EUCTR2016-003186-25-Outside-EU/EEA进行中（未招募）1 期
A Phase 3b, Controlled, Open-Label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Single Dose of GlaxoSmithKline’s Meningococcal ACWY Conjugate Vaccine (Menveo), Administered to Healthy Individuals 15 through 55 years of age, approximately 4-6 years after primary ACWY vaccination. - MENACWY CONJ-038 (V59_77)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 700
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) Individuals of 15 through 55 years of age on the day of informed consent or assent.
- •2) Individuals who received Menveo 4 to 6 years prior to en-rolment at an age of 11 years or older
- •Individuals who received Menactra 4 to 6 years prior to enrolment at an age of 11 years or older
- •Individuals who have not received any previous meningo-coccal vaccine.
- •3) Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. If the subject is under age 18 at the time of enrol-ment, the parent(s)/legal guardian(s) of the subject should have voluntarily given written informed consent.
- •4) Individuals who can comply with study procedures including follow-up.
- •Females of non-childbearing potential
- •Females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days after the study vaccination.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 250
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 450
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) History of any meningococcal vaccine administration other than the single vaccination given 4 to 6 years before
- •History of any meningococcal vaccine administration.
- •2) Current or previous, confirmed or suspected disease caused by N. meningitidis.
- •3) Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis in-fection within 60 days prior to study vaccination.
- •4) Progressive, unstable or uncontrolled clinical conditions.
- •5) Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
- •6) Clinical conditions representing a contraindication to in-tramuscular vaccination (IM) and blood draws.
- •7) Abnormal function of the immune system resulting from:
- •a. Clinical conditions.
- •b. Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to study vaccination.
- •c. Administration of antineoplastic and immunomodulat-ing agents or radiotherapy within 90 days prior to study vaccination.
- •8) Received immunoglobulins or any blood products within 180 days prior to informed consent.
- •9) Received systemic antibiotic treatment within 3 days prior to study vaccination or blood draw.
- •10) Received an investigational or non-registered medicinal product within 30 days prior to study vaccination.
- •11) Study personnel as an immediate family or household member.
- •12) Individuals who have received any other vaccines within 7 days or 14 days prior to vaccination in this study or who are planning to receive any vaccine within 28 days from the study vaccination.
- •13) Individuals who have experienced a moderate or severe acute infection and/or fever defined as a temperature =38°C (100.4°F) within 3 days prior to study vaccination.
- •14) Any other clinical condition that, in the opinion of the in-vestigator, might pose additional risk to the subject due to participation in the study.
研究者
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