Infections, Meningococcal, Meningococcal Disease, Pregnancy
Conditions
Brief summary
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.
Interventions
This pregnancy registry is strictly observational. Decisions of vaccination are made by health care providers.
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Sufficient evidence to confirm that MENVEO exposure occurred within 28 days prior to conception or at any time during pregnancy * Sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (ie, whether the outcome of pregnancy was known at the time of first contact with the registry) * Date the pregnancy exposure is registered * Full reporter (ie, HCP) contact information to allow for follow-up (name, address, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy | 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) | 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. |
| Percentage of Preterm Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy | 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) | 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. |
| Percentage of Low Birth Weight (LBW) Live Births Reported on Exposure to Menveo Vaccine Vaccine Within 28 Days Prior to Conception | 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) | 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. |
| Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the First Trimester | 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) | 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. |
| Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the Second Trimester | 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) | 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. |
| Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the Third Trimester | 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) | 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. |
| Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Within 28 Days Prior to Conception | 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) | 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 |
| Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the First Trimester | 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) | 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. |
| Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the Second Trimester | 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) | 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 |
| Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During Third Trimester | 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) | 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 |
| 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 | 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) | 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 |
| Percentage of Preterm Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception | 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) | 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. |
| Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the First Trimester | 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) | 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. |
| Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the Second Trimester | 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) | 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. |
| Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the Third Trimester | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo During the First Trimester | 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) | The pregnancy outcomes assessed were: live births, stillbirths, SABs, IABs, ectopic pregnancy, molar pregnancy and others. |
| Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Second Trimester | 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) | The pregnancy outcomes assessed were: live births, stillbirths, SAB, IAB, ectopic pregnancy, molar pregnancy and others |
| Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Third Trimester | 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) | The pregnancy outcomes assessed were: Live births, stillbirths, SAB,IAB, ectopic pregnancy, molar pregnancy and others. |
| Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy | 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) | The pregnancy outcomes assessed were: Live births,stillbirths, SAB, IAB, ectopic pregnancy, molar pregnancy and others. |
| Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Within 28 Days Prior to Conception | 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) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 82 |
| Total | 82 |
Baseline characteristics
| Characteristic | Exposure Group |
|---|---|
| Age, Continuous | 18.9 Months STANDARD_DEVIATION 1.7 |
| Race/Ethnicity, Customized Ethnicity - Hispanic or Latino | 57 Participants |
| Race/Ethnicity, Customized Ethnicity - Not Hispanic or Latino | 23 Participants |
| Race/Ethnicity, Customized Ethnicity - Unknown | 2 Participants |
| Race/Ethnicity, Customized Race - Asian | 1 Participants |
| Race/Ethnicity, Customized Race - Black or African American | 12 Participants |
| Race/Ethnicity, Customized Race - Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race/Ethnicity, Customized Race - Other | 52 Participants |
| Race/Ethnicity, Customized Race - Unknown | 1 Participants |
| Race/Ethnicity, Customized Race - White or Caucasian | 14 Participants |
| Sex: Female, Male Female | 82 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
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)
Population: The analysis was performed on live births who were exposed to Menveo vaccine during the first trimester of pregnancy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Live Births Group | Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the First Trimester | 5.3 Percentage of LBW live birth without MCM |
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.
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)
Population: The analysis was performed on the live births who were exposed to Menveo vaccine during the second trimester of pregnancy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Live Births Group | Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the Second Trimester | 100.0 Percentage of LBW live birth without MCM |
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.
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)
Population: The analysis was performed on the live births who were exposed to Menveo vaccine during the third trimester of pregnancy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Live Births Group | Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the Third Trimester | 0.0 Percentage of LBW live birth without MCM |
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.
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)
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Live Births Group | Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy | 9.4 Percentage of LBW live birth without MCM |
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.
