EUCTR2010-023858-37-DE进行中（未招募）不适用
A Phase IIIb, Open-Label, Controlled, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine
ovartis Vaccines and Diagnostics S.r.l.0 个研究点开始时间: 2011年1月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Children eligible to be enrolled in the study are those whose parents provide written
- •informed consent, and are in generally good health based on the clinical judgment of the investigators. Subjects must be 22-45 months of age at the time of enrollment into V59P22E1 and have participated in the original V59P22 study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •Serious, acute, or chronic illnesses are reasons for exclusion. Non-standard exclusion
- •criteria include the following:
- •? Subjects who have received any vaccine (excluding influenza vaccines) 28 days
- •preceding enrollment visit. Influenza vaccines are excluded for the 14 days prior to
- •the enrollment visit.
- •? Subjects who have received any Meningococcal vaccine since the study dose of
- •MenACWY or Men C at 12 months of age in V59P22 trial.
研究者
相似试验
进行中（未招募）
不适用
Study conducted in immunocompromized patients, 2 to 17 years of age, who are at increased risk of acquiring severe meningococcus diasease because of asplenia or deficiencies of the complement system, in comparison with healthy individuals as controls, in order to evaluate safety, tolerability and antibody response after the administration of two doses of the Novartis investigational vaccine directed mainly against Meningococcus serogroup B.Meningococcal Group B disease.MedDRA version: 16.1Level: PTClassification code 10027202Term: Meningitis bacterialSystem Organ Class: 10021881 - Infections and infestationsEUCTR2013-002454-78-ITovartis Vaccines and Diagnostics S.r.l.150
进行中（未招募）
不适用
Study conducted in immunocompromized patients, 2 to 17 years of age, who are at increased risk of acquiring severe meningococcus diasease because of asplenia or deficiencies of the complement system, in comparison with healthy individuals as controls, in order to evaluate safety, tolerability and antibody response after the administration of two doses of the Novartis investigational vaccine directed mainly against Meningococcus serogroup B.Meningococcal Group B disease.MedDRA version: 16.1Level: PTClassification code 10027202Term: Meningitis bacterialSystem Organ Class: 10021881 - Infections and infestationsEUCTR2013-002454-78-ESovartis Vaccines and Diagnostics S.r.l.150
进行中（未招募）
不适用
Study conducted in immunocompromized patients, 2 to 17 years of age, who are at increased risk of acquiring severe meningococcus diasease because of asplenia or deficiencies of the complement system, in comparison with healthy individuals as controls, in order to evaluate safety, tolerability and antibody response after the administration of two doses of the Novartis investigational vaccine directed mainly against Meningococcus serogroup B.EUCTR2013-002454-78-PLovartis Vaccines and Diagnostics S.r.l.150
进行中（未招募）
不适用
Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate VaccineProphylaxis for Neisseria meningitidis serogroup A, C,W-135, and Y.EUCTR2014-005133-30-Outside-EU/EEAovartis Vaccines & Diagnostics, Inc.500
进行中（未招募）
1 期
Study to assess the safety and immunogenicity of a single dose of GlaxoSmithKline’s (GSK) Meningococcal MenACWY-CRM vaccine (Menveo), administered to subjects 15 through 55 years of age, approximately 4-6 years after primary ACWY vaccination.EUCTR2016-003186-25-Outside-EU/EEAGlaxoSmithKline Biologicals700