Blood culture confirmed typhoid fever Infections and Infestations Prevention of typhoid fever (Salmonella typhi infection)
Conditions
Interventions
Current intervention as of 09/03/2021:
Intervention: Vi Typhoid conjugate vaccine (Vi-TCV), trade name: TyBar
Control: Japanese Encephalitis vaccine: trade name: SA14-14-2, Japanese Encephalitis Vacci
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
9 Months to 16 Years
Inclusion criteria
Inclusion criteria: 1. Parent/guardian is willing and competent to provide informed consent. If the participant is 11 to <16 years of age, 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. Apparently healthy (no complaints of febrile illness) on the day of vaccination 4. Parent/guardian confirms that their child will be willing and be able to comply with study requirements including follow-up contact, according the schedule (Appendix B) 5. Living within the study catchment area at the time of vaccination
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 13/08/2018: 1. Has knowingly received a typhoid or Japanese encephalitis vaccine in the last three years 2. Known allergy to any of the vaccine components 3. Medical or social reasons that will prevent the participant from conforming to the study requirements as judged by a medical professional 4. Planning to move away from the catchment area within the next month 5. Pregnant at the time of vaccination, as confirmed by a urine test (urine pregnancy test will be done in girls who are married) Temporary exclusion criteria: 1. Receipt of any other vaccines in the last 30 days 2. Current temperature of at least 38°C or reported fever within 24 hours prior to vaccination 3. Use of antipyretics within 4 hours prior to vaccination 4. Unmarried girls between the ages of =12 and <16 years old whose first day of their last menstrual period (LMP) is more than 28 days ago or who do not know the date they last menstruated upon presentation Previous participant exclusion criteria: 1. Has knowingly received a typhoid or Japanese encephalitis vaccine in the last three years 2. Known allergy to any of the vaccine components 3. Medical or social reasons that will prevent the participant from conforming to the study requirements as judged by a medical professional 4. Planning to move away from the catchment area within the next month 5. Pregnant at the time of vaccination, as confirmed by a urine test (urine pregnancy test will be done in girls who are married)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 09/03/2021: 1. Vi-TCV vaccine safety, measured as the proportion of participants developing local and solicited adverse events within the first 7 days post-vaccination, and serious adverse events within 6 months of vaccination, as determined through sub-sample at 7 days, and self-reporting at follow-up contact 2. The efficacy and rate reduction of the Vi-TCV in preventing blood culture-confirmed symptomatic infection caused by S. typhi among all residents in the clusters allocated to Vi-TCV (overall vaccine protection), measured through the incidence of blood culture confirmed typhoid fever in all residents of the intervention clusters compared to control clusters 3. Rates of participants with a history of =2 days of persistent fever, and a temperature of >38°C upon presentation, together with abdominal discomfort, at all study surveillance sites in vaccinees in intervention clusters compared to control clusters 4.Rates of residents with a history of =2 days of persistent fever, and a temperature of >38°C upon presentation, together with abdominal discomfort, at all study surveillance sites among all residents of the Vi-TCV clusters compared to the control vaccine clusters 5. Rates of patients with clinical diagnoses of typhoid fever at a study surveillance site in vaccinees in intervention clusters compared to control clusters 6. Rates of patients with clinical diagnoses of typhoid fever at a study surveillance site among all residents of the Vi-TCV clusters compared to the control vaccine clusters 7. Paratyphoid infection rates in each vaccination arm as measured by incidence of blood culture confirmed paratyphoid fever in vaccinees in intervention clusters compared to control clusters 8. Incidence of blood culture confirmed typhoid fever in vaccinees in previously Vi-TCV vaccinated clusters (original Vi-TCV clusters) compared with recently Vi-TCV vaccinated clusters (original control clusters) at 2 years post-vaccinatio | — |
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 vaccinees in intervention clusters compared to control clusters. | — |
Countries
Bangladesh
Outcome results
None listed