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)
Population: The analysis was performed on live births who were exposed to Menveo vaccine during the first trimester of pregnancy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Live Births Group | Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the First Trimester | Live births with MCM | 2.6 Percentage of Live Births with MCM |
| Live Births Group | Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the First Trimester | Live births without MCM | 87.2 Percentage of Live Births with MCM |
| Live Births Group | Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the First Trimester | Live births with no known defects | 10.3 Percentage of Live Births with MCM |
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
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)
Population: The analysis was performed on live births who were exposed to Menveo vaccine during second trimester of pregnancy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Live Births Group | Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the Second Trimester | Live births with MCM | 50.0 Percentage of Live Births with MCM |
| Live Births Group | Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the Second Trimester | Live births without MCM | 50.0 Percentage of Live Births with MCM |
| Live Births Group | Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the Second Trimester | Live births with no known defects | 0.0 Percentage of Live Births with MCM |
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
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)
Population: The analysis was performed on live births who were exposed to Menveo vaccine during third trimester of pregnancy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Live Births Group | Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During Third Trimester | Live births with MCM | 0.0 Percentage of Live Births with MCM |
| Live Births Group | Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During Third Trimester | Live births without MCM | 100.0 Percentage of Live Births with MCM |
| Live Births Group | Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During Third Trimester | Live births with no known defects | 0.0 Percentage of Live Births with MCM |
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
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)
Population: The analysis was performed on live births who were exposed to Menveo vaccine within 28 days prior to conception
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Live Births Group | Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Within 28 Days Prior to Conception | Live births with MCM | 0.0 Percentage of Live Births with MCM |
| Live Births Group | Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Within 28 Days Prior to Conception | Live births without MCM | 84.6 Percentage of Live Births with MCM |
| Live Births Group | Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Within 28 Days Prior to Conception | Live births with no known defects | 15.4 Percentage of Live Births with MCM |
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
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)
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Live Births Group | 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 | Live births with MCM | 3.6 Percentage of Live Births with MCM |
| Live Births Group | 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 | Live births without MCM | 85.5 Percentage of Live Births with MCM |
| Live Births Group | 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 | Live births with no known defects | 10.9 Percentage of Live Births with MCM |
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.
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)
Population: The analysis was performed on live births who were exposed to Menveo vaccine within 28 days prior to conception
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Live Births Group | Percentage of Low Birth Weight (LBW) Live Births Reported on Exposure to Menveo Vaccine Vaccine Within 28 Days Prior to Conception | 15.4 Percentage of LBW live birth without MCM |
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.
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)
Population: The analysis was performed on the live births who were exposed to Menveo vaccine during the first trimester of pregnancy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Live Births Group | Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the First Trimester | 10.5 Percentage of preterm births without MCM |
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.
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)
Population: The analysis was performed on the live births who were exposed to Menveo vaccine during the second trimester of pregnancy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Live Births Group | Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the Second Trimester | 100.0 Percentage of preterm births without MCM |
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.
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)
Population: The analysis was performed on the live births who were exposed to Menveo vaccine during the third trimester of pregnancy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Live Births Group | Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the Third Trimester | 0.0 Percentage of preterm births without MCM |
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.
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)
Population: The analysis was performed on live births who were exposed to Menveo vaccine within 28 days prior to conception
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Live Births Group | Percentage of Preterm Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception | 23.1 Percentage of preterm births without MCM |
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.
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)
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Live Births Group | Percentage of Preterm Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy | 15.1 Percentage of preterm births without MCM |
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.
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)
Population: The analysis was performed on subjects who were exposed to Menveo vaccine during the first trimester of pregnancy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo During the First Trimester | Live Births | 39 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo During the First Trimester | Stillbirths | 0 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo During the First Trimester | SAB | 7 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo During the First Trimester | IAB | 13 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo During the First Trimester | Ectopic pregnancy | 0 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo During the First Trimester | Molar pregnancy | 0 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo During the First Trimester | Others | 0 Pregnancy outcomes |
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
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)
Population: The analysis was performed on subjects who were exposed to Menveo vaccine during the second trimester of pregnancy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Second Trimester | Live Births | 2 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Second Trimester | Stillbirths | 0 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Second Trimester | SAB | 0 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Second Trimester | IAB | 0 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Second Trimester | Ectopic pregnancy | 0 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Second Trimester | Molar pregnancy | 0 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Second Trimester | Others | 0 Pregnancy outcomes |
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.
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)
Population: The analysis was performed on subjects who were exposed to Menveo vaccine during the third trimester of pregnancy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Third Trimester | Molar pregnancy | 0 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Third Trimester | Live Births | 1 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Third Trimester | Stillbirths | 0 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Third Trimester | SAB | 0 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Third Trimester | IAB | 0 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Third Trimester | Ectopic pregnancy | 0 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Third Trimester | Others | 0 Pregnancy outcomes |
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.
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)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy | Live Births | 54 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy | Stillbirths | 0 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy | SAB | 10 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy | IAB | 18 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy | Ectopic pregnancy | 0 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy | Molar pregnancy | 0 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy | Others | 0 Pregnancy outcomes |
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.
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)
Population: The analysis was performed on subjects who were exposed to Menveo vaccine within 28 days prior to conception
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Within 28 Days Prior to Conception | Live Births | 12 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Within 28 Days Prior to Conception | Stillbirth | 0 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Within 28 Days Prior to Conception | SAB | 2 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Within 28 Days Prior to Conception | IAB | 2 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Within 28 Days Prior to Conception | Ectopic pregnancy | 0 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Within 28 Days Prior to Conception | Molar pregnancy | 0 Pregnancy outcomes |
| Live Births Group | Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Within 28 Days Prior to Conception | Others | 0 Pregnancy outcomes |