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| ID | Type | Description | Link |
|---|---|---|---|
| V59_72OB | Other Identifier | Novartis |
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The GlaxoSmithKline's Meningococcal quadrivalent CRM-197 conjugate vaccine pregnancy registry is established to meet a post marketing commitment agreed upon with CBER to prospectively collect data on pregnancy exposures to Meningococcal quadrivalent CRM-197 conjugate vaccine.
It is an observational study of women inadvertently immunized with the Meningococcal quadrivalent CRM-197 conjugate vaccine within 28 days prior to conception or at any time during pregnancy as part of routine care.
The objective of the pregnancy registry is to evaluate pregnancy outcomes among women immunized with the Meningococcal quadrivalent CRM-197 conjugate vaccine within 28 days prior to conception or at any time during pregnancy. The primary outcomes of interest include major congenital malformation, preterm birth, and low birth weight. Other pregnancy outcomes will be collected, including spontaneous abortions and stillbirths.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposure group | Pregnant women who were exposed to ≥1 dose of Menveo vaccine within 28 days prior to conception or at any time during pregnancy were included. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal quadrivalent CRM-197 conjugate vaccine | Biological | This pregnancy registry is strictly observational. Decisions of vaccination are made by health care providers. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Within 28 Days Prior to Conception | The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine within 28 days prior to conception. The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births | From the time of enrolment until the date of pregnancy outcome documentation (i.e. From registration upon Menveo exposure within 28 days prior to conception until the estimated delivery date) |
| Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the First Trimester | The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine during the first trimester of pregnancy.The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births. | From the time of enrolment until the date of pregnancy outcome documentation (i.e.From registration upon Menveo exposure during first trimester of pregnancy [0-13 weeks] until the estimated delivery date) |
| Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the Second Trimester | The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine during the second trimester of pregnancy.The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Within 28 Days Prior to Conception | The pregnancy outcomes assessed were: live births, stillbirths, SABs, IABs, ectopic pregnancy, molar pregnancy and others. Spontaneous abortions (SABs) are defined as fetal death or expulsion of products of conception prior to 20 weeks gestation. Induced abortions (IABs) are defined as voluntary interruption of pregnancy, including pregnancy termination that occurs electively, to preserve maternal health, or due to fetal abnormalities. Stillbirths are defined as fetal death occurring at 20 weeks gestation or greater, or if gestation age is unknown, a fetus weighing 500 g or more. Ectopic pregnancy is defined as implantation of a conception outside of the uterus. Molar pregnancy is defined as a conception that results in a gestational trophoblastic tumor. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include pregnant women within the United States who were immunized with the GlaxoSmithKline's Meningococcal quadrivalent CRM-197 conjugate vaccine within 28 days prior to conception or at any time during pregnancy.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Wilmington | North Carolina | 28401-3331 | United States | ||
| GSK Investigational Site |
Of the 93 subjects included in the registry,82 subjects were included for analysis as 7 lost to follow up & 4 were invalid cases. Of these 82 subjects,1 pregnancy resulted in 1 set of twins birth.Analyses on outcome measures were performed on pregnant outcomes(Analysis population pregnancy outcomes)& on live births(Analysis population live births)
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| ID | Title | Description |
|---|---|---|
| FG000 | Exposure Group | Pregnant women who were exposed to ≥1 dose of Menveo vaccine within 28 days prior to conception or at any time during pregnancy were included. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exposure Group | Pregnant women who were exposed to ≥1 dose of Menveo vaccine within 28 days prior to conception or at any time during pregnancy were included. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Within 28 Days Prior to Conception | The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine within 28 days prior to conception. The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births | The analysis was performed on live births who were exposed to Menveo vaccine within 28 days prior to conception | Posted | Number | Percentage of Live Births with MCM | From the time of enrolment until the date of pregnancy outcome documentation (i.e. From registration upon Menveo exposure within 28 days prior to conception until the estimated delivery date) |
|
No adverse events data was collected in this study.
