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Children are at increased risk for influenza and its complications, so including them in vaccine trials is critical. Researchers have now conducted a manufacturer-funded, multinational, phase III, observer-blinded trial of a novel inactivated quadrivalent influenza vaccine (QIV) in children aged 3 to 8 years.
About 5200 children were randomly assigned to receive either the QIV vaccine (which contains both B lineages to prevent B-lineage mismatch) or hepatitis A vaccine as a control. The primary endpoint was influenza A or B confirmed by polymerase chain reaction (PCR) assay; secondary endpoints included moderate-to-severe PCR-confirmed influenza and culture-confirmed influenza, caused by seasonal strains that antigenically matched the vaccin…