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Simultaneous mRNA COVID-19 and IIV Vaccination in Pregnancy Study

NCT06503900 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-01-15

No results posted yet for this study

Summary

This study is a prospective, randomized clinical trial. During this study, pregnant women will be randomly assigned to receive IIV and mRNA COVID-19 vaccine either simultaneously or sequentially (7-14 days apart). All participants will receive an mRNA COVID-19 vaccine at Visit 1 (Day 1).

Solicited local and systemic symptoms of reactogenicity will be assessed on day of visit for Visits 1 and 2 and daily during the 6 days following each visit using either electronic or paper symptoms diaries, depending on study participant preference. Serious adverse events (SAE) and adverse events of special interest (AESI) will be collected throughout the duration of the study.

Pregnant women will be followed through delivery with comprehensive obstetric and infant outcomes obtained from medical record review for 90 days post-delivery.

Maternal serum samples will be collected for antibody titers relevant to Influenza and COVID-19 prior to vaccination, at Day 29 (both groups), as well as Days 36-43 if in sequential group. When feasible, maternal blood at delivery and cord blood serum will be analyzed for serological analyses of placental influenza and COVID-19 antibody transfer (cord blood: maternal antibody ratio) will be determined.

Conditions

  • Birth Outcomes
  • Safety
  • Adverse Event Following Immunization

Interventions

BIOLOGICAL

mRNA COVID-19 vaccine

ACIP-CDC recommended vaccine

BIOLOGICAL

IIV4 (quadrivalent inactivated influenza vaccine)

ACIP recommended vaccine

Sponsors & Collaborators

Principal Investigators

  • Geeta Swamy, MD · Duke University

  • Tarayn Fairlie, MD · Centers for Disease Control and Prevention

  • Elizabeth Barnett, MD · Boston Medical Center

  • Elizabeth Schlaudecker, MD, MPH · Cincinnati Children's Hospital Medical Center

  • Satoshi Kamidani, MD, PhD · Emory University

  • Matthew Zuber, MD · Wake Forest University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-12
Primary Completion
2025-08-20
Completion
2025-11-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT06503900 on ClinicalTrials.gov