A study to evaluate safety, reactogenicity, and immune response of GSK Vaccines Institute for Global Health invasive nontyphoidal Salmonella (iNTS) TCV vaccine against invasive nontyphoidal Salmonella and Typhoid Fever
- Conditions
- invasive nontyphoidal salmonellosis and typhoid fever
- Registration Number
- PACTR202306838192573
- Lead Sponsor
- GlaxoSmithKline Biologicals SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 155
Participants, who, in the opinion of the Investigator, can and will comply with the
requirements of the protocol (eg, completion of the pDiary cards, return for
follow-up visits).
• Written or witnessed/thumb printed informed consent obtained from the participant
prior to performance of any study-specific procedure.
• Healthy participants as established by medical history, clinical examination, and
laboratory assessment.
• Participant satisfying screening requirements.
• 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 nonchildbearing potential may be enrolled in the study.
Nonchildbearing 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 trial if the
participant:
- Has practiced adequate contraception (as indicated in Appendix 4) 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.
• Blood sample for simultaneous follicle-stimulating hormone (FSH) and estradiol
levels may be collected at the discretion of the Investigator to confirm
non-reproductive potential according to local laboratory reference range.
• Genetic testing for HLA-B27 will be performed at Screening and only participants
with a negative result will be allowed to participate in the study*.
*Only for Stage 1
• For Malawi (Stage 2), the participant lives in Blantyre and has agreed to remain in
Blantyre for the study duration.
• Known exposure to S. Typhi and NTS from 3 years pre 1st vaccination.
• 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.
• History of receiving any typhoid vaccine in the participant’s life.
• History of receiving any investigational iNTS or GMMA vaccines in the
participant’s life.
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method