Respiratory Syncytial Virus Infections
Conditions
Keywords
third trimester, Respiratory Syncytial Virus (RSV) illness, Pregnancy, Maternal Immunization, Pregnant Women, Neonates, Respiratory Tract Illness
Brief summary
The purpose of this study is to assess pregnancy outcomes, and maternal, as well as neonatal events of interest in healthy pregnant women and their new-borns. The study will also determine incidence of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV) in the new-borns during their first year of life.
Interventions
PROCEDUREBlood sample collection
Venous blood samples will be collected from the maternal subjects at Day 1 and Day 56 of the study and at delivery.
PROCEDURECord blood sample collection
Collection of cord blood samples from maternal subjects will occur, at delivery
OTHERMaternal Diary Card
Completion of Diary Card about health by pregnant woman/ mother, from enrolment through week 6 post delivery.
PROCEDURENasal Swab collection
Collection of nasal swabs from infants with potential LRTIs, from birth to 12 months of age.
OTHERInfant Diary Card
Completion of Diary Card about health of infant from birth to 12 months of age.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Single Group Assignment is selected because this is a low-interventional, epidemiological study. As such, the study does not have multiple groups/treatment arms that will be compared against one another statistically in the way two study arms would be compared against each other in a clinical trial. Instead, the study will longitudinally follow pregnant women through a 42-day post-delivery period and will also follow the infants born to these women. It should be noted that these are the two populations listed in the protocol, but these are not two groups that will compared against one another. Statistical analyses will be conducted within each group and some analyses will be done across the two groups. However, these two groups should not be considered equivalent to two study arms. This explains why a single group assignment is appropriate while two study groups (mothers and infants) will be examined.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy pregnant women 18-45years of age who are ≥ 24 0/7 weeks GA at screening and ≤ 27 6/7 weeks GA at Visit 1, as established by ultrasound examination and/or last menstrual period (LMP) date * Women with pre-pregnancy body mass index (BMI) ≥18.5 and ≤ 39.9 kg/m2. * Women whose pregnancy is considered low risk, based on medical history, obstetric history, and clinical findings during the current pregnancy * Women who had no significant findings (such as abnormal fetal morphology, amniotic fluid levels, placenta, or umbilical cord) observed during a Level 2 ultrasound (fetal morphology assessment). * Human Immunodeficiency Virus (HIV) uninfected women who have been tested within the past year and have documented HIV negative test results. * Individuals who give written or witnessed/thumb printed informed consent after the study has been explained according to local regulatory requirements. * The informed consent given at screening should either include consent for both the mother's participation and participation of the infant after the infant's birth (if consistent with local regulations/guidelines), or consent for the mother's participation and expressed willingness to consider permitting the infant to take part after the infant has been born (if local regulations/guidelines require parent(s) to provide an additional informed consent after the infant's birth). * Both mother and father should consent if local regulations/guidelines require it. * Individuals who consent to have cord blood collected at delivery for the purpose of the study; * Individuals who plan to reside in the study area for at least one year after delivery. * Individuals who are in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator; * Individuals who, in the opinion of the investigator can and will comprehend and comply with all study procedures * Infants who were in utero at the time maternal (and paternal, if required) informed consent was given, and who are live-born. * If local law requires it: Written or witnessed/thumb printed informed consent for study participation of the infant obtained from parent(s)/Legally Accepted Representative \[LAR(s)\] within 21 days of birth.
