Blood culture confirmed typhoid fever Infections and Infestations Typhoid fever
Conditions
Interventions
Current interventions as of 13/08/2018:
Participants will be randomised (block randomisation) 1:1 to receive a single dose of either Vi-TCV or MenA vaccine:
Intervention: Vi Typhoid conjugate vaccine
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Parent/legal guardian is willing and competent to provide informed consent. If the participant is 12 years of age or older, informed assent will also be sought 2. Aged between 9 months (or eligible for measles vaccination according to local protocol) and <16 years (i.e. up to 15 years 364 days) at time of vaccination 3. In good health on the day of vaccination 4. Parent/legal guardian confirms that their child will be wiling and be able to comply with study requirements including follow-up contact, according the trial schedule 5. Live within the study catchment area at the time of vaccination
Exclusion criteria
Exclusion criteria: The participant will not be enrolled if any of the following criteria apply: 1. They have knowingly received a typhoid vaccine in the last three years 2. They have a known allergy to any of the vaccine components 3. Any medical or social reasons that will prevent the participant from conforming to the study requirements as judged by a medical professional 4. They are planning to move away from the catchment area within the next 6 months Participants will be temporarily excluded from being vaccinated if, at point of vaccination, any of the following apply: 1. Reported fever within 24 hours prior to vaccination 2. Use of anti-pyretics within 4 hours prior to vaccination If these apply, the participant will be temporarily excluded for vaccination until 48 hours has passed. A re-assessment will be conducted to ensure these temporary exclusion criteria no longer exist
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Vi-TCV vaccine safety, measured as the proportion of participants developing all adverse events within the first 7 days post-vaccination, and serious adverse events within 6 months of vaccination, as determined through self-reporting at three-monthly follow-up contact 2. The impact of vaccination with Vi-TCV on the incidence of inpatient/outpatient admission rates for fever, measured by the rates of participants with at least =2 days of subjective persistent fever, or a temperature of at least 38 degrees C, at presentation at Patan Hospital or trial clinics in each vaccination arm, stratified by duration and severity of fever 3. The difference in rates of hospital and clinic presentation for febrile illness in each vaccination arm, measured as the rates of hospital or clinic presentation with febrile illness of any duration in each vaccination arm, measured by hospital presentation logs, hospital records, trial clinic records and self-reporting during three monthly follow-up 4. Days spent in hospital from febrile illness, measured as the length of stay in hospital, collected from Patan hospital patient records, and parent/self-reported, in each vaccination arm 5. Incidence of clinically-suspected enteric fever, measured as the number of clinical diagnoses of typhoid fever, as determined by trial staff in Patan hospital outpatient clinics and trial clinic, in each vaccination arm throughout the two year follow-up period 6. Paratyphoid infection rates in each vaccination arm, measured as the rates of blood culture confirmed Paratyphoid cases in participants presenting to hospital or clinic for the duration of the trial, in each vaccination arm Added 20/06/2019: 7. The efficacy and rate reduction of the Vi-TCV in preventing blood culture-confirmed symptomatic infection caused by S. Typhi, measured through the incidence of blood culture confirmed typhoid fever in participants presenting to hospital or clinic with at least 3 days of fever, for the duration of the tri | — |
Primary
| Measure | Time frame |
|---|---|
| The efficacy and rate reduction of the Vi-TCV in preventing blood culture-confirmed symptomatic infection caused by S. Typhi, measured through the incidence of blood culture confirmed typhoid fever in participants presenting to hospital or clinic for the duration of the trial, in each vaccination arm | — |
Countries
Nepal
Outcome results
None listed