A Phase II, Randomized, Controlled, Double-Blind, Dosage and Adjuvant Justification, Safety and Immunogenicity Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine Adjuvanted with or without Monophosphoryl Lipid A and Aluminum Hydroxide in Adolescents and Adults - NOR-107 Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent VLP Vaccine

Takeda Vaccines (Montana), Inc.0 个研究点目标入组 420 人开始时间: 2013年12月4日最近更新: 2022年5月23日

适应症

试验速览

暂无简介。

•- Male and female subjects between 17 and 64 years of age at the time of enrollment.
•- Subjects who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and clinical judgment of the investigator.
•- The subject or, when applicable, the subject’s legally acceptable representative signs and dates a written, informed consent form (and assent form in the case of adolescents) and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
•- Subjects who can comply with trial procedures and are available for the duration of the trial.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 20
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 400
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Subjects who have received any vaccination that included Hepatitis A vaccine within the last 5 years.
•- Subjects with known hypersensitivity to any of the vaccine components.
•- Subjects with contraindications, warnings, and/or precautions to vaccinations with Havrix.
•- Subjects with known or suspected impairment/alteration of immune function.
•- Female subjects who are pregnant or breastfeeding

发起方

Takeda Vaccines (Montana), Inc.