Table 2.

Schedule of activities—women in group A

Visit #	1	2	3	4	5	6	7 a	8	9	10	11a	EE
Visit timingp		Dose 1	Dose 1  + 7 days	Dose 1 +  28 days	Dose 2	Dose 2 +  7 days	Dose 2 +  21 days	Dose 2 +  28 days	Pregnancy completion/ termination	PP 1 + 42	Dose 1 +  365 days	Early Exit
Visit day and window	− 28 to 1	D1	D8 ± 3 days	D29 ± 7 days	D57  − 14 days, + 28 days	D64 ± 3 days	D78 ± 3 days	D85 ± 7 days	PP 1 b  + 2 days	PP 43 c  ± 14 days	Dose 1 + 365 ± 28 days
Visit type	Screening	DOSE 1 group A	Safety	Safety	DOSE 2 group A	Safety	Immuno	Safety	Safety and immuno	Safety	Safety and immuno	Early exit
Assessment of understanding	•
Written informed consent (ICF) d	•
Inclusion/exclusion criteria	•	•
Demographics e	•
Medical and obstetric history f; pre-pregnancy and pre-study meds	•
Physical examination f	•				•					•		•
Obstetric exam f	•	•			•				•			•o
Targeted physical exam f		•	•	•		•	•	•			•
Vital signs f incl. body temperature	•		•	•		•	•	•	•	•	•	•
Urine pregnancy test g	•
Hematology, chemistry g	•
Urine dipstick/urinalysis g	•	•		•	•			•
Syphilis, HIV, hepatitis B and C, malaria screeningg	•
Obstetric ultrasound h	•	•h						•				•o
Biometric scan	•	•	•	•	•	•	•	•	•	•	•	•
Contact information	•	•	•	•	•	•	•	•	•	•	•	•
Randomization		•
Pre-vaccination symptoms i
Vaccination		•			•
30 min post-vaccination observation j		•			•
Solicited AE collection k		•	•		•	•
Unsolicited AE collection k		•	•	•	•	•	•	•
Distribution of participant diary, rulers and thermometers k		•			•
Participant diary review by site staff			•			•
Adverse maternal, fetal outcomes		•	•	•	•	•	•	•	•	•
SAE recording		•	•	•	•	•	•	•	•	•	•	•
Concomitant medications l	•	•	•	•	•	•	•	•	•	•	•	•
Delivery history m									•
Post pregnancy physical examination m									•
Laboratory assessmentsn									•
Acceptability questionnaire									•	•		•
Group A immunology subset supplemental procedures (N = 150)	1	2	3	4	5	6	7	8	9	10	11
Humoral immunogenicity sample (serum)							•		•
Cord blood sample									•		•
Breast milk sample (N = 50)										•

 pre-dose; pre- and post-dose

^aVisits 7 and 11 for group A immunology subset participants only

^bPP 1 refers to the day of pregnancy completion/termination. Visit 9 (PP 1) should occur on the day of pregnancy completion/termination or within 2 days

^cVisit 10 (PP 43) scheduled to occur at routine 6 week post-partum visit. For women from group A not part of the immunogenicity subset, this visit will be the end of the trial

^dMust be signed before first study-related activity

^eMaternal 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

^fInformation to be collected for medical and obstetric history, physical exams, and vital signs is specified in the protocol

^gUrine dipstick for protein and glucose will be performed at these visits. If results 1 + or greater, then additional work-up for pre-eclampsia or gestational diabetes may be warranted

^hUltrasound not required at visit 2 if screening (visit 1) ultrasound completed within past 10 days and no other indication for ultrasound

ⁱInvestigator 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

^jParticipants will be closely observed for a minimum of 30 min post-vaccination

^kIn all women of group A, solicited AEs (reactogenicity) and unsolicited AEs will be assessed 7 days post each dose and 28 post each dose respectively

^lIncludes any medical treatment/medications given to the mother during delivery (e.g., antibiotic prophylaxis)-specifying names of medications administered

^mInformation to be collected for delivery history and post-pregnancy examination is specified in the protocol

ⁿAny routine laboratory assessment performed at time of delivery and other laboratory tests as medically indicated

^oNot required if participant is not pregnant

^pIn case pregnancy completion/termination in a group A pregnant woman occurs prior to receipt of dose 2, visits 9 and 10 should be performed: visit 10 being relative to visit 9 (2 day window). Visit 5 (dose 2 vaccination with a window of – 14 days, + 28 days) should in this case be performed after visit 9, with visits 6 and 8 being relative to actual dose 2 receipt (visit 5). All of these visits should be captured in RedCap cloud in addition to source documentation. Reactogenicity data (diary completion) should still be performed following dose 2 for group A women that have a pregnancy completion/termination prior to receipt of dose 2