Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
NCT ID: NCT02223637
Last Updated: 2019-06-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
93 participants
OBSERVATIONAL
2014-09-30
2017-12-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study
NCT02287688
Safety of 4CMenB Exposure During Pregnancy
NCT02640677
Comparison of GSK Biologicals' Meningococcal Vaccine (GSK134612) and Licensed MenC-CRM197 Vaccine in Healthy Children
NCT00674583
Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)
NCT04843111
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US
NCT03537508
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Meningococcal quadrivalent CRM-197 conjugate vaccine
This pregnancy registry is strictly observational. Decisions of vaccination are made by health care providers.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Meningococcal quadrivalent CRM-197 conjugate vaccine
This pregnancy registry is strictly observational. Decisions of vaccination are made by health care providers.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.)
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GSK Investigational Site
Wilmington, North Carolina, United States
GSK Investigational Site
Wilmington, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
V59_72OB
Identifier Type: OTHER
Identifier Source: secondary_id
205531
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.