Tam J.S.Capeding M.R.Z.Lum L.C.S.Chotpitayasunondh T.Jiang Z.LI-MIN HUANGLee B.W.Qian Y.Samakoses R.Lolekha S.Rajamohanan K.P.Narayanan S.N.Kirubakaran C.Rappaport R.Razmpour A.Gruber W.C.Forrest B.D.2021-06-242021-06-2420070891-3668https://www.scopus.com/inward/record.uri?eid=2-s2.0-34347361688&doi=10.1097%2fINF.0b013e31806166f8&partnerID=40&md5=7d8de2c631c53592fb9fb616dedf7029https://scholars.lib.ntu.edu.tw/handle/123456789/566576BACKGROUND: This study was designed to evaluate the efficacy and safety of cold-adapted influenza vaccine, trivalent (CAIV-T) against culture-confirmed influenza in children 12 to <36 months of age during 2 consecutive influenza seasons at multiple sites in Asia. METHODS: In year 1, 3174 children 12 to <36 months of age were randomized to receive 2 doses of CAIV-T (n = 1900) or placebo (n = 1274) intranasally ?28 days apart. In year 2, 2947 subjects were rerandomized to receive 1 dose of CAIV-T or placebo. RESULTS: Mean age at enrollment was 23.5 ± 7.4 months. In year 1, efficacy of CAIV-T compared with placebo was 72.9% [95% confidence interval (CI): 62.8-80.5%] against antigenically similar influenza subtypes, and 70.1% (95% CI: 60.9-77.3%) against any strain. In year 2, revaccination with CAIV-T demonstrated significant efficacy against antigenically similar (84.3%; 95% CI: 70.1-92.4%) and any (64.2%; 95% CI: 44.2-77.3%) influenza strains. In year 1, fever, runny nose/nasal congestion, decreased activity and appetite, and use of fever medication were more frequent with CAIV-T after dose 1. Runny nose/nasal congestion after dose 2 (year 1) and dose 3 (year 2) and use of fever medication after dose 3 (year 2) were the only other events reported significantly more frequently in CAIV-T recipients. CONCLUSIONS: CAIV-T was well tolerated and effective in preventing culture-confirmed influenza illness over multiple and complex influenza seasons in young children in Asia. ? 2007 Lippincott Williams & Wilkins, Inc.Children; Influenza; Live-attenuated; Vaccine[SDGs]SDG3influenza vaccine; live vaccine; placebo; triple vaccine; age distribution; antigenicity; appetite; article; Asia; bronchitis; bronchospasm; clinical trial; confidence interval; controlled clinical trial; controlled study; coughing; double blind procedure; drug efficacy; drug fever; drug safety; drug tolerability; female; human; immunogenicity; infant; influenza; influenza vaccination; Influenza virus A; Influenza virus A H1N1; Influenza virus B; irritability; major clinical study; male; physical activity; pneumonia; preschool child; priority journal; randomized controlled trial; rhinitis; rhinorrhea; side effect; single drug dose; statistical significance; stomach pain; virus culture; virus strain; vomiting; Adaptation, Physiological; Asia; Child, Preschool; Cold; Double-Blind Method; Female; Humans; Infant; Influenza Vaccines; Influenza, Human; Male; Orthomyxoviridae; Vaccines, Attenuatedjournal article10.1097/INF.0b013e31806166f8175968052-s2.0-34347361688