Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Duke University
Age
18–any
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible 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 be 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:
1. 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
2. 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
Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or after previous dose of any influenza vaccine
History of a severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of the mRNA COVID-19 vaccine
History of Guillain-Barré syndrome within 6 weeks of a prior dose of any influenza vaccine.
History of a diagnosed non-severe allergy to a component of the mRNA COVID-19 vaccine
History of a non-severe, immediate (onset less than 4 hours) allergic reaction after administration of a previous dose of mRNA COVID-19 vaccine
History of multisystem inflammatory syndrome in children (MIS-C) or multisystem inflammatory syndrome in adults (MIS-A)
History of myocarditis or pericarditis within 3 weeks after a dose of any COVID-19 vaccine
Documented COVID-19 infection within 6 weeks prior to enrollment confirmed by either medical history or lab testing
Individuals who are known to be delivering early (\<37 weeks)
Receipt of blood or plasma products or immunoglobulin from 3 months before study vaccine administration, or planned receipt through delivery, with an exception of Rho(D) immune globulin.
Anyone who is a first-degree relative of any research study personnel or is an employee supervised by study staff.
Prior enrollment in the study
Anyone who is already enrolled or plans to enroll in another clinical trial with an investigational product during the study period.\*
\*Per protocol, co-enrollment in observational or behavioral intervention studies is permitted at any time. An investigational product may be permitted for therapy of an illness condition that occurs during the study period.
Bleeding disorder or condition associated with prolonged bleeding that would present as a safety risk per opinion of the investigator
Any condition which, in the opinion of the investigators, may pose a health risk to the subject or interfere with the evaluation of the study objectives.
Temporary Delay Criteria at Visit 1 and 2
History of febrile illness (\> 100.4°F or 38°C) within the past 72 hours prior to vaccine administration
Any condition which, in the opinion of the investigators, may pose a temporary health risk to the subject or interfere with the evaluation of the study objectives.
Visit 2 Eligibility Criteria Review
History of Guillain-Barré syndrome within 6 weeks of a prior dose of any influenza vaccine.
Prior receipt of influenza vaccine during the respective influenza season in which they are being enrolled
Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or after previous dose of any influenza vaccine
Any condition which, in the opinion of the investigators, may pose a health risk to the subject or interfere with the evaluation of the study objectives.
