PER-044-22招募中2 期
A Phase 2b, Double-blind, Randomized, Multi-site, Placebo-controlled Trial to Evaluate the Efficacy, Safety and Immunogenicity of Intramuscular HIL-214 Norovirus Vaccine in Healthy Children 5 Months of Age at Initial Vaccination.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 424
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. The subject is aged 5 months (-14/+14 days).
- •2.Male or female.
- •3. Children 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.
- •4. The subject’s 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.
- •5. Children whose LARs can and are willing to comply with trial procedures and are available for the duration of follow-up.
排除标准
- •8. Subjects with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- •1. Clinically significant abnormality in growth by height, weight, or head circumference (according to local guidelines).
- •2. Gastrointestinal abnormalities or any chronic gastrointestinal disease, including any uncorrected congenital malformation of the gastrointestinal tract according to medical history and/or physical examination.
- •3. Known hypersensitivity or allergy to any of the investigational vaccine components (including
- •excipients).
- •4. Any clinically significant active infection (as assessed by the investigator) or temperature =38.0°C (>100.4°F), within 3 days of intended trial vaccination
- •5. Any serious chronic or progressive disease according to the judgment of the investigator (e.g., cardiac, renal or hepatic disease).
- •6. Individuals with history of, e.g., convulsions/febrile convulsions, or any illness, that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the subjects due to participation in the trial.
- •7. Known or suspected impairment/alteration of immune function.
- •9. Subjects who received or are scheduled to receive any routine or authorized vaccine within 14 days (for non-live or orally administered live vaccines) or 28 days (for parenterally administered live vaccines) before or after any dose of trial vaccine.
- •10. Subjects participating in any clinical trial with another investigational product 30 days prior to first trial visit or intend to participate in another clinical trial at any time during the conduct of this trial.
- •11. Subjects known to be positive for or in evaluation for possible human immunodeficiency virus infection.
- •12. Subject’s LAR or subject’s first-degree relatives involved in the trial conduct.
研究者
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