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Multisite Observational Maternal and Infant Study for COVID-19

NCT05031468 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 562

Last updated 2024-06-27

No results posted yet for this study

Summary

This is an observational, non-interventional, prospective cohort study designed to collect clinical information and specimens to evaluate the immune responses from pregnant individuals and postpartum individuals and their infants following maternal receipt of licensed or Emergency Use Authorization (EUA) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines.

Conditions

Interventions

BIOLOGICAL

Licensed or EUA SARS-CoV-2 vaccine

Several SARS-CoV-2 vaccines utilizing different platforms (e.g., mRNA, viral vector, etc.), are available under EUA (and soon to be licensed) and are being administered to individuals who are pregnant or postpartum who belong to high-risk priority groups for vaccination. Participants will receive the SARS-CoV-2 vaccine of their choice or the type that is available to them. The researchers anticipate including up to 3 vaccines, whether given as part of the primary series or additional doses, as part of this non-interventional study.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Flor Munoz, MD · Baylor College of Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-06
Primary Completion
2023-08-16
Completion
2023-08-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05031468 on ClinicalTrials.gov