EUCTR2008-007789-51-PL进行中（未招募）不适用
A Randomized, Single-Blind, Placebo-Controlled, Phase 2 Trial of the Safety, Immunogenicity, and Tolerability of Meningococcal Serogroup B (MnB) rLP2086 Vaccine at Doses of 60 µg, 120 µg, and 200 µg in Healthy Adolescents Aged 11 to 18 Years
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc
- 入组人数
- 715
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
- •1. Male or female subjects between the ages of =11 and =18 years at the time of enrollment.
- •2. Healthy male or female subjects as determined by medical history and physical examination.
- •3. Negative urine pregnancy test for all female subjects.
- •4. All female and male subjects who are biologically capable of having children must agree to abstinence or commit to the use of a reliable method of hormonal and/or nonhormonal contraception during the 6-month vaccination period and for 30 days after the final vaccination or early discontinuation of the study. A subject is biologically capable of having children if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives.
- •5. Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation.
- •1. Healthy male or female subjects as determined by medical history and physical examination.
- •2. Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation.
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pregnant or breastfeeding women.
- •2. Receipt of any vaccination with a serogroup B meningococcal vaccine at any time prior to the administration of the first dose of test article.
- •3. History of any invasive meningococcal disease.
- •4. A previous anaphylactic or severe vaccine-associated adverse reaction.
- •5. A known hypersensitivity to any study vaccine components.
- •6. Any clinically significant chronic disease.
- •7. A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids. Topical, inhaled or intra-articular corticosteroids are allowed.
- •8. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular (IM) injection.
- •9. Receipt of any blood products, including gamma globulin, in the period from 6 months before study vaccination through the study conclusion.
- •10. Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.
- •11. Any major illness/condition that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in and completion of, the study, or could preclude the evaluation of the subject’s response.
- •12. Subject is a direct descendant (child or grandchild) of the study site personnel.
- •1. Receipt of any vaccination with a serogroup B meningococcal vaccine at any time prior to the administration of the first dose of test article.
- •2. History of any invasive meningococcal disease.
- •3. Any clinically significant chronic disease.
- •4. A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids. Topical, inhaled or intra-articular corticosteroids are allowed.
- •5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular (IM) injection.
- •6. Receipt of any blood products, including gamma globulin, in the period from 6 months before study vaccination through the study conclusion.
- •7. Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.
研究者
相似试验
进行中（未招募）
不适用
A clinical study to test the safety and immune response of a vaccine against a bacteria causing meningitis B at doses of 60 µg, 120 µg, and 200 µg in healthy adolescents aged 11 to 18 YearsPrevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MnB) in adolescents and young adults, aged 10 through 25 years.MedDRA version: 17.1Level: LLTClassification code 10004049Term: Bacterial meningitisSystem Organ Class: 100000004862EUCTR2008-007789-51-Outside-EU/EEAWyeth Research Division of Wyeth Pharmaceuticals Inc.539
已完成
1 期
To evaluate safety and tolerability after multiple oral doses of AZD1656 in type 2 diabetes patients on top of metformiCTRI/2009/091/000774AstraZeneca AB, 151 85 Södertälje, Sweden24
Unknown
2 期
A clinical Study to assess the Efficacy and Safety of Ursodiol Injection in covid-19 patientsCTRI/2021/11/038307Shilpa Medicare Limited16
已完成
3 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients with Familial Chylomicronemia Syndrome (FCS)Familial Chylomicronemia Syndrome (FCS)10013317NL-OMON42059ISIS Pharmaceuticals4
进行中（未招募）
1 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ibrutinib or Placebo in Combination With Rituximab in Subjects with Previously Treated Waldenstrom’s MacroglobulinemiaEUCTR2013-005478-22-ITPharmacyclics, Incorporated181