Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-01-05 @ 6:34 PM
Study NCT ID:
NCT02757950
Status:
COMPLETED
Last Update Posted:
2019-10-01
First Post:
2016-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Post-marketing, Observational, Retrospective Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'id': 'D003354', 'term': 'Corynebacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013745', 'term': 'Tetanus Toxoid'}], 'ancestors': [{'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '877-379-3718', 'title': 'GSK Clinical Trials', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Entire study period (From week 27 of pregnancy up to birth).', 'description': 'During this retrospective, observational study safety data was not recorded/collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Unexposed Cohort', 'description': 'Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) before implementation of the maternal immunization program in Brazil in September 2014 and who did not receive Tdap vaccination during pregnancy.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Exposed Cohort', 'description': 'Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) from May 2015 and who received one dose of Refortrix during 27 to 36 weeks of pregnancy (or as late as 20 days before delivery due date).', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Reporting Gestational Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1199', 'groupId': 'OG000'}, {'value': '1259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed Cohort', 'description': 'Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) from May 2015 and who received one dose of Refortrix during 27 to 36 weeks of pregnancy (or as late as 20 days before delivery due date).'}, {'id': 'OG001', 'title': 'Unexposed Cohort', 'description': 'Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) before implementation of the maternal immunization program in Brazil in September 2014 and who did not receive Tdap vaccination during pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1147', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.548', 'ciLowerLimit': '0.259', 'ciUpperLimit': '1.157', 'pValueComment': 'A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.', 'groupDescription': 'The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After week 27 of pregnancy', 'description': 'Gestational diabetes was defined as: Onset or first recognition of abnormal glucose tolerance during pregnancy (the diagnosis is based on administration of glucose challenge test at 24-28 weeks of gestation). Includes Class A1: Euglycaemia achieved with diet and/or exercise and Class A2: Euglycaemia achieved with medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Cohort (TC), which included all the subjects enrolled in the study with symptom sheets filled-in.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Reporting Pregnancy-related Hypertension, Pre-eclampsia, Eclampsia, and HELLP Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1199', 'groupId': 'OG000'}, {'value': '1259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed Cohort', 'description': 'Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) from May 2015 and who received one dose of Refortrix during 27 to 36 weeks of pregnancy (or as late as 20 days before delivery due date).'}, {'id': 'OG001', 'title': 'Unexposed Cohort', 'description': 'Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) before implementation of the maternal immunization program in Brazil in September 2014 and who did not receive Tdap vaccination during pregnancy.'}], 'classes': [{'title': 'Pregnancy-related hypertension', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Pre-eclampsia', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Eclampsia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HELLP syndrome', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0155', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.428', 'ciLowerLimit': '0.215', 'ciUpperLimit': '0.851', 'pValueComment': 'A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.', 'groupDescription': 'The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After week 27 of pregnancy', 'description': 'Pregnancy-related hypertension is defined as:\n\nBlood pressure systolic higher than (\\>) 140 and/or diastolic \\> 90 millimetre of mercury (mmHg), documented in at least two separate measurements after 20 weeks of gestation, without proteinuria or other stigmata of pre-eclampsia, and returning to normal post-partum. Hypertension usually resolves by 12 weeks post-partum, included pre-eclampsia, eclampsia and haemolysis elevated liver enzymes low platelet (HELLP) Syndrome for this study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Cohort (TC), which included all the subjects enrolled in the study with symptom sheets filled-in.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Reporting Pregnancy Hemorrhage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1199', 'groupId': 'OG000'}, {'value': '1259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed Cohort', 'description': 'Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) from May 2015 and who received one dose of Refortrix during 27 to 36 weeks of pregnancy (or as late as 20 days before delivery due date).'