TY - JOUR T1 - A randomized trial of candidate inactivated quadrivalent influenza vaccine versus trivalent influenza vaccines in children aged 3-17 years. AU - Domachowske,Joseph B, AU - Pankow-Culot,Heidemarie, AU - Bautista,Milagros, AU - Feng,Yang, AU - Claeys,Carine, AU - Peeters,Mathieu, AU - Innis,Bruce L, AU - Jain,Varsha, Y1 - 2013/03/07/ PY - 2013/3/9/entrez PY - 2013/3/9/pubmed PY - 2013/7/28/medline KW - noninferiority KW - pediatric KW - quadrivalent KW - seasonal influenza KW - superiority KW - trivalent SP - 1878 EP - 87 JF - The Journal of infectious diseases JO - J Infect Dis VL - 207 IS - 12 N2 - BACKGROUND: Two antigenically distinct influenza B lineages have cocirculated since 2001, yet trivalent influenza vaccines (TIVs) contain 1 influenza B antigen, meaning lineage mismatch with the vaccine is frequent. We assessed a candidate inactivated quadrivalent influenza vaccine (QIV) containing both B lineages vs TIV in healthy children aged 3-17 years. METHODS: Children were randomized 1:1:1 to receive QIV or 1 of 2 TIVs (either B/Victoria or B/Yamagata lineage; N = 2738). Hemagglutination-inhibition assays were performed 28 days after 1 or 2 doses in primed and unprimed children, respectively. Immunological noninferiority of QIV vs TIV against shared strains, and superiority against alternate-lineage B strains was based on geometric mean titers (GMTs) and seroconversion rates. Reactogenicity and safety were also assessed (Clinicaltrials.gov NCT01196988). RESULTS: Noninferiority against shared strains and superiority against alternate-lineage B strains was demonstrated for QIV vs TIV. QIV was highly immunogenic; seroconversion rates were 91.4%, 72.3%, 70.0%, and 72.5% against A/H1N1, A/H3N2, B/Victoria, and B/Yamagata, respectively. Reactogenicity and safety of QIV was consistent with TIV. CONCLUSIONS: QIV vs TIV showed superior immunogenicity for the additional B strain without interfering with immune responses to shared strains. QIV may offer improved protection against influenza B in children compared with current trivalent vaccines. SN - 1537-6613 UR - https://www.unboundmedicine.com/medline/citation/23470848/A_randomized_trial_of_candidate_inactivated_quadrivalent_influenza_vaccine_versus_trivalent_influenza_vaccines_in_children_aged_3_17_years_ L2 - https://academic.oup.com/jid/article-lookup/doi/10.1093/infdis/jit091 DB - PRIME DP - Unbound Medicine ER -