No adverse events data was collected in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exposure Group | Pregnant women who were exposed to ≥1 dose of Menveo vaccine within 28 days prior to conception or at any time during pregnancy were included. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | geetha.x.kamath@gsk.com |
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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 | Sep 1, 2014 | Mar 28, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 11, 2016 | Mar 28, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during second trimester of pregnancy [14-27 weeks] until the estimated delivery date) |
| Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During Third Trimester | The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine during the third trimester of pregnancy.The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births | From the time of enrolment until the date of pregnancy outcome documentation (i.e.From registration upon Menveo exposure during third trimester of pregnancy [>27 weeks] until the estimated delivery date) |
| Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Within 28 Days Prior to Conception or at Any Time During the Pregnancy | The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the pregnancy.The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon exposure to Menveo within 28 days prior to conception or at any time during pregnancy until the estimated delivery date) |
| Percentage of Preterm Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception | A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined. | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure within 28 days prior to conception until the estimated delivery date) |
| Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the First Trimester | A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined. | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during first trimester of pregnancy [0-13 weeks] until the estimated delivery date) |
| Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the Second Trimester | A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined. | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during second trimester of pregnancy [14-27 weeks] until the estimated delivery date) |
| Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the Third Trimester | A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined. | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during third trimester of pregnancy (>27 weeks) until the estimated delivery date) |
| Percentage of Preterm Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy | A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined. | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon exposure to Menveo within 28 days prior to conception or at any time during pregnancy until the estimated delivery date) |
| Percentage of Low Birth Weight (LBW) Live Births Reported on Exposure to Menveo Vaccine Vaccine Within 28 Days Prior to Conception | A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW. | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure within 28 days prior to conception until the estimated delivery date) |
| Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the First Trimester | A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW. | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during first trimester of pregnancy [0-13 weeks] until the estimated delivery date) |
| Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the Second Trimester | A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW. | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during second trimester of pregnancy [14-27 weeks] until the estimated delivery date) |
| Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the Third Trimester | A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW. | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during third trimester of pregnancy (>27 weeks) until the estimated delivery date) |
| Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy | A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW. | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon exposure to Menveo within 28 days prior to conception or at any time during pregnancy until the estimated delivery date) |
| From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure within 28 days prior to conception until the estimated delivery date) |
| Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo During the First Trimester | The pregnancy outcomes assessed were: live births, stillbirths, SABs, IABs, ectopic pregnancy, molar pregnancy and others. | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during first trimester of pregnancy [0-13 weeks] until the estimated delivery date) |
| Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Second Trimester | The pregnancy outcomes assessed were: live births, stillbirths, SAB, IAB, ectopic pregnancy, molar pregnancy and others | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during second trimester of pregnancy [14-27 weeks] until the estimated delivery date) |
| Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Third Trimester | The pregnancy outcomes assessed were: Live births, stillbirths, SAB,IAB, ectopic pregnancy, molar pregnancy and others. | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during third trimester of pregnancy (>27 weeks) until the estimated delivery date) |
| Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy | The pregnancy outcomes assessed were: Live births,stillbirths, SAB, IAB, ectopic pregnancy, molar pregnancy and others. | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon exposure to Menveo within 28 days prior to conception or at any time during pregnancy until the estimated delivery date) |
| Wilmington |
| North Carolina |
| 28401- |
| United States |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
All live births (single or multiple) who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the mother's pregnancy |
|
|
| Primary | Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the First Trimester | The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine during the first trimester of pregnancy.The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births. | The analysis was performed on live births who were exposed to Menveo vaccine during the first trimester of pregnancy | Posted | Number | Percentage of Live Births with MCM | From the time of enrolment until the date of pregnancy outcome documentation (i.e.From registration upon Menveo exposure during first trimester of pregnancy [0-13 weeks] until the estimated delivery date) |
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| Primary | Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the Second Trimester | The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine during the second trimester of pregnancy.The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births | The analysis was performed on live births who were exposed to Menveo vaccine during second trimester of pregnancy | Posted | Number | Percentage of Live Births with MCM | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during second trimester of pregnancy [14-27 weeks] until the estimated delivery date) |
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| Primary | Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During Third Trimester | The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine during the third trimester of pregnancy.The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births | The analysis was performed on live births who were exposed to Menveo vaccine during third trimester of pregnancy | Posted | Number | Percentage of Live Births with MCM | From the time of enrolment until the date of pregnancy outcome documentation (i.e.From registration upon Menveo exposure during third trimester of pregnancy [>27 weeks] until the estimated delivery date) |
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| Primary | Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Within 28 Days Prior to Conception or at Any Time During the Pregnancy | The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the pregnancy.The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births | The analysis was performed on live births who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the pregnancy | Posted | Number | Percentage of Live Births with MCM | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon exposure to Menveo within 28 days prior to conception or at any time during pregnancy until the estimated delivery date) |
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| Primary | Percentage of Preterm Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception | A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined. | The analysis was performed on live births who were exposed to Menveo vaccine within 28 days prior to conception | Posted | Number | Percentage of preterm births without MCM | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure within 28 days prior to conception until the estimated delivery date) |
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| Primary | Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the First Trimester | A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined. | The analysis was performed on the live births who were exposed to Menveo vaccine during the first trimester of pregnancy | Posted | Number | Percentage of preterm births without MCM | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during first trimester of pregnancy [0-13 weeks] until the estimated delivery date) |
