PMID- 21668683 OWN - NLM STAT- MEDLINE DCOM- 20120207 LR - 20220309 IS - 1750-2659 (Electronic) IS - 1750-2640 (Print) IS - 1750-2640 (Linking) VI - 5 IP - 6 DP - 2011 Nov TI - An integrated, multistudy analysis of the safety of Ann Arbor strain live attenuated influenza vaccine in children aged 2-17 years. PG - 389-97 LID - 10.1111/j.1750-2659.2011.00243.x [doi] AB - BACKGROUND: Trivalent, Ann Arbor strain, live attenuated influenza vaccine (LAIV) is approved in several countries for use in eligible children aged >/=2 years. OBJECTIVE: To describe the safety of Ann Arbor strain LAIV in children aged 2-17 years. METHODS: An integrated analysis of randomized, controlled trials of LAIV. RESULTS: A total of 4245 and 10,693 children received >/=1 dose of LAIV in year 1 of 6 trivalent inactivated influenza vaccine (TIV)-controlled and 14 placebo-controlled studies, respectively; 3212 children were revaccinated in year 2 of 4 placebo-controlled studies. Compared with placebo for days 0-10 post-vaccination, LAIV recipients exhibited increased runny/stuffy nose (+7%), headache (+7%), and tiredness/decreased activity (+2%) after dose 1; and a higher rate of decreased appetite (+4%) after year 2 revaccination. Compared with TIV, only runny/stuffy nose was increased (dose 1, +12%; dose 2, +4%). Compared with initial vaccination, LAIV reactogenicity was lower after dose 2 in year 1 and revaccination in year 2. Unsolicited adverse events (AEs) increased with LAIV in some comparisons were headache, nasal congestion/rhinorrhea, rhinitis, and pyrexia; ear pain and lower respiratory illness were decreased. There was no evidence of an increase in any potential vaccine-related serious AE in LAIV recipients. Among children aged 2-17 years and specifically aged 24-35 months, there was no evidence that lower respiratory illness or wheezing illness occurred at a higher rate in LAIV recipients. CONCLUSION: This analysis supports the safety of Ann Arbor strain LAIV in children aged 2-17 years and provides a consensus assessment of events expected after vaccination. CI - (c) 2011 Blackwell Publishing Ltd. FAU - Ambrose, Christopher S AU - Ambrose CS AD - MedImmune LLC, Gaithersburg, MD, USA. ambrosec@medimmune.com FAU - Yi, Tingting AU - Yi T FAU - Falloon, Judith AU - Falloon J LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20110404 PL - England TA - Influenza Other Respir Viruses JT - Influenza and other respiratory viruses JID - 101304007 RN - 0 (Influenza Vaccines) RN - 0 (Vaccines, Attenuated) SB - IM MH - Adolescent MH - Child MH - Child, Preschool MH - Female MH - Humans MH - Influenza Vaccines/*administration & dosage/adverse effects MH - Influenza, Human/*prevention & control/virology MH - Male MH - Vaccination MH - Vaccines, Attenuated/administration & dosage/adverse effects PMC - PMC3256242 EDAT- 2011/06/15 06:00 MHDA- 2012/02/09 06:00 PMCR- 2011/11/01 CRDT- 2011/06/15 06:00 PHST- 2011/06/15 06:00 [entrez] PHST- 2011/06/15 06:00 [pubmed] PHST- 2012/02/09 06:00 [medline] PHST- 2011/11/01 00:00 [pmc-release] AID - IRV243 [pii] AID - 10.1111/j.1750-2659.2011.00243.x [doi] PST - ppublish SO - Influenza Other Respir Viruses. 2011 Nov;5(6):389-97. doi: 10.1111/j.1750-2659.2011.00243.x. Epub 2011 Apr 4.