}, {'id': 'OG001', 'title': 'Unexposed Cohort', 'description': 'Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) before implementation of the maternal immunization program in Brazil in September 2014 and who did not receive Tdap vaccination during pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0127', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.254', 'ciLowerLimit': '0.086', 'ciUpperLimit': '0.746', 'pValueComment': 'A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.', 'groupDescription': 'The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After week 27 of pregnancy', 'description': 'Pregnancy vaginal hemorrhage is defined as: excessive blood loss after delivery i.e. estimated blood loss in excess of 500 milliliters (ml) after vaginal delivery and estimated blood loss in excess of 1000 ml after Caesarean delivery. The other symptoms are higher than or equal to (≥) 10 percent (%) drop in hematocrit, need for blood transfusion, symptomatic hypotension, dizziness, pallor and oliguria.\n\nVaginal or intrauterine hemorrhage that encompasses antepartum (i.e. bleeding from the genital tract after 24 weeks of gestation), intrapartum, and postpartum bleeding (i.e. within 24 hours post-delivery).\n\nA major obstetric hemorrhage is defined as blood loss from uterus or genital tract \\>1500 ml or a decrease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Cohort (TC), which included all the subjects enrolled in the study with symptom sheets filled-in.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Pre-specified Neonate-related Outcomes Resulting in Preterm Birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1199', 'groupId': 'OG000'}, {'value': '1259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed Cohort', 'description': 'Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) from May 2015 and who received one dose of Refortrix during 27 to 36 weeks of pregnancy (or as late as 20 days before delivery due date).'}, {'id': 'OG001', 'title': 'Unexposed Cohort', 'description': 'Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) before implementation of the maternal immunization program in Brazil in September 2014 and who did not receive Tdap vaccination during pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0036', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.638', 'ciLowerLimit': '0.471', 'ciUpperLimit': '0.863', 'pValueComment': 'A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.', 'groupDescription': 'The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From week 27 up to week 37 of pregnancy', 'description': 'Preterm birth is defined as: Birth before 37 weeks of gestation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Cohort (TC), which included all the subjects enrolled in the study with symptom sheets filled-in.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Pre-specified Neonate-related Outcomes, Resulting in Neonates Small for Their Gestational Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1199', 'groupId': 'OG000'}, {'value': '1259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed Cohort', 'description': 'Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) from May 2015 and who received one dose of Refortrix during 27 to 36 weeks of pregnancy (or as late as 20 days before delivery due date).'}, {'id': 'OG001', 'title': 'Unexposed Cohort', 'description': 'Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) before implementation of the maternal immunization program in Brazil in September 2014 and who did not receive Tdap vaccination during pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0931', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.342', 'ciLowerLimit': '0.952', 'ciUpperLimit': '1.890', 'pValueComment': 'A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.', 'groupDescription': 'The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After week 27 of pregnancy', 'description': 'Small for gestational age is defined as: Birth weight less than (\\<) 10% for infants of same gestational age and gender in same population.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Cohort (TC), which included all the subjects enrolled in the study with symptom sheets filled-in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Pregnancy-related Adverse Events (AEs) of Interest/Neonate-related Events up to Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1199', 'groupId': 'OG000'}, {'value': '1259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed Cohort', 'description': 'Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) from May 2015 and who received one dose of Refortrix during 27 to 36 weeks of pregnancy (or as late as 20 days before delivery due date).'}, {'id': 'OG001', 'title': 'Unexposed Cohort', 'description': 'Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) before implementation of the maternal immunization program in Brazil in September 2014 and who did not receive Tdap vaccination during pregnancy.'