features after QIV in healthy populations, supporting clinical vaccination and post-vaccination safety surveillance with exploratory data.Systematic Review Registrationhttps://www.crd.york.ac.uk/PROSPERO/view/CRD420251233388, identifier CRD420251233388.
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BibTeX
@article{kang2026characteristics,
title = {{Characteristics of adverse events of inactivated quadrivalent influenza vaccine in healthy populations: a meta-analysis based on randomized controlled trials}},
author = {Liuyang Kang and Jing Yang and Jingru Cheng and Shaowen Tang and Youcai An and Hang Tao and Hui Jin},
journal = {Frontiers in Public Health},
year = {2026},
month = nov,
doi = {10.3389/fpubh.2026.1954409},
url = {https://www.frontiersin.org/articles/10.3389/fpubh.2026.1954409},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Characteristics of adverse events of inactivated quadrivalent influenza vaccine in healthy populations: a meta-analysis based on randomized controlled trials
AU - Liuyang Kang
AU - Jing Yang
AU - Jingru Cheng
AU - Shaowen Tang
AU - Youcai An
AU - Hang Tao
AU - Hui Jin
PY - 2026
DA - 2026/11/03
JO - Frontiers in Public Health
DO - 10.3389/fpubh.2026.1954409
UR - https://www.frontiersin.org/articles/10.3389/fpubh.2026.1954409
AB - BackgroundInfluenza constitutes a critical global public health issue, and quadrivalent inactivated influenza vaccine (QIV) is widely used, yet systematic analyses of its adverse events (AEs) remain lacking. This meta-analysis aimed to characterize AEs following QIV vaccination in healthy populations.MethodsWe searched for randomized controlled trials (RCTs) of QIV vaccination in healthy populations, extracted AE data from QIV groups, pooled incidence rates, and compared the risks of AEs between QIV and trivalent influenza vaccine (TIV) using a random-effects model. Subgroup analyses, meta-regression, and sensitivity analyses were applied to explore heterogeneity and result robustness. Publication bias was evaluated utilizing Begg's and Egger's tests.ResultsA total of 29 studies published from 2008 to 2025 were included, involving 28,410 participants with 8,197 reported AEs in total. The overall incidence of AEs after QIV vaccination in healthy populations was 43% (95% CI: 31%−54%), with an incidence of 27% (95% CI: 18%−37%) for local AEs and 20% (95% CI: 14%−26%) for systemic AEs. The incidence of SAEs was 0.96%. The QIV group showed significantly elevated risks of overall and local AEs relative to TIV (P < 0.05), while no significant differences were detected in systemic AEs and SAEs between the two groups (P > 0.05). Heterogeneity was associated with study period, study region, AE collection duration, and vaccine origin. Sensitivity analyses and publication bias analyses confirmed result stability.ConclusionThis study summarizes AE incidence and features after QIV in healthy populations, supporting clinical vaccination and post-vaccination safety surveillance with exploratory data.Systematic Review Registrationhttps://www.crd.york.ac.uk/PROSPERO/view/CRD420251233388, identifier CRD420251233388.
SN - 2296-2565
ER -