PACTR202305722094480
Not yet recruiting
Phase 2
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 sites516 target enrollmentMarch 13, 2023
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Invasive nontyphoidal Salmonella
- Sponsor
- GlaxoSmithKline Biologicals SA GSK
- Enrollment
- 516
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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