Immunogenicity and safety of a fully liquid aluminum phosphate ... - Core

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Jul 26, 2016 - Study investigators and sites were as follows: Shinya Enomoto,. MD, Enomoto ... Japan; Hiroshi Taniguchi, MD, Taniguchi Children Clinic,.
Vaccine 34 (2016) 4635–4641

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Immunogenicity and safety of a fully liquid aluminum phosphate adjuvanted Haemophilus influenzae type b PRP-CRM197-conjugate vaccine in healthy Japanese children: A phase III, randomized, observer-blind, multicenter, parallel-group study Takehiro Togashi a, Nodoka Mitsuya b,⇑, Osamu Kogawara b, Shuji Sumino b, Yohei Takanami b, Kayoko Sugizaki b a b

Hokkaido Anti-Tuberculosis Assoiciation, Kita 8, Nishi 3-28, Kita-ku, Sapporo 060-0808, Japan Takeda Pharmaceutical Company Limited, 1-1 Doshomachi 4-chome, Chuo-ku, Osaka 540-8645, Japan

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Article history: Received 17 February 2016 Received in revised form 18 May 2016 Accepted 18 May 2016 Available online 26 July 2016 Keywords: Haemophilus influenzae type b Vaccine Phase III trial Immunogenicity Safety Japan

a b s t r a c t Background: Broad use of monovalent Haemophilus influenzae type b (Hib) conjugate vaccines based on the capsular polysaccharide polyribosyl-ribitol phosphate (PRP), has significantly reduced invasive Hib disease burden in children worldwide, particularly in children aged