ArticlePharmacoepidemiology and drug safety2018
The safety of live attenuated influenza vaccine in children and adolescents 2 through 17 years of age: A Vaccine Safety Datalink study.
Article in Pharmacoepidemiology and drug safety, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed, 17 citations in OpenAlex.
- Pharmacovigilance-based 12-year post-marketing safety analysis of quadrivalent influenza vaccines in children: a VAERS surveillance study.Frontiers in pediatrics · 2025Article
- Syncope after live attenuated influenza vaccine: Reports to the Vaccine Adverse Event Reporting System (2003-2024).Vaccine · 2024Article
- Pharmacovigilance in Vaccines: Importance, Main Aspects, Perspectives, and Challenges-A Narrative Review.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Quadrivalent Live-Attenuated Influenza Vaccine in Milan preschools: an Italian experience of school-located flu vaccination within the 2022-2023 season.Italian journal of pediatrics · 2024Article
- [Health Technology Assessment: a value-based tool for the evaluation of healthcare technologies. Reassessment of the cell-culture-derived quadrivalent influenza vaccine: Flucelvax TetraJournal of preventive medicine and hygiene · 2022Article
- [Health Technology Assessment (HTA) of the introduction of influenza vaccination for Italian children with Fluenz TetraJournal of preventive medicine and hygiene · 2021Article
- Analyzing self-controlled case series data when case confirmation rates are estimated from an internal validation sample.Biometrical journal. Biometrische Zeitschrift · 2018Article
Corrections and comments
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Authors and funding
14 authors at 7 institutions in 2 countries.
Funding
Abstract
purposeTo evaluate the safety of live attenuated influenza vaccine (LAIV) in children 2 through 17 years of age.
methodsThe study was conducted in 6 large integrated health care organizations participating in the Vaccine Safety Datalink (VSD). Trivalent LAIV safety was assessed in children who received LAIV between September 1, 2003 and March 31, 2013. Eighteen pre-specified adverse event groups were studied, including allergic, autoimmune, neurologic, respiratory, and infectious conditions. Incident rate ratios (IRRs) were calculated for each adverse event, using self-controlled case series analyses. For adverse events with a statistically significant increase in risk, or an IRR > 2.0 regardless of statistical significance, manual medical record review was performed to confirm case status.
resultsDuring the study period, 396 173 children received 590 018 doses of LAIV. For 13 adverse event groups, there was no significant increased risk of adverse events following LAIV. Five adverse event groups (anaphylaxis, syncope, Stevens-Johnson syndrome, adverse effect of drug, and respiratory failure) met criteria for manual medical record review. After review to confirm cases, 2 adverse event groups remained significantly associated with LAIV: anaphylaxis and syncope. One confirmed case of anaphylaxis was observed following LAIV, a rate of 1.7 per million LAIV doses. Five confirmed cases of syncope were observed, a rate of 8.5 per million doses.
conclusionsIn a study of trivalent LAIV safety in a large cohort of children, few serious adverse events were detected. Anaphylaxis and syncope occurred following LAIV, although rarely. These data provide reassurance regarding continued LAIV use.
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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.