tetano
Editor, Senior Moderator
Vaccine. 2018 Dec 14. pii: S0264-410X(18)31637-2. doi: 10.1016/j.vaccine.2018.11.074. [Epub ahead of print]
[h=1]Efficacy, immunogenicity, and safety of a quadrivalent inactivated influenza vaccine in children aged 6-35 months: A multi-season randomised placebo-controlled trial in the Northern and Southern Hemispheres.[/h] Pepin S[SUP]1[/SUP], Dupuy M[SUP]2[/SUP], Borja-Tabora CFC[SUP]3[/SUP], Montellano M[SUP]4[/SUP], Bravo L[SUP]5[/SUP], Santos J[SUP]6[/SUP], de Castro JA[SUP]7[/SUP], Rivera-Medina DM[SUP]8[/SUP], Cutland C[SUP]9[/SUP], Ariza M[SUP]10[/SUP], Diez-Domingo J[SUP]11[/SUP], Gonzalez CD[SUP]12[/SUP], Martin?n-Torres F[SUP]13[/SUP], Papadopoulou-Alataki E[SUP]14[/SUP], Theodoriadou M[SUP]15[/SUP], Kazek-Duret MP[SUP]16[/SUP], Gurunathan S[SUP]17[/SUP], De Bruijn I[SUP]18[/SUP]; GQM05 Study Group.
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] A quadrivalent split-virion inactivated influenza vaccine (VaxigripTetra?, Sanofi Pasteur; IIV4) containing two A strains (H1N1 and H3N2) and B strains from both lineages (Victoria and Yamagata) was approved in Europe in 2016 for individuals aged ≥ 3 years. This study examined the efficacy and safety of IIV4 in children aged 6-35 months.
[h=4]METHODS:[/h] This was a phase III randomised controlled trial conducted in Latin America, Asia, Africa, and Europe during the Northern Hemisphere 2014/2015 and 2015/2016 and Southern Hemisphere 2014 and 2015 influenza seasons. Healthy children aged 6-35 months not previously vaccinated against influenza were randomised to receive two full doses 28 days apart of IIV4, placebo, the licensed trivalent split-virion inactivated vaccine (IIV3), an investigational IIV3 containing a B strain from the alternate lineage. The primary objective was to demonstrate efficacy against influenza illness caused by any strain or vaccine-similar strains.
[h=4]RESULTS:[/h] The study enrolled 5806 participants. Efficacy, assessed in 4980 participants completing the study according to protocol, was demonstrated for IIV4. Vaccine efficacy was 50.98% (97% CI, 37.36-61.86%) against influenza caused by any A or B type and 68.40% (97% CI, 47.07-81.92%) against influenza caused by vaccine-like strains. Safety profiles were similar for IIV4, placebo, and the IIV3s, although injection-site reactions were slightly more frequent for IIV4 than placebo.
[h=4]CONCLUSIONS:[/h] IIV4 was safe and effective for protecting children aged 6-35 months against influenza illness caused by vaccine-similar or any circulating strains.
[h=4]CLINICAL TRIAL REGISTRATION:[/h] EudraCT no. 2013-001231-51.
Copyright ? 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.
[h=4]KEYWORDS:[/h] Children; Efficacy; Immunogenicity; Quadrivalent inactivated influenza vaccine; Safety
PMID: 30558818 DOI: 10.1016/j.vaccine.2018.11.074
[h=1]Efficacy, immunogenicity, and safety of a quadrivalent inactivated influenza vaccine in children aged 6-35 months: A multi-season randomised placebo-controlled trial in the Northern and Southern Hemispheres.[/h] Pepin S[SUP]1[/SUP], Dupuy M[SUP]2[/SUP], Borja-Tabora CFC[SUP]3[/SUP], Montellano M[SUP]4[/SUP], Bravo L[SUP]5[/SUP], Santos J[SUP]6[/SUP], de Castro JA[SUP]7[/SUP], Rivera-Medina DM[SUP]8[/SUP], Cutland C[SUP]9[/SUP], Ariza M[SUP]10[/SUP], Diez-Domingo J[SUP]11[/SUP], Gonzalez CD[SUP]12[/SUP], Martin?n-Torres F[SUP]13[/SUP], Papadopoulou-Alataki E[SUP]14[/SUP], Theodoriadou M[SUP]15[/SUP], Kazek-Duret MP[SUP]16[/SUP], Gurunathan S[SUP]17[/SUP], De Bruijn I[SUP]18[/SUP]; GQM05 Study Group.
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] A quadrivalent split-virion inactivated influenza vaccine (VaxigripTetra?, Sanofi Pasteur; IIV4) containing two A strains (H1N1 and H3N2) and B strains from both lineages (Victoria and Yamagata) was approved in Europe in 2016 for individuals aged ≥ 3 years. This study examined the efficacy and safety of IIV4 in children aged 6-35 months.
[h=4]METHODS:[/h] This was a phase III randomised controlled trial conducted in Latin America, Asia, Africa, and Europe during the Northern Hemisphere 2014/2015 and 2015/2016 and Southern Hemisphere 2014 and 2015 influenza seasons. Healthy children aged 6-35 months not previously vaccinated against influenza were randomised to receive two full doses 28 days apart of IIV4, placebo, the licensed trivalent split-virion inactivated vaccine (IIV3), an investigational IIV3 containing a B strain from the alternate lineage. The primary objective was to demonstrate efficacy against influenza illness caused by any strain or vaccine-similar strains.
[h=4]RESULTS:[/h] The study enrolled 5806 participants. Efficacy, assessed in 4980 participants completing the study according to protocol, was demonstrated for IIV4. Vaccine efficacy was 50.98% (97% CI, 37.36-61.86%) against influenza caused by any A or B type and 68.40% (97% CI, 47.07-81.92%) against influenza caused by vaccine-like strains. Safety profiles were similar for IIV4, placebo, and the IIV3s, although injection-site reactions were slightly more frequent for IIV4 than placebo.
[h=4]CONCLUSIONS:[/h] IIV4 was safe and effective for protecting children aged 6-35 months against influenza illness caused by vaccine-similar or any circulating strains.
[h=4]CLINICAL TRIAL REGISTRATION:[/h] EudraCT no. 2013-001231-51.
Copyright ? 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.
[h=4]KEYWORDS:[/h] Children; Efficacy; Immunogenicity; Quadrivalent inactivated influenza vaccine; Safety
PMID: 30558818 DOI: 10.1016/j.vaccine.2018.11.074