}], 'classes': [{'title': 'Premature rupture of membranes', 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}]}, {'title': 'Preterm premature rupture of membranes', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Premature uterine contractions', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Neonatal death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Maternal death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Still births', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Neonatal hypoxic ischaemic encephalopathy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After week 27 of pregnancy', 'description': 'Pregnancy-related AEs of interest and neonate-related events are defined as: premature rupture of membranes, preterm premature rupture of membranes, premature uterine contraction, neonatal death, maternal death, still birth, neonatal hypoxic ischaemic encephalopathy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Cohort (TC), which included all the subjects enrolled in the study with symptom sheets filled-in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Cases of Congenital Anomalies in the Neonates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1199', 'groupId': 'OG000'}, {'value': '1259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed Cohort', 'description': 'Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) from May 2015 and who received one dose of Refortrix during 27 to 36 weeks of pregnancy (or as late as 20 days before delivery due date).'}, {'id': 'OG001', 'title': 'Unexposed Cohort', 'description': 'Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) before implementation of the maternal immunization program in Brazil in September 2014 and who did not receive Tdap vaccination during pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From week 27 of pregnancy up to birth', 'description': 'Congenital anomalies include morphological, functional, chromosomal or genetic anomalies, regardless of whether detected at birth or not, the foetus is delivered dead or alive, or defects are identified by prenatal ultrasound, amniocentesis or examination of the products of conception.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Cohort (TC), which included all the subjects enrolled in the study with symptom sheets filled-in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Pregnancy-related AEs and Birth Outcomes Per Calendar Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '633', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Unexposed Cohort', 'description': 'Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) before implementation of the maternal immunization program in Brazil in September 2014 and who did not receive Tdap vaccination during pregnancy.'}], 'classes': [{'title': 'Gestational diabetes, Sep2012-Aug2013', 'denoms': [{'units': 'Participants', 'counts': [{'value': '615', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Gestational diabetes, Sep2013-Aug2014', 'denoms': [{'units': 'Participants', 'counts': [{'value': '633', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Pregnancy-related hypertension, Sep2012-Aug2013', 'denoms': [{'units': 'Participants', 'counts': [{'value': '615', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Pregnancy-related hypertension, Sep2013-Aug2014', 'denoms': [{'units': 'Participants', 'counts': [{'value': '633', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Vaginal hemorrhage, Sep2012-Aug2013', 'denoms': [{'units': 'Participants', 'counts': [{'value': '615', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Vaginal hemorrhage, Sep2013-Aug2014', 'denoms': [{'units': 'Participants', 'counts': [{'value': '633', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Preterm birth, Sep2012-Aug2013', 'denoms': [{'units': 'Participants', 'counts': [{'value': '615', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': 'Preterm birth, Sep2013-Aug2014', 'denoms': [{'units': 'Participants', 'counts': [{'value': '633', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}, {'title': 'Small for gestational age, Sep2012-Aug2013', 'denoms': [{'units': 'Participants', 'counts': [{'value': '615', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Small for gestational age, Sep2013-Aug2014', 'denoms': [{'units': 'Participants', 'counts': [{'value': '633', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Pre-Eclampsia, Sep2012-Aug2013', 'denoms': [{'units': 'Participants', 'counts': [{'value': '615', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Pre-Eclampsia, Sep2013-Aug 2014', 'denoms': [{'units': 'Participants', 'counts': [{'value': '633', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Eclampsia, Sep2012-Aug2013', 'denoms': [{'units': 'Participants', 'counts': [{'value': '633', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Eclampsia, Sep2013-Aug 2014', 'denoms': [{'units': 'Participants', 'counts': [{'value': '633', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'HELLP Syndrome, Sep2012-Aug2013', 'denoms': [{'units': 'Participants', 'counts': [{'value': '633', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'HELLP Syndrome, Sep2013-Aug 2014', 'denoms': [{'units': 'Participants', 'counts': [{'value': '633', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After week 27 of pregnancy', 'description': 'Pregnancy related AEs include: gestational diabetes, pregnancy-related hypertension, pre-eclampsia, eclampsia, HELLP Syndrome and pregnancy hemorrhage. Birth outcomes include: preterm birth and small for gestational age.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on the Unexposed Cohort which included women pregnant before implementation of the maternal immunization program, who didn't receive Refortrix, the study vaccine."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exposed Cohort', 'description': 'Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) from May 2015 and who received one dose of Refortrix during 27 to 36 weeks of pregnancy (or as late as 20 days before delivery due date).'