EUCTR2021-001367-24-ES进行中（未招募）1 期
A Phase II, randomized, partially blinded study to assess the safety, tolerability and immunogenicity of meningococcal combined ABCWY vaccine when administered to healthy infants.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 688
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’ 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.
- •Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
- •Healthy participants as established by medical history and clinical examination before entering into the study.
- •A male or female between, and including, 55 and 89 days of age (approximately 2 MoA) at the time of the first study vaccination.
- •Born after a gestation period of =37 weeks, with a birth weight =2.5 kg.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 688
- •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
- •Medical conditions
- •Current or previous, confirmed or suspected disease caused by N. meningitidis.
- •Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection from birth.
- •Progressive, unstable or uncontrolled clinical conditions.
- •Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
- •Any neuroinflammatory disorders, congenital and peripartum neurological conditions, encephalopathies, seizures.
- •Congenital or peripartum disorders resulting in a chronic condition
- •Major congenital defects, as assessed by the investigator.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product(s).
- •Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM197) and latex medicinal products or medical equipment whose use is foreseen in this study.
- •Abnormal function or modification of the immune system resulting from:
- •- Autoimmune disorders or immunodeficiency syndromes.
- •- Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days starting from birth until Visit 5. This will mean prednisone equivalent =0.5 mg/kg/day with maximum 20 mg/day. Inhaled and topical steroids are allowed.
- •- Administration of antineoplastic and immunomodulating agents or radiotherapy from birth.
- •- Administration of long-acting immune-modifying drugs at any time during the study period.
- •Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
- •Prior/Concomitant therapy
- •Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccines from birth, or planned use during the study period.
- •Previous vaccination with any meningococcal vaccine.
- •Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period until Visit 5.
- •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting from birth until Visit 5. For corticosteroids, this will mean prednisone equivalent =0.5 mg/kg/day with maximum 20 mg/day. Inhaled and topical steroids are allowed.
- •Prior/Concurrent clinical study experience
- •Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or medical device).
- •Other exclusions
- •Child in care.
- •Study personnel as an immediate family or household member.
- •For contraindications to administering routine vaccines foreseen in the study, refer to their approved product label/package insert.
研究者
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