Table 1.
Visit and Sample Schedule
| Visit | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11a |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Day | 0 | 7 | 28 | 90 | 180 | 270 | 365 | 455 | 545 | 635 | 730 |
| Permissible time window (days) | … | +7/-1 | ±4 | ±14 | ±28 | ±28 | ±56 | ±56 | ±56 | ±56 | ±90 |
| Screening | X | … | … | … | … | … | … | … | … | … | … |
| Consent | X | … | … | … | … | … | … | … | … | … | … |
| Randomization | X | … | … | … | … | … | … | … | … | … | … |
| Vaccination | X | … | … | … | … | … | … | … | … | … | … |
| Medical history and exam | X | … | … | … | … | … | … | … | … | … | … |
| Blood collectionb | X | … | X | … | … | … | … | … | X | … | X |
| Height and weightc | X | … | … | … | … | … | … | … | … | … | X |
| Follow-up contactd | … | Xe | X | X | X | X | X | X | X | X | |
| Vaccination with either Vi-TCV or MenAf | … | … | … | … | … | … | … | … | … | … | X |
| Documentation of vaccine receiptg | X | … | … | … | … | … | … | … | … | … | X |
Abbreviations: AEFI, adverse event following immunisation; MenA, Neisseria meningitidis serogroup A; TCV, typhoid conjugate vaccine.
aIdeally, all of the visit 11 activities will occur simultaneously, but the follow-up contact may occur separately, if necessary.
bBlood sampling for immunogenicity will be in a subset of 1000 Vi-TCV and 500 control participants. The planned blood draws are ~5 ml per visit. The total maximum volume will be ~20 ml per participant. The blood draw on Day 0 will occur before vaccination; the blood draw at Day 545 will aim to occur at the same time as the follow-up; and the blood draw at Day 730 will occur at the same time as unblinding and vaccine documentation.
cHeight and weight will be measured only in children under 5 years of age at the time of enrollment.
dFollow-up contact includes: ensuring the participant and family still live in the area and are happy to continue with the study; inquiring regarding work and school absenteeism; recording mortality and morbidity in the participant, including fevers; and providing a reminder to attend a trial health-care facility if they develop a fever of ≥2 days.
eAt 7 days, full AEFI reporting will be collected during the follow-up contact.
fEither Vi-TCV or MenA vaccine will offered at the end of the trial, depending on which vaccine the child initially received.
gBoth the intervention and control arms will be asked to return for unblinding (at Day 730 only) and documentation of vaccination.