@article{3186331,
    title = "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",
    author = "Pepin, Stephanie and Dupuy, Martin and Corazon Borja-Tabora, Charissa and Fay and Montellano, May and Bravo, Lulu and Santos, Jaime and de Castro, and Jo-Anne and Rivera-Medina, Doris Maribel and Cutland, Clare and Ariza, and Miguel and Diez-Domingo, Javier and Diaz Gonzalez, Celia and and Martinon-Torres, Federico and Papadopoulou-Alataki, Efimia and and Theodoriado, Maria and Kazek-Duret, Marie Pierre and Gurunathan, Sanjay and and De Bruijn, Iris and Abalos, Karina and Aurell, Helena and Maria and Baldo, Jose and Bona, Gianni and Angel, Miguel and Cadorna-Carlos, and Josefina and Cangrejo, Marcela and Capilna, Brindusa Ruxandra and Cara, and Alexandra Carmen and Carmona Martinez, Alfonso and Chemin, Frederic and and Closa, Ricardo and Cots, Manuel Baca and Coux, Florence and and Diez-Domingo, Javier and Dracea, Laura Larisa and Emporiadou, Maria and and Espiau, Maria and Esposito, Susanna and Pecurariu, Oana Asso Falup and and Garces-Sanchez, Maria and Garg, Sanjay and Gil, Amparo and Gonzales, and Laurie and Guevel, Ronan and Guillen, Sara and Icardi, Giancarlo and and Laot, Thelma and Lacroix, Isabelle and Mares, Josep and Martinez Pons, and Manuel and Moreau, Catherine and Neamtu, Mihai Leonida and Neculau, and Andrea Elena and Ojeda, Joyce and Papaevangelou, Vana and Penon, Maria and Gabriella and Petit, Celine and Philibert, Marie and Planelles and Cantarino, Victoria and Py, Marie-Laure and Ramos, Jose T. and Rivas, and Enrique and Roilides, Emmanouel and Rosich, Angels and Salamand, Camille and and Suarez, Eva and Surdu, Gabriel Doru and Cerdan Vera, Teresa and and Tsolia, Mariza and Vicedo, Mira and Woods, Anne and GQM05 Study Grp",
    journal = "Vaccine",
    year = "2019",
    volume = "37",
    number = "13",
    pages = "1876-1884",
    publisher = "Elsevier Sci Ltd, Exeter, United Kingdom",
    issn = "0264-410X",
    doi = "10.1016/j.vaccine.2018.11.074",
    keywords = "Quadrivalent inactivated influenza vaccine; Children; Efficacy; Safety;
Immunogenicity",
    abstract = "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."
}