}, {'id': 'FG001', 'title': 'Unexposed Cohort', 'description': 'Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) before implementation of the maternal immunization program in Brazil in September 2014 and who did not receive Tdap vaccination during pregnancy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1203'}, {'groupId': 'FG001', 'numSubjects': '1259'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1199'}, {'groupId': 'FG001', 'numSubjects': '1248'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}], 'recruitmentDetails': 'A total of 2462 subjects were enrolled in the study in one center in Brazil.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1203', 'groupId': 'BG000'}, {'value': '1259', 'groupId': 'BG001'}, {'value': '2462', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exposed Cohort', 'description': 'Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) from May 2015 and who received one dose of Refortrix during 27 to 36 weeks of pregnancy (or as late as 20 days before delivery due date).'}, {'id': 'BG001', 'title': 'Unexposed Cohort', 'description': 'Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) before implementation of the maternal immunization program in Brazil in September 2014 and who did not receive Tdap vaccination during pregnancy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1203', 'groupId': 'BG000'}, {'value': '1259', 'groupId': 'BG001'}, {'value': '2462', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26.49', 'spread': '6.15', 'groupId': 'BG000'}, {'value': '26.28', 'spread': '6.24', 'groupId': 'BG001'}, {'value': '26.38', 'spread': '6.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1203', 'groupId': 'BG000'}, {'value': '1259', 'groupId': 'BG001'}, {'value': '2462', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1203', 'groupId': 'BG000'}, {'value': '1259', 'groupId': 'BG001'}, {'value': '2462', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-09-11', 'size': 1187071, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-09-04T05:38', 'hasProtocol': True}, {'date': '2017-04-01', 'size': 208012, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-09-04T05:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2462}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-04', 'studyFirstSubmitDate': '2016-04-28', 'resultsFirstSubmitDate': '2018-12-13', 'studyFirstSubmitQcDate': '2016-04-28', 'lastUpdatePostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-04', 'studyFirstPostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Reporting Gestational Diabetes', 'timeFrame': 'After week 27 of pregnancy', 'description': 'Gestational diabetes was defined as: Onset or first recognition of abnormal glucose tolerance during pregnancy (the diagnosis is based on administration of glucose challenge test at 24-28 weeks of gestation). Includes Class A1: Euglycaemia achieved with diet and/or exercise and Class A2: Euglycaemia achieved with medication.'}, {'measure': 'Number of Subjects Reporting Pregnancy-related Hypertension, Pre-eclampsia, Eclampsia, and HELLP Syndrome', 'timeFrame': 'After week 27 of pregnancy', 'description': 'Pregnancy-related hypertension is defined as:\n\nBlood pressure systolic higher than (\\>) 140 and/or diastolic \\> 90 millimetre of mercury (mmHg), documented in at least two separate measurements after 20 weeks of gestation, without proteinuria or other stigmata of pre-eclampsia, and returning to normal post-partum. Hypertension usually resolves by 12 weeks post-partum, included pre-eclampsia, eclampsia and haemolysis elevated liver enzymes low platelet (HELLP) Syndrome for this study.'}, {'measure': 'Number of Subjects Reporting Pregnancy Hemorrhage', 'timeFrame': 'After week 27 of pregnancy', 'description': 'Pregnancy vaginal hemorrhage is defined as: excessive blood loss after delivery i.e. estimated blood loss in excess of 500 milliliters (ml) after vaginal delivery and estimated blood loss in excess of 1000 ml after Caesarean delivery. The other symptoms are higher than or equal to (≥) 10 percent (%) drop in hematocrit, need for blood transfusion, symptomatic hypotension, dizziness, pallor and oliguria.\n\nVaginal or intrauterine hemorrhage that encompasses antepartum (i.e. bleeding from the genital tract after 24 weeks of gestation), intrapartum, and postpartum bleeding (i.e. within 24 hours post-delivery).\n\nA major obstetric hemorrhage is defined as blood loss from uterus or genital tract \\>1500 ml or a decrease.'}, {'measure': 'Number of Subjects With Pre-specified Neonate-related Outcomes Resulting in Preterm Birth', 'timeFrame': 'From week 27 up to week 37 of pregnancy', 'description': 'Preterm birth is defined as: Birth before 37 weeks of gestation.'}, {'measure': 'Number of Subjects With Pre-specified Neonate-related Outcomes, Resulting in Neonates Small for Their Gestational Age', 'timeFrame': 'After week 27 of pregnancy', 'description': 'Small for gestational age is defined as: Birth weight less than (\\<) 10% for infants of same gestational age and gender in same population.