Quality of LifePhase 4NCT05028361
Simultaneous mRNA COVID-19 and IIV4 Vaccination Study
A Phase 4 study testing mRNA COVID-19 and IIV4 in people with Quality of Life and Injection Site Reaction, run by Duke University at 3 sites in United States.
Trial summary
This study is a prospective, randomized clinical trial. During this study, participants will be randomly assigned to receive quadrivalent inactivated influenza vaccine (IIV4) and mRNA COVID-19 vaccine either simultaneously or sequentially, 7-14 days apart. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Injection Site Reaction, Adverse Drug Event
- What is being tested?
- mRNA COVID-19 and IIV4
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 348 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Oct 2021to 15 Jun 2023
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Persons aged ≥5 years if receiving primary two-dose mRNA COVID-19 vaccine series or persons aged ≥12 years if receiving a booster mRNA COVID-19 vaccine dose according to FDA authorization or approval and ACIP recommendation. Note: receipt of an mRNA COVID-19 vaccine within 8 hours of enrollment is permitted
- Individuals age 5-11 receiving a booster may be enrolled in the event a booster for individuals age 5-11 is authorized or approved and recommended by the ACIP.
- English or Spanish literate
- Intention of receiving influenza vaccine and COVID-19 vaccine based on ACIP-CDC guidelines
- 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 clinic visits
Who cannot join
- Currently pregnant, planning to become pregnant within the first three months of the study per participant self-report or likely to be pregnant per screening criteria as defined in Section 5.1 at Visit 1
- Prior receipt of IIV4 during the respective influenza season in which they are being enrolled
- <9 years of age and recommended to receive two doses of IIV4 during the respective influenza season in which they are being enrolled
- Prior receipt of non-mRNA COVID-19 vaccine
- Documented COVID-19 infection within 6 weeks prior to enrollment confirmed by either medical history or lab testing
- History of severe allergic reaction after a previous dose of any influenza vaccine; or to an influenza vaccine component, including egg protein
Show all 28Show fewer
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of an mRNA vaccine
- Receipt of any licensed inactivated vaccine within 2 weeks prior to enrollment in this study, receipt of any licensed live vaccine within 4 weeks prior to enrollment in this study, or receipt of Shingrix (Zoster Vaccine Recombinant, Adjuvanted) or HEPLISAV-B (Hepatitis B Vaccine (Recombinant), Adjuvanted) vaccine within 6 weeks prior to enrollment in this study or planning receipt of any vaccines following enrollment until 6 weeks after receipt of the second dose of mRNA COVID-19 vaccine
- Has an active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematologic malignancy* *Participants with a history of malignancy may be included if, after previous treatment by surgical excision, chemotherapy or radiation therapy, the participant has been observed for a period that in the investigator's estimation provides a reasonable assurance of sustained cure
- Thrombocytopenia, bleeding disorder, or anticoagulant use contraindicating intramuscular injection (a daily aspirin may be acceptable).
- Has immunosuppression as a result 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 (HBC). Stable HBV or HBC 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)
- Use of oral, parenteral, or high-dose inhaled glucocorticoids*
- For definition of high-dose inhaled glucocorticoids, reference Appendix B.
- History of Guillain-Barré syndrome
- Prior enrollment in this study during the 2021-22 flu season
- 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 are permitted at any time. An investigational product may be permitted for therapy of an illness condition that occurs during the study period e.g. COVID-19 illness.
- Hearing loss determined by the investigators to prevent successful communication over the phone
- History of myocarditis or pericarditis
- History of multisystem inflammatory syndrome in children (MIS-C) or adults (MIS-A).
- Has injury or other reason why deltoid site on both arms cannot be used for vaccinations.
- 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.
- Anyone who is a relative of any research study personnel.
