Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry

March 28, 2019 updated by: GlaxoSmithKline

MENVEO Pregnancy Registry: an Observational Study on the Safety of MENVEO Exposure in Pregnant Women and Their Offspring

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

93

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Wilmington, North Carolina, United States, 28401-3331
        • GSK Investigational Site
      • Wilmington, North Carolina, United States, 28401-
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.)

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Biological: Meningococcal quadrivalent CRM-197 conjugate vaccine
This pregnancy registry is strictly observational. Decisions of vaccination are made by health care providers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Within 28 Days Prior to Conception
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)
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
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)
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
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)
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
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)

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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Within 28 Days Prior to Conception
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)

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.
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
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)
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
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)
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
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)
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
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2014

Primary Completion (Actual)

December 8, 2017

Study Completion (Actual)

December 8, 2017

Study Registration Dates

First Submitted

August 20, 2014

First Submitted That Met QC Criteria

August 21, 2014

First Posted (Estimate)

August 22, 2014

Study Record Updates

Last Update Posted (Actual)

June 21, 2019

Last Update Submitted That Met QC Criteria

March 28, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205531
  • V59_72OB (Other Identifier: Novartis)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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