A Phase 2, Long-Term Immunogenicity Follow-up Trial of Adult and Elderly Subjects who have Previously Received an Intramuscular Injection of Norovirus GI.1/GII.4 BivalentVirus-Like Particle Vaccine

Takeda Vaccines, Inc.0 个研究点目标入组 800 人开始时间: 2017年2月14日最近更新: 2021年10月26日

适应症

试验速览

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•1. The subject is aged over 18 years.
•2. Male and female subjects who previously received at least 1 dose of NoV vaccine in trials NOR-107, NOR-210, NOR-204 and NOR-222, have baseline and post-vaccination data, and completed the primary vaccination trial protocol as initially described.
•3. The subject signs and dates a written, informed consent form (ICF) 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.
•4. Individuals who can comply with trial procedures and are available for the duration of follow-up
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 550
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 250

•Any subject who meets any of the following criteria will not qualify for entry into the trial:
•1. Participation in any clinical trial is allowed, on condition that no investigational product is administered within 30 days prior to blood sampling.
•2. In the opinion of the investigator, the subject is not medically eligible to provide blood specimens.
•3. Individuals with behavioural or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject’s ability to participate in the trial.
•There may be instances when individuals meet all entry criteria except one that relates to transient clinical circumstances (e.g., temperature elevation or recent vaccine). Under these circumstances,
•eligibility for trial enrolment may be considered if the appropriate window for delay has passed, inclusion/exclusion criteria have been rechecked, and if the subject is confirmed to be eligible.

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