Simultaneous mRNA COVID-19 and IIV4 Vaccination Study
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. 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.
Timeline
- Start
- 2021-10-04
- Primary completion
- 2023-03-03
- Completion
- 2023-06-15
Outcome
Met primary endpoint
registry The upper limit of the 95% CI of the difference was 4% with a noninferiority margin of 10%. NCT05028361 ↗
paper The proportion with the primary composite reactogenicity outcome in the simultaneous group (25.6% [n = 43]) was noninferior to the proportion in the sequential group (31.3% [n = 52]) PMID 39504023 ↗
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.
- Walter 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IIV4 | Vaccine | — | Intramuscular |
| Subject | mRNA COVID-19 | Messenger RNA (mRNA) | — | Intramuscular |
Indications
No indication recorded.