EUCTR2016-003722-16-IT进行中（未招募）1 期
A Phase IIIB, Randomized, Observer-blind, Multicenter Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine when Administered Concomitantly with GSK Meningococcal MenACWY Conjugate Vaccine to Healthy Subjects 16-18 Years of Age - MENB REC 2ND GEN-045 (V72_79)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 945
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
- •Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol or/and subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
- •Previous vaccination with 1 dose of quadrivalent meningococcal
- •conjugate vaccine (MenACWY, Menveo or Menactra) at least 4 years
- •prior to informed consent and assent as applicable.
- •Written or /witnessed/thumb printed informed consent obtained
- •from the subject/parent(s)/LAR(s) of the subject prior to performance
- •of any study specific procedure.
- •Written informed assent obtained from the subject (if applicable)
- •along with informed consent from the subject's parent(s)/LAR(s) prior
- •to performing any study specific procedure.
- •A male or female between, and including, 16 and 18 years of age at
- •the time of the first vaccination.
- •Healthy subjects as established by medical history and clinical
- •examination before entering into the study.
- •Female subjects of non-childbearing potential may be enrolled in the
- •study. Non-childbearing potential is defined as pre-menarche, current
- •bilateral tubal ligation or occlusion, hysterectomy, bilateral
- •ovariectomy or post-menopause.
- •Female subjects of childbearing potential may be enrolled in the
- •study, if the subject:
- •has practiced adequate contraception for 30 days prior to vaccination,
- •has a negative pregnancy test on the day of vaccination, and
- •has agreed to continue adequate contraception during the entire
- •treatment period and for 2 months after completion of the vaccination
- •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 500
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Medical conditions
- •Progressive, unstable or uncontrolled clinical conditions.
- •Clinical conditions representing a contraindication to intramuscular
- •vaccination and blood draws.
- •Abnormal function of the immune system resulting from:
- •Clinical conditions.
- •Systemic administration of corticosteroids (PO/IV/IM) for more than
- •14 consecutive days within 90 days prior to study vaccination. This will
- •mean prednisone =20 mg/day (for adult subjects) or =0.5 mg/kg/day
- •or 20 mg/day whichever is the maximum dose for paediatric subjects,
- •or equivalent. Inhaled and topical steroids are allowed.
- •Administration of antineoplastic or immunomodulating agents or
- •radiotherapy within 90 days prior to informed consent.
- •Are obese at screening (obesity is defined as a BMI of = 95th
- •percentile for age and gender).
- •Any other clinical condition that, in the opinion of the investigator,
- •XML File Identifier: LC2h0w8o+1kUDrK+HIYC3dHFyec=
- •might pose additional risk to the subject due to participation in the
- •History of any reaction or hypersensitivity likely to be exacerbated by
- •any component of the vaccines.
- •History of any reaction or hypersensitivity likely to be exacerbated by
- •any medicinal products or medical equipment whose use is foreseen in
- •this study.
- •Current or previous, confirmed or suspected disease caused by N.
- •meningitidis.
- •Known contact to an individual with any laboratory-confirmed N.
- •meningitidis infection within 60 days, prior to enrolment.
- •History of neuroinflammatory or autoimmune condition.
- •Recurrent history or un-controlled neurological disorders or seizures.
- •Prior/Concomitant therapy
- •Use of any investigational or non-registered product other than the
- •study vaccine(s) during the period starting 30 days before the informed
- •consent or planned use during the study period.
- •Administration of immunoglobulins and/or any blood products or
- •plasma derivatives during the period starting 180 days before the
- •informed consent or planned administration during the study period.
- •Previous vaccination with any group B meningococcal vaccine at any
- •time prior to informed consent and assent as applicable.
- •Previous vaccination with 2 doses of quadrivalent meningococcal
- •conjugate vaccine (MenACWY, Menveo or Menactra).
- •Prior/Concurrent clinical study experience
- •Subject concurrently participating in another clinical study, at any
- •time during the study period, in which the subject has been or will be
- •exposed to an investigational or a non-investigational vaccine/product,
- •will not be enrolled.
- •Other exclusions
- •Child in care.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue
- •contraceptive precautions.
- 另有 1 项未显示
研究者
相似试验
招募中
1 期
A Phase 3/3b, Randomized, Observer-blind, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine Compared to a Quadrivalent Influenza Vaccine in Adults =65 Years of AgeInfluenza virusMedDRA version: 20.0Level: PTClassification code: 10022000Term: Influenza Class: 100000004862CTIS2022-503004-24-00Seqirus UK Limited35,800
进行中（未招募）
不适用
A study to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18 years.Influenza, humanEUCTR2014-003768-19-Outside-EU/EEACSL Limited1,350
进行中（未招募）
不适用
Evaluate the Safety, Tolerability, and Immunogenicity of Fluad and AgrifluPrevent the attack rates of influenza during both pandemic and interpandemic periods..EUCTR2014-005053-40-Outside-EU/EEAovartis Vaccines and Diagnostics S.r.l5,750
进行中（未招募）
不适用
A vaccine study to evaluate the safety of and the immune protection produced by different doses of two influenza vaccines in healthy children aged at least 6 months but less than 48 monthshealthy volunteers (protection against influenza)MedDRA version: 16.1Level: LLTClassification code 10016794Term: Flu vaccinationSystem Organ Class: 100000004865EUCTR2013-002081-39-FIovartis Vaccines & Diagnostics AG672
进行中（未招募）
不适用
A phase III, randomized, observer blind, multi-centre study to evaluate the immunogenicity, safety and reactogenicity of study vaccine GSK1557482A (FluLaval thiomersal-free), Fluarix and FluLaval thiomersal-containing vaccines in young adult (18 to 60 years) and elderly subjects (over 60 years) - FLU-Q-TIV-TF-003 PRIEUCTR2008-001445-26-EEGlaxoSmithKline Biologicals1,540