Typhoid fever
Conditions
Interventions
MCVA
ViTT
Sponsors
International Vaccine Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Healthy participants aged 9 months to <16 years (i.e. =15 years and 364 days) of age at time of vaccination • Participants/Parents/legally authorised representative (LAR) who have voluntarily given informed assent (sought from participants aged 12 years to <16 years)) and informed consent • Participants/Parents/LAR living within study target area at the time of vaccination and willing to follow the study procedures and be available for the entire duration of the study
Exclusion criteria
Exclusion criteria: • Known allergy to any vaccine component • Self-reported ongoing acute and/or chronic illness • Any self-reported coagulopathies • Any medical or social compelling reasons in the judgment of a clinical physician • Self-reported pregnancy/Positive urine pregnancy test or lactating • Previous typhoid vaccination in the last 5 years (proven by presentation of a vaccine card or self-reporting). Temporary exclusion criteria • Self-reported fever (elevated tympanic (=38°C) or axillary temperature (=37.5°C)) within 24 hours of vaccination • Self-reported use of antipyretics within 4hours prior to vaccination • Any other vaccination during the last 4 weeks (proven by presentation of a vaccine card or self-reporting) • Girls =11 years of age with self-reported irregular menstruation or who do not know their last menstruation date
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of blood culture-confirmed symptomatic TF in all vaccine recipients of the intervention clusters, compared with control clusters. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Vi-TT vaccine safety in participants receiving Vi-TT compared with MCV-A, measured by: • The proportion of participants in each group of a sub-sample of the cohort developing local and/or systemic solicited adverse events/adverse reactions within the first 7 days post-vaccination. • The proportion of participants in each group of the cohort developing serious adverse events during the entire study period, as determined by self-reporting at follow-up contact. 2) The incidence of blood culture-confirmed symptomatic TF in all residents of the intervention clusters compared with that in all residents of control clusters 3.1) The incidence of severe TF in vaccinated individuals in intervention clusters compared to control clusters 3.2) The incidence of severe TF in all residents of the intervention clusters compared with that in all residents of control clusters 4.1) The incidence of clinical typhoid fever cases, defined as persistent fever (tympanic (=38.0?) or axillary temperature (=37.5?) or reported fever for =3 consecutive days) with abdominal complaints at a study surveillance site in vaccinated individuals in intervention clusters compared to control clusters. 4.2) The incidence of clinical typhoid fever cases presenting at a study surveillance site among all residents of the Vi-TT clusters compared to the control vaccine clusters. 5) The incidence of blood culture-confirmed symptomatic TF in non-vaccinees of the intervention clusters compared with control clusters. 6) The seroconversion rates and antibody concentration as measured by enzyme linked immunosorbent assay (anti-Vi IgM and IgG) for S. Typhi and iNTS at defined time points in a age-stratified subset of intervention and control vaccinees. | — |
Countries
Ghana
Contacts
Public ContactAndrea Haselbeck
Senior Research Scientist
Outcome results
None listed