Exclusion criteria
* Individuals determined to have one of the following conditions associated with increased risk for a serious obstetrical complication * Gestational hypertension; * Gestational diabetes uncontrolled by diet and exercise; * Pre-eclampsia or eclampsia; * Multiple pregnancy; * Intrauterine growth restriction; * Placenta previa; * Polyhydramnios; * Oligohydramnios; * Individuals determined to have (during the current pregnancy) one of the following infections or conditions associated with risk of adverse outcome: * Known or suspected: * Syphilis infection, * Parvovirus B19, * Rubella infection, * primary herpes simplex infection, * primary cytomegalovirus infection, * varicella infection, * Zika infection, * Active tuberculosis infection, * Incompetent cervix or cerclage * Individuals who have any underlying condition or infection that would predispose them to increased risk for a serious obstetrical complication that is not mentioned above * Individuals who have behavioural or cognitive impairment or psychiatric disease that, in the opinion of the investigator, could interfere with the subject's ability to participate in the study; * Individuals who have known or suspected impairment of the immune system, an active autoimmune disorder that is not well-controlled, or who are receiving systemic immunosuppressive therapy; * Individuals participating in any concurrent clinical trial during the current pregnancy; * Individuals pregnant with a fetus with a confirmed or suspected major congenital anomaly at the time of enrolment. * Child in care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Maternal Subjects With Pregnancy Outcomes | From Day 1 up to Day 42 post delivery | Pregnancy outcomes included: live birth with no congenital anomalies, live birth with congenital anomalies, fetal death/stillbirth loss at or after 22 weeks of gestation (antepartum stillbirth, Intrapartum stillbirth) with no congenital anomalies, fetal death/still birth loss at or after 22 weeks of gestation (antepartum stillbirth, Intrapartum stillbirth) with congenital anomalies, elective/therapeutic termination with no congenital anomalies, elective/therapeutic termination with congenital anomalies. |
| Number of Maternal Subjects With Pregnancy Related Events of Interest | From Day 1 up to Day 42 post-delivery | Pregnancy related events of interest included: maternal death, hypertensive disorders of pregnancy including gestational hypertension, pre-eclampsia and pre-eclampsia with severe features (including eclampsia), antenatal bleeding (morbidly adherent placenta, placental abruption, Caesarean scar pregnancy, uterine rupture), postpartum haemorrhage, fetal growth restriction, dysfunctional labor (first stage of labor, second stage of labor), gestational diabetes mellitus, non-reassuring fetal status, pathways to preterm birth including premature preterm rupture of membranes, preterm labour, and provider initiated preterm birth, chorioamnionitis, oligohydramnios, polyhydramnios, gestational liver disease (intrahepatic cholestasis of pregnancy \[ICP\], acute fatty liver of pregnancy), and maternal sepsis. |
| Number of Infant Subjects With Neonatal Events of Interest | From birth up to Day 28 post-birth | Neonatal events of interest included: small for gestational age, low birth weight including very low birth weight, neonatal encephalopathy, congenital microcephaly (postnatally diagnosed, prenatally diagnosed), congenital anomalies \[CA\] (major external structural defects, internal structural defects, functional defects), neonatal death (neonatal death in a preterm live birth \[gestational age greater than or equal to (≥) 28 to less than (\<) 37 weeks\], neonatal death in a term live birth), neonatal infections, (blood stream infections, meningitis, respiratory infection), respiratory distress in the neonate, preterm birth, failure to thrive, large for gestational age, macrosomia, any other neonatal event considered by the investigator to be of concern (e.g. neurodevelopmental delay). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RSV-A Neutralizing Antibodies Titers in Cord Blood | At delivery | Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were presented as GMTs, expressed in ED60. The antibodies were measured on the cord blood sample collected at delivery. |
| Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | From Day 1 up to Day 42 post-delivery | Pregnancy related events of interest by GAIA level (Lv.) of diagnostic certainty (where applicable/feasible) range from Level 1 to Level 2 or 3 (Highest level of diagnostic certainty (1) to lowest level of diagnostic certainty (2 or 3)): maternal death, hypertensive disorders of pregnancy including gestational hypertension, pre-eclampsia and Pre-eclampsia with severe features (including eclampsia), antenatal bleeding (morbidly adherent placenta, placental abruption, Cesarean scar pregnancy, uterine rupture), postpartum haemorrhage, fetal growth restriction, dysfunctional labor, (first stage of labor, second stage of labor), gestational diabetes mellitus, non-reassuring fetal status, pathways to preterm birth including premature preterm rupture of membranes, preterm labour, and provider initiated preterm birth. |
| Incidence Rates of Infant Subjects With RSV Hospitalizations | From birth up to 1 year of age | The incidence rate was calculated by dividing the number of subjects reporting first episodes over the follow-up period to the total person-years. RSV hospitalizations definition by WHO (Modjarrad, 2015): Infant has confirmed RSV infection AND hospitalized for acute medical condition. |
| Incidence Rates of RSV Lower Respiratory Tract Infection (LRTI) or Severe LRTI or Very Severe LRTI for Infant Subjects as Defined by the LRTI Case Definition | From birth up to 1 year of age | The incidence rate was calculated by dividing the number of infant subjects reporting first episodes over the follow-up period, to the total person-years. LRTI Case definition by WHO (Modjarrad, 2016): LRTI is diagnosed when infant has history of cough OR difficulty in breathing AND SpO2 \< 95%, OR RR increase AND Confirmed RSV infection. Severe LRTI is diagnosed when an infant with RSV LRTI has oxygen saturation \<93% or lower chest wall drawing. Very severe LRTI is diagnosed when an infant with RSV LRTI has oxygen saturation \<90%, OR inability to feed OR failure to respond / unconscious. |
| Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | From birth through Day 28 of life | Neonatal events of interest by GAIA level (Lv.) of diagnostic certainty, range from Level 1 to Level 4 or 5 (Highest level of diagnostic certainty (1) to lowest level of diagnostic certainty (4 or 5 based on the neonatal events)): small for gestational age, low birth weight including very low birth weight, neonatal encephalopathy, congenital microcephaly (postnatally diagnosed, prenatally diagnosed), congenital anomalies \[CA\] (major external structural defects, internal structural defects, functional defects), neonatal death (neonatal death in a preterm live birth \[gestational age ≥ 28 to \<37 weeks\], neonatal death in a term live birth), neonatal infections (blood stream infections, meningitis, respiratory infection, respiratory distress in the neonate, preterm birth, failure to thrive, large for gestational age, macrosomia, any other neonatal event considered by the investigator to be of concern (e.g. neurodevelopmental delay). |
| Respiratory Syncytial Virus Type A (RSV-A) Neutralizing Antibody Titers in Maternal Blood | At delivery | Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed Geometric Mean Titers (GMT) with 95% Confidence Interval (CI) in Estimated Dilution 60 (ED60) and were measured on blood samples collected from vaccinated maternal subjects. |
Countries
Argentina, Bangladesh, Brazil, Colombia, Malaysia, Mexico, Panama, Philippines, South Africa, Thailand
Participant flow
Pre-assignment details
Out of the 4493 subjects enrolled, data was not collected for one enrolled infant subject. This infant subject was therefore excluded from the study analysis. Deaths reported in the all-cause mortality module include neonatal deaths, infant deaths and maternal deaths, while deaths reported in the participant flow include only infant deaths.
Participants by arm
| Arm | Count |
|---|---|
| Pregnant Women/Mothers Group Subjects, 18 to 45 years of age enrolled in the study in view of determining pregnancy outcomes and related events of interest, as well as the occurrence of lower respiratory tract illness (LRTI) associated with respiratory syncytial virus (RSV). | 2,311 |
| Neonates/Infants Group Infants born to mothers aged 18-45 years old, enrolled for the collection of infant events of interest, nasal swabs and the incidence of RSV LRTI and RSV hospitalization. | 2,181 |
| Total | 4,492 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Consent withdrawal, not due to SAE related to study or a pregnancy related event of special interest | 34 | 0 |
| Overall Study | Consent withdrawal not due to SAE related to study or neonatal event of special interest | 0 | 17 |
| Overall Study | Death in infant greater than 28 days old | 0 | 12 |
| Overall Study | Delivery before planned visit | 2 | 0 |
| Overall Study | Lost to Follow-up | 17 | 42 |
| Overall Study | Migrated / moved from the study area | 30 | 22 |
| Overall Study | Neonatal event of interest | 0 | 6 |
| Overall Study | Not willing/ not able to participate in this visit | 17 | 16 |
| Overall Study | Other | 16 | 47 |
| Overall Study | Protocol Violation | 0 | 2 |
Baseline characteristics
| Characteristic | Total | Neonates/Infants Group | Pregnant Women/Mothers Group |
|---|---|---|---|
| Age, Customized 0-1 year | 2181 Participants | 2181 Participants | 0 Participants |
| Age, Customized 18-34 years | 1994 Participants | 0 Participants | 1994 Participants |
| Age, Customized 35-39 years | 262 Participants | 0 Participants | 262 Participants |
| Age, Customized >=40 years | 55 Participants | 0 Participants | 55 Participants |
| Race/Ethnicity, Customized African Heritage/ African American | 378 Participants | — | 378 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 51 Participants | — | 51 Participants |
| Race/Ethnicity, Customized Asian-Central/South Asian Heritage | 214 Participants | — | 214 Participants |
| Race/Ethnicity, Customized Asian-East Asian Heritage | 11 Participants | — | 11 Participants |
| Race/Ethnicity, Customized Asian-Japanese Heritage | 1 Participants | — | 1 Participants |
| Race/Ethnicity, Customized Asian-South East Asian Heritage | 693 Participants | — | 693 Participants |
| Race/Ethnicity, Customized Other - Not specified | 2736 Participants | 2181 Participants | 555 Participants |
| Race/Ethnicity, Customized White-Arabic/North African Heritage | 48 Participants | — | 48 Participants |
| Race/Ethnicity, Customized White-Caucasian/ European Heritage | 360 Participants | — | 360 Participants |
| Sex: Female, Male Female | 3360 Participants | 1049 Participants | 2311 Participants |
| Sex: Female, Male Male | 1132 Participants | 1132 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 2,311 | 23 / 2,181 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Infant Subjects With Neonatal Events of Interest
Neonatal events of interest included: small for gestational age, low birth weight including very low birth weight, neonatal encephalopathy, congenital microcephaly (postnatally diagnosed, prenatally diagnosed), congenital anomalies \[CA\] (major external structural defects, internal structural defects, functional defects), neonatal death (neonatal death in a preterm live birth \[gestational age greater than or equal to (≥) 28 to less than (\<) 37 weeks\], neonatal death in a term live birth), neonatal infections, (blood stream infections, meningitis, respiratory infection), respiratory distress in the neonate, preterm birth, failure to thrive, large for gestational age, macrosomia, any other neonatal event considered by the investigator to be of concern (e.g. neurodevelopmental delay).
