COMPLETED

Simultaneous mRNA COVID-19 and IIV Vaccination in Pregnancy Study

Conditions

Birth Outcomes Safety Adverse Event Following Immunization

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Safety of Simultaneous Versus Sequential Administration of mRNA COVID-19 Vaccine and Inactivated Influenza Vaccine (IIV) in Pregnant Women

Quick Facts

Study Start:2024-09-12

Study Completion:2025-11-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06503900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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: * 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.\* * 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. * 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. * 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.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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:
* 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.\*
* 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.
* 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.
* 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.

Contacts and Locations

Principal Investigator

Geeta Swamy, MD

PRINCIPAL_INVESTIGATOR

Duke University

Tarayn Fairlie, MD

PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Elizabeth Barnett, MD

PRINCIPAL_INVESTIGATOR

Boston Medical Center

Elizabeth Schlaudecker, MD, MPH

PRINCIPAL_INVESTIGATOR

Cincinnati Children's Hospital Medical Center

Satoshi Kamidani, MD, PhD

PRINCIPAL_INVESTIGATOR

Emory University

Matthew Zuber, MD

PRINCIPAL_INVESTIGATOR

Wake Forest University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Duke University

Geeta Swamy, MD, PRINCIPAL_INVESTIGATOR, Duke University
Tarayn Fairlie, MD, PRINCIPAL_INVESTIGATOR, Centers for Disease Control and Prevention
Elizabeth Barnett, MD, PRINCIPAL_INVESTIGATOR, Boston Medical Center
Elizabeth Schlaudecker, MD, MPH, PRINCIPAL_INVESTIGATOR, Cincinnati Children's Hospital Medical Center
Satoshi Kamidani, MD, PhD, PRINCIPAL_INVESTIGATOR, Emory University
Matthew Zuber, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-12

Study Completion Date2025-11-19

Study Record Updates

Study Start Date2024-09-12

Study Completion Date2025-11-19

Terms related to this study

Additional Relevant MeSH Terms

Birth Outcomes
Safety
Adverse Event Following Immunization