A Phase II, Randomized, Partially Blinded Study to Assess the Safety, Tolerability and Immunogenicity of Meningococcal Combined ABCWY Vaccine when Administered to Healthy Infants - 217043

GlaxoSmithKline Biologicals0 个研究点目标入组 703 人开始时间: 2023年11月29日最近更新: 2024年7月22日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方: GlaxoSmithKline Biologicals
入组人数: 703

研究概览入排标准研究者记录与标识符相似试验

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

年龄范围: 0 至 17（—）
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.

排除标准

•Current or previous, confirmed or suspected disease caused by N. meningitidis., Clinical conditions representing a contraindication to intramuscular vaccination and blood draws., Any neuroinflammatory disorders (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital and peripartum neurological conditions, encephalopathies, seizures (including all subtypes such as: absence seizures, generalised tonic-clonic seizures, partial complex seizures, partial simple seizures or febrile convulsions)., Congenital or peripartum disorders resulting in a chronic condition (including but not limited to chromosomal abnormalities, cerebral palsy, metabolism or synthesis disorders, cardiac disorders)., 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., 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)., 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., Abnormal function or modification of the immune system resulting from: - Autoimmune disorders (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders; lupus erythematosus and associated conditions; rheumatoid arthritis and associated conditions; scleroderma and associated disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary 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 (e.g. infliximab).., Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study., 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., Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection from birth., Progressive, unstable or

研究者

发起方

GlaxoSmithKline Biologicals

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