A Phase 2 single-blind, randomized, controlled, single center study to assess the immunogenicity and safety of a 2-dose schedule with GVGH altSonflex1-2-3 vaccine in African infants (H06_02TP)

GlaxoSmithKline Biologicals SA0 个研究点目标入组 200 人开始时间: 2024年1月8日最近更新: 2024年3月4日

适应症

试验速览

阶段: 2 期
状态: 尚未招募
发起方: GlaxoSmithKline Biologicals SA
入组人数: 200

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

入排标准

年龄范围: 0 Month(s) 至 23 Month(s)（—）
性别: All

入选标准

•Participants are eligible to be included in the study only if all of the following criteria
•Participants’ parent(s)/LAR(s), who, in the opinion of the investigator, can and will
•comply with the requirements of the protocol (e.g., completion of the diary cards,
•return for follow-up visits).
•Written or witnessed/thumb printed informed consent obtained from the
•parent(s)/LAR(s) of the participant prior to performance of any study specific
•Healthy participants as established by medical history, clinical examination, and
•laboratory assessment.
•Participants satisfying all screening requirements.
•Participants seronegative for hepatitis B, and hepatitis C.
•A male or female 9 months of age at the time of the first study intervention
•administration.
•Normal nutritional (weight-for-length) Z score (-2 standard deviations or greater).
•Previously completed routine childhood vaccinations to the best knowledge of the
•participant’s parent(s)/LAR(s).
•Born at a gestation period of =37 weeks to the best knowledge of the participant’s
•parent(s)/LAR(s).
•Participants negative for human immunodeficiency virus as confirmed by DNA
•polymerase chain reaction testing.
•Participants negative for HLA-B27.

排除标准

•History of any reaction or hypersensitivity associated with any component of the study interventions.
•Any confirmed or suspected immunosuppressive or immunodeficient condition,
•Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality
•Recurrent history or uncontrolled neurological disorders or seizures.
•Any clinically significant hematological and/or biochemical laboratory abnormality.
•Clinical conditions representing a contraindication to IM injections and/or blood draws.
•Any behavioral or cognitive impairment or psychiatric disease that may interfere with the participant’s ability to participate in the study.
•Confirmed positive COVID-19 from 28 days before the 1st dose
•Acute or chronic illness which may be severe enough to preclude participation.
•Any other clinical condition that, might pose additional risk to the participant due to participation in the study.
•All medical conditions will be assessed by the Investigator who may use his/her discretion to decide if the participant meets the exclusion criteria.
•Use of any investigational or non-registered product from (D-30 to 1) before the 1st dose of study interventions, or planned use during the study.
•A vaccine not foreseen by the study protocol administered 14D pre 1st dose to 28D post last dose, with the exception of flu vaccines or COVID-19 vaccine.
•Administration of long-acting immune-modifying drugs any time during the study period.
•Administration of immunoglobulins and/or any blood products or plasma derivatives From 3Mo before 1st admin or throughout the study.
•Chronic admin of immunosuppressants or other immune-modifying drugs from 3 Mo before 1st dose.
•Prior receipt of an experimental Shigella vaccine or live Shigella challenge.
•Known exposure to Shigella during lifetime of the participant as confirmed during interview with the participant’s parent(s)/LAR(s) or documented by participant’s records.
•Child in care

研究者

发起方

GlaxoSmithKline Biologicals SA

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