Table 1.
Participant timeline in the study
| Contact with participant | |||||||||
| Visit 1 | Visit 2 | Visit 3–9 | Visit 10 | Visit 11–17 | Visit 18 | Visit 19–25 | Visit 26 | Visit 27 |
|
| Days | −1 | 0 | 1–7 | 30* | 31–37* | 180* | 181–187* | 210* | 2½ years |
| Enrolment | |||||||||
| Invitation visit | X | ||||||||
| Eligibility screening | X | X | X | ||||||
| Informed consent | X | ||||||||
| Demographics (age, height, weight, BMI), medications/medical history |
X | X | X | X | X | ||||
| Interventions | |||||||||
| Vaccination | X | X | X | ||||||
| Blood sample† | X | X† | |||||||
| Surveillance | |||||||||
| Hepatitis surveillance (active and passive) | Throughout the study period | ||||||||
| Pregnancy surveillance | Throughout the study period | ||||||||
| Assessments | |||||||||
| Pregnancy home visit | Every 2 weeks | ||||||||
| Physical examination | X | ||||||||
| Harms/safety | |||||||||
| Immediate reactions | X | X | X | ||||||
| Home visit | X | X | X | X | |||||
| SAE | At any time following first vaccine dose | ||||||||
| Participant reporting of AEs | At any time following first vaccine dose | ||||||||
| Withdrawal | At any time following enrolment | ||||||||
*±2 days.
†Dried blood spots (DBSs) are collected before vaccination and 1 month after last vaccine dose, or earlier if off study.
AE, adverse event; BMI, body mass index; SAE, serious adverse events.