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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant Women/Mothers Group | Other | 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). |
|
| Neonates/Infants Group | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample collection | Procedure | Venous blood samples will be collected from the maternal subjects at Day 1 and Day 56 of the study and at delivery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Day 1 up to Day 42 post delivery |
| 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. | From Day 1 up to Day 42 post-delivery |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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.
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
Individuals determined to have (during the current pregnancy) one of the following infections or conditions associated with risk of adverse outcome:
Known or suspected:
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
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Villanueva- Guaymallen | Mendoza Province | 5521 | Argentina | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41535781 | Derived | Tullio AN, Yanni E, Coutinho CM, Sivapatham L, Lee CMF, Pallem S, Pu Y, Akawung A, Kim JH, Henry O, Mussi-Pinhata MM, Ahmed K, Del Carmen Flores Acosta C, Reyes O, Abadia de Regalado I, Arias Fernandez DA, Aurpibul L, Taher SW, Caccavo J, Ceballos A, Pichailuck C, D'Andrea Nores U, De Leon T, De Bernardi M, Dieser P, D'Silva EC, Falaschi A, Fry S, Gentile A, Teo IH, Kotze S, Lopez-Medina E, Luca R, Lucion MF, Mantaring JBIV, Marin B, Moelo M, Pinto J, Puthanakit T, Roa MF, Rodriguez Brieschke MT, Rodriguez CE, Rodriguez Nino JN, Schwarzbold AV, Sierra Garcia A, Soon R, Tinoco JC, Velasquez Penagos JA, Zaman K, Dos Santos G. A multicountry study to establish rates for pregnancy and neonatal outcomes in low- and middle-income regions. BMC Pregnancy Childbirth. 2026 Jan 14;26(1):679. doi: 10.1186/s12884-025-08012-1. | |
| 38088983 |
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Anonymized data sets Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | Neonates/Infants Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 29, 2020 | Jul 25, 2022 |
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.
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| Cord blood sample collection | Procedure | Collection of cord blood samples from maternal subjects will occur, at delivery |
|
| Maternal Diary Card | Other | Completion of Diary Card about health by pregnant woman/ mother, from enrolment through week 6 post delivery. |
|
| Nasal Swab collection | Procedure | Collection of nasal swabs from infants with potential LRTIs, from birth to 12 months of age. |
|
| Infant Diary Card | Other | Completion of Diary Card about health of infant from birth to 12 months of age. |
|
| From birth up to Day 28 post-birth |
| From Day 1 up to Day 42 post-delivery |
| 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). | From birth through Day 28 of life |
| 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. | At delivery |
| 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. | At delivery |
| 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. | From birth up to 1 year of age |
| 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. | From birth up to 1 year of age |
| Buenos Aires |
| C1408INH |
| Argentina |
| GSK Investigational Site | Buenos Aires | C1425EFD | Argentina |
| GSK Investigational Site | Mendoza | 5515 | Argentina |
| GSK Investigational Site | Mendoza | 6400 | Argentina |
| GSK Investigational Site | RÃo Cuarto | 5800 | Argentina |
| GSK Investigational Site | Dhaka | 1204 | Bangladesh |
| GSK Investigational Site | Dhaka | Bangladesh |
| GSK Investigational Site | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
| GSK Investigational Site | Santa Maria | Rio Grande do Sul | 97105-900 | Brazil |
| GSK Investigational Site | Ribeirão Preto | São Paulo | 14049-900 | Brazil |
| GSK Investigational Site | Bogotá | 110111 | Colombia |
| GSK Investigational Site | Bogotá | 111411 | Colombia |
| GSK Investigational Site | Cali | 760042 | Colombia |
| GSK Investigational Site | MedellÃn | 0500 | Colombia |
| GSK Investigational Site | MedellÃn | 50042 | Colombia |
| GSK Investigational Site | Villavicencio | 660003 | Colombia |
| GSK Investigational Site | Alor Star | 05350 | Malaysia |
| GSK Investigational Site | Alor Star | 05400 | Malaysia |
| GSK Investigational Site | Kota Kinabalu | 88996 | Malaysia |
| GSK Investigational Site | Kuala Lumpur | 68000 | Malaysia |
| GSK Investigational Site | Kuching | 93586 | Malaysia |
| GSK Investigational Site | Monterrey | Nuevo León | 64060 | Mexico |
| GSK Investigational Site | Monterrey | Nuevo León | 64460 | Mexico |
| GSK Investigational Site | Durango | 34000 | Mexico |
| GSK Investigational Site | Oaxaca City | 68000 | Mexico |
| GSK Investigational Site | Chiriquà | 0401 | Panama |
| GSK Investigational Site | Juán Diaz | 3449 | Panama |
| GSK Investigational Site | La Chorrera | 07079 | Panama |
| GSK Investigational Site | Panama City | 32401 | Panama |
| GSK Investigational Site | Panama City | Panama |
| GSK Investigational Site | Cebu | 6000 | Philippines |
| GSK Investigational Site | Manila | 1000 | Philippines |
| GSK Investigational Site | Manila | 1008 | Philippines |
| GSK Investigational Site | Pretoria | Gauteng | 0122 | South Africa |
