Trial Profile

A Randomized, Double-Blind, Multicenter, Parallel-Group Comparative Phase III Study Evaluating the Efficacy and Safety of TAK-816 Compared With ActHIB in Healthy Infants.

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 22 Oct 2018

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At a glance

Drugs TAK 816 (Primary) ; Diphtheria tetanus and pertussis vaccine; Hib vaccine conjugate
Indications Diphtheria; Haemophilus infections; Pertussis; Tetanus
Focus Pharmacodynamics; Registrational
Sponsors Takeda

16 Feb 2018 Results published in the Vaccine
22 Jan 2016 According to Takeda media release, the Japanese Ministry of Health, Labour and Welfare has approved the New Drug Application ("NDA") for a conjugate vaccine to prevent infections caused by Haemophilus influenzae type b (Hib) in children aged from 2 months to under 5 years of age.
26 Sep 2013 An NDA was submitted in Japan for TAK-816 for prevention of invasive Hib disease in children based on positive results from this trial, according to a Takeda media release.

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