Table 5.

Schedule of activities—neonates/infants from groups A, B, and Umurinzi

Visit #	1 a	2 b	3
Visit timing	Pregnancy completion/termination	PP1 + 42 days	PP1 + 98 days
Visit day and window	PP 1  + 2 days	PP 43  ± 14 days	PP 99 ± 14 days
Visit type	Safety	Safety	Safety and immuno
Fetal monitoring during laborc	•
Birth outcomed	•
Apgar scoree	•
Neonatal physical examf	•
Medicationg	•	•	•
Nutritionh	•	•	•
Infant physical exam f		•	•
Adverse neonatal/infant outcomes	•	•	•
SAE collection	•	•	•
Humoral immunogenicity sample (serum)i			•

^aVisit 1 (PP 1) should occur on the day of pregnancy completion or within 2 days

^bInformed consent for any study procedures to be performed for infants ≥ 28 days of age will be obtained from mother at enrolment

^cRecord key findings of fetal monitoring such as fetal position at delivery, gestational age, complications, fetal heart rate, and uterine contractions during labor

^dLive birth, stillbirth, neonatal death, parity

^eMeasured at 1, 5, and 10 min

^fInformation to be collected for neonatal physical examination and infant physical examination is specified in the protocol

^gAny medical or intervention given to the neonate (e.g., antibiotic treatment, exchange transfusion, intravenous fluids, steroids or other immunosuppressive therapies, herbal remedies, respiratory support)

^hType of feeds (e.g., breast milk (mother/donor), formula feeding, parenteral nutrition, mixed feeding) and their respective start and stop times should be recorded in months of age

ⁱBlood sample (1 mL) of 75 infants born to women from the group A immunology subset