EUCTR2020-000948-60-GR进行中（未招募）1 期
A PHASE 2b TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY INFANTS 2 AND 6 MONTHS OF AGE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,272
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
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Age and Sex:
- •1. Male and female participants:
- •Open-label sentinel-cohort stage: 2 months of age (=60 to =98 days) or 6 months of age (=150 to =210 days) at the time of randomization.
- •Open-label expanded-enrollment stage and blinded expandedenrollment stage: 2 months of age (=60 to =98 days) at the time of randomization.
- •Type of Participant and Disease Characteristics:
- •2.Participant’s parent(s)/legal guardian who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •3.Participant is available for the entire study period and the participant’s parent(s)/legal guardian can be reached by telephone.
- •4.Healthy participant as determined by medical history, physical examination, and judgment of the investigator.
- •5.Body weight =4 kg for participants 2 months of age at the time of randomization.
- •Informed Consent:
- •6.Participants whose parent(s)/legal guardian are capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1272
- •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
- •Participants are excluded from the study if any of the following criteria apply:
- •Medical Conditions:
- •1.Prior adverse reaction to paracetamol use, including allergic reactions.
- •2.Participant was born prematurely (<37 weeks of gestation).
- •3.A previous anaphylactic reaction to any vaccine or vaccine-related component.
- •4.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- •5.A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as participants with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Please refer to the ISF for additional details.
- •6.History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
- •7.Significant neurological disorder or history of seizure (including simple febrile seizure).
- •8.Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
- •9.Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- •Prior/Concomitant Therapy:
- •10.Previous vaccination with any meningococcal vaccine. Written vaccination history must be obtained prior to randomization.
- •11.For participants 2 months of age, prior vaccination with any of the following licensed or investigational vaccines: pneumococcal vaccine and hexavalent DTPa-HBV-IPV-Hib or its component, except for the birth dose of hepatitis B vaccine.
- •12.Participants receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
- •13.Receipt of any blood products, including immunoglobulin, before the first study vaccination.
- •14.Current chronic use of systemic antibiotics.
- •Prior/Concurrent Clinical Study Experience:
- •15.Participation in other studies involving investigational drug(s) or investigational vaccine(s) within 28 days prior to study entry and/or during study participation.
- •Diagnostic Assessments:
- •Not applicable.
- •Other Exclusions:
- •16.Children or grandchildren of investigator site staff or Pfizer employees directly involved in the conduct of the study.
研究者
相似试验
进行中（未招募）
1 期
A Phase 2b Study to Describe the Safety and Immunogenicity of MenABCWY in Healthy Infants 2 and 6 Months of AgeInvasive Meningococcal Disease (IMD)MedDRA version: 21.1Level: LLTClassification code 10076062Term: Meningococcal immunizationSystem Organ Class: 100000004865EUCTR2020-000948-60-DEPfizer Inc., 235 East 42nd Street, New York, NY 100171,272
进行中（未招募）
1 期
OPAon-Cystic Fibrosis Bronchiectasis with Pseudomonas Aeruginosa or other Potentially Pathogenic Micro-organismsMedDRA version: 23.0Level: LLTClassification code: 10083611Term: Non-cystic fibrosis bronchiectasis Class: 10038738CTIS2023-508706-23-00Thirty Respiratory Limited60
已完成
不适用
An Open-Label Phase I Dose-Escalation Study of Sorafenib Plus S-1 in Advanced Solid Tumors-C18 Malignant neoplasm of colon-C20 Malignant neoplasm of rectumMalignant neoplasm of colonMalignant neoplasm of rectumC18C20PER-015-10CureTech Ltd,7
进行中（未招募）
1 期
CLINICAL TRIAL TO ASSESS THE TOLERABILITY, SAFETY AND EFFICACY OF SUBLINGUAL IMMUNOTHERAPY IN PATIENTS SUFFERING FROM HOUSE DUST MITE ALLERGYPatients with house dust mites related allergic rhinitis/rhino-conjunctivitis (with or without well controlled asthma).EUCTR2011-002321-22-ESRoxall Medicina España S.A.165
进行中（未招募）
1 期
CLINICAL TRIAL TO ASSESS THE TOLERABILITY, SAFETY AND EFFICACY OF SUBLINGUAL IMMUNOTHERAPY IN PATIENTS SUFFERING FROM GRASS POLLEN ALLERGYPatients with grass pollen related allergic rhinitis/rhino-conjunctivitis (with or without well controlled asthma).EUCTR2011-002301-29-ESROXALL Medicina España S.A.165