Time frame: From birth up to Day 28 post-birth
Population: The analysis was performed on the infant PPS which included all neonates/infants who born to pregnant women in the maternal PPS, meeting all eligibility criteria up to the time of their censoring, either at study completion or prematurely as drop-out (e.g. withdrawn consent, lost-to-follow-up), who have at least one time point evaluation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest | Meningitis | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest | Small for gestational age | 111 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest | Low birth weight including very low birth weight | 156 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest | Neonatal encephalopathy | 6 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest | Congenital microcephaly-Postnatally diagnosed | 16 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest | Congenital microcephaly-Prenatally diagnosed | 1 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest | CA -Major external structural defects | 38 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest | CA -Internal structural defects | 46 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest | CA -Functional defects | 19 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest | Neonatal death in a preterm live birth | 3 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest | Neonatal death in a term live birth | 7 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest | Blood stream infections | 33 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest | Respiratory infection | 36 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest | Respiratory distress in the neonate | 94 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest | Preterm birth | 141 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest | Failure to thrive | 7 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest | Large for gestational age | 54 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest | Macrosomia | 53 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest | Other neonatal event considered to be of concern | 213 Participants |
Primary
Number of Maternal Subjects With Pregnancy Outcomes
Pregnancy outcomes included: live birth with no congenital anomalies, live birth with congenital anomalies, fetal death/stillbirth loss at or after 22 weeks of gestation (antepartum stillbirth, Intrapartum stillbirth) with no congenital anomalies, fetal death/still birth loss at or after 22 weeks of gestation (antepartum stillbirth, Intrapartum stillbirth) with congenital anomalies, elective/therapeutic termination with no congenital anomalies, elective/therapeutic termination with congenital anomalies.
Time frame: From Day 1 up to Day 42 post delivery
Population: The analysis was performed on the maternal Per Protocol Set (PPS) which included all pregnant women (mothers) meeting all eligibility criteria up to the time of their censoring, either at study completion or prematurely as drop-out (e.g. withdrawn consent, lost-to-follow-up).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Outcomes | Live birth with no congenital anomalies | 2088 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Outcomes | Live birth with congenital anomalies | 18 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Outcomes | Antepartum fetal death/still birth with no congenital anomalies | 8 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Outcomes | Intrapartum fetal death/still birth with no congenital anomalies | 5 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Outcomes | Antepartum fetal death/still birth with congenital anomalies | 0 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Outcomes | Intrapartum fetal death/still birth with congenital anomalies | 1 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Outcomes | Elective/therapeutic termination with no congenital anomalies | 11 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Outcomes | Elective/therapeutic termination with congenital anomalies | 1 Participants |
Primary
Number of Maternal Subjects With Pregnancy Related Events of Interest
Pregnancy related events of interest included: maternal death, hypertensive disorders of pregnancy including gestational hypertension, pre-eclampsia and pre-eclampsia with severe features (including eclampsia), antenatal bleeding (morbidly adherent placenta, placental abruption, Caesarean scar pregnancy, uterine rupture), postpartum haemorrhage, fetal growth restriction, dysfunctional labor (first stage of labor, second stage of labor), gestational diabetes mellitus, non-reassuring fetal status, pathways to preterm birth including premature preterm rupture of membranes, preterm labour, and provider initiated preterm birth, chorioamnionitis, oligohydramnios, polyhydramnios, gestational liver disease (intrahepatic cholestasis of pregnancy \[ICP\], acute fatty liver of pregnancy), and maternal sepsis.
