Simultaneous mRNA COVID-19 and IIV Vaccination in Pregnancy Study

NCT06503900 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: Pro00115925
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 6

Brief 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

Adverse Event Following Immunization; Safety; Birth Outcomes

Outcome Measures

Primary Outcomes (1)

• Number of participants with an adverse birth outcome

  Adverse birth outcome is defined as having at least one of the following: preterm birth (birth \<37 weeks), spontaneous abortion (loss prior to 20 weeks), fetal death (loss after 20 weeks), or neonatal death (death ≤ 28 days of life).

  Visit 1; birth outcomes monitored within postnatal day 28

Secondary Outcomes (5)

• Number of participants with preterm births

  Visit 1, Delivery

• Number of participants with combined fetal/neonatal death

  Visit 1, Delivery

• Number of participants with spontaneous abortion (SAB)

  Visit 1, delivery

• Number of participants with moderate or more severe systemic reactogenicity events (including injection site pain/swelling/redness, fever, malaise, chills)

  Up to 7 days post Visit 1, up to 7 days post Visit 2

• Number of participants with moderate or more severe fever, chills, myalgia, or arthralgia

  Up to 7 days post Visit 1, up to 7 days post Visit 2

Study Arms (2)

Simultaneous Vaccination Group

EXPERIMENTAL

Subjects will receive a dose of mRNA COVID-19 vaccine and IIV at Visit 1.

Biological: mRNA COVID-19 vaccine; Biological: IIV4 (quadrivalent inactivated influenza vaccine)

Sequential Vaccination Group

EXPERIMENTAL

Subjects will receive a dose of mRNA COVID-19 vaccine at Visit 2 and a dose of IIV at Visit 2.

Biological: mRNA COVID-19 vaccine; Biological: IIV4 (quadrivalent inactivated influenza vaccine)

Interventions

IIV4 (quadrivalent inactivated influenza vaccine) BIOLOGICAL

ACIP recommended vaccine

Sequential Vaccination Group; Simultaneous Vaccination Group

mRNA COVID-19 vaccine BIOLOGICAL

ACIP-CDC recommended vaccine

Sequential Vaccination Group; Simultaneous Vaccination Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women ages 18 years or older at enrollment
• Gestational age \< 34 weeks 0 days based on reconciliation of last menstrual period and ultrasound dating. Estimated due date (EDD) and Gestational Age (GA-EDD) will be based on reconciliation of "sure" first day of the last menstrual period (LMP) and earliest dating ultrasound. If the LMP is uncertain, then the earliest dating ultrasound will be used to determine EDD and GA. If the ultrasound derived-EDD is in agreement with sure-LMP derived EDD, then the LMP-derived EDD is used to determine GA. If the ultrasound derived EDD is not in agreement with the LMP-derived EDD, the ultrasound-derived EDD is used to determine GA.
• Intention to receive mRNA COVID-19 vaccine
• Intention to receive influenza vaccine
• Willing to provide written informed consent
• Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls and collection of delivery information.
• Ability to speak English, Spanish or Haitian/Creole depending on site\*
• Duke will enroll English and Spanish speaking individuals.
• Boston will enroll English, Spanish and Haitian Creole speaking individuals.
• CCHMC will enroll English speaking individuals.
• Emory will enroll English speaking individuals.
• Wake Forest will enroll English and Spanish speaking individuals.
• Receiving or planning to receive prenatal care.

You may not qualify if:

• Has immunosuppression because of an underlying illness or medications, such as antirejection/transplant regimens or immunomodulatory agents. Stable HIV disease is permitted per the following parameters:
• a. Confirmed stable HIV disease defined as documented viral load \<50 copies/mL and CD4 count \>200 within 6 months before enrollment, and on stable antiretroviral therapy for at least 6 months
• Has known hepatitis B (HBV) or hepatitis C (HCV). Stable HBV or HCV are permitted per the following parameters:
• If known HBV: confirmed inactive chronic HBV infection: HBsAg present for ≥6 months and HBeAg negative, anti-HBe positive; serum HBV DNA \<2000 IU/mL; persistently normal ALT or AST levels; in those who had liver biopsy, findings that confirm absence of significant necroinflammation
• If known HCV: evidence of sustained virological response for ≥12 weeks after treatment or without evidence of HCV RNA viremia (undetectable HCV RNA)
• Received oral, intramuscular or intravenous systemic immunosuppressants, or immune-modifying drugs for \>14 days in total within 6 months prior to any study vaccine dose (for corticosteroids ≥ 20 mg/day of prednisone equivalent). Note: Topical medications are allowed.
• Has an active neoplastic disease (excluding nonmelanoma skin cancer), including those who used anticancer chemotherapy or radiation therapy during the current pregnancy or recently (within 36 months of enrollment into study.)
• Signs or symptoms of active preterm labor, defined as regular uterine contractions with cervical change (dilation/effacement)
• Known multi-fetal gestation
• Known fetal congenital anomaly, e.g., genetic abnormality or major congenital malformation based on antenatal ultrasound
• Intending to deliver at a site un-affiliated with the study team
• Prior receipt of influenza vaccine during the respective influenza season in which they are being enrolled
• Prior receipt of COVID-19 vaccine during the respective influenza season in which they are being enrolled
• Receipt of any licensed non-live vaccine within 7 days prior to study vaccination or intention of receiving any vaccines during the 7-day post-vaccination periods
• Receipt of any live vaccine during the current pregnancy

Sponsors & Collaborators

• Duke University: lead

Study Sites (6)

Emory University

Atlanta, Georgia, 30322, United States

Location

Centers for Disease Control and Prevention

Atlanta, Georgia, 30341, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27101, United States

Location

Elizabeth Schlaudecker

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Interventions

CVnCoV COVID-19 vaccine; Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Geeta Swamy, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Tarayn Fairlie, MD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Elizabeth Barnett, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

• Elizabeth Schlaudecker, MD, MPH

  Cincinnati Children&#39;s Hospital Medical Center

  PRINCIPAL INVESTIGATOR

• Satoshi Kamidani, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

• Matthew Zuber, MD

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 16, 2024
• Study Start: September 12, 2024
• Primary Completion: August 20, 2025
• Study Completion: November 19, 2025
• Last Updated: January 15, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)