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

被引：36

作者：

Pepin, Stephanie ^{[1
]}

Dupuy, Martin ^{[1
]}

Corazon Borja-Tabora, Charissa Fay ^{[2
]}

Montellano, May ^{[3
]}

Bravo, Lulu ^{[4
]}

Santos, Jaime ^{[5
]}

de Castro, Jo-Anne ^{[6
]}

Rivera-Medina, Doris Maribel ^{[7
]}

Cutland, Clare ^{[8
]}

Ariza, Miguel ^{[9
]}

Diez-Domingo, Javier ^{[10
,27
]}

Diaz Gonzalez, Celia ^{[11
]}

Martinon-Torres, Federico ^{[12
,13
]}

Papadopoulou-Alataki, Efimia ^{[14
]}

Theodoriado, Maria ^{[15
]}

Kazek-Duret, Marie Pierre ^{[1
]}

Gurunathan, Sanjay ^{[16
]}

De Bruijn, Iris ^{[1
]}

Abalos, Karina ^{[17
]}

Aurell, Helena ^{[1
]}

Maria Baldo, Jose ^{[18
]}

Bona, Gianni ^{[19
]}

Angel, Miguel ^{[20
]}

Cadorna-Carlos, Josefina ^{[21
]}

Cangrejo, Marcela ^{[22
]}

Capilna, Brindusa Ruxandra ^{[23
]}

Cara, Alexandra Carmen

Carmona Martinez, Alfonso ^{[24
]}

Chemin, Frederic

Closa, Ricardo ^{[25
]}

Cots, Manuel Baca ^{[26
]}

Coux, Florence ^{[1
]}

Diez-Domingo, Javier ^{[10
,27
]}

Dracea, Laura Larisa

Emporiadou, Maria ^{[28
]}

Espiau, Maria ^{[29
]}

Esposito, Susanna ^{[30
]}

Pecurariu, Oana Asso Falup ^{[31
]}

Garces-Sanchez, Maria ^{[27
]}

Garg, Sanjay ^{[1
]}

Gil, Amparo ^{[32
]}

Gonzales, Laurie ^{[1
]}

Guevel, Ronan ^{[1
]}

Guillen, Sara ^{[33
]}

Icardi, Giancarlo ^{[30
]}

Laot, Thelma ^{[34
]}

Lacroix, Isabelle ^{[1
]}

Mares, Josep ^{[35
]}

Martinez Pons, Manuel ^{[36
]}

Moreau, Catherine ^{[1
]}

机构：

[1] Sanofi Pasteur, 1541 Ave Marcel Merieux, F-69280 Marcy Letoile, France

[2] Res Inst Trop Med, Muntinlupa, Philippines

[3] Mary Chiles Gen Hosp, Manila, Philippines

[4] Univ Philippines Manila, Natl Inst Hlth, Manila, Philippines

[5] Philippine Childrens Med Ctr, Quezon City, Philippines

[6] DLSUMC De La Salle Hlth Sci Inst, Dasmarinas, Cavite, Philippines

[7] Invers Invest Med SA, Tegucigalpa, Honduras

[8] Chris Hani Baragwanath Hosp, Johannesburg, South Africa

[9] Caimed Dominicana AS Invest Salud, Santo Domingo, Dominican Rep

[10] FISABIO Publ Hlth, Valencia, Spain

[11] Hosp Infanta La Paz, Madrid, Spain

[12] Univ Santiago de Compostela, Translat Pediat & Infect Dis, Santiago De Compostela, Spain

[13] Univ Santiago, Inst Invest Sanitaria Santiago, Genet Vaccines & Infect Dis Res Grp GENVIP, Santiago, Spain

[14] Aristotle Univ Thessaloniki, Sch Med, Thessaloniki, Greece

[15] Childrens Hosp Aghia Sofia, Athens, Greece

[16] Sanofi Pasteur, Swiftwater, PA USA

[17] Sanofi Pasteur, Taguig City, Philippines

[18] Ctr Salud Quart de Poblet, Valencia, Spain

[19] Univ Piemonte Orientale, Novara, Italy

[20] Ctr Salud Illes Columbretes, Castellon De La Plana, Castellon, Spain

[21] Univ East Ramon Magsaysay, Quezon City, Philippines

[22] Sanofi Pasteur, Bogota, Colombia

[23] Ultratest SRL, Targu Mures, Romania

[24] Inst Hispalense Pediat Sevilla, Seville, Spain

[25] Univ Rovira & Virgili, Tarragona, Spain

[26] Hosp Quiron Salud, Madrid, Spain

[27] Ctr Super Invest Salud Publ, Valencia, Spain

[28] Aristotle Univ Thessaloniki, Thessaloniki, Greece

[29] Univ Hosp Vall dHebron, Barcelona, Spain

[30] Univ Genoa, Genoa, Italy

[31] Transylvania Univ, Brasov, Romania

[32] Ctr Salud Malvarrosa, Valencia, Spain

[33] Hosp Univ Getafe, Madrid, Spain

[34] Sanofi Pasteur, Manila, Philippines

[35] Inst Pediat Mares Riera, Girona, Spain

[36] CS Republ Argentina, Valencia, Spain

[37] Lucian Blaga Univ Sibiu, Sibiu, Romania

[38] Sanofi Pasteur, Mexico City, DF, Mexico

[39] Univ Athens, Sch Med, Athens, Greece

[40] ULSS179 Presidio Osped Este Dipartimento PD, Este, Italy

[41] Hosp Clin San Carlos, Madrid, Spain

[42] Aristotle Univ Thessaloniki, Thessaloniki, Greece

[43] Ctr Salud Burriana 2, Borriana, Castello, Spain

[44] Ctr Salud Petrer 1, Petrer, Alacant, Spain

来源：

VACCINE | 2019年 / 37卷 / 13期

关键词：

Quadrivalent inactivated influenza vaccine; Children; Efficacy; Safety; Immunogenicity; PHASE-III; BURDEN; VIRUS; ADULTS; IMPACT;

D O I：

10.1016/j.vaccine.2018.11.074

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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.

引用

页码：1876 / 1884

页数：9

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