Paediatrics non-Typhoidal Salomonella
Conditions
Interventions
Interventional
Placebo
Sponsors
University of Maryland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Healthy individuals, female or male Age (all age ranges are inclusive) Step 1A: Adults 20-35 years of age Step 1B: Children, 5-9 years of age Step 1 C: Pre-school children, 24-59 mos. of age Step 1D: Older toddlers, 16-23 months of age Step 2A: Young toddlers, 12-16 months of age Step 2B: Older infants, 8-11 months of age Step 3: Young infants,12-14 weeks of age OR 16-18 weeks of age Step 4: Young infants, 12-18 weeks of age For potential pediatric participants, the parents must live within the catchment area of the clinical study facility at the time of the study vaccinations and must intend to continue to reside in the area for the duration of the study Adult subjects and parents/ guardians of pediatric subjects must have provided informed consent Infant and toddler subjects in Steps 2, 3, and 4 must have received their scheduled EPI vaccines at least 14 days prior to receiving a study product.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: A history of documented hypersensitivity to any component of the Trivalent Salmonella Conjugate Vaccine or of Typbar-TCV™ A history of previous vaccination with any licensed or experimental typhoid vaccine A known history of diabetes, tuberculosis, malignancy, chronic kidney disease, cardiac disease, liver disease, progressive neurological disorder, poorly controlled seizure disorder, or a terminal illness based on participant interview and review of screening laboratory results. Severe malnutrition: i.e., weight-for-length Z-score of less than - 3. Receipt of any other investigational intervention in the last 6 months Known HIV infection or other forms of immunocompromise Receipt of systemic immunosuppressive medication including systemic corticosteroids For Step 1A, for females of child-bearing potential, a positive pregnancy test at the time of enrollment. For Step 1B, any female child who has experienced menarche
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and reactogenicity of Full-strength and Half-strength TSCV [ Time Frame: first 30 minutes after parenteral immunization ] The proportion of participants in each product group and within each age group who develop adverse events (AEs) in the first 30 minutes after parenteral immunization Safety and reactogenicity of Full-strength and Half-strength TSCV [ Time Frame: over 7 days post-vaccination. ] The proportion of participants in each product group and within each age group who develop adverse events (AEs) in the 7 days post-vaccination. Safety and reactogenicity of Full-strength and Half-strength TSCV [ Time Frame: through Day 29 of follow-up post-vaccination ] The proportion of participants who experience AEs through Day 29 of follow-up post-vaccination. Safety and reactogenicity of Full-strength and Half-strength TSCV [ Time Frame: Through Day 366 of follow-up post vaccination ] The proportion of participants who experience Serious Adverse Events through their participation in the study. Non-inferiority analysis: immunogenicity of Full-strength vs. Half-strength TSCV [ Time Frame: Through day 29 post vaccination ] Serum IgG anti-COPS antibodies (to both S. Enteritidis and S. Typhimurium antigens) Non-inferiority analysis: immunogenicity of Full-strength vs. Half-strength TSCV [ Time Frame: Through day 29 post vaccination ] Serum IgG anti-Vi antibodies Safety and reactogenicity after primary dose of TSCV and after booster dose of TSCV or Typbar-TCV™ [At each booster age group (9, 12, or 15-17 mo. of age)] [ Time Frame: over 7 days post-vaccination. ] The proportion of participants in each product group who develop adverse events (AEs) in 7 days post-vaccination. Safety and reactogenicity after primary dose of TSCV and after booster dose of TSCV or Typbar-TCV™ [At each booster age group (9, 12, or 15-17 mo. of age)] [ Time Frame: through Day 29 of follow-up after each vaccination. ] The proport | — |
Secondary
| Measure | Time frame |
|---|---|
| B memory responses. Systems Serology Opsonophagocytic activity (OPA) | — |
Countries
Kenya, Mali
Contacts
Public ContactAlyson Kwon
Regulatory Affairs Specialist
Outcome results
None listed