TY - JOUR
TI - 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
AU - Pepin, Stephanie
AU - Dupuy, Martin
AU - Corazon Borja-Tabora, Charissa
AU - Fay
AU - Montellano, May
AU - Bravo, Lulu
AU - Santos, Jaime
AU - de Castro,
AU - Jo-Anne
AU - Rivera-Medina, Doris Maribel
AU - Cutland, Clare
AU - Ariza,
AU - Miguel
AU - Diez-Domingo, Javier
AU - Diaz Gonzalez, Celia and
AU - Martinon-Torres, Federico
AU - Papadopoulou-Alataki, Efimia and
AU - Theodoriado, Maria
AU - Kazek-Duret, Marie Pierre
AU - Gurunathan, Sanjay
AU - and De Bruijn, Iris
AU - Abalos, Karina
AU - Aurell, Helena
AU - Maria
AU - Baldo, Jose
AU - Bona, Gianni
AU - Angel, Miguel
AU - Cadorna-Carlos,
AU - Josefina
AU - Cangrejo, Marcela
AU - Capilna, Brindusa Ruxandra
AU - Cara,
AU - Alexandra Carmen
AU - Carmona Martinez, Alfonso
AU - Chemin, Frederic and
AU - Closa, Ricardo
AU - Cots, Manuel Baca
AU - Coux, Florence and
AU - Diez-Domingo, Javier
AU - Dracea, Laura Larisa
AU - Emporiadou, Maria and
AU - Espiau, Maria
AU - Esposito, Susanna
AU - Pecurariu, Oana Asso Falup and
AU - Garces-Sanchez, Maria
AU - Garg, Sanjay
AU - Gil, Amparo
AU - Gonzales,
AU - Laurie
AU - Guevel, Ronan
AU - Guillen, Sara
AU - Icardi, Giancarlo and
AU - Laot, Thelma
AU - Lacroix, Isabelle
AU - Mares, Josep
AU - Martinez Pons,
AU - Manuel
AU - Moreau, Catherine
AU - Neamtu, Mihai Leonida
AU - Neculau,
AU - Andrea Elena
AU - Ojeda, Joyce
AU - Papaevangelou, Vana
AU - Penon, Maria
AU - Gabriella
AU - Petit, Celine
AU - Philibert, Marie
AU - Planelles
AU - Cantarino, Victoria
AU - Py, Marie-Laure
AU - Ramos, Jose T.
AU - Rivas,
AU - Enrique
AU - Roilides, Emmanouel
AU - Rosich, Angels
AU - Salamand, Camille
AU - and Suarez, Eva
AU - Surdu, Gabriel Doru
AU - Cerdan Vera, Teresa and
AU - Tsolia, Mariza
AU - Vicedo, Mira
AU - Woods, Anne
AU - GQM05 Study Grp
JO - Vaccine
PY - 2019
VL - 37
TODO - 13
SP - 1876-1884
PB - Elsevier Sci Ltd, Exeter, United Kingdom
SN - 0264-410X
TODO - 10.1016/j.vaccine.2018.11.074
TODO - Quadrivalent inactivated influenza vaccine; Children; Efficacy; Safety;
Immunogenicity
TODO - Background: A quadrivalent split-virion inactivated influenza vaccine
(VaxigripTetre (TM), 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.
Methods: 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 splitvirion 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.
Results: 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.
Conclusions: IIV4 was safe and effective for protecting children aged
6-35 months against influenza illness caused by vaccine-similar or any
circulating strains. (C) 2018 The Authors. Published by Elsevier Ltd.
ER -