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| Primary | Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the Second Trimester | A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined. | The analysis was performed on the live births who were exposed to Menveo vaccine during the second trimester of pregnancy | Posted | Number | Percentage of preterm births without MCM | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during second trimester of pregnancy [14-27 weeks] until the estimated delivery date) |
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| Primary | Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the Third Trimester | A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined. | The analysis was performed on the live births who were exposed to Menveo vaccine during the third trimester of pregnancy | Posted | Number | Percentage of preterm births without MCM | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during third trimester of pregnancy (>27 weeks) until the estimated delivery date) |
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| Primary | Percentage of Preterm Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy | A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined. | The analysis was performed on the live births who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the mother's pregnancy | Posted | Number | Percentage of preterm births without MCM | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon exposure to Menveo within 28 days prior to conception or at any time during pregnancy until the estimated delivery date) |
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| Primary | Percentage of Low Birth Weight (LBW) Live Births Reported on Exposure to Menveo Vaccine Vaccine Within 28 Days Prior to Conception | A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW. | The analysis was performed on live births who were exposed to Menveo vaccine within 28 days prior to conception | Posted | Number | Percentage of LBW live birth without MCM | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure within 28 days prior to conception until the estimated delivery date) |
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| Primary | Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the First Trimester | A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW. | The analysis was performed on live births who were exposed to Menveo vaccine during the first trimester of pregnancy | Posted | Number | Percentage of LBW live birth without MCM | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during first trimester of pregnancy [0-13 weeks] until the estimated delivery date) |
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| Primary | Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the Second Trimester | A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW. | The analysis was performed on the live births who were exposed to Menveo vaccine during the second trimester of pregnancy | Posted | Number | Percentage of LBW live birth without MCM | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during second trimester of pregnancy [14-27 weeks] until the estimated delivery date) |
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| Primary | Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the Third Trimester | A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW. | The analysis was performed on the live births who were exposed to Menveo vaccine during the third trimester of pregnancy | Posted | Number | Percentage of LBW live birth without MCM | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during third trimester of pregnancy (>27 weeks) until the estimated delivery date) |
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| Secondary | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Within 28 Days Prior to Conception | The pregnancy outcomes assessed were: live births, stillbirths, SABs, IABs, ectopic pregnancy, molar pregnancy and others. Spontaneous abortions (SABs) are defined as fetal death or expulsion of products of conception prior to 20 weeks gestation. Induced abortions (IABs) are defined as voluntary interruption of pregnancy, including pregnancy termination that occurs electively, to preserve maternal health, or due to fetal abnormalities. Stillbirths are defined as fetal death occurring at 20 weeks gestation or greater, or if gestation age is unknown, a fetus weighing 500 g or more. Ectopic pregnancy is defined as implantation of a conception outside of the uterus. Molar pregnancy is defined as a conception that results in a gestational trophoblastic tumor. | The analysis was performed on subjects who were exposed to Menveo vaccine within 28 days prior to conception | Posted | Number | Pregnancy outcomes | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure within 28 days prior to conception until the estimated delivery date) |
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| Secondary | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo During the First Trimester | The pregnancy outcomes assessed were: live births, stillbirths, SABs, IABs, ectopic pregnancy, molar pregnancy and others. | The analysis was performed on subjects who were exposed to Menveo vaccine during the first trimester of pregnancy | Posted | Number | Pregnancy outcomes | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during first trimester of pregnancy [0-13 weeks] until the estimated delivery date) |
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| Secondary | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Second Trimester | The pregnancy outcomes assessed were: live births, stillbirths, SAB, IAB, ectopic pregnancy, molar pregnancy and others | The analysis was performed on subjects who were exposed to Menveo vaccine during the second trimester of pregnancy | Posted | Number | Pregnancy outcomes | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during second trimester of pregnancy [14-27 weeks] until the estimated delivery date) |
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|
|
| Secondary | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Third Trimester | The pregnancy outcomes assessed were: Live births, stillbirths, SAB,IAB, ectopic pregnancy, molar pregnancy and others. | The analysis was performed on subjects who were exposed to Menveo vaccine during the third trimester of pregnancy | Posted | Number | Pregnancy outcomes | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during third trimester of pregnancy (>27 weeks) until the estimated delivery date) |
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|
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| Secondary | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy | The pregnancy outcomes assessed were: Live births,stillbirths, SAB, IAB, ectopic pregnancy, molar pregnancy and others. | The analysis was performed on subjects who were exposed to Menveo vaccine within 28 days prior to pregnancy or at any time during the pregnancy. | Posted | Number | Pregnancy outcomes | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon exposure to Menveo within 28 days prior to conception or at any time during pregnancy until the estimated delivery date) |
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| Primary | Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy | A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW. | The analysis was performed on the live births who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the pregnancy | Posted | Number | Percentage of LBW live birth without MCM | From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon exposure to Menveo within 28 days prior to conception or at any time during pregnancy until the estimated delivery date) |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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 trials.
| D007239 | Infections |
| Title | Measurements |
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| Title | Measurements |
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| IAB |
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| Ectopic pregnancy |
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| Molar pregnancy |
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| Others |
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| Title | Measurements |
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| IAB |
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| Ectopic pregnancy |
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| Molar pregnancy |
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| Others |
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| Title | Measurements |
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| IAB |
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| Ectopic pregnancy |
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| Molar pregnancy |
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| Others |
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| Title | Measurements |
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| IAB |
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| Ectopic pregnancy |
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| Molar pregnancy |
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| Others |
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| Title | Measurements |
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| IAB |
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| Ectopic pregnancy |
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| Molar pregnancy |
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| Others |
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