Vaccination
allergic, ®, fever, febrile illness, typhoid
ADVERSE EVENTS, RECRUITMENT, FEBRILE ILLNESS, TYPHOID
Once the fever surveillance is operational, eligible participants from selected vaccine clusters will be invited to designated vaccination clinics over a period of 2 months and have a unique vaccination code sent to their phones. This process will be repeated after the mop-up recruitment drive. In case of vaccination with any other vaccine within 30 days of the TyphiBEV® vaccination date, or a febrile illness in the week prior, the date will be rescheduled. Participants will be excluded if they decline consent, have received a typhoid vaccine in the past 3 years, are allergic to any component of TyphiBEV®, are nursing mothers, are pregnant, or are planning pregnancy around the vaccination date. If a participant is absent on their scheduled vaccination date, or subsequent rescheduled date, and does not respond to two reminders sent 7 days apart, they will be considered as having refused the vaccine. Participants that are ineligible or refuse the vaccine will continue to be part of the fever surveillance.At the clinic, a trained vaccinator will check each participant’s unique code and government-issued identity card against the study database to verify their assignment to the intervention arm, and then dispense a single 0.5-mL, intramuscular dose of TyphiBEV® to eligible participants. Vaccinators, a doctor, and a nurse will make up the vaccination team at each clinic, which will also observe the patient for 30 min after vaccination in case of any immediate adverse events. The first 3600 vaccinated participants will be asked to maintain an adverse events diary for 7 days. Participants will also be contacted every month to check for any illnesses in that period.Serious adverse events (SAEs) will be monitored by a study investigator who will inform the study’s Principal Investigator (PI) of them. Any that are unexpected and related to the vaccination in the PI’s opinion will be reported to the CMC IRB within 24 h of the PI being aware of them, using the SAE reporting form. Trial-related adverse events will be treated as per CMC Vellore’s institutional guidelines.