Actively Recruiting
Trivalent Salmonella Conjugate Vaccine (TSCV)
Led by University of Maryland, Baltimore · Updated on 2025-05-02
800
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
Sponsors
U
University of Maryland, Baltimore
Lead Sponsor
B
Bharat Biotech International
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an age-descending, randomized, placebo-controlled trial that will evaluate the safety and immunogenicity of a Trivalent Salmonella conjugate vaccine (TSCV). The trial will proceed from adults, to children, to toddlers, and then to infants.
CONDITIONS
Official Title
Trivalent Salmonella Conjugate Vaccine (TSCV)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male or female individuals
- Adults aged 20 to 35 years (Step 1A)
- Children aged 5 to 9 years (Step 1B)
- Preschool children aged 24 to 59 months (Step 1C)
- Older toddlers aged 16 to 23 months (Step 1D)
- Young toddlers aged 12 to 16 months (Step 2A)
- Older infants aged 8 to 11 months (Step 2B)
- Young infants aged 12 to 14 weeks or 16 to 18 weeks (Step 3)
- Young infants aged 12 to 18 weeks (Step 4)
- Parents of pediatric participants must live in the study area and plan to stay during the study
- Adult participants and parents/guardians of children must provide informed consent
- Infants and toddlers in Steps 2, 3, and 4 must have received their scheduled routine vaccines at least 14 days before study vaccine
You will not qualify if you...
- History of allergy to any component of TSCV or Typbar-TCV
- Previous vaccination with any licensed or experimental typhoid vaccine
- Known history of diabetes, tuberculosis, cancer, chronic kidney, heart or liver disease, progressive neurological disorder, poorly controlled seizures, or terminal illness
- Severe malnutrition (weight-for-length Z-score less than -3)
- Participation in any other investigational intervention in the past 6 months
- Known HIV infection or other immune system problems
- Use of systemic immunosuppressive medicines including corticosteroids
- For Step 1A females who can have children, a positive pregnancy test at enrollment
- Female children in Step 1B who have started menstruation
- Current acute illness or fever above 38.0°C (temporary exclusion)
- Positive malaria test (temporary exclusion until treatment completed)
- Any condition that might interfere with vaccine evaluation, pose a health risk, or prevent study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Centre for Vaccine Development (CVD-Mali)
Bamako, Mali
Actively Recruiting
Research Team
F
Fleesie Hubbard
CONTACT
A
Alyson Kwon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
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