Περίληψη:
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.
Συγγραφείς:
Pepin, Stephanie
Dupuy, Martin
Corazon Borja-Tabora, Charissa
Fay
Montellano, May
Bravo, Lulu
Santos, Jaime
de Castro,
Jo-Anne
Rivera-Medina, Doris Maribel
Cutland, Clare
Ariza,
Miguel
Diez-Domingo, Javier
Diaz Gonzalez, Celia and
Martinon-Torres, Federico
Papadopoulou-Alataki, Efimia and
Theodoriado, Maria
Kazek-Duret, Marie Pierre
Gurunathan, Sanjay
and De Bruijn, Iris
Abalos, Karina
Aurell, Helena
Maria
Baldo, Jose
Bona, Gianni
Angel, Miguel
Cadorna-Carlos,
Josefina
Cangrejo, Marcela
Capilna, Brindusa Ruxandra
Cara,
Alexandra Carmen
Carmona Martinez, Alfonso
Chemin, Frederic and
Closa, Ricardo
Cots, Manuel Baca
Coux, Florence and
Diez-Domingo, Javier
Dracea, Laura Larisa
Emporiadou, Maria and
Espiau, Maria
Esposito, Susanna
Pecurariu, Oana Asso Falup and
Garces-Sanchez, Maria
Garg, Sanjay
Gil, Amparo
Gonzales,
Laurie
Guevel, Ronan
Guillen, Sara
Icardi, Giancarlo and
Laot, Thelma
Lacroix, Isabelle
Mares, Josep
Martinez Pons,
Manuel
Moreau, Catherine
Neamtu, Mihai Leonida
Neculau,
Andrea Elena
Ojeda, Joyce
Papaevangelou, Vana
Penon, Maria
Gabriella
Petit, Celine
Philibert, Marie
Planelles
Cantarino, Victoria
Py, Marie-Laure
Ramos, Jose T.
Rivas,
Enrique
Roilides, Emmanouel
Rosich, Angels
Salamand, Camille
and Suarez, Eva
Surdu, Gabriel Doru
Cerdan Vera, Teresa and
Tsolia, Mariza
Vicedo, Mira
Woods, Anne
GQM05 Study Grp
