Clinical trial NCT02223637: Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
Official title: MENVEO Pregnancy Registry: an Observational Study on the Safety of MENVEO Exposure in Pregnant Women and Their Offspring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningococcal Disease
Pregnancy
Infections, Meningococcal
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-08-22
Enrollment: 93
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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:

Primary outcomes:
measure: Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Within 28 Days Prior to Conception
timeFrame: 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)
measure: Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the First Trimester
timeFrame: 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)
measure: Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the Second Trimester
timeFrame: 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)
measure: Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During Third Trimester
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: Percentage of Preterm Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception
timeFrame: 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)
measure: Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the First Trimester
timeFrame: 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)
measure: Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the Second Trimester
timeFrame: 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)
measure: Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the Third Trimester
timeFrame: 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)
measure: Percentage of Preterm Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy
timeFrame: 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)
measure: Percentage of Low Birth Weight (LBW) Live Births Reported on Exposure to Menveo Vaccine Vaccine Within 28 Days Prior to Conception
timeFrame: 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)
measure: Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the First Trimester
timeFrame: 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)
measure: Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the Second Trimester
timeFrame: 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)
measure: Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the Third Trimester
timeFrame: 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)
measure: Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy
timeFrame: 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 outcomes:
measure: Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Within 28 Days Prior to Conception
timeFrame: 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)
measure: Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo During the First Trimester
timeFrame: 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)
measure: Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Second Trimester
timeFrame: 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)
measure: Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Third Trimester
timeFrame: 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)
measure: Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy
timeFrame: 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)
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: GSK Investigational Site
state: North Carolina
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: