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Human Vaccines & Immunotherapeutics Volume 12, 2016 - Issue 12
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Research Papers

Safety and immunogenicity of an intramuscular quadrivalent influenza vaccine in children 3 to 8 y of age: A phase III randomized controlled study

Stephanie PepinSanofi Pasteur, Marcy-l'Étoile, FranceCorrespondence[email protected]
,
Henryk SzymanskiDepartment of Pediatrics, St. Hedvig of Silesia Hospital, Trzebnica, Poland
,
Ilya Angélica Rochín KobashiCentro de Investigación Clínica del Pacífico (CICPA), Acapulco, Guerrero, Mexico
,
Sandra Villagomez MartinezInstituto Nacional de Pediatria, Centro Pediátrico de Investigación Comunitario-Tlaltizapan, Tlaltizapan, Morelos, Mexico
,
José Francisco González ZamoraInstituto Nacional de Pediatria, Unidad de Apoyo a la Investigación Clinica – Planta Baja Insurgentes Sur #3700-C, Coyoacán, Mexico, D.F.
,
Jerzy BrzostekZespół Opieki Zdrowotnej, Poradnia Chorób Zakaźnych, Dębica, Poland
,
Li-Min HuangNational Taiwan University Hospital, Department of Pediatrics, Division of Infectious Diseases 7, Taipei, Taiwan, R.O.C
,
Cheng-Hsun ChiuDepartment of Pediatrics, Chang Gung Children's Hospital, Chang Gung University, Kweishan, Taoyuan, Taiwan, R.O.C.
,
Po-Yen ChenTaichung Veterans General Hospital, Taichung, Taiwan, R.O.C
,
Anitta AhonenVaccine Research Centre, University of Tampere Medical School, Tampere, Finland
,
Aino ForsténVaccine Research Centre, University of Tampere Medical School, Tampere, Finland
,
Ilkka SeppäVaccine Research Centre, University of Tampere Medical School, Tampere, Finland
,
René Farfán QuirozHospital Infantil de Tlaxcala, Calle 20 de Noviembre s/n, Carretera a San Damian Tlacocalpan, Km. 2.5 San Matías Tepetomatitlan, Municipio de Apetatitlan de Antonio Carvajal, Tlaxcala, Mexico
,
Tiina KorhonenVaccine Research Centre, University of Tampere Medical School, Tampere, Finland
,
Enrique RivasSanofi Pasteur, Coyoacan, Cd de Mexico, D.F.
,
Celine MonfredoSanofi Pasteur, Marcy-l'Étoile, France
,
Yanee HutagalungSanofi Pasteur, Singapore
,
Josemund MenezesSanofi Pasteur, Singapore
&
Timo VesikariVaccine Research Centre, University of Tampere Medical School, Tampere, Finland
 show all
Pages 3072-3078 | Received 28 Apr 2016, Accepted 07 Jul 2016, Published online: 16 Sep 2016

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Jianmin Chen, Feng Jiang, Chenyan Zhao, Jing Chai, Lanshu Li, Qinghu Guan, Xiaoyu Li, Feiyu Wang, Ansheng Li, Hongxia Gao, Minghui Wang, Liandi Fu, Fei Nie, Weijun Ling, Haobin Deng & Lei Zhou. (2023) Immunogenicity and safety of the quadrivalent inactivated split-virion influenza vaccine in populations aged ≥ 3 years: A phase 3, randomized, double-blind, non-inferiority clinical trial. Human Vaccines & Immunotherapeutics 19:2.
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Xiaoqiang Liu, Juliana Park, Shengli Xia, Bin Liang, Shuangmin Yang, Yanxia Wang, Olga Syrkina, Nathalie Lavis, Shuzhen Liu, Chenyan Zhao, Jian Ding, Jieqiong Hu, Sandrine I. Samson & Iris A. de Bruijn. (2022) Immunological non-inferiority and safety of a quadrivalent inactivated influenza vaccine versus two trivalent inactivated influenza vaccines in China: Results from two studies. Human Vaccines & Immunotherapeutics 18:6.
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Xiaoyuan Huang, Ting Fan, Li Li, Xuanxuan Nian, Jiayou Zhang, Xuefen Gao, Wei Zhao, Wei Chen, Zhaoqing Zhang, Zhihao Yao, Xixin Han, Jinrong Shi, Ying Wang, Haihe Bian, Nianmin Shi, Xinguo Li, Kai Duan, Guohua Li & Xiaoming Yang. (2022) Safety and immunogenicity of a quadrivalent, inactivated, split-virion influenza vaccine (IIV4-W) in healthy people aged 3-60 years: a phase III randomized clinical noninferiority trial. Human Vaccines & Immunotherapeutics 18:5.
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Vu Dinh Thiem, Anne-Laure Chabanon, Marion Fournier, Nathalie Lavis, Nguyen Dang Quang, Vu Hai Ha & Melvin Sanicas. (2021) Safety of a quadrivalent influenza vaccine in Vietnamese healthy subjects aged 6 months and older. Human Vaccines & Immunotherapeutics 17:3, pages 690-693.
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Joyce Ojeda, José Luis Arredondo, Perla Salcedo, Mercedes Paredes-Paredes, Martin Dupuy, Celine Petit, Anne Laure Chabanon, Enrique Rivas, Sanjay Gurunathan, Iris De Bruijn & Stephanie Pepin. (2020) Immunogenicity and safety of a multi-dose quadrivalent inactivated influenza vaccine in individuals aged 6 months to 17 years: a randomized phase III trial. Human Vaccines & Immunotherapeutics 16:6, pages 1380-1384.
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Sanie Sesay, Jerzy Brzostek, Ingo Meyer, Yves Donazzolo, Geert Leroux-Roels, Régine Rouzier, Béatrice Astruc, Henryk Szymanski, Nicole Toursarkissian, Corinne Vandermeulen, Edyta Kowalska, Pierre Van Damme, Camille Salamand & Stephanie Pepin. (2018) Safety, immunogenicity, and lot-to-lot consistency of a split-virion quadrivalent influenza vaccine in younger and older adults: A phase III randomized, double-blind clinical trial. Human Vaccines & Immunotherapeutics 14:3, pages 596-608.
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Viviane Gresset-Bourgeois, Phillip S. Leventhal, Stéphanie Pepin, Rosalind Hollingsworth, Marie-Pierre Kazek-Duret, Iris De Bruijn & Sandrine I. Samson. (2018) Quadrivalent inactivated influenza vaccine (VaxigripTetra™). Expert Review of Vaccines 17:1, pages 1-11.
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Margaret Haugh, Viviane Gresset-Bourgeois, Bérengère Macabeo, Anne Woods & Sandrine I. Samson. (2017) A trivalent, inactivated influenza vaccine (Vaxigrip®): summary of almost 50 years of experience and more than 1.8 billion doses distributed in over 120 countries. Expert Review of Vaccines 16:6, pages 545-564.
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Articles from other publishers (11)

Sunho Choe, Oxana Talanova, Sooyoun Shin, Olga Syrkina & Marion Fournier. (2023) Post-Marketing Safety Surveillance of Quadrivalent Influenza Vaccine (VaxigripTetra) in Children Aged 6 to 35 Months in South Korea. Infectious Diseases and Therapy 12:6, pages 1715-1723.
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Sookyung Lim, Xiaoling Li, Olga Syrkina & Marion Fournier. (2022) Post-marketing Surveillance of a Quadrivalent Influenza Vaccine (Vaxigrip Tetra) in South Korea. Infectious Diseases and Therapy 11:5, pages 2035-2043.
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Amit Bansal, Mai-Chi Trieu, Kristin G. I. Mohn & Rebecca Jane Cox. (2021) Safety, Immunogenicity, Efficacy and Effectiveness of Inactivated Influenza Vaccines in Healthy Pregnant Women and Children Under 5 Years: An Evidence-Based Clinical Review. Frontiers in Immunology 12.
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Jidang Chen, Jiehuang Wang, Jipei Zhang & Hinh Ly. (2021) Advances in Development and Application of Influenza Vaccines. Frontiers in Immunology 12.
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Timo Vesikari, Jos Nauta, Giulia Lapini, Emanuele Montomoli & Serge van de Witte. (2020) Immunogenicity and safety of quadrivalent versus trivalent inactivated subunit influenza vaccine in children and adolescents: A phase III randomized study. International Journal of Infectious Diseases 92, pages 29-37.
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Chenyang Huang, Xiaofang Fu, Yuqing Zhou, Fenfang Mi, Guo Tian, Xiaoxiao Liu, Jie Wu, Cheng Ding, Danying Yan, Lanjuan Li & Shigui Yang. (2020) Comparison of the immunogenicity and safety of quadrivalent and tetravalent influenza vaccines in children and adolescents. Vaccine 38:6, pages 1332-1344.
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Byung Wook Eun, Taek Jin Lee, Jina Lee, Ki Hwan Kim, Dong Ho Kim, Dae Sun Jo, Sun Hee Shin, Hun Kim, Kyung-Ho Kim & Yun-Kyung Kim. (2019) A Randomized, Double-blind, Active-controlled Phase III Trial of a Cell Culture-derived Quadrivalent Inactivated Influenza Vaccine in Healthy South Korean Children and Adolescents 6 Months to 18 Years of Age. Pediatric Infectious Disease Journal 38:9, pages e209-e215.
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Stephanie Pepin, Martin Dupuy, Charissa Fay Corazon Borja-Tabora, May Montellano, Lulu Bravo, Jaime Santos, Jo-Anne de Castro, Doris Maribel Rivera-Medina, Clare Cutland, Miguel Ariza, Javier Diez-Domingo, Celia Diaz Gonzalez, Federico Martinón-Torres, Efimia Papadopoulou-Alataki, Maria Theodoriadou, Marie Pierre Kazek-Duret, Sanjay Gurunathan & Iris De Bruijn. (2019) 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. Vaccine 37:13, pages 1876-1884.
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Timo Vesikari, Judith Kirstein, Grace Devota Go, Brett Leav, Mary Ellen Ruzycky, Leah Isakov, Marianne de Bruijn, Janine Oberye & Esther Heijnen. (2018) Efficacy, immunogenicity, and safety evaluation of an MF59-adjuvanted quadrivalent influenza virus vaccine compared with non-adjuvanted influenza vaccine in children: a multicentre, randomised controlled, observer-blinded, phase 3 trial. The Lancet Respiratory Medicine 6:5, pages 345-356.
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Emanuele Montomoli, Alessandro Torelli, Ilaria Manini & Elena Gianchecchi. (2018) Immunogenicity and Safety of the New Inactivated Quadrivalent Influenza Vaccine Vaxigrip Tetra: Preliminary Results in Children ≥6 Months and Older Adults. Vaccines 6:1, pages 14.
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Janienne Kondrich & Michele Rosenthal. (2017) Influenza in children. Current Opinion in Pediatrics 29:3, pages 297-302.
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