Birth OutcomesPhase 4NCT06503900
Simultaneous mRNA COVID-19 and IIV Vaccination in Pregnancy Study
A Phase 4 study testing mRNA COVID-19 vaccine and IIV4 (quadrivalent inactivated influenza vaccine) in people with Birth Outcomes and Safety, run by Duke University at 6 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth Outcomes, Safety, Adverse Event Following Immunization
- What is being tested?
- mRNA COVID-19 vaccine and IIV4 (quadrivalent inactivated influenza vaccine)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 6 sitesUnited States
- Study dates
- 12 Sep 2024to 19 Nov 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Emory University
Atlanta, Georgia, 30322
Centers for Disease Control and Prevention
Atlanta, Georgia, 30341
Boston Medical Center
Boston, Massachusetts, 02118
Elizabeth Schlaudecker
Cincinnati, Ohio, 45229
Duke University
Durham, North Carolina, 27710
Wake Forest University
Winston-Salem, North Carolina, 27101
About this study
Official title: Safety of Simultaneous Versus Sequential Administration of mRNA COVID-19 Vaccine and Inactivated Influenza Vaccine (IIV) in Pregnant Women
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.
Read more
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
- Birth Outcomes, Safety, Adverse Event Following Immunization
- Being tested
- mRNA COVID-19 vaccine, IIV4 (quadrivalent inactivated influenza vaccine)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA COVID-19 vaccineBiological
ACIP-CDC recommended vaccine
IIV4 (quadrivalent inactivated influenza vaccine)Biological
ACIP recommended vaccine
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous Vaccination Group | Experimental | Subjects will receive a dose of mRNA COVID-19 vaccine and IIV at Visit 1. Receives: 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 1 and a dose of IIV at Visit 2. Receives: Biological: mRNA COVID-19 vaccine; Biological: IIV4 (quadrivalent inactivated influenza vaccine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to postnatal day 28
Secondary outcomes (5)
Number of Participants With Preterm Births
Preterm birth is defined as born alive at less than 37 weeks and 0 days gestation.
Measured: At delivery, up to 37 weeks gestation
Number of Participants With Fetal or 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.
Measured: Up to 28 days post-delivery
Number of Participants With Spontaneous Abortion (SAB)
Spontaneous abortion (SAB) is defined as pregnancy loss prior to 20 weeks 0 days.
Measured: Up to 20 weeks gestation
Number of Participants With Moderate or Severe Systemic Reactogenicity Events After Visit 1
Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
Measured: Up to 7 days post Visit 1
Number of Participants With Moderate or Severe Systemic Reactogenicity Events After Visit 2
Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
Measured: up to 7 days post Visit 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start12 Sep 2024
- Primary completion20 Aug 2025
- Study completion19 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Birth OutcomesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geeta Swamy, MD, Principal investigator, Duke UniversityMatthew Crist, MD, Principal investigator, Centers for Disease Control and PreventionElizabeth Barnett, MD, Principal investigator, Boston Medical CenterElizabeth Schlaudecker, MD, MPH, Principal investigator, Cincinnati Children's Hospital Medical CenterSatoshi Kamidani, MD, PhD, Principal investigator, Emory UniversityMatthew Zuber, MD, Principal investigator, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503900
- Sponsor's protocol ID
- Pro00115925
- Status last verified
- Sep 2026
- First submitted
- 12 Jul 2024
- Last updated
- 7 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Simultaneous Versus Sequential Administration of mRNA COVID-19 Vaccine and Inactivated Influenza Vaccine (IIV) in Pregnant Women
- ClinicalTrials.gov ID
- NCT06503900
- Acronym / sponsor ID
- Pro00115925
- Conditions
- Birth Outcomes, Safety, Adverse Event Following Immunization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 19 Nov 2025 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Posted 7 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simultaneous Vaccination Group | Experimental | Biological: mRNA COVID-19 vaccine, Biological: IIV4 (quadrivalent inactivated influenza vaccine)Subjects will receive a dose of mRNA COVID-19 vaccine and IIV at Visit 1. |
| Sequential Vaccination Group | Experimental | Biological: mRNA COVID-19 vaccine, Biological: IIV4 (quadrivalent inactivated influenza vaccine)Subjects will receive a dose of mRNA COVID-19 vaccine at Visit 1 and a dose of IIV at Visit 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (39 listed)
- 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:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA COVID-19 vaccineACIP-CDC recommended vaccine | Biological | Sequential Vaccination Group, Simultaneous Vaccination Group |
| IIV4 (quadrivalent inactivated influenza vaccine)ACIP recommended vaccine | Biological | Sequential Vaccination Group, Simultaneous Vaccination Group |
Primary outcome
Number of Participants With an Adverse Birth Outcome
Time frame: Up to postnatal day 28
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).
5 secondary outcomes
Number of Participants With Preterm Births
Time frame: At delivery, up to 37 weeks gestation
Number of Participants With Fetal or Neonatal Death
Time frame: Up to 28 days post-delivery
Number of Participants With Spontaneous Abortion (SAB)
Time frame: Up to 20 weeks gestation
Number of Participants With Moderate or Severe Systemic Reactogenicity Events After Visit 1
Time frame: Up to 7 days post Visit 1
Number of Participants With Moderate or Severe Systemic Reactogenicity Events After Visit 2
Time frame: up to 7 days post Visit 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geeta Swamy, MD principal investigator
Duke University
Matthew Crist, MD principal investigator
Centers for Disease Control and Prevention
Elizabeth Barnett, MD principal investigator
Boston Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mRNA COVID-19 vaccine and IIV4 (quadrivalent inactivated influenza vaccine) in people with Birth Outcomes and Safety, run by Duke University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With an Adverse Birth Outcome (time frame: Up to postnatal day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.