EUCTR2015-003324-32-BE
进行中（未招募）
1 期
A Phase 4 study to evaluate the safety and immunogenicity of trivalent oral polio vaccine in adults previously vaccinated with oral polio vaccine
niversity of Antwerp0 个研究点目标入组 128 人2015年8月25日
适应症Historic tOPV can result in the emergence of circulating vaccine-derived polioviruses (cVDPVs): the attenuated strains of poliovirus from the vaccine infect un-immunized individuals, replicate, circulate in the population, and may eventually mutate enough to become virulent and effect vaccine-associated paralytic poliomyelitis (VAPP).MedDRA version: 18.0Level: HLTClassification code 10036017Term: Poliomyelitis viral infectionsSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Historic tOPV can result in the emergence of circulating vaccine-derived polioviruses (cVDPVs): the attenuated strains of poliovirus from the vaccine infect un-immunized individuals, replicate, circulate in the population, and may eventually mutate enough to become virulent and effect vaccine-associated paralytic poliomyelitis (VAPP).
- 发起方
- niversity of Antwerp
- 入组人数
- 128
- 状态
- 进行中（未招募）
- 最后更新
- 9年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Healthy male or female, between 18 and 50 years old, extremes included
- •2\. Received at least 4 doses of OPV in the past (more than 12 months before the start of the study)
- •3\. In good physical and mental health as determined on the basis of medical history and general physical examination performed at Day 0
- •4\. Female subjects of childbearing potential must agree to the use of an effective method of birth control throughout the study and up to 3 months after last vaccine dose
- •5\. Willing to adhere to the prohibitions and restrictions specified in this protocol
- •6\. Informed Consent Form (ICF) signed voluntarily by the subject before any study\-related procedure is performed, indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study.
- •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 128
排除标准
- •1\. A condition that, in the opinion of the Investigator, could compromise the well being of the subject or course of the study, or prevent the subject from meeting or performing any study requirements
- •2\. Having Crohn’s disease or ulcerative colitis or having had major surgery of the gastrointestinal tract involving significant loss or resection of the bowel
- •3\. A known allergy, hypersensitivity, or intolerance to the study vaccine, or to any of its components or to any antibiotics
- •4\. Any confirmed or suspected immunosuppressive or immunodeficiency condition (including human immunodeficiency virus \[HIV] infection)
- •5\. Will have household or professional contact with known immunosuppressed people or people without full polio vaccination (i.e. complete priming) within 28 days after vaccination
- •6\. Neonatal nurses or others having professional contact with children under 6 months old within 28 days after vaccination
- •7\. Chronic administration (i.e., longer than 14 days) of immunosuppressant drugs or other immune\-modifying drugs within 6 months prior to the first vaccine dose or planned use during the study. For instance, for corticosteroids, this means prednisone, or equivalent, \= 0\.5 mg/kg/day (inhaled and topical steroids are allowed whereas intra\-articular and epidural injection/administration of steroids are not allowed)
- •8\. Presence of contraindications to administration of the study vaccine on Day 0: acute severe febrile illness deemed by the Investigator to be a contraindication for vaccination or persistent diarrhea or vomiting
- •9\. Indications of drug abuse or excessive use of alcohol at Day 0
- •10\. Being pregnant or breastfeeding. Women of childbearing potential will undergo a urine pregnancy test at Day 0\. Subjects with a positive pregnancy test will be excluded
结局指标
主要结局
未指定
相似试验
进行中（未招募）
1 期
A clincal study to evaluate the safety of a polio vaccine type 2 given orally in healthy children aged 1 to 5 years previously treated with inactivated polio vaccine in Lithuaniaevaluation of safety of SABIN mOPV2 in healthy IPV-vaccinated children of 1 – 5 years of age (Polio disease)MedDRA version: 18.0Level: LLTClassification code 10036016Term: Poliomyelitis NOSSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]EUCTR2015-003544-39-LTFIDEC - Fighting Infectious Diseases in Emerging Countries
进行中（未招募）
1 期
A vaccine study in healthy adults to evaluate the safety and immune response of a licensed oral polio vaccine containing the polio vaccine 2 straiPolio diseaseMedDRA version: 18.0Level: HLTClassification code 10036017Term: Poliomyelitis viral infectionsSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]EUCTR2015-003325-33-BEniversity of Antwerp100
尚未招募
4 期
Study to evaluate the effects of the COVID-19 (inactivated) vaccine of the Instituto Butantan in immucompromised personsRespiratory diseasesCOVID-19Immunocompromised hostsTransplant recipientsChronic kidney diseaseLiver cirrhosisNeoplasmsPrimary immunodeficiency diseasesC01.918RBR-9ksh5f4Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
进行中（未招募）
1 期
A phase I study to evaluate safety and immunogenicity of recombinant protein candidate vaccine against SARS-CoV-2 in healthy volunteers.SARS-CoV-2MedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]EUCTR2021-001411-82-ESABORATORIOS HIPRA, S.A.30
进行中（未招募）
1 期
Investigating a vaccine against plague in Uganda (PlaVac Uganda)Prevention of plague caused by the intracellular bacterium Yersinia pestisInfections and InfestationsISRCTN79243381niversity of Oxford36