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Immunogenicity and safety of three 2010-2011 seasonal trivalent influenza vaccines in Chinese toddlers, children and older adults: a double-blind and randomized trial.
Hum Vaccin Immunother. 2013 Aug; 9(8):1725-34.HV

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+Show Affiliations

Beijing Chaoyang District Center for Disease Control and Prevention; Beijing, P.R. China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23896581

Citation

Luo, Feng-Ji, et al. "Immunogenicity and Safety of Three 2010-2011 Seasonal Trivalent Influenza Vaccines in Chinese Toddlers, Children and Older Adults: a Double-blind and Randomized Trial." Human Vaccines & Immunotherapeutics, vol. 9, no. 8, 2013, pp. 1725-34.
Luo FJ, Yang LQ, Ai X, et al. Immunogenicity and safety of three 2010-2011 seasonal trivalent influenza vaccines in Chinese toddlers, children and older adults: a double-blind and randomized trial. Hum Vaccin Immunother. 2013;9(8):1725-34.
Luo, F. J., Yang, L. Q., Ai, X., Bai, Y. H., Wu, J., Li, S. M., Zhang, Z., Lu, M., Li, L., Wang, Z. Y., & Shi, N. M. (2013). Immunogenicity and safety of three 2010-2011 seasonal trivalent influenza vaccines in Chinese toddlers, children and older adults: a double-blind and randomized trial. Human Vaccines & Immunotherapeutics, 9(8), 1725-34. https://doi.org/10.4161/hv.24832
Luo FJ, et al. Immunogenicity and Safety of Three 2010-2011 Seasonal Trivalent Influenza Vaccines in Chinese Toddlers, Children and Older Adults: a Double-blind and Randomized Trial. Hum Vaccin Immunother. 2013;9(8):1725-34. PubMed PMID: 23896581.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of three 2010-2011 seasonal trivalent influenza vaccines in Chinese toddlers, children and older adults: a double-blind and randomized trial. AU - Luo,Feng-Ji, AU - Yang,Li-Qing, AU - Ai,Xing, AU - Bai,Yun-Hua, AU - Wu,Jiang, AU - Li,Shu-Ming, AU - Zhang,Zheng, AU - Lu,Min, AU - Li,Li, AU - Wang,Zhao-Yun, AU - Shi,Nian-Min, Y1 - 2013/06/04/ PY - 2013/7/31/entrez PY - 2013/7/31/pubmed PY - 2014/5/7/medline KW - immunogenicity KW - influenza KW - influenza A (H1N1) KW - safety KW - seasonal trivalent influenza vaccine KW - vaccine SP - 1725 EP - 34 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 9 IS - 8 N2 - 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. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/23896581/Immunogenicity_and_safety_of_three_2010_2011_seasonal_trivalent_influenza_vaccines_in_Chinese_toddlers_children_and_older_adults:_a_double_blind_and_randomized_trial_ L2 - https://www.tandfonline.com/doi/full/10.4161/hv.24832 DB - PRIME DP - Unbound Medicine ER -