| GSK Investigational Site | Parow Valley | 7505 | South Africa |
| GSK Investigational Site | Soshanguve | 0152 | South Africa |
| GSK Investigational Site | Bangkok | 10330 | Thailand |
| GSK Investigational Site | Bangkok | 10700 | Thailand |
| GSK Investigational Site | Chiang Mai | 50200 | Thailand |
| Derived |
| Fry S, Chokephaibulkit K, Pallem S, Henry O, Pu Y, Akawung A, Kim JH, Yanni E, Tullio AN, Aurpibul L, Lee CMF, Ceballos A, Zaman K, Abadia de Regalado I, Ahmed K, Arias Fernandez DA, Taher SW, Caccavo J, Coutinho CM, D'Andrea Nores U, De Leon T, D'Silva EC, De Bernardi M, Dieser P, Falaschi A, Flores Acosta CDC, Gentile A, Teo IH, Kotze S, Lopez-Medina E, Luca R, Lucion MF, Mantaring JBIV, Marin B, Moelo M, Mussi-Pinhata MM, Pinto J, Puthanakit T, Reyes O, Roa MF, Rodriguez Brieschke MT, Rodriguez CE, Rodriguez Nino JN, Schwarzbold AV, Sierra Garcia A, Sivapatham L, Soon R, Tinoco JC, Velasquez Penagos JA, Dos Santos G. Incidence of Respiratory Syncytial Virus-Associated Lower Respiratory Tract Illness in Infants in Low- and Middle-Income Regions During the Coronavirus Disease 2019 Pandemic. Open Forum Infect Dis. 2023 Dec 1;10(12):ofad553. doi: 10.1093/ofid/ofad553. eCollection 2023 Dec. |
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. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Race/Ethnicity analysis was performed only for Pregnant Women/Mothers Group. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Count of Participants | Participants | From Day 1 up to Day 42 post delivery |
|
|
| ||||||||||||||||||||||||||||||||||||
| 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. | 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). | Posted | Count of Participants | Participants | From Day 1 up to Day 42 post-delivery |
| ||||||||||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Count of Participants | Participants | From birth up to Day 28 post-birth |
| ||||||||||||||||||||||||||||||||||||||
| 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. | 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). | Posted | Count of Participants | Participants | From Day 1 up to Day 42 post-delivery |
| ||||||||||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Count of Participants | Participants | From birth through Day 28 of life |
| ||||||||||||||||||||||||||||||||||||||
| 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. | 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). | Posted | Geometric Mean | 95% Confidence Interval | Titers | At delivery |
|
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| 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. | 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). | Posted | Geometric Mean | 95% Confidence Interval | Titers | At delivery |
|
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Cases per 100 person-years | From birth up to 1 year of age |
|
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Cases per 100 person-years | From birth up to 1 year of age |
|
|
No AEs or SAEs were reported in this study.
The study does not include the administration of any vaccine and no AEs or SAEs were reported in this study. Pregnancy outcomes and events of interests reported in the record did not meet the criteria for AEs or SAEs according to the standard definition in the protocol. 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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 1 | 2,311 | 0 | 0 | 0 | 0 |
| EG001 | 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. | 23 | 2,181 | 0 | 0 | 0 | 0 |
Not provided
Not provided
The study period partly overlapped with COVID-19 pandemic. RSV LRTI findings might not reflect a standard RSV season due to low virus circulation, social distancing, travel restriction and other actions to control COVID-19 spreading. GAIA classification is not used as care standard in participating sites. Some sites might face challenges into classify the outcomes of interest. Background rates for less frequent events were difficult to estimate due to the relatively limited size.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 24, 2021 | Jul 25, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| 35-39 years |
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| >=40 years |
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| 0-1 year |
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| American Indian or Alaska Native |
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| Asian-Central/South Asian Heritage |
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| Asian-East Asian Heritage |
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| Asian-Japanese Heritage |
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| Asian-South East Asian Heritage |
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| White-Arabic/North African Heritage |
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| White-Caucasian/ European Heritage |
|
|
| Other - Not specified |
|
|
| Title | Measurements |
|---|---|
|
| Intrapartum fetal death/still birth with no congenital anomalies |
|
| Antepartum fetal death/still birth with congenital anomalies |
|
| Intrapartum fetal death/still birth with congenital anomalies |
|
| Elective/therapeutic termination with no congenital anomalies |
|
| Elective/therapeutic termination with congenital anomalies |
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
| Participants |
|
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