Table 4 Schedule of activities—women From Umurinzi
Visit # | 1 | 2 | 3 | 4 | 5 | EE |
|---|---|---|---|---|---|---|
Visit timing | Dose 2 | Dose 2 + 28 days | Pregnancy completion/termination | PP 1 + 42 days | Early exit | |
Visit day and window | − 28 to 1 | D57 − 14 days, + 28 days | D85 ± 7 days | PP 1 a + 2 days | PP 43 b ± 14 days | |
Visit type | Screening | Dose 2 | Safety | Safety and immuno | Safety | Early exit |
Assessment of understanding | • | |||||
Written informed consent (ICF) c | • | |||||
Inclusion/exclusion criteria | • | |||||
Demographics d | • | |||||
Medical and obstetric history e; pre-pregnancy and pre-study meds | • | |||||
Physical examination e | • | • | • | |||
Obstetric exam e | • | • | • | •m | ||
Targeted physical exam e | • | • | ||||
Vital signs e incl. body temperature | • |
| • | • | • | • |
Urine pregnancy test f | • | |||||
Hematology, chemistry f | • | |||||
Urine dipstick/urinalysis f | • | • | • | |||
Syphilis, HIV, hepatitis B and C, malaria screening f | • | |||||
Obstetric ultrasound g | • | • | •m | |||
Biometric scan | • | • | • | • | • | • |
Contact information | • | • | • | • | • | • |
Pre-vaccination symptoms h |
| |||||
Vaccination | • | |||||
30 min post-vaccination observationi | • | |||||
Adverse maternal, fetal outcomes | • | • | • | • | ||
SAE recording | • | • | • | • | • | |
Concomitant medications j | • | • | • | • | • | • |
Delivery history k | • | |||||
Post pregnancy physical examination k | • | |||||
Laboratory assessments l | • |
-
pre-dose;
pre- and post-dose - aPP 1 refers to the day of pregnancy completion/termination. Visit 4 (PP 1) should occur on the day of pregnancy completion/termination or within 2 days
- bVisit 5 (PP 43) scheduled to occur at routine 6 week post-partum visit
- cMust be signed before first study-related activity
- dMaternal demographic information to be collected at screening includes: date of birth, race/ethnicity, education level, geographical location/residence, occupation, household size (number of persons living in the same home), and international travel history
- eInformation to be collected for medical and obstetric history, physical exams, and vital signs is specified in the protocol
- fUrine dipstick for protein and glucose will be performed at these visits. If results are 1 + or greater, additional work-up for pre-eclampsia and gestational diabetes may be warranted
- gUltrasound not required at visit 2 if screening (visit 1) ultrasound completed within past 10 days and no other indication for ultrasound
- hInvestigator must check for acute illness or body temperature ≥ 38.0 °C at the time of vaccination. In such cases, the participant may be vaccinated at later time point
- iParticipants will be closely observed for a minimum of 30 min post-vaccination
- jIncludes any medical treatment/medications given to the mother during delivery (e.g., antibiotic prophylaxis)-specifying names of medications administered
- kInformation to be collected for delivery history and post-pregnancy examination is specified in the protocol
- lAny routine laboratory assessment performed at time of delivery and other laboratory tests as medically indicated
- mNot required if participant is not pregnant
pre-dose;
pre- and post-dose