Time frame: From Day 1 up to Day 42 post-delivery
Population: The analysis was performed on the maternal PPS which included all pregnant women (mothers) meeting all eligibility criteria up to the time of their censoring, either at study completion or prematurely as drop-out (e.g. withdrawn consent, lost-to-follow-up).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest | Maternal death | 1 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest | Gestational hypertension | 72 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest | Pre-eclampsia | 37 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest | Pre-eclampsia with severe features | 16 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest | Morbidly adherent placenta | 1 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest | Placental abruption | 10 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest | Caesarean scar pregnancy | 0 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest | Uterine rupture | 0 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest | Postpartum haemorrhage | 37 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest | Fetal growth restriction | 19 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest | First stage of labor | 49 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest | Second stage of labor | 31 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest | Gestational diabetes mellitus | 58 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest | Non-reassuring fetal status | 137 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest | Preterm rupture of membranes | 40 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest | Preterm labor | 101 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest | Provider-initiated preterm birth | 25 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest | Chorioamnionitis | 13 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest | Oligohydramnios | 42 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest | Polyhydramnios | 9 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest | Intrahepatic Cholestatis of Pregnancy (ICP) | 3 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest | Acute Fatty Liver of Pregnancy | 0 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest | Maternal Sepsis | 0 Participants |
Secondary
Incidence Rates of Infant Subjects With RSV Hospitalizations
The incidence rate was calculated by dividing the number of subjects reporting first episodes over the follow-up period to the total person-years. RSV hospitalizations definition by WHO (Modjarrad, 2015): Infant has confirmed RSV infection AND hospitalized for acute medical condition.
Time frame: From birth up to 1 year of age
Population: The analysis was performed on the infant PPS which included all neonates/infants meeting all eligibility criteria up to the time of their censoring, either at study completion or prematurely as drop-out (e.g. withdrawn consent, lost-to-follow-up), who have at least one time point evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregnant Women/Mothers Group | Incidence Rates of Infant Subjects With RSV Hospitalizations | 0 months | 0.6 Cases per 100 person-years |
| Pregnant Women/Mothers Group | Incidence Rates of Infant Subjects With RSV Hospitalizations | 1 month | 0.6 Cases per 100 person-years |
| Pregnant Women/Mothers Group | Incidence Rates of Infant Subjects With RSV Hospitalizations | 2 months | 0 Cases per 100 person-years |
| Pregnant Women/Mothers Group | Incidence Rates of Infant Subjects With RSV Hospitalizations | 3 months | 0 Cases per 100 person-years |
| Pregnant Women/Mothers Group | Incidence Rates of Infant Subjects With RSV Hospitalizations | 4 months | 0.6 Cases per 100 person-years |
| Pregnant Women/Mothers Group | Incidence Rates of Infant Subjects With RSV Hospitalizations | 5 months | 0.6 Cases per 100 person-years |
| Pregnant Women/Mothers Group | Incidence Rates of Infant Subjects With RSV Hospitalizations | 6 months | 0 Cases per 100 person-years |
| Pregnant Women/Mothers Group | Incidence Rates of Infant Subjects With RSV Hospitalizations | 7 months | 0 Cases per 100 person-years |
| Pregnant Women/Mothers Group | Incidence Rates of Infant Subjects With RSV Hospitalizations | 8 months | 0.6 Cases per 100 person-years |
| Pregnant Women/Mothers Group | Incidence Rates of Infant Subjects With RSV Hospitalizations | 9 months | 0 Cases per 100 person-years |
| Pregnant Women/Mothers Group | Incidence Rates of Infant Subjects With RSV Hospitalizations | 10 months | 0.6 Cases per 100 person-years |
| Pregnant Women/Mothers Group | Incidence Rates of Infant Subjects With RSV Hospitalizations | 11 months | 0.7 Cases per 100 person-years |
Secondary
Incidence Rates of RSV Lower Respiratory Tract Infection (LRTI) or Severe LRTI or Very Severe LRTI for Infant Subjects as Defined by the LRTI Case Definition
The incidence rate was calculated by dividing the number of infant subjects reporting first episodes over the follow-up period, to the total person-years. LRTI Case definition by WHO (Modjarrad, 2016): LRTI is diagnosed when infant has history of cough OR difficulty in breathing AND SpO2 \< 95%, OR RR increase AND Confirmed RSV infection. Severe LRTI is diagnosed when an infant with RSV LRTI has oxygen saturation \<93% or lower chest wall drawing. Very severe LRTI is diagnosed when an infant with RSV LRTI has oxygen saturation \<90%, OR inability to feed OR failure to respond / unconscious.
