PACTR202305722094480尚未招募2 期
A Phase IIa observer-blind, randomized, controlled, age-de-escalation, single center interventional study to evaluate the safety, reactogenicity, and immune response of the invasive nontyphoidal Salmonella vaccine against S. Typhimurium and S. Enteritidis, in adults, children and infants, including dose-finding in infants, in Africa
GlaxoSmithKline Biologicals SA GSK0 个研究点目标入组 516 人开始时间: 2023年3月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 516
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
- 1 Month(s) 至 23 Month(s)（—）
- 性别
- All
入选标准
- •All participants:
- •Participants and/or participants’ parent(s)/Legally Acceptable Representative(s) (LAR), 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 participant/parent(s)/LAR(s) of the participant prior to performance of any study-specific procedure.
- •Healthy participants as established by medical history, clinical examination, and laboratory investigations.
- •Participants satisfying screening requirements.
- •Participants negative for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.
- •Adults 18 to 50 years of age:
- •A male or female between and including 18 and 50 years of age at the time of the first study intervention administration.
- •Female participants of non-childbearing potential may be enrolled in the study.
- •Female participants of childbearing potential may be enrolled in the study, if the participant:
- •has practiced adequate contraception for 1 month prior to study intervention administration, and
- •has a negative pregnancy test on the day of study intervention administration, and
- •has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration series.
- •Child participants:
- •A male or female between and including 24 and 59 months of age at the time of the first study intervention administration.
- •Previously completed routine childhood vaccinations to the best knowledge of the participant’s parent(s)/LAR’s.
- •Born after a gestation period of =37 weeks.
- •Infant participants:
- •A male or female 6 weeks or 9 months of age at the time of the first study intervention administration.
- •Born after a gestation period of =37 weeks.
- •Born to a mother seronegative for HIV, hepatitis B virus and hepatitis C virus.
排除标准
- •Known exposure to S. Typhimurium or S. Enteritidis during the period starting at birth for infants and children, and at 3 years for adults,
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
- •Hypersensitivity, including allergy, to medicinal products
- •Progressive, unstable, or uncontrolled clinical conditions.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition
- •Major congenital defects
- •Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality
- •Acute disease and/or fever at the time of enrollment
- •uncontrolled neurological disorders or seizures
- •Any clinically significant hematological and/or biochemical laboratory abnormality.
- •Undernutrition
- •Malaria infection
- •Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
- •Any behavioral or cognitive impairment or psychiatric disease.
- •Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study
- •Received any investigational iNTS or GMMA vaccines
- •Use of any investigational or non-registered product other than the study interventions
- •Planned administration/administration of a vaccine not foreseen by the study
- •Administration of long-acting immune-modifying drugs at any time during the study period.
- •Administration of immunoglobulins and/or any blood products or plasma derivatives from birth (for infant 6 weeks of age) or 3 Mo before study start
- •Chronic administration of immunosuppressants/immune-modifying drugs from 3mo before 1st dose.
- •Concurrently participating in another interventional clinical study,
- •Pregnant or lactating female.
- •Female planning to become pregnant
- •History of/current chronic alcohol consumption and/or drug abuse.
- •Study personnel, their immediate dependents, family or household
- •Child in care
研究者
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