Trial reportThe Pediatric infectious disease journal2020
Quadrivalent Influenza Vaccine Prevents Illness and Reduces Healthcare Utilization Across Diverse Geographic Regions During Five Influenza Seasons: A Randomized Clinical Trial.
Trial report in The Pediatric infectious disease journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 3 of them syntheses that pooled it.
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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
18 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Comparison of 2 Doses vs 1 Dose in the First Season Children Are Vaccinated Against Influenza: A Systematic Review and Meta-Analysis.JAMA network open · 2025Pooled it
- Effectiveness of interventions to improve vaccine efficacy: a systematic review and meta-analysis.Systematic reviews · 2025Pooled it
- The impact of influenza and pneumococcal vaccination on antibiotic use: an updated systematic review and meta-analysis.Antimicrobial resistance and infection control · 2023Pooled it
- Article
- Antibiotic-induced gut microbiome perturbation alters the immune responses to the rabies vaccine.Cell host & microbe · 2025Article
- Helminth infections affect host immune responses to viral infections and vaccines.FEMS microbiology reviews · 2025Review
- Recent advances in the influenza virus vaccine landscape: a comprehensive overview of technologies and trials.Clinical microbiology reviews · 2024Review
- Sequential early-life viral infections modulate the microbiota and adaptive immune responses to systemic and mucosal vaccination.PLoS pathogens · 2024Article
- Immunity and Protective Efficacy of a Plant-Based Tobacco Mosaic Virus-like Nanoparticle Vaccine against Influenza a Virus in Mice.Vaccines · 2024Article
- Article
- Enhancing the yield of seasonal influenza viruses through manipulation of microRNAs in Madin-Darby canine kidney cells.Experimental biology and medicine (Maywood, N.J.) · 2022Article
- Antibiotic prescribing across age groups in the Kaiser Permanente Northern California population in association with different diagnoses, and with influenza incidence, 2010-2018.Epidemiology and infection · 2022Article
- Modulation of immune responses to vaccination by the microbiota: implications and potential mechanisms.Nature reviews. Immunology · 2022Review
- [Health Technology Assessment (HTA) of the introduction of influenza vaccination for Italian children with Fluenz TetraJournal of preventive medicine and hygiene · 2021Article
- Influenza vaccination: protecting the most vulnerable.European respiratory review : an official journal of the European Respiratory Society · 2021Review
- The impact of human vaccines on bacterial antimicrobial resistance. A review.Environmental chemistry letters · 2021Review
- Impact of influenza vaccination on amoxicillin prescriptions in older adults: A retrospective cohort study using primary care data.PloS one · 2021Article
- Epidemiological and evolutionary dynamics of influenza B virus in coastal Kenya as revealed by genomic analysis of strains sampled over a single season.Virus evolution · 2020Article
Corrections and comments
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Authors and funding
42 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe evaluated an inactivated quadrivalent influenza vaccine (IIV4) in children 6-35 months of age in a phase III, observer-blind trial.
methodsThe aim of this analysis was to estimate vaccine efficacy (VE) in preventing laboratory-confirmed influenza in each of 5 independent seasonal cohorts (2011-2014), as well as vaccine impact on healthcare utilization in 3 study regions (Europe/Mediterranean, Asia-Pacific and Central America). Healthy children were randomized 1:1 to IIV4 or control vaccines. VE was estimated against influenza confirmed by reverse transcription polymerase chain reaction on nasal swabs. Cultured isolates were characterized as antigenically matched/mismatched to vaccine strains.
resultsThe total vaccinated cohort included 12,018 children (N = 1777, 2526, 1564, 1501 and 4650 in cohorts 1-5, respectively). For reverse transcription polymerase chain reaction confirmed influenza of any severity (all strains combined), VE in cohorts 1-5 was 57.8%, 52.9%, 73.4%, 30.3% and 41.4%, respectively, with the lower limit of the 95% confidence interval >0 for all estimates. The proportion of vaccine match for all strains combined in each cohort was 0.9%, 79.3%, 72.5%, 24.1% and 28.6%, respectively. Antibiotic use associated with influenza illness was reduced with IIV4 by 71% in Europe, 36% in Asia Pacific and 59% in Central America.
conclusionsIIV4 prevented influenza in children 6-35 months of age in each of 5 separate influenza seasons in diverse geographical regions. A possible interaction between VE, degree of vaccine match and socioeconomic status was observed. The IIV4 attenuated the severity of breakthrough influenza illness and reduced healthcare utilization, particularly antibiotic use.
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