Trial · NCT03614676
A Study of Outcomes and Events of Interest in Pregnant Women, Neonates and Infants and of RSV Surveillance
NCT03614676, Not applicable, Completed, GlaxoSmithKline; results first posted 2023-08-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Outcomes and Events of Interest in Pregnant Women, Neonates and Infants and of RSV Surveillance. Trials, record NCT03614676. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03614676
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Outcomes and Events of Interest in Pregnant Women, Neonates and Infants and of RSV Surveillance
- NCT number
- NCT03614676
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 4,493 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Blood sample collection, Cord blood sample collection, Maternal Diary Card, Nasal Swab collection, Infant Diary Card
- First posted
- 2018-08-03
- Last updated
- 2023-08-14
- Results first posted
- 2023-08-14
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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 | 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. |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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. |
| 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 | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Maternal Subjects With Pregnancy Outcomes | From Day 1 up to Day 42 post delivery | 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). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Maternal Subjects With Pregnancy Related Events of Interest | From Day 1 up to Day 42 post-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). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Infant Subjects With Neonatal Events of Interest | From birth up to Day 28 post-birth | 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. | Participants | COUNT_OF_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 | From Day 1 up to Day 42 post-delivery | 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). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty | From birth through Day 28 of life | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Respiratory Syncytial Virus Type A (RSV-A) Neutralizing Antibody Titers in Maternal Blood | 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). | Titers | GEOMETRIC_MEAN |
| SECONDARY | RSV-A Neutralizing Antibodies Titers in Cord Blood | 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). | Titers | GEOMETRIC_MEAN |
| 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 | From birth up to 1 year of age | 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. | Cases per 100 person-years | NUMBER |
| SECONDARY | Incidence Rates of Infant Subjects With RSV Hospitalizations | From birth up to 1 year of age | 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. | Cases per 100 person-years | NUMBER |
Source ClinicalTrials.gov
Results by group187
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Maternal Subjects With Pregnancy Outcomes | Pregnant Women/Mothers Group | Live birth with no congenital anomalies | 2088 | Participants | |
| Number of Maternal Subjects With Pregnancy Outcomes | Pregnant Women/Mothers Group | Live birth with congenital anomalies | 18 | Participants | |
| Number of Maternal Subjects With Pregnancy Outcomes | Pregnant Women/Mothers Group | Antepartum fetal death/still birth with no congenital anomalies | 8 | Participants | |
| Number of Maternal Subjects With Pregnancy Outcomes | Pregnant Women/Mothers Group | Intrapartum fetal death/still birth with no congenital anomalies | 5 | Participants | |
| Number of Maternal Subjects With Pregnancy Outcomes | Pregnant Women/Mothers Group | Antepartum fetal death/still birth with congenital anomalies | 0 | Participants | |
| Number of Maternal Subjects With Pregnancy Outcomes | Pregnant Women/Mothers Group | Intrapartum fetal death/still birth with congenital anomalies | 1 | Participants | |
| Number of Maternal Subjects With Pregnancy Outcomes | Pregnant Women/Mothers Group | Elective/therapeutic termination with no congenital anomalies | 11 | Participants | |
| Number of Maternal Subjects With Pregnancy Outcomes | Pregnant Women/Mothers Group | Elective/therapeutic termination with congenital anomalies | 1 | Participants | |
| Number of Maternal Subjects With Pregnancy Related Events of Interest | Pregnant Women/Mothers Group | Maternal death | 1 | Participants | |
| Number of Maternal Subjects With Pregnancy Related Events of Interest | Pregnant Women/Mothers Group | Gestational hypertension | 72 | Participants |
1 to 10 of 187Source ClinicalTrials.gov
See all 187 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregnant Women/Mothers Group | 2,311 | |
| Overall Study | STARTED | Neonates/Infants Group | 2,181 | |
| Overall Study | COMPLETED | Pregnant Women/Mothers Group | 2,195 | |
| Overall Study | COMPLETED | Neonates/Infants Group | 2,017 | |
| Overall Study | NOT COMPLETED | Pregnant Women/Mothers Group | 116 | |
| Overall Study | NOT COMPLETED | Neonates/Infants Group | 164 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregnant Women/Mothers Group | 1 | 2,311 |
| Total, all-cause mortality | Neonates/Infants Group | 23 | 2,181 |
| Total, other adverse events | Pregnant Women/Mothers Group | 0 | 0 |
| Total, other adverse events | Neonates/Infants Group | 0 | 0 |
| Total, serious adverse events | Pregnant Women/Mothers Group | 0 | 0 |
| Total, serious adverse events | Neonates/Infants Group | 0 | 0 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pregnant Women/Mothers Group vs Neonates/Infants Group: deaths from any cause |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03614676
GET https://conductscience.org/api/trials/v1/NCT03614676/results?page=2