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.
Study Type
OBSERVATIONAL
Enrollment
93
This pregnancy registry is strictly observational. Decisions of vaccination are made by health care providers.
GSK Investigational Site
Wilmington, North Carolina, United States
GSK Investigational Site
Wilmington, North Carolina, United States
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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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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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.
Time frame: 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)