Abstract
BackgroundInfluenza is an acute respiratory illness caused by influenza viruses, which occurs in epidemics worldwide every year. Children are an important target for prevention methods, including vaccination. While evidence about the decision on whether to vaccinate healthy children is robust, evidence supporting the decision of which of available vaccines to use remains unclear.This review will summarize the evidence about the efficacy and safety of the available vaccines for seasonal influenza licensed in the United States for use in healthy children.Methods/designAn umbrella systematic review (SR) and network meta-analysis will be conducted of randomized controlled trials (RCTs). We will search for SRs to identify parallel RCTs evaluating inactive and/or live attenuated influenza vaccines licensed in the United States for use in healthy children to prevent influenza. Subsequently, we will update the literature search of the selected SRs to the present time to capture recent controlled studies. To complement the work focused on harms, we will also select observational studies focusing on post marketing retrospective studies. Inclusion will not be limited by language, publication date or publication status. To identify additional candidate studies, we will review the reference lists of the eligible primary studies and narrative reviews; we will query the expert members of the Advisory Committee on Immunization Practices and review references from their previous statement. Additionally, we will review the reports from the Institute of Medicine on the adverse effects of vaccines. Two reviewers will independently determine study eligibility and will extract descriptive, methodological (using the Cochrane risk of bias tool for RCTs and the Newcastle–Ottawa scale for observational studies) and efficacy data. When possible, we will conduct meta-analyses and network meta-analyses by combining indirect and direct comparisons.We will evaluate heterogeneity using the I2 statistic and the agreement of indirect comparisons and direct evidence. We will report the Cochrane Q test to determine the statistical significance of heterogeneity.The overall quality of evidence will be assessed following the GRADE (Grading of Recommendation, Assessment, Development and Evaluation) approach.DiscussionOur systematic review will allow patients, clinicians, guideline developers and policy makers to make evidence-based choices between the two available vaccine options, by providing information regarding benefits and harms of these types of vaccines.
Highlights
Influenza is an acute respiratory illness caused by influenza viruses, which occurs in epidemics worldwide every year
Influenza is an acute respiratory illness caused by influenza A or B viruses, which occurs in seasonal outbreaks worldwide each year, causing substantial morbidity and mortality—between 3,000 and 49,000 deaths [1] and over 200,000 hospitalizations [2] annually
While the majority of influenza-related deaths occur among adults aged 65 years and older [1], children are at risk of severe disease, those under 5 years of age [3]
Summary
Influenza is an acute respiratory illness caused by influenza A or B viruses, which occurs in seasonal outbreaks worldwide each year, causing substantial morbidity and mortality—between 3,000 and 49,000 deaths [1] and over 200,000 hospitalizations [2] annually. Study objectives This systematic review (SR) aims to summarize the evidence concerning the efficacy and safety of US-licensed seasonal influenza vaccines for healthy children 6months through 18-years old. Eligible trials must evaluate the efficacy of seasonal influenza vaccines (not pandemic vaccines) licensed in the United States and administered as recommended by the ACIP, and must enroll healthy children (
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