N/A N=82

Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry

Meningococcal Disease · Pregnancy · Infections, Meningococcal

Bottom Line

View on ClinicalTrials.gov: NCT02223637 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Jun 2019

Primary outcome: Primary: Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Within 28 Days Prior to Conception — 0.0; 84.6; 15.4 Percentage of Live Births with MCM

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Meningococcal quadrivalent CRM-197 conjugate vaccine (Biological)
Age: Pediatric, Adult, Older Adult
Sex: Female
Sponsor: GlaxoSmithKline
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Within 28 Days Prior to Conception	0.0; 84.6; 15.4	—
PRIMARY Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the First Trimester	2.6; 87.2; 10.3	—
PRIMARY Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the Second Trimester	50.0; 50.0; 0.0	—
PRIMARY Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During Third Trimester	0.0; 100.0; 0.0	—
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	3.6; 85.5; 10.9	—
PRIMARY Percentage of Preterm Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception	23.1	—
PRIMARY Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the First Trimester	10.5	—
PRIMARY Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the Second Trimester	100.0	—
PRIMARY Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the Third Trimester	0.0	—
PRIMARY 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	—
PRIMARY Percentage of Low Birth Weight (LBW) Live Births Reported on Exposure to Menveo Vaccine Vaccine Within 28 Days Prior to Conception	15.4	—
PRIMARY Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the First Trimester	5.3	—
PRIMARY Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the Second Trimester	100.0	—
PRIMARY Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the Third Trimester	0.0	—
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	9.4	—
SECONDARY Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Within 28 Days Prior to Conception	12; 0; 2; 2; 0; 0	—
SECONDARY Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo During the First Trimester	39; 0; 7; 13; 0; 0	—
SECONDARY Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Second Trimester	2; 0; 0; 0; 0; 0	—
SECONDARY Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Third Trimester	1; 0; 0; 0; 0; 0	—
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	54; 0; 10; 18; 0; 0	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02223637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.