• Pediatr. Infect. Dis. J. · Jul 2015

    Randomized Controlled Trial Multicenter Study

    Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine in Children 6 Months to 17 Years of Age, Previously Vaccinated with an AS03-Adjuvanted A(H1N1)Pdm09 Vaccine: Two Open-label, Randomized Trials.

    • Timo Vesikari, Jan Hendrik Richardus, Johan Berglund, Tiina Korhonen, Carl-Erik Flodmark, Ann Lindstrand, Sven Arne Silfverdal, Vinod Bambure, Adrian Caplanusi, Ilse Dieussaert, Sumita Roy-Ghanta, and David W Vaughn.
    • From the *Vaccine Research Center, University of Tampere Medical School, Tampere, Finland; †Department of Infectious Disease Control, Municipal Public Health Service (GGD) Rotterdam-Rijnmond, Rotterdam, The Netherlands; ‡School of Health Science, Blekinge Institute of Technology, Karlskrona, Sweden; §Childhood Obesity Unit, Skåne University Hospital, Malmö, Sweden; ¶Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden; ‖Department of Clinical Sciences, Umeå University, Umeå, Sweden; **Quanticate, Bangalore, India; ††GSK Vaccines, Wavre, Belgium; ‡‡GSK Vaccines, Rixensart, Belgium; and §§GSK Vaccines, King of Prussia, PA.
    • Pediatr. Infect. Dis. J. 2015 Jul 1; 34 (7): 774-82.

    BackgroundDuring the influenza pandemic 2009-2010, an AS03-adjuvanted A(H1N1)pdm09 vaccine was used extensively in children 6 months of age and older, and during the 2010-2011 influenza season, the A(H1N1)pdm09 strain was included in the seasonal trivalent inactivated influenza vaccine (TIV) without adjuvant. We evaluated the immunogenicity and safety of TIV in children previously vaccinated with the AS03-adjuvanted A(H1N1)pdm09 vaccine.MethodsHealthy children were randomized (1:1) to receive TIV or a control vaccine. Children were aged 6 months to 9 years (n = 154) and adolescents 10-17 years (n = 77) when they received AS03-adjuvanted A(H1N1)pdm09 vaccine at least 6 months before study enrolment. Hemagglutination inhibition (HI) and neutralizing antibody responses against the A(H1N1)pdm09 strain were evaluated before (day 0) and at day 28 and month 6 after study vaccination. Reactogenicity was assessed during the 7 day postvaccination period, and safety was assessed for 6 months.ResultsAt day 0, >93.9% of all children had HI titers ≥1:40 for the A(H1N1)pdm09 strain, which increased to 100% at both day 28 and month 6 in the TIV group. Between days 0 and 28, HI antibody geometric mean titers against A(H1N1)pdm09 increased by 9-fold and 4-fold in children 6 months to 9 years of age and 10-17 years of age, respectively.ConclusionAS03-adjuvanted A(H1N1)pdm09 vaccine-induced robust immune responses in children that persisted into the next season, yet were still boosted by TIV containing A(H1N1)pdm09. The reactogenicity and safety profile of TIV did not appear compromised by prior receipt of AS03-adjuvanted A(H1N1)pdm09 vaccine.

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