Time frame: From birth up to 1 year of age
Population: The analysis was performed on the infant PPS which included all neonates/infants meeting all eligibility criteria up to the time of their censoring, either at study completion or prematurely as drop-out (e.g. withdrawn consent, lost-to-follow-up), who have at least one time point evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregnant Women/Mothers Group | Incidence Rates of RSV Lower Respiratory Tract Infection (LRTI) or Severe LRTI or Very Severe LRTI for Infant Subjects as Defined by the LRTI Case Definition | 0 months | 0 Cases per 100 person-years |
| Pregnant Women/Mothers Group | Incidence Rates of RSV Lower Respiratory Tract Infection (LRTI) or Severe LRTI or Very Severe LRTI for Infant Subjects as Defined by the LRTI Case Definition | 1 month | 2.3 Cases per 100 person-years |
| Pregnant Women/Mothers Group | Incidence Rates of RSV Lower Respiratory Tract Infection (LRTI) or Severe LRTI or Very Severe LRTI for Infant Subjects as Defined by the LRTI Case Definition | 2 months | 0.6 Cases per 100 person-years |
| Pregnant Women/Mothers Group | Incidence Rates of RSV Lower Respiratory Tract Infection (LRTI) or Severe LRTI or Very Severe LRTI for Infant Subjects as Defined by the LRTI Case Definition | 3 months | 0 Cases per 100 person-years |
| Pregnant Women/Mothers Group | Incidence Rates of RSV Lower Respiratory Tract Infection (LRTI) or Severe LRTI or Very Severe LRTI for Infant Subjects as Defined by the LRTI Case Definition | 4 months | 0.6 Cases per 100 person-years |
| Pregnant Women/Mothers Group | Incidence Rates of RSV Lower Respiratory Tract Infection (LRTI) or Severe LRTI or Very Severe LRTI for Infant Subjects as Defined by the LRTI Case Definition | 5 months | 1.2 Cases per 100 person-years |
| Pregnant Women/Mothers Group | Incidence Rates of RSV Lower Respiratory Tract Infection (LRTI) or Severe LRTI or Very Severe LRTI for Infant Subjects as Defined by the LRTI Case Definition | 6 months | 1.8 Cases per 100 person-years |
| Pregnant Women/Mothers Group | Incidence Rates of RSV Lower Respiratory Tract Infection (LRTI) or Severe LRTI or Very Severe LRTI for Infant Subjects as Defined by the LRTI Case Definition | 7 months | 3.5 Cases per 100 person-years |
| Pregnant Women/Mothers Group | Incidence Rates of RSV Lower Respiratory Tract Infection (LRTI) or Severe LRTI or Very Severe LRTI for Infant Subjects as Defined by the LRTI Case Definition | 8 months | 3.6 Cases per 100 person-years |
| Pregnant Women/Mothers Group | Incidence Rates of RSV Lower Respiratory Tract Infection (LRTI) or Severe LRTI or Very Severe LRTI for Infant Subjects as Defined by the LRTI Case Definition | 9 months | 3.6 Cases per 100 person-years |
| Pregnant Women/Mothers Group | Incidence Rates of RSV Lower Respiratory Tract Infection (LRTI) or Severe LRTI or Very Severe LRTI for Infant Subjects as Defined by the LRTI Case Definition | 10 months | 1.2 Cases per 100 person-years |
| Pregnant Women/Mothers Group | Incidence Rates of RSV Lower Respiratory Tract Infection (LRTI) or Severe LRTI or Very Severe LRTI for Infant Subjects as Defined by the LRTI Case Definition | 11 months | 0.7 Cases per 100 person-years |
Secondary
Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty
Neonatal events of interest by GAIA level (Lv.) of diagnostic certainty, range from Level 1 to Level 4 or 5 (Highest level of diagnostic certainty (1) to lowest level of diagnostic certainty (4 or 5 based on the neonatal events)): small for gestational age, low birth weight including very low birth weight, neonatal encephalopathy, congenital microcephaly (postnatally diagnosed, prenatally diagnosed), congenital anomalies \[CA\] (major external structural defects, internal structural defects, functional defects), neonatal death (neonatal death in a preterm live birth \[gestational age ≥ 28 to \<37 weeks\], neonatal death in a term live birth), neonatal infections (blood stream infections, meningitis, respiratory infection, respiratory distress in the neonate, preterm birth, failure to thrive, large for gestational age, macrosomia, any other neonatal event considered by the investigator to be of concern (e.g. neurodevelopmental delay).
