PMID- 23896581 OWN - NLM STAT- MEDLINE DCOM- 20140506 LR - 20211021 IS - 2164-554X (Electronic) IS - 2164-5515 (Print) IS - 2164-5515 (Linking) VI - 9 IP - 8 DP - 2013 Aug TI - Immunogenicity and safety of three 2010-2011 seasonal trivalent influenza vaccines in Chinese toddlers, children and older adults: a double-blind and randomized trial. PG - 1725-34 LID - 10.4161/hv.24832 [doi] AB - The 2009 influenza A(H1N1) pandemic strain was for the first time included in the 2010-2011 seasonal trivalent influenza vaccine (TIV). We conducted a double-blind, randomized trial in Chinese population to assess the immunogenicity and safety of the 2010-2011 TIV manufactured by GlaxoSmithKline and compared it with the counterpart vaccines manufactured by Sanofi Pasteur and Sinovac Biotech. Healthy toddlers (6-36 mo), children (6-12 y) and older adults (>/=60 y) with 300 participants in each age group were enrolled to randomly receive two doses (toddlers, 28 d apart) or one dose (children and older adults). The immunogenicity was assessed by hemagglutination-inhibition (HI) assay. The solicited injection-site and systemic adverse events (AEs) were collected within 7 d after vaccination. All the three TIVs were well-tolerated with 15.1% of participants reporting AEs, most of which were mild. No serious AEs and unusual AEs were reported. Fever and pain were the most common systemic and injection-site AEs, respectively. The three TIVs showed good immunogenicity. The seroprotection rates against both H1N1 and H3N2 strains were more than 87% in toddlers after two doses and more than 95% in children and more than 86% in older adults after one dose. The seroprotection rates against B strain were 68-71% in toddlers after two doses, 70-74% in children and 69-72% in older adults after one dose. In conclusion, the three 2010-2011 TIVs had good immunogenicity and safety in Chinese toddlers, children and older adults and were generally comparable in immunogenicity and reactogenicity. FAU - Luo, Feng-Ji AU - Luo FJ AD - Beijing Chaoyang District Center for Disease Control and Prevention; Beijing, P.R. China. FAU - Yang, Li-Qing AU - Yang LQ FAU - Ai, Xing AU - Ai X FAU - Bai, Yun-Hua AU - Bai YH FAU - Wu, Jiang AU - Wu J FAU - Li, Shu-Ming AU - Li SM FAU - Zhang, Zheng AU - Zhang Z FAU - Lu, Min AU - Lu M FAU - Li, Li AU - Li L FAU - Wang, Zhao-Yun AU - Wang ZY FAU - Shi, Nian-Min AU - Shi NM LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20130604 PL - United States TA - Hum Vaccin Immunother JT - Human vaccines & immunotherapeutics JID - 101572652 RN - 0 (Antibodies, Viral) RN - 0 (Influenza Vaccines) SB - IM MH - Aged MH - Aged, 80 and over MH - Antibodies, Viral/blood MH - Child MH - Child, Preschool MH - China/epidemiology MH - Double-Blind Method MH - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology MH - Female MH - Hemagglutination Inhibition Tests MH - Humans MH - Infant MH - Influenza A Virus, H1N1 Subtype/immunology MH - Influenza A Virus, H3N2 Subtype/immunology MH - Influenza B virus/immunology MH - Influenza Vaccines/administration & dosage/*adverse effects/*immunology MH - Influenza, Human/*epidemiology/*prevention & control MH - Male MH - Middle Aged PMC - PMC3906273 OTO - NOTNLM OT - immunogenicity OT - influenza OT - influenza A (H1N1) OT - safety OT - seasonal trivalent influenza vaccine OT - vaccine EDAT- 2013/07/31 06:00 MHDA- 2014/05/07 06:00 PMCR- 2014/08/01 CRDT- 2013/07/31 06:00 PHST- 2013/07/31 06:00 [entrez] PHST- 2013/07/31 06:00 [pubmed] PHST- 2014/05/07 06:00 [medline] PHST- 2014/08/01 00:00 [pmc-release] AID - 24832 [pii] AID - 2013HV0059R [pii] AID - 10.4161/hv.24832 [doi] PST - ppublish SO - Hum Vaccin Immunother. 2013 Aug;9(8):1725-34. doi: 10.4161/hv.24832. Epub 2013 Jun 4.