EUCTR2017-001071-23-GB进行中（未招募）1 期
A Randomized, Observer Blind, Phase 3 Trial to Investigate the Immunogenicity and Safety of the Co-administration of a Subcutaneous Tetravalent Dengue Vaccine Candidate (TDV) and an Intramuscular Hepatitis A Virus (Inactivated) Vaccine in Healthy Subjects Aged 18 to 60 Years in a Non-endemic Country(ies) for Dengue - Immunogenicity and Safety of TDV Co-administered with an Hepatitis A Virus Vaccine
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 900
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
入选标准
- •1. The subject is aged 18 to 60 years, inclusive.
- •2. Individuals 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.
- •3. The subject signs and dates a written informed consent form 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. Assent is obtained from the subject where required.
- •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 900
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Individuals with an elevated oral temperature (=38°C or 100.4°F) within 3 days of the intended date of vaccination (consider whether applicable as an exclusion criterion or criterion for delay.
- •2. Known hypersensitivity or allergy to any of the vaccine components (including excipients of the investigational vaccines or placebo).
- •3. Individuals 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.
- •4. Individuals with any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (eg, Guillain-Barré syndrome).
- •5. Individuals with history or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose additional risk to the subject due to participation in the trial.
- •6. Known or suspected impairment/alteration of immune function, including:
- •a. Chronic use of oral steroids (equivalent to 20 mg/day prednisone =12 weeks/=2 mg/kg body weight/day prednisone =2 weeks) within 60 days prior to Day 1 (M0) (use of inhaled, intranasal, or topical corticosteroids is allowed).
- •b. Receipt of parenteral steroids (equivalent to 20 mg/day prednisone =12 weeks/= 2 mg/kg body weight/day prednisone =2 weeks) within 60 days prior to Day 1 (M0).
- •c. Administration of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (M0) or planned administration during the trial.
- •d. Receipt of immunostimulants within 60 days prior to Day 1(M0).
- •e. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (M0).
- •f. Human immunodeficiency virus (HIV) infection or HIV-related disease.
- •g. HAV infection.
- •h. Hepatitis C virus infection.
- •i. Genetic immunodeficiency.
- •7. Abnormalities of splenic or thymic function.
- •8. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- •9. Individuals with any serious chronic or progressive disease according to judgment of the Investigator (eg, neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
- •10. Individuals with body mass index (BMI) greater than or equal to 35 kg/m2 (=weight in kg/[height in meters2]).
- •11. Individuals participating in any clinical trial with another investigational product 30 days prior to Day 1 (M0) or intent to participate in another clinical trial at any time during the
- •conduct of this trial.
- •12. Individuals who received any other vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or who are planning to receive any
- •vaccine within 28 days of trial vaccine administration.
- •13. Previous HAV vaccination (in a clinical trial or with an approved product).
- •14. Individuals involved in the trial conduct or their first degree relatives.
- •15. Individuals with history of substance or alcohol abuse within the past 2 years.
- •16. Female subjects who are pregnant or breastfeeding.
研究者
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