Visit # | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9a | 10n | 11 a | EE |
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Visit timingp | Randomiz-ation (D1) | D1 + 28 days | D1 + 56 days | D1 + 12 weeks | Pregnancy completion/ termination | Dose 1 | Dose 2 | Dose 2 + 21 days | Dose 2 + 28 days | Dose 1 + 365 days | Early exit | |
Visit day and window | -28 to 1 | D1 | D29 ± 7 days | D57 − 14 days, + 28 days | D85 ± 7 days | PP 1 b + 2 days | PP 43 c + 28 days | PP 99 -14 days, + 28 days | PP 120 ± 14 days | PP 127 ± 3 days | Dose 1 + 365 ± 28 days | |
Visit type | Screening | Random-ization | Safety | Safety | Safety | Safety and immuno | DOSE 1 group B | DOSE 2 group B | 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 and prestudy meds | • | |||||||||||
Physical examination f | • | • | • | • | ||||||||
Obstetric exam f | • | • | • | •o | ||||||||
Targeted physical examination f | • | • | • | • | • | • | • | |||||
Vital signs f incl. body temperature | • | • | • | • | • | • |
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| • | • | • | • |
Urine pregnancy test g | • |
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Hematology, chemistry g | • | |||||||||||
Urine dipstick/urinalysis g | • | • | • | • | • | |||||||
Syphilis, HIV, hepatitis B and C, malaria screening g | • | |||||||||||
Obstetric ultrasound h | • | •h | • | •o | ||||||||
Biometric scan | • | • | • | • | • | • | • | • | • | • | • | |
Contact information | • | • | • | • | • | • | • | • | • | • | • | • |
Randomization | • | |||||||||||
Pre-vaccination symptomsi |
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Vaccination | • | • | ||||||||||
30 min post-vaccination observation j | • | • | ||||||||||
Adverse maternal, fetal outcomes | • | • | • | • | • | • | ||||||
SAE recording | • | • | • | • | • | • | • | • | • | • | • | |
Concomitant medications k | • | • | • | • | • | • | • | • | • | • | • | • |
Delivery history l | • | |||||||||||
Post pregnancy physical examination l | • | |||||||||||
Laboratory assessments m | • | |||||||||||
Group B immunology subset supplemental procedures (N = 150) | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | EE |
Humoral immunogenicity sample (serum) |
| • | • | |||||||||
Breast milk sample (N = 10) |
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