EUCTR2020-004501-30-DE进行中（未招募）1 期
A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Three Different Potency Levels of V181 (Dengue Quadrivalent Vaccine rDENV?30 [live, attenuated]) in Healthy Adults - Safety and Immunogenicity of Three V181 Dengue Vaccine Potencies in Adults
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.0 个研究点目标入组 1,265 人开始时间: 2021年12月14日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,265
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. Is healthy based on review of medical history and physical examination, according to the clinical judgement of the investigator.
- •2. Is male or female, from 18 years to 50 years of age inclusive, at the time of signing the informed consent.
- •3. Male participants are eligible to participate if they agree to the
- •following for at least 90 days after administration of study intervention:
- •Abstain from heterosexual intercourse as their preferred and usual
- •lifestyle (abstinent on a long term and persistent basis) and agree to
- •remain abstinent
- •Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
- •Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below:
- •- Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant.
- •Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •4. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- •Is not a WOCBP
- •Is a WOCBP and using a contraceptive method that is highly effective
- •(with a failure rate of <1% per year), or be abstinent from heterosexual
- •intercourse as their preferred and usual lifestyle (abstinent on a long
- •term and persistent basis), for at least 90 days after administration of
- •study intervention. The investigator should evaluate the potential for
- •contraceptive method failure (ie, noncompliance, recently initiated) in
- •relationship to the first dose of study intervention.
- •A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) before the first dose of study intervention.
- •If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- •The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- •Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •5. The participant (or legally acceptable representative) has provided documented informed consent for the study. The participant may also provide consent for Future Biomedical Research. However, the participant may participate in the main study without participating in Future Biomedical Research
- •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 1265
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •2. * Has an acute febrile illness (temperature =38.0°C [=100.4°F] oral
- •or equivalent) occurring within 72 hours before receipt of study
- •vaccine/placebo.
- •3. Has a serious or progressive disease according to the investigator,
- •including but not limited to cancer; uncontrolled diabetes; severe
- •cardiac, renal, or hepatic insufficiency; or systemic autoimmune or
- •neurologic disorder.
- •4. Has known or suspected impairment of immunological function,
- •including but not limited to congenital or acquired immunodeficiency,
- •HIV infection, hematologic malignancy, or treatment for autoimmune
- •5. Has a condition in which repeated venipuncture or injections pose
- •more than minimal risk for the participant, such as hemophilia,
- •thrombocytopenia, other severe coagulation disorders, or significantly
- •impaired venous access.
- •6. Has a known hypersensitivity to any component of the study
- •vaccine/placebo, or history of severe allergic reaction (eg, swelling of
- •the mouth and throat, difficulty breathing, hypotension or shock) that
- •required medical intervention.
- •7. Has received a dose of any dengue vaccine (investigational or
- •approved) before study entry, or plans to receive any dengue vaccine
- •(investigational or approved) for the duration of the trial.
- •8. * Has received other licensed non-live vaccines within 14 days before
- •receipt of study vaccine/placebo or is scheduled to receive any licensed
- •non-live vaccine within 28 days following receipt of study
- •vaccine/placebo. Exception: Inactivated influenza vaccine may be
- •vaccine/placebo or at least 28 days after receipt of study
- •vaccine/placebo.
- •9. * Has received a licensed live vaccine within 28 days before receipt of
- •study vaccine/placebo or is scheduled to receive any live vaccine within
- •28 days after receipt of study vaccine/placebo.
- •10. Has received systemic corticosteroids (equivalent of =2 mg/kg/day
- •of prednisone or =20 mg/d for persons weighing >10 kg) for =14
- •consecutive days and has not completed treatment at least 30 days
- •before study entry or is expected to receive systemic corticosteroids at
- •aforementioned dose and duration within 28 days after receipt of study
- •vaccine/placebo.
- •11. Has received systemic corticosteroids exceeding physiologic
- •replacement doses (approximately 5 mg/day prednisone equivalent)
- •within 14 days before vaccination.
- •12. Has received immunosuppressive therapies, including
- •chemotherapeutic agents used to treat cancer or other conditions,
- •treatments associated with organ or bone marrow transplantation, or
- •autoimmune disease, within 6 months before receipt of study
- •vaccine/placebo or plans to receive immunosuppressive therapies within
- •28 days after receipt of study vaccine/placebo.
- •13. Has received a blood transfusion or blood products (including
- •immunoglobulins) within 6 months before receipt of a study
- •vaccine/placebo or plans to receive a blood transfusion or blood
- •products (including immunoglobulins) within 28 days after receipt of
- •study vaccine/placebo.
- 另有 8 项未显示
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