A Study of a 2-dose Ebola Vaccine Regimen of Ad26.ZEBOV Followed by MVA-BN-Filo in Healthy Pregnant Women

Percentage of participants with maternal deaths will be reported. Maternal death is the death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the duration and site of the pregnancy, from any cause related to or aggravated by the pregnancy or its management but not from accidental or incidental causes.

Percentage of participants with spontaneous abortion will be reported. Spontaneous abortion is a pregnancy loss that occurs up to 21 weeks 6 days of gestation.

Percentage of participants with stillbirth will be reported. Stillbirth is fetal death at or after 21 weeks 6 days of gestation.

Percentage of participants on the pathways to preterm birth will be reported. Pathways to preterm birth is a clinical syndrome characterized by any one or some combination of the following four pathways: 1) Premature preterm rupture of membranes, 2) Preterm labor, 3) Insufficient cervix, 4) Provider- initiated preterm birth.

Percentage of participants with pre-eclampsia/ eclampsia will be reported. Pre-eclampsia is new-onset or worsening of existing hypertension with new-onset proteinuria after 20 weeks gestation.

Percentage of participants with antenatal bleeding will be reported. Antenatal bleeding is vaginal or suspected intrauterine, intraperitoneal, or retroperitoneal bleeding in the second or third trimester of pregnancy.

Percentage of participants with postpartum hemorrhage will be reported. Postpartum hemorrhage is genital bleeding after delivery estimated at 1000 ml or more, or leading to hypotension or blood transfusion, or leading to severe maternal outcome (maternal death or maternal near miss) as defined by World Health Organization (WHO).

Percentage of newborns with major congenital malformations born to participants will be reported. Major congenital malformations are abnormalities of body structure or function that are present at birth and are of prenatal origin. Major congenital malformations include structural changes that have significant medical, social or cosmetic consequences for the affected individual, and typically require medical intervention (for example, cleft lip and spina bifida).

Percentage of newborns small for gestational age (SGA) born to participants will be reported. Small for gestational age (SGA) means newborns that are smaller in size than normal for the gestational age (weight below the tenth percentile for the gestational age using Rwandan standards).

Percentage of newborns with low birth weight born to participants will be reported. Low birth weight newborns are babies, weighing less than 2500 grams at birth (regardless of child's sex).

Percentage of newborns with preterm birth born to participants will be reported. Preterm birth means neonates born at less than 37 weeks' gestation.

Percentage of neonatal deaths in neonates born to participants will be reported. Neonatal deaths mean neonate dying in the first 28 days of life.

Percentage of infants (of participants) who fail to thrive will be reported. Failure to thrive means weight for age deceleration through at least 2 centile spaces on growth chart of infants or as defined according to Rwandan standards.

A SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above

A SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

Solicited local AEs: pain/tenderness, erythema, and induration/swelling. Solicited systemic AEs: headache, fatigue, myalgia, arthralgia, chills and fever.

Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary.

Percentage of participants with normal delivery will be reported.

Percentage of participants with caesarian section will be reported.

Blood samples will be collected for analysis of binding antibodies against EBOV GP using Filovirus Animal Non-Clinical Group (FANG) enzyme-linked immunosorbent assay (ELISA).

Blood samples will be collected from infants at 14 weeks of age for analysis of binding antibodies against EBOV GP using Filovirus Animal Non-Clinical Group (FANG) enzyme-linked immunosorbent assay (ELISA).