Simultaneous mRNA COVID-19 and IIV Vaccination in Pregnancy Study
NCT Number: NCT06503900
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Birth Outcomes|Safety|Adverse Event Following Immunization
Interventions: BIOLOGICAL: mRNA COVID-19 vaccine|BIOLOGICAL: IIV4 (quadrivalent inactivated influenza vaccine)
Sponsor: Duke University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2026-02-28
Locations: Emory University, Atlanta, Georgia, 30322, United States|Centers for Disease Control and Prevention, Atlanta, Georgia, 30341, United States|Boston Medical Center, Boston, Massachusetts, 02118, United States|Duke University, Durham, North Carolina, 27710, United States|Wake Forest University, Winston-Salem, North Carolina, 27101, United States|Elizabeth Schlaudecker, Cincinnati, Ohio, 45229, United States

Summary:
This study is a prospective, randomized clinical trial. During this study,pregnant participants 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 people 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.

Primary Outcome Measures: 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 Outcome Measures: Number of participants with preterm births, Preterm birth is defined as born alive at less than 37 weeks and 0 days gestation., Visit 1, Delivery|Number of participants with combined fetal/neonatal death, Fetal death is defined as intrauterine death of fetus at or after 20 weeks 0 days. Neonatal death is defined as infant death within first 28 days of life., Visit 1, Delivery|Number of participants with spontaneous abortion (SAB), Spontaneous abortion (SAB) is defined as pregnancy loss prior to 20 weeks 0 days., Visit 1, delivery|Number of participants with moderate or more severe systemic reactogenicity events (including injection site pain/swelling/redness, fever, malaise, chills), Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily., 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, Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily., Up to 7 days post Visit 1, up to 7 days post Visit 2