title: Immunogenicity and safety of three 2010-2011 seasonal trivalent influenza vaccines in Chinese toddlers, children and older adults: a double-blind and randomized trial.
abstract: 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.
authors.affiliation: Beijing Chaoyang District Center for Disease Control and Prevention; Beijing, P.R. China.
authors.forename: Feng-Ji
authors.initials: FJ
authors.lastname: Luo
authors.forename: Li-Qing
authors.initials: LQ
authors.lastname: Yang
authors.forename: Xing
authors.initials: X
authors.lastname: Ai
authors.forename: Yun-Hua
authors.initials: YH
authors.lastname: Bai
authors.forename: Jiang
authors.initials: J
authors.lastname: Wu
authors.forename: Shu-Ming
authors.initials: SM
authors.lastname: Li
authors.forename: Zheng
authors.initials: Z
authors.lastname: Zhang
authors.forename: Min
authors.initials: M
authors.lastname: Lu
authors.forename: Li
authors.initials: L
authors.lastname: Li
authors.forename: Zhao-Yun
authors.initials: ZY
authors.lastname: Wang
authors.forename: Nian-Min
authors.initials: NM
authors.lastname: Shi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D002681:China / Q000453:epidemiology; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007223:Infant; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology; D053122:Influenza A Virus, H3N2 Subtype / Q000276:immunology; D009981:Influenza B virus / Q000276:immunology; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000453:epidemiology* / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines
keywords: immunogenicity; influenza; influenza A (H1N1); safety; seasonal trivalent influenza vaccine; vaccine
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