EUCTR2023-000944-46-Outside-EU/EEA
Active, not recruiting
Phase 1
A Phase IIa observer-blind, randomized, controlled, age-de-escalation, single center interventional study to evaluate the safety, reactogenicity, and immune response of the GVGH iNTS vaccine against S. Typhimurium and S. Enteritidis, in adults, children and infants, including dose finding in infants, in Africa - INTS GMMA GVGH-004 (H04_03TP)
DrugsMenveo
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GLAXOSMITHKLINE BIOLOGICALS SA
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All participants (adults, children, infants at 9 months of age and infants at 6 weeks of age) will be enrolled in the clinical site in Ghana and must satisfy ALL the following criteria at study entry:
- •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.
- •Adult participants must satisfy ALL the following criteria at study entry:
- •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. Non\-childbearing potential is defined as pre\-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post\-menopause.
- •Female participants of childbearing potential may be enrolled in the study if the participant:
Exclusion Criteria
- •Medical conditions:
- •Known exposure to S. Typhimurium or S. Enteritidis during the period starting at birth for infants and children, and at 3 years for adults, as documented by patient records
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
- •Hypersensitivity, including allergy, to medicinal products or medical equipment whose use is foreseen in this study.
- •Progressive, unstable, or uncontrolled clinical conditions.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- •Major congenital defects, as assessed by the investigator.
- •Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Acute disease and/or fever at the time of enrollment (fever is defined as temperature \= 38\.0°C).
- •Recurrent history or uncontrolled neurological disorders or seizures.
Outcomes
Primary Outcomes
Not specified
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