A Phase II, Randomized, Double-Blind, Dosage, Safety and Immunogenicity Trial ofIntramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine combined withAluminum Hydroxide adjuvant in Children, Toddlers, and Infants - NOR-202 Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent VLP Vaccine in Children

Takeda Vaccines, Inc.0 个研究点目标入组 840 人开始时间: 2014年4月24日最近更新: 2018年11月26日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Takeda Vaccines, Inc.
入组人数: 840

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•* Male and female subjects aged between 6 weeks and less than 9 years 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’s legally authorized representative (LAR) 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. An assent will also be obtained according to age appropriate country-specific regulations.
•* Individuals 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: 840
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•1. Subjects with a clinically significant active infection (as assessed by the investigator) or body temperature 38.0°C (100.4°F) or higher within 3 days of the intended date of vaccination.
•2. Subjects who have received antipyretic/analgesic medications within 24 hours prior to the intended vaccine administration.
•3. Known hypersensitivity or allergy to investigational vaccine
•4. Subjects with behavioral 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.
•5. Subjects with a history of any progressive or severe neurologic disorder, seizure disorder, or neuroinflammatory disease (eg, Guillain-Barré syndrome).
•6. Known or suspected impairment/alteration of immune function, including the following:
•a. Children <18 months of age with history of repeated episodes of acute otitis media (AOM) in the first 6 months of life (AOM defined as a bulging tympanic membrane) and not to be confused with otitis media with effusion (OME).
•b. Chronic use of oral steroids (equivalent to 20 mg/day prednisone for =12 weeks/=2 mg/kg body weight/day for =2 weeks) within 60 days prior to Day 1 (use of inhaled, intranasal, or topical corticosteroids is allowed).
•c. Receipt of parenteral steroids (equivalent to 20 mg/day prednisone =12 weeks/=2 mg/kg body weight/day for =2 weeks) within 60 days prior to Day 1.
•d. Receipt of immunostimulants within 60 days prior to Day 1.
•e. Receipt of parenteral, epidural, or intra-articular immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Day 1 or planned during the full length of the trial.
•f. Receipt of immunosuppressive therapy within 6 months prior to Day 1.
•g. Human immunodeficiency virus (HIV) infection or HIV-related disease.
•h. Chronic Hepatitis B or C infection.
•i. Heritable immunodeficiency.
•7. Abnormalities of splenic or thymic function.
•8. Subjects with a known bleeding diathesis or any condition that may be associated with a prolonged bleeding time.
•9. Subjects with any serious chronic or progressive disease according to judgment of the investigator (eg, neoplasm, insulin dependent diabetes, cardiac, renal, or hepatic disease).
•10. Subjects participating in any clinical trial with another investigational product 30 days prior to first trial visit or intent to participate in another clinical trial at any time during the conduct of this trial.
•11. Subjects who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial.
•12. Subjects who are first degree relatives of individuals involved in trial conduct.
•13. Subjects with a history of autoimmune disease.
•14. There may be instances when individuals meet all entry criteria except one that relates to transient clinical circumstances (eg, body temperature elevation or recent use of excluded medication or vaccine). Under these circumstances, a subject may be considered eligible for trial enrollment if the appropriate window for delay has passed, inclusion/exclusion criteria have been rechecked, and if the subject is confirmed to be eligible

研究者

发起方

Takeda Vaccines, Inc.

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