A study on the safety and immune responses to the GVGH altSonflex1-2-3 vaccine against shigellosis in adults, children, and infants
- Conditions
- Diarrhoeal disease due to Shigella infection
- Registration Number
- PACTR202208635693932
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 550
All participants:
•Participants and/or 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 (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 assessment.
•Participants satisfying all screening requirements.
•Participants seronegative for hepatitis B, and hepatitis C.
•Participants negative for human leukocyte antigen B27 (HLA-B27).
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 participant 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.
•Participants seronegative for human immunodeficiency virus (HIV).
Children 24 to 59 months of age:
• A male or female between, and including, 24 and 59 months of age at the time of first vaccination.
•Normal nutritional Z score (-2 standard deviation or greater).
•Previously completed routine childhood vaccinations to the best knowledge of the participant's parent(s)/LAR(s).
•Born after gestation period of =37 weeks.
•Participants seronegative for HIV.
•Participants negative for HIV as confirmed by DNA PCR testing
All participants:
• Known exposure to Shigella during lifetime of the participant as confirmed during interview with the participant or documented by patient records, recent travel* to a country where Shigella or other enteric infections are endemic, or recent occupation* involving Shigella species.
*Limited to Adults 18 to 50 years of age in Europe.
• Progressive, unstable or uncontrolled clinical conditions.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
• Any confirmed or suspected immunosuppressive or immunodeficient condition.
• Hypersensitivity, including allergy, to medicinal products or medical equipment whose use is foreseen in this study.
• Clinical conditions representing a contraindication to IM vaccination and blood draws.
oAny behavioural or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the study.
oAcute disease and/or fever at the time of enrolment*
• Any clinically significant haematological and/or biochemical laboratory abnormality.
oConfirmed positive COVID-19 test during the period starting 30 days before the first administration of study vaccines.
oAny other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
oAdministration of long-acting immune-modifying drugs at any time during the study period.
oPrior receipt of an experimental Shigella vaccine or live Shigella challenge.
oUse of any investigational or non-registered product* other than the study vaccine during the period.
•Acute or chronic illness
•Chronic administration of immunosuppressants or other immune-modifying drugs
•Pregnant or lactating female
•History of or current chronic alcohol consumption and/or drug abuse
•Administration of immunoglobulins and/or any blood products or plasma derivatives, or bone marrow transplant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method