- Anyone who is an employee of any research study personnel.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
John Hopkins University
Baltimore, Maryland, 21205
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Duke University
Durham, North Carolina, 27709
About this study
Official title: Safety of Simultaneous Versus Sequential Administration of mRNA COVID-19 Vaccines and Quadrivalent Inactivated Influenza (IIV4) in Adults, Adolescents and Children: A Randomized Observer Blinded Study
This study is a prospective, randomized clinical trial. During this study, participants will be randomly assigned to receive quadrivalent inactivated influenza vaccine (IIV4) and mRNA COVID-19 vaccine either simultaneously or sequentially, 7-14 days apart. Persons in the simultaneous group will receive mRNA COVID-19 and IIV4 at Visit 1 (Day 1) and a saline placebo injection at Visit 2. Persons in the sequential group will receive mRNA COVID-19 vaccine and a saline placebo at Visit 1 (Day 1) and IIV4 injection at Visit 2. For participants receiving their primary dose series, a second dose of mRNA COVID-19 vaccine will be administered either 3 to 8 weeks or 4 to 8 weeks following the first dose, depending upon the mRNA COVID-19 vaccine provided. For those receiving a booster dose of mRNA COVID-19 only a single mRNA COVID-19 will be received in this study. Solicited symptoms of reactogenicity and adverse events will be assessed on vaccination day and daily during the 7 days following each Vaccination Visit using either electronic or paper symptoms diaries, depending on study participant preference. Quality of life data will be collected using electronic or paper diaries on day of Vaccination Visit 1 and daily during the 7 days following the visit. Serious adverse events and adverse events of special interest will be collected throughout the duration of the study. Participants are followed through Day 121. Serum samples from participants will be collected for determination of SARS-CoV-2 seropositivity at baseline. Serum samples will be taken throughout the study to determine IIV4 and COVID-19 vaccine immunogenicity and for potential future studies.
- Being tested
- mRNA COVID-19, IIV4, Placebo (saline)
- Keywords
- COVID-19, Influenza, vaccine, mRNA COVID-19 vaccine, influenza vaccine, safety, quality of life, pain following vaccination, fever following vaccination
- Medical subject headings
- Injection Site Reaction, Drug-Related Side Effects and Adverse Reactions, COVID-19, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA COVID-19Biological
ACIP-CDC recommended vaccine
IIV4Biological
ACIP recommended vaccine
Placebo (saline)Other
Saline Control
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous Vaccination Group | Other | Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and IIV4 at Visit 1, saline placebo at Visit 2, and mRNA COVID-19 vaccine at Visit 3 (only for participants receiving their primary series of mRNA COVID-19 vaccine.) Receives: Biological: mRNA COVID-19; Biological: IIV4; Other: Placebo (saline) |
| Sequential Vaccination Group | Other | Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and saline placebo at Visit 1, IIV4 at Visit 2, and mRNA COVID-19 vaccine at Visit 3 (only for participants receiving their primary series of mRNA COVID-19 vaccine.) Receives: Biological: mRNA COVID-19; Biological: IIV4; Other: Placebo (saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Participants With Moderate or More Severe Fever, Chills, Myalgia, or Arthralgia in the Simultaneous Group and the Sequential Group Following Both Vaccination Visit 1 and 2
Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
Measured: Up to 7 Days Post Vaccination (combined for Visits 1 and 2)
Secondary outcomes (4)
Number of Participants With Moderate or More Severe Fever, Chills, Myalgia, or Arthralgia in the Simultaneous Versus the Sequential Group Following the First Vaccination Visit
Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
Measured: Up to 7 Days Post Vaccination
Number of Participants With Moderate or More Severe Fever, Chills, Myalgia, or Arthralgia in the Simultaneous Versus Sequential Group Following the Second Vaccination Visit
Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
Measured: Up to 7 Days Post Vaccination
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
Measured: Up to 7 Days Post Vaccination
Number of Participants With Observed Serious Adverse Events
Measured: 120 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start4 Oct 2021
- Primary completion3 Mar 2023
- Study completion15 Jun 2023
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Johns Hopkins University, Children's Hospital Medical Center, Cincinnati
- Responsible party
- Sponsor
- Investigators
- Emmanuel B Walter, MD, MPH, Principal investigator, Duke UniversityKaren R Broder, MD, Principal investigator, Centers for Disease Control and PreventionKawsar Talaat, MD, Principal investigator, Johns Hopkins UniversityElizabeth Schlaudecker, MD, MPH, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028361
- Sponsor's protocol ID
- Pro00109102
- Status last verified
- Feb 2024
- First submitted
- 30 Aug 2021
- Last updated
- 19 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Walter EB, Schlaudecker EP, Talaat KR, Rountree W, Broder KR, Duffy J, Montefiori D, Poniewierski MS, Spreng RL, Staat MA, Tekalign R, Museru O, Goel A, Davis GN, Schmader KE. Immunogenicity of mRNA COVID-19 vaccine with either simultaneous or sequentially administered inactivated influenza vaccines: a randomized clinical trial. Vaccine. 2026 Feb 6;72:128072. doi: 10.1016/j.vaccine.2025.128072. Epub 2025 Dec 10.
