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