PACTR202110626944896Other3 期
Phase 2/3 Randomized, Blinded, Placebo-Controlled Trial to Evaluate the Safety, Immunogenicity, and Efficacy of INO-4800, a Prophylactic Vaccine Against COVID-19 Disease, Administered Intradermally Followed by Electroporation in Adults at High Risk of SARS-CoV-2 Exposure
Inovio Pharmaceuticals Inc.0 个研究点目标入组 7,116 人开始时间: 2021年9月10日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 入组人数
- 7,116
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
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Working or residing in an environment with high risk of exposure to SARS-CoV-2 for whom exposure may be relatively prolonged or for whom personal protective equipment (PPE) may be inconsistently used, especially in confined settings.
- •Phase 2 only: Screening laboratory results within normal limits for testing laboratory or are deemed not clinically significant by the Investigator.
- •Be post-menopausal or be surgically sterile or have a partner who is sterile or use medically effective contraception with a failure rate of < 1% per year when used consistently and correctly from Screening until 3 months following last dose (Phase 2) or until last dose (Phase 3).
排除标准
- •Acute febrile illness with temperature higher than or equal to 100.4°F (38.0°C) or acute onset of upper or lower respiratory tract symptoms.
- •Positive serologic or molecular (Reverse transcription polymerase chain reaction (RT-PCR)) test for SARS-CoV-2 at Screening (this criterion applies to all Phase 2 participants and only applies after approximately 402 participants positive for SARS-CoV-2 serologic test are randomized in the Phase 3 segment of the study).
- •Pregnant or breastfeeding or intending to become pregnant or intending to father children within the projected duration of the trial starting from the Screening visit until 3 months following the last dose (Phase 2) or until last dose (Phase 3).
- •Known history of uncontrolled HIV based on a CD4 count less than 200 cells per cubic millimeter (/mm^3) or a detectable viral load within the past 3 months.
- •Is currently participating or has participated in a study with an investigational product within 30 days preceding Day 0.
- •Previous or planned receipt of an investigational (including Emergency Use Authorization (EUA) or local equivalent authorization) or licensed vaccine for prevention or treatment of COVID-19, middle east respiratory syndrome (MERS), or severe acute respiratory syndrome (SARS) (documented receipt of placebo in previous trial would be permissible for trial eligibility).
- •Respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease) requiring significant changes in therapy or hospitalization for worsening disease during the 6 weeks prior to enrolment.
- •Immunosuppression as a result of underlying illness or treatment.
- •Lack of acceptable sites available for ID injection and EP.
- •Blood donation or transfusion within 1 month prior to Day 0.
- •Reported alcohol or substance abuse or dependence, or illicit drug use (excluding marijuana use).
- •Any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint.
研究者
相似试验
招募中
1 期
A study to determine if ALXN2220 is effective, safe, and tolerable in adults with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)Adults with Transthyretin Amyloid Cardiomyopathy (ATTR-CM).CTIS2023-506669-70-00Alexion Pharmaceuticals Inc.982
进行中（未招募）
1 期
Pembrolizumab as adjuvant therapy for resectable high-risk LA cSCCResectable high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC)MedDRA version: 20.0 Level: PT Classification code 10041823 Term: Squamous cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-001974-76-FRMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.570
进行中（未招募）
1 期
Phase 3 Study of Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)Recurrent, Platinum-Sensitive Ovarian CancerMedDRA version: 21.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-005099-21-NOMersana Therapeutics, Inc.581
进行中（未招募）
1 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to study the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents = 6 to <18 years of ageAcute Migraine (with or without aura)MedDRA version: 20.0Level: PTClassification code 10052787Term: Migraine without auraSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10027607Term: Migraine with auraSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: HLTClassification code 10027603Term: Migraine headachesSystem Organ Class: 10029205 - Nervous system disordersEUCTR2021-005246-15-PLPfizer Inc.640
进行中（未招募）
1 期
Combining chemotherapy with either the medication entospletinib or a placebo for adults with acute myeloid leukemia that has a nucleophosmin-1 abnormalityMedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864Acute Myeloid LeukemiaEUCTR2021-000761-33-PLKronos Bio, Inc.180