EUCTR2021-005903-11-Outside-EU/EEA进行中（未招募）1 期
A Phase 3, Randomized, Observer-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of The Vaccine Candidate BNT162b2 Against COVID-19 in Healthy Subjects 12 Through 50 Years of Age and the Safety, Tolerability, and Immunogenicity of BNT162b2 RNA-Based COVID-19 Vaccine Candidates as a Booster Dose in Healthy Subjects 18 Through 50 Years of Age
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- BioNTech SE
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
- •Inclusion Criteria:
- •Primary study: Male or female participants between the ages of 12 and 50 years, inclusive, at randomization.
- •Booster study: Male or female participants between the ages of 18 and 50 years, inclusive, at rerandomization.
- •Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- •Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
- •Capable of giving personal signed informed consent/have parent(s)/legal guardian capable of giving signed informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 445
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1128
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria:
- •Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- •Known infection with HIV, HCV, or HBV.
- •History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.
- •Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19.
- •. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- •Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- •Women who are pregnant or breastfeeding.
- •Primary study: Previous vaccination with any coronavirus vaccine.
- •Booster study: Previous vaccination with any coronavirus vaccine outside of this study.
- •Receipt of medications intended to prevent COVID-19.
- •Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
- •Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
- •Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
- •Previous participation in other studies involving study intervention containing lipid nanoparticles.
- •Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
- •Additional Exclusion Criteria for the Booster study:
- •Current febrile illness (body temperature =100.4°F [=38.0°C]) or other acute illness within 48 hours before study intervention administration.
- •Receipt of any seasonal or pandemic influenza vaccine within 14 days, or any other nonstudy vaccine within 28 days, before or after study intervention administration.
- •Receipt of short-term (<14 days) systemic corticosteroids. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
研究者
相似试验
已完成
3 期
Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL)RespiratoryPACTR201907754270299PATH660
进行中（未招募）
3 期
A clinical trial to study the effects of BAL8557 Versus a Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections.CTRI/2012/01/002351Astellas Pharma Global Development Inc APGD526
已完成
3 期
A clinical trial to study the effects of BAL8557 Versus Voriconazole for Primary Treatment of Invasive Fungal Disease Caused by Aspergillus Species or Other Filamentous Fungi.CTRI/2012/01/002331Astellas Pharma Global Development Inc APGD510
进行中（未招募）
1 期
A Phase III, Randomized, Double-blind Study to Evaluate Chemotherapy plus Pembrolizumab vs Chemotherapy plus Placebo as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)eoadjuvant and adjuvant treatment for locally-advanced TNBCEUCTR2016-004740-11-ESMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.855
进行中（未招募）
1 期
A Phase III, Randomized, Double-blind Study to Evaluate Chemotherapy plus Pembrolizumab vs Chemotherapy plus Placebo as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)eoadjuvant and adjuvant treatment for locally-advanced TNBCMedDRA version: 19.1Level: PTClassification code 10075566Term: Triple negative breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-004740-11-FRMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.855