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects Reporting Pregnancy-related Adverse Events (AEs) of Interest/Neonate-related Events up to Delivery', 'timeFrame': 'After week 27 of pregnancy', 'description': 'Pregnancy-related AEs of interest and neonate-related events are defined as: premature rupture of membranes, preterm premature rupture of membranes, premature uterine contraction, neonatal death, maternal death, still birth, neonatal hypoxic ischaemic encephalopathy.'}, {'measure': 'Number of Subjects Reporting Cases of Congenital Anomalies in the Neonates', 'timeFrame': 'From week 27 of pregnancy up to birth', 'description': 'Congenital anomalies include morphological, functional, chromosomal or genetic anomalies, regardless of whether detected at birth or not, the foetus is delivered dead or alive, or defects are identified by prenatal ultrasound, amniocentesis or examination of the products of conception.'}, {'measure': 'Number of Subjects With Pregnancy-related AEs and Birth Outcomes Per Calendar Year', 'timeFrame': 'After week 27 of pregnancy', 'description': 'Pregnancy related AEs include: gestational diabetes, pregnancy-related hypertension, pre-eclampsia, eclampsia, HELLP Syndrome and pregnancy hemorrhage. Birth outcomes include: preterm birth and small for gestational age.'}]}, 'conditionsModule': {'keywords': ['exposed and unexposed cohorts', 'post-marketing, maternal immunization', 'neonate related Adverse Events', 'Congenital anomaly', 'RefortrixTM', 'Pregnancy related Adverse Events'], 'conditions': ['Diphtheria']}, 'referencesModule': {'references': [{'pmid': '31216218', 'type': 'BACKGROUND', 'citation': 'Sancovski M, Mesaros N, Feng Y, Ceregido MA, Luyts D, De Barros E. Safety of reduced antigen content diphtheria-tetanus-acellular pertussis vaccine when administered during pregnancy as part of the maternal immunization program in Brazil: a single center, observational, retrospective, cohort study. Hum Vaccin Immunother. 2019;15(12):2873-2881. doi: 10.1080/21645515.2019.1627161. Epub 2019 Jun 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety of RefortrixTM (Tdap) when administered during pregnancy in a maternal immunization program in Brazil.', 'detailedDescription': 'In this retrospective cohort study the safety of RefortrixTM (Tdap) administered during pregnancy as part of the National immunization program in Brazil will be assessed by comparing the risk of pre-defined adverse events before and after introduction of the RefortrixTM (Tdap) maternal immunization program.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The subjects who delivered in the study centre from May 2015 onwards will be considered as potentially exposed and those who delivered before September 2014 will be considered as potentially unexposed', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects between 18 and 45 years of age at the time of pregnancy under consideration for the study, who deliver in the study centre.\n* Residents of the study area\n* Subjects who were compliant with the routine antenatal care including at least one ultrasound assessment report early in the pregnancy.\n* Subjects with the complete and relevant medical records available.\n\nInclusion criteria for the Exposed cohort:\n\n* Subjects who received one dose of Refortrix vaccine in the recommended time period between 27 and 36 completed weeks of pregnancy (or as late as 20 days before delivery due date) as part of the maternal immunization program in Brazil, and according to the program recommendations from May 2015 onwards.\n* Subjects with appropriate vaccination records.\n\nInclusion criteria for the Unexposed cohort:\n\n* Subjects who had delivered in the same hospital (study centre) before 01 September 2014 (September 2012-August 2014) and who did not receive Tdap vaccination during pregnancy to the best knowledge of the investigator.\n\nExclusion Criteria:\n\n* Subjects who have been transferred to other specialised centres, where their medical records would be inaccessible for the study (private clinics, psychiatric or prison hospitals, other state hospitals, etc).'}, 'identificationModule': {'nctId': 'NCT02757950', 'briefTitle': 'A Post-marketing, Observational, Retrospective Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Post-marketing, Observational, Retrospective, Cohort Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.', 'orgStudyIdInfo': {'id': '203153'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exposed cohort', 'description': 'Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) from May 2015 and who received one dose of Refortrix during 27 to 36 weeks of pregnancy (or as late as 20 days before delivery due date).', 'interventionNames': ['Biological: Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [Refortrix (Tdap)]']}, {'label': 'Unexposed cohort', 'description': 'Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) before implementation of the maternal immunization program in Brazil in September 2014 and who did not receive Tdap vaccination during pregnancy.', 'interventionNames': ['Biological: Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [Refortrix (Tdap)]']}], 'interventions': [{'name': 'Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [Refortrix (Tdap)]', 'type': 'BIOLOGICAL', 'description': 'Subjects were included in the Exposed cohort if they received Refortrix as part of the maternal immunization program in Brazil.', 'armGroupLabels': ['Exposed cohort', 'Unexposed cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09060-650', 'city': 'Santo André', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}