Time frame: From birth through Day 28 of life
Population: The analysis was performed on the infant PPS which included all neonates/infants meeting all eligibility criteria up to the time of their censoring, either at study completion or prematurely as drop-out (e.g. withdrawn consent, lost-to-follow-up), who have at least one time point evaluation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Small for gestational age-Lv. 1 | 46 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Small for gestational age-Lv. 2a | 28 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Small for gestational age-Lv. 2b | 11 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Small for gestational age-Lv. 3a | 2 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Small for gestational age-Lv. 3b | 2 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Small for gestational age-Lv. 4 | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Low birth weight including very low weight-Lv. 1 | 106 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Low birth weight including very low weight-Lv. 2 | 11 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Low birth weight including very low weight-Lv. 3 | 16 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Low birth weight including very low weight-Lv. 4 | 5 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Neonatal encephalopathy-Lv. 1 | 4 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Neonatal encephalopathy-Lv. 2 | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Neonatal encephalopathy-Lv. 3 | 2 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Congenital microcephaly postnat. diagnosed-Lv. 1 | 7 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Congenital microcephaly postnat. diagnosed-Lv. 2a | 3 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Congenital microcephaly postnat. diagnosed-Lv. 2b | 4 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Congenital microcephaly postnat. diagnosed-Lv. 3a | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Congenital microcephaly postnat. diagnosed-Lv. 3b | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Congenital microcephaly postnat. diagnosed-Lv. 4 | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Congenital microcephaly prenat. diagnosed-Lv. 1a | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Congenital microcephaly prenat. diagnosed-Lv. 1b | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Congenital microcephaly prenat. diagnosed-Lv. 2 | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Congenital microcephaly prenat. diagnosed-Lv. 3a | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Congenital microcephaly prenat. diagnosed-Lv. 3b | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Congenital microcephaly prenat. diagnosed-Lv. 4 | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | CA- Major external structural defects-Lv. 1 | 9 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | CA- Major external structural defects-Lv. 2 | 5 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | CA- Major external structural defects-Lv. 3 | 3 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | CA- Major external structural defects-Lv. 4 | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | CA- Internal structural defects-Lv. 1 | 12 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | CA- Internal structural defects-Lv. 2 | 9 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | CA- Internal structural defects-Lv. 3 | 22 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | CA- Internal structural defects-Lv. 4 | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | CA- Functional defects-Lv. 1 | 14 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | CA- Functional defects-Lv. 2 | 3 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | CA- Functional defects-Lv. 3 | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | CA- Functional defects-Lv. 4 | 1 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Neonatal death in a preterm live birth-Lv. 1 | 2 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Neonatal death in a preterm live birth-Lv. 2 | 1 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Neonatal death in a preterm live birth-Lv. 3 | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Neonatal death in a term live birth-Lv. 1 | 3 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Neonatal death in a term live birth-Lv. 2 | 3 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Neonatal death in a term live birth-Lv. 3 | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Blood stream infections-Lv. 1 | 7 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Blood stream infections-Lv. 2 | 9 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Blood stream infections-Lv. 3 | 6 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Meningitis-Lv. 1 | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Meningitis-Lv. 2 | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Meningitis-Lv. 3a | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Meningitis-Lv. 3b | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Respiratory infection-Lv. 1 | 3 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Respiratory infection-Lv. 2 | 9 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Respiratory infection-Lv. 3 | 13 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Respiratory distress in the neonate-Lv. 1 | 59 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Respiratory distress in the neonate-Lv. 2 | 14 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Respiratory distress in the neonate-Lv. 3 | 2 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Respiratory distress in the neonate-Lv. 4 | 11 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Respiratory distress in the neonate-Lv. 5 | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Preterm birth-Lv. 1 | 73 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Preterm birth-Lv. 2a | 43 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Preterm birth-Lv. 2b | 19 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Preterm birth-Lv. 3a | 2 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Preterm birth-Lv. 3b | 1 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Failure to thrive-Lv. 1 | 4 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Failure to thrive-Lv. 2a | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Failure to thrive-Lv. 2v | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Failure to thrive-Lv. 3a | 0 Participants |
| Pregnant Women/Mothers Group | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | Failure to thrive-Lv. 3b | 0 Participants |
Secondary
Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty
Pregnancy related events of interest by GAIA level (Lv.) of diagnostic certainty (where applicable/feasible) range from Level 1 to Level 2 or 3 (Highest level of diagnostic certainty (1) to lowest level of diagnostic certainty (2 or 3)): maternal death, hypertensive disorders of pregnancy including gestational hypertension, pre-eclampsia and Pre-eclampsia with severe features (including eclampsia), antenatal bleeding (morbidly adherent placenta, placental abruption, Cesarean scar pregnancy, uterine rupture), postpartum haemorrhage, fetal growth restriction, dysfunctional labor, (first stage of labor, second stage of labor), gestational diabetes mellitus, non-reassuring fetal status, pathways to preterm birth including premature preterm rupture of membranes, preterm labour, and provider initiated preterm birth.
