Typhoid fever prophylaxis Infections and Infestations Typhoid fever
Conditions
Interventions
Subjects deemed eligible after screening will be randomised to receive an oral dose of either active vaccine or matching placebo.
Safety will be monitored by:
1. Diary recordings of body temperatur
Sponsors
Emergent Product Development UK Ltd (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy paediatric subjects aged five to 14 years 2. Are able and willing to take part in the trial 3. Parents or guardians give written permission for their child?s participation, following a detailed explanation of the study
Exclusion criteria
Exclusion criteria: 1. Any clinically significant medical or psychiatric condition or abnormal laboratory results on screening, which preclude participation in the study 2. A body weight under 17 kg (five to ten year olds), or under 27 kg (11 to 14 year olds) 3. A confirmed pregnancy, or are breast feeding 4. A known hypersensitivity to two or more of the following antibiotics: ciprofloxacin, azithromycin or trimethoprim-sulfamethoxazole, or have used antibiotics/antibacterials within 14 days prior to administration of study medication 5. A known hypersensitivity to any component of the vaccine or bicarbonate solution, phenylketonuria or those who have experienced anaphylactic shock after any vaccination 6. Received Vivotif, in the last ten years or any other vaccine against S. typhi, in the last five years, or who have ever suffered from typhoid fever 7. Direct contact with patients in special care units or immuno-compromised individuals, a positive bacterial culture of their faecal sample, obtained at the screening visit, for any Salmonella species, a known impairment of immune function or family members who are Human Immunodeficiency Virus (HIV) positive 8. A significant acute febrile illness at time of dosing chronic diseases, a current problem of substance abuse or who are currently or recently involved in a clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects reporting Serious Adverse Events (SAEs) attributed to the study medication. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety - the proportion of subjects: 1. Experiencing an elevated body temperature, of 38.5°C or greater, in the 14 days following dosing, attributed to study medication 2. Demonstrating persistent faecal shedding of the vaccine strain 3. Withdrawn from the study due to adverse events, including bacteraemia, attributed to study medication 4. With clinically significant changes in laboratory parameters, from day zero to any time post dosing, which are attributed to study medication Immunogenicity: 1. Develop a positive immune response to S. typhi LipoPolySaccharide (LPS) as assessed by an increase in S. typhi LPS specific IgG 2. Develop a positive immune response to S. typhi LPS as assessed by an increase S.typhi LPS specific IgA 3. At day seven, have more than or equal to 4 Antibody-Secreting Cells (ASCs) per 10^6 Peripheral Blood Mononuclear Cells (PBMC), secreting IgA specific for S. typhi LPS detected by ELISPOT assay (subjects over ten years of age) | — |
Countries
Viet Nam
Outcome results
None listed