Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02223637
Study type	Observational [Patient Registry]
Source	GlaxoSmithKline
Contact
Status	Completed
Phase
Start date	September 30, 2014
Completion date	December 8, 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03442582` - Afluria Pregnancy Registry
Terminated	`NCT02161861` - Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study	N/A
Not yet recruiting	`NCT05934318` - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)	N/A
Enrolling by invitation	`NCT05415371` - Persistent Poverty Counties Pregnant Women With Medicaid	N/A
Completed	`NCT04548102` - Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman	N/A
Completed	`NCT03218956` - Protein Requirement During Lactation	N/A
Completed	`NCT02191605` - Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy	N/A
Recruiting	`NCT06049953` - Maternal And Infant Antipsychotic Study
Completed	`NCT02577536` - PregSource: Crowdsourcing to Understand Pregnancy
Not yet recruiting	`NCT06336434` - CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy	Phase 1/Phase 2
Not yet recruiting	`NCT04786587` - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Not yet recruiting	`NCT05412238` - Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months	N/A
Not yet recruiting	`NCT05028387` - Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
Completed	`NCT02683005` - Study of Hepatitis C Treatment During Pregnancy	Phase 1
Completed	`NCT02783170` - Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women	Phase 4
Recruiting	`NCT02507180` - Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
Recruiting	`NCT02564250` - Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women	N/A
Recruiting	`NCT02619188` - Nutritional Markers in Normal and Hyperemesis Pregnancies	N/A
Completed	`NCT02523755` - Evaluation of Regional Distribution of Ventilation During Labor With or Without Epidural Analgesia	Phase 4
Completed	`NCT02408315` - Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium (IMPROVE)	Phase 3