PubMed 41380398Walter EB, Schlaudecker EP, Talaat KR, Rountree W, Broder KR, Duffy J, Grohskopf LA, Poniewierski MS, Spreng RL, Staat MA, Tekalign R, Museru O, Goel A, Davis GN, Schmader KE. Safety of Simultaneous vs Sequential mRNA COVID-19 and Inactivated Influenza Vaccines: A Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2443166. doi: 10.1001/jamanetworkopen.2024.43166.
PubMed 39504023
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. 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 Vaccines and Quadrivalent Inactivated Influenza (IIV4) in Adults, Adolescents and Children: A Randomized Observer Blinded Study
- ClinicalTrials.gov ID
- NCT05028361
- Acronym / sponsor ID
- Pro00109102
- Keywords
- COVID-19, Influenza, vaccine, mRNA COVID-19 vaccine, influenza vaccine, safety, quality of life, pain following vaccination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Johns Hopkins University, Children's Hospital Medical Center, Cincinnati
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Posted 19 Mar 2024
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, participants will be randomly assigned to receive quadrivalent inactivated influenza vaccine (IIV4) and mRNA COVID-19 vaccine either simultaneously or sequentially, 7-14 days apart. Persons in the simultaneous group will receive mRNA COVID-19 and IIV4 at Visit 1 (Day 1) and a saline placebo injection at Visit 2. Persons in the sequential group will receive mRNA COVID-19 vaccine and a saline placebo at Visit 1 (Day 1) and IIV4 injection at Visit 2. For participants receiving their primary dose series, a second dose of mRNA COVID-19 vaccine will be administered either 3 to 8 weeks or 4 to 8 weeks following the first dose, depending upon the mRNA COVID-19 vaccine provided. For those receiving a booster dose of mRNA COVID-19 only a single mRNA COVID-19 will be received in this study. Solicited symptoms of reactogenicity and adverse events will be assessed on vaccination day and daily during the 7 days following each Vaccination Visit using either electronic or paper symptoms diaries, depending on study participant preference. Quality of life data will be collected using electronic or paper diaries on day of Vaccination Visit 1 and daily during the 7 days following the visit. Serious adverse events and adverse events of special interest will be collected throughout the duration of the study. Participants are followed through Day 121. Serum samples from participants will be collected for determination of SARS-CoV-2 seropositivity at baseline. Serum samples will be taken throughout the study to determine IIV4 and COVID-19 vaccine immunogenicity and for potential future studies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simultaneous Vaccination Group | Other | Biological: mRNA COVID-19, Biological: IIV4, Other: Placebo (saline)Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and IIV4 at Visit 1, saline placebo at Visit 2, and mRNA COVID-19 vaccine at Visit 3 (only for participants receiving their primary series of mRNA COVID-19 vaccine.) |
| Sequential Vaccination Group | Other | Biological: mRNA COVID-19, Biological: IIV4, Other: Placebo (saline)Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and saline placebo at Visit 1, IIV4 at Visit 2, and mRNA COVID-19 vaccine at Visit 3 (only for participants receiving their primary series of mRNA COVID-19 vaccine.) |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Persons aged ≥5 years if receiving primary two-dose mRNA COVID-19 vaccine series or persons aged ≥12 years if receiving a booster mRNA COVID-19 vaccine dose according to FDA authorization or approval and ACIP recommendation. Note: receipt of an mRNA COVID-19 vaccine within 8 hours of enrollment is permitted
- Individuals age 5-11 receiving a booster may be enrolled in the event a booster for individuals age 5-11 is authorized or approved and recommended by the ACIP.
- English or Spanish literate
- Intention of receiving influenza vaccine and COVID-19 vaccine based on ACIP-CDC guidelines
- Willing to provide written informed consent
Key exclusion criteria (28 listed)
- Currently pregnant, planning to become pregnant within the first three months of the study per participant self-report or likely to be pregnant per screening criteria as defined in Section 5.1 at Visit 1
- Prior receipt of IIV4 during the respective influenza season in which they are being enrolled
- <9 years of age and recommended to receive two doses of IIV4 during the respective influenza season in which they are being enrolled
- Prior receipt of non-mRNA COVID-19 vaccine
- Documented COVID-19 infection within 6 weeks prior to enrollment confirmed by either medical history or lab testing
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-19ACIP-CDC recommended vaccine | Biological | Sequential Vaccination Group, Simultaneous Vaccination Group |
| IIV4ACIP recommended vaccine | Biological | Sequential Vaccination Group, Simultaneous Vaccination Group |
| Placebo (saline)Saline Control | Other | Sequential Vaccination Group, Simultaneous Vaccination Group |
Primary outcome
Total Number of Participants With Moderate or More Severe Fever, Chills, Myalgia, or Arthralgia in the Simultaneous Group and the Sequential Group Following Both Vaccination Visit 1 and 2
Time frame: Up to 7 Days Post Vaccination (combined for Visits 1 and 2)
Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
4 secondary outcomes
Number of Participants With Moderate or More Severe Fever, Chills, Myalgia, or Arthralgia in the Simultaneous Versus the Sequential Group Following the First Vaccination Visit
Time frame: Up to 7 Days Post Vaccination
Number of Participants With Moderate or More Severe Fever, Chills, Myalgia, or Arthralgia in the Simultaneous Versus Sequential Group Following the Second Vaccination Visit
Time frame: Up to 7 Days Post Vaccination
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Time frame: Up to 7 Days Post Vaccination
Number of Participants With Observed Serious Adverse Events
Time frame: 120 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41380398Walter EB, Schlaudecker EP, Talaat KR, Rountree W, Broder KR, Duffy J, Montefiori D, Poniewierski MS, Spreng RL, Staat MA, Tekalign R, Museru O, Goel A, Davis GN, Schmader KE. Immunogenicity of mRNA COVID-19 vaccine with either simultaneous or sequentially administered inactivated influenza vaccines: a randomized clinical trial. Vaccine. 2026 Feb 6;72:128072. doi: 10.1016/j.vaccine.2025.128072. Epub 2025 Dec 10.
- Derived from this study: PubMed 39504023Walter EB, Schlaudecker EP, Talaat KR, Rountree W, Broder KR, Duffy J, Grohskopf LA, Poniewierski MS, Spreng RL, Staat MA, Tekalign R, Museru O, Goel A, Davis GN, Schmader KE. Safety of Simultaneous vs Sequential mRNA COVID-19 and Inactivated Influenza Vaccines: A Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2443166. doi: 10.1001/jamanetworkopen.2024.43166.
- 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.
Emmanuel B Walter, MD, MPH principal investigator
Duke University
Karen R Broder, MD principal investigator
Centers for Disease Control and Prevention
Kawsar Talaat, MD principal investigator
Johns Hopkins University
3 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 and IIV4 in people with Quality of Life and Injection Site Reaction, run by Duke University at 3 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 6 inclusion and 28 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 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 19 Mar 2024). 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?
Total Number of Participants With Moderate or More Severe Fever, Chills, Myalgia, or Arthralgia in the Simultaneous Group and the Sequential Group Following Both Vaccination Visit 1 and 2 (time frame: Up to 7 Days Post Vaccination (combined for Visits 1 and 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05028361, which also lists 2 linked publications.
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 19 Mar 2024.