Time frame: From Day 1 up to Day 42 post-delivery
Population: The analysis was performed on the maternal Per Protocol Set (PPS) which includes all pregnant women (mothers) meeting all eligibility criteria up to the time of their censoring, either at study completion or prematurely as drop-out (e.g. withdrawn consent, lost-to-follow-up).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Maternal death-Lv.1 | 0 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Maternal death-Lv. 2 | 0 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Maternal death-Lv. 3 | 1 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Gestational hypertension-Lv. 1 | 27 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Gestational hypertension-Lv. 2 | 23 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Pre-eclampsia-Lv. 1 | 17 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Pre-eclampsia-Lv. 2 | 12 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Pre-eclampsia with severe features-Lv. 1 | 13 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Pre-eclampsia with severe features-Lv. 2 | 0 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Morbidly adherent placenta-Lv. 1 | 0 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Morbidly adherent placenta-Lv. 2 | 1 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Placental abruption-Lv. 1 | 3 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Placental abruption-Lv. 2 | 4 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Caesarean scar pregnancy-Lv. 1 | 0 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Caesarean scar pregnancy-Lv. 2 | 0 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Uterine rupture-Lv. 1 | 0 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Uterine rupture-Lv. 2 | 0 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Postpartum haemorrhage-Lv. 1 | 5 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Postpartum haemorrhage-Lv. 2 | 17 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Postpartum haemorrhage-Lv. 3 | 6 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Fetal growth restriction-Lv. 1a | 5 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Fetal growth restriction-Lv. 2a | 2 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Fetal growth restriction-Lv. 1b | 2 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Fetal growth restriction-Lv. 2b | 7 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Dysfunctional labor: First stage of labor-Lv. 1 | 34 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Dysfunctional labor: First stage of labor-Lv. 2 | 9 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Dysfunctional labor: Second stage of labor-Lv. 1 | 17 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Dysfunctional labor: Second stage of labor-Lv. 2 | 10 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Gestational diabetes mellitus-Lv. 1 | 43 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Gestational diabetes mellitus-Lv. 2 | 3 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Gestational diabetes mellitus-Lv. 3 | 11 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Non-reassuring fetal status-Lv. 1 | 26 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Non-reassuring fetal status-Lv. 2 | 17 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Non-reassuring fetal status-Lv. 3 | 30 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Preterm rupture of membranes-Lv. 1 | 14 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Preterm rupture of membranes-Lv. 2 | 7 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Preterm rupture of membranes-Lv. 3 | 13 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Preterm labor-Lv. 1 | 29 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Preterm labor-Lv. 2 | 16 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Preterm labor-Lv. 3 | 14 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Provider-initiated preterm birth-Lv. 1 | 23 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Provider-initiated preterm birth-Lv. 2 | 1 Participants |
| Pregnant Women/Mothers Group | Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty | Provider-initiated preterm birth-Lv. 3 | 1 Participants |
Secondary
Respiratory Syncytial Virus Type A (RSV-A) Neutralizing Antibody Titers in Maternal Blood
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed Geometric Mean Titers (GMT) with 95% Confidence Interval (CI) in Estimated Dilution 60 (ED60) and were measured on blood samples collected from vaccinated maternal subjects.
Time frame: At delivery
Population: The analysis was performed on the maternal PPS which included all pregnant women (mothers) meeting all eligibility criteria up to the time of their censoring, either at study completion or prematurely as drop-out (e.g. withdrawn consent, lost-to-follow-up).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Pregnant Women/Mothers Group | Respiratory Syncytial Virus Type A (RSV-A) Neutralizing Antibody Titers in Maternal Blood | 547.6 Titers |
Secondary
RSV-A Neutralizing Antibodies Titers in Cord Blood
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were presented as GMTs, expressed in ED60. The antibodies were measured on the cord blood sample collected at delivery.
Time frame: At delivery
Population: The analysis was performed on the maternal PPS which included all pregnant women (mothers) meeting all eligibility criteria up to the time of their censoring, either at study completion or prematurely as drop-out (e.g. withdrawn consent, lost-to-follow-up).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Pregnant Women/Mothers Group | RSV-A Neutralizing Antibodies Titers in Cord Blood | 751.5 Titers |