EUCTR2023-000764-58-Outside-EU/EEA进行中（未招募）1 期
A Phase 4, single-arm, open-label, multi-center study to assess the immune response and safety of the meningococcal Group B vaccine MenB+OMV NZ when administered to healthy infants from 2 months of age in the Republic of Korea - MENB REC 2ND GEN-097
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •Participant’s parent(s)/legally acceptable representative (LAR) (s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol
- •Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
- •Healthy participants as established by medical history and clinical examination before entering the study.
- •A male or female between and including 2 to 5 months (8 to 20 weeks) of age at the time of the first study intervention administration.
- •Born full term
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Medical Conditions
- •Current or previous, confirmed or suspected disease caused by N. meningitidis.
- •Known exposure from birth to an individual with laboratory confirmed N. meningitidis infection.
- •Progressive, unstable or uncontrolled clinical conditions.
- •Any contraindications to group B meningococcal vaccine, including but not limited to: history of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
- •Medical conditions representing a contraindication to intramuscular vaccination and blood draws.
- •Any neuroinflammatory condition (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), any congenital neurological condition, encephalopathies, seizures (including all subtypes such as: absence seizures, generalized tonic-clinic seizures, partial complex seizures, partial simple seizures).
- •Congenital or peripartum disorders resulting in a chronic illness (including but not limited to: chromosomal abnormalities, cerebral palsy, metabolism or synthesis disorders, cardiac disorders).
- •Other serious chronic illness.
- •Hypersensitivity to latex.
- ••Abnormal function of the immune system resulting from clinical conditions, or administration of antineoplastic and immunomodulating agents or radiotherapy for any duration from birth or autoimmune disorders (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes).
- •Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
- •Prior/Concomitant Therapy
- •Use of any investigational or non-registered product since birth, or their planned use during the study period.
- •Previous vaccination with any group B meningococcal vaccine at any time prior to informed consent.
- •Administration of long acting (defined as administered once per week or less frequently) immunosuppressants, including monoclonal antibodies since birth and/or planned use at any time during the study period.
- •Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) since birth and/or planned use of long-acting immune-modifying treatments at any time during the study period. For corticosteroids, this will mean prednisone equivalent 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
- •Administration of immunoglobulins and/or any blood products or plasma derivatives since birth and/or planned use at any time during the study period.
- •Prior/Concurrent Clinical Study Experience
- •Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).
- •Other Exclusion Criteria
- •Child in care.
- •Any immediate dependents, family, or household member of study personnel.
研究者
相似试验
进行中（未招募）
1 期
An Open-Label, Phase IV Study of Velaglucerase alfa on Bone Related Pathology in Adult, Treatment-Naïve Patients with Type 1 Gaucher DiseaseGaucher DiseaseMedDRA version: 20.0Level: PTClassification code 10075697Term: Gaucher's disease type ISystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2015-001578-17-ITSHIRE HUMAN GENETIC THERAPIES, INC40
进行中（未招募）
1 期
An Open-Label, Phase IV Study of Velaglucerase alfa on Bone Related Pathology in Adult, Treatment-Naïve Patients with Type 1 Gaucher DiseaseMedDRA version: 20.0Level: PTClassification code 10075697Term: Gaucher's disease type ISystem Organ Class: 10010331 - Congenital, familial and genetic disordersGaucher DiseaseEUCTR2015-001578-17-DEShire Human Genetic Therapies, Inc.40
进行中（未招募）
1 期
An Open-Label, Phase IV Study of Velaglucerase alfa on Bone Related Pathology in Adult, Treatment-Naïve Patients with Type 1 Gaucher DiseaseMedDRA version: 20.0Level: PTClassification code 10075697Term: Gaucher's disease type ISystem Organ Class: 10010331 - Congenital, familial and genetic disordersGaucher DiseaseEUCTR2015-001578-17-GBShire Human Genetic Therapies, Inc.19
进行中（未招募）
1 期
An Open-Label, Phase IV Study of Velaglucerase alfa on Bone Related Pathology in Adult, Treatment-Naïve Patients with Type 1 Gaucher DiseaseGaucher DiseaseMedDRA version: 18.1Level: PTClassification code 10075697Term: Gaucher's disease type ISystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2015-001578-17-ESShire Human Genetic Therapies, Inc.21
尚未招募
4 期
Phase IV study of Brentuximab Vedotin in Hodgkin LymphomaCTRI/2024/07/069820Baxalta US Inc