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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
98
ACIP-CDC recommended vaccine
ACIP recommended vaccine
Emory University
Atlanta, Georgia, United States
Centers for Disease Control and Prevention
Atlanta, Georgia, United States
Boston Medical Center
Boston, Massachusetts, United States
Duke University
Durham, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Elizabeth Schlaudecker
Cincinnati, Ohio, United States
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).
Time frame: Visit 1; birth outcomes monitored within postnatal day 28
Number of participants with preterm births
Preterm birth is defined as born alive at less than 37 weeks and 0 days gestation.
Time frame: 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.
Time frame: Visit 1, Delivery
Number of participants with spontaneous abortion (SAB)
Spontaneous abortion (SAB) is defined as pregnancy loss prior to 20 weeks 0 days.
Time frame: 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.
Time frame: 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.
Time frame: Up to 7 days post Visit 1, up to 7 days post Visit 2
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