Phase 3
N=45,789
A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older
Influenza, Human
Bottom Line
View on ClinicalTrials.gov: NCT05540522 ↗Enrolled (actual)
45,789
Serious AEs
1.7%
Results posted
May 2025
Primary outcome: Primary: Percentage of Participants Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years — 0.63; 0.95 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Quadrivalent influenza modRNA vaccine (Biological); Quadrivalent influenza vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years |
0.63; 0.95 | — |
| PRIMARY Percentage of Participants Reporting First Episode of Laboratory-Confirmed Influenza (LCI) Cases With Associated Per-Protocol Influenza-Like Illness (ILI) Caused by Any Strain at Least 14 Days After Vaccination: >= 65 Years |
0.59; 0.56 | — |
| PRIMARY Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: 18-64 Years |
70.1; 43.1 | — |
| PRIMARY Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: >=65 Years |
68.7; 25.8 | — |
| PRIMARY Percentage of Participants Reporting Any Systemic Events Within 7 Days After Study Vaccination: 18-64 Years |
65.8; 48.7 | — |
| PRIMARY Percentage of Participants Reporting Any Systemic Events Within 7 Days After Study Vaccination: >=65 Years |
58.6; 34.9 | — |
| PRIMARY Percentage of Participants Reporting Adverse Events (AEs) From Study Vaccination Through 4 Weeks After Study Vaccination: 18-64 Years |
6.7; 4.9 | — |
| PRIMARY Percentage of Participants Reporting AEs From Study Vaccination Through 4 Weeks After Study Vaccination: >=65 Years |
8.7; 5.9 | — |
| PRIMARY Percentage of Participants Reporting AEs From Study Vaccination Through 4 Weeks After Study Vaccination: >=18 Years |
7.9; 5.5 | — |
| PRIMARY Percentage of Participants Reporting Serious Adverse Events (SAEs) From Study Vaccination Through 6 Months After Study Vaccination: 18-64 Years |
0.9; 1.0 | — |
| PRIMARY Percentage of Participants Reporting SAEs From Study Vaccination Through 6 Months After Study Vaccination: >=65 Years |
2.3; 2.2 | — |
| PRIMARY Percentage of Participants Reporting SAEs From Study Vaccination Through 6 Months After Study Vaccination: >=18 Years |
1.8; 1.7 | — |
| SECONDARY Percentage of Participants Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by All Matched Strains at Least 14 Days After Vaccination: 18-64 Years |
0.23; 0.34 | — |
| SECONDARY Percentage of Participants Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by All Matched Strains at Least 14 Days After Vaccination: >=65 Years |
0.34; 0.36 | — |
| SECONDARY Percentage of Participants Reporting First Episode of Culture Confirmed Influenza (CCI) With Associated Per-Protocol ILI Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years |
0.23; 0.34 | — |
| SECONDARY Percentage of Participants Reporting First Episode of CCI With Associated Per-Protocol ILI Caused by Any Strain at Least 14 Days After Vaccination: >=65 Years |
0.34; 0.36 | — |
| SECONDARY Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by Modified Centers for Disease Control and Prevention (CDC) Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years |
0.46; 0.61 | — |
| SECONDARY Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by Modified CDC Caused by Any Strain at Least 14 Days After Vaccination: >=65 Years |
0.36; 0.30 | — |
| SECONDARY Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by World Health Organization (WHO) Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years |
0.27; 0.35 | — |
| SECONDARY Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by WHO Caused by Any Strain at Least 14 Days After Vaccination: >=65 Years |
0.23; 0.22 | — |
| SECONDARY Percentage of Participants Reporting First Episode Cases of Influenza as Confirmed by RT-PCR or Local RT-PCR or Culture, With Associated Per-Protocol ILI at Least 14 Days After Vaccination: 18-64 Years |
0.66; 0.98 | — |
| SECONDARY Percentage of Participants Reporting First Episode Cases of Influenza as Confirmed by Central RT-PCR or Local RT-PCR or Culture, With Associated Per-Protocol ILI at Least 14 Days After Vaccination: >=65 Years |
0.65; 0.62 | — |
| SECONDARY HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV at 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years |
222.3; 180.4; 397.7; 321.7; 84.5; 115.9 | — |
| SECONDARY HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination- Based on HAI Assay 2: >=65 Years |
296.0; 179.8; 240.0; 140.6; 57.6; 55.3 | — |
| SECONDARY Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years |
64.2; 52.8; 66.1; 52.5; 13.9; 29.2 | — |
| SECONDARY Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years |
53.2; 31.6; 50.2; 24.5; 6.4; 8.5 | — |
| SECONDARY HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination- Based on HAI Assay 1: 18-64 Years |
117.3; 61.1; 203.7; 121.2; 55.0; 62.4 | — |
| SECONDARY HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination - Based on HAI Assay 1: >=65 Years |
98.2; 41.3; 131.8; 55.6; 38.9; 28.6 | — |
| SECONDARY Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere-Based on HAI Assay 1: 18-64 Years |
73.1; 46.3; 78.3; 51.4; 30.0; 33.5 | — |
| SECONDARY Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years |
66.0; 28.1; 68.4; 23.5; 22.6; 12.0 | — |
| SECONDARY HAI GMTs at Baseline for the 2022-2023 Northern Hemisphere - Based on HAI Assay 2: 18-64 Years |
42.9; 42.3; 58.0; 50.5; 49.2; 46.2 | — |
| SECONDARY HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years |
71.2; 68.6; 60.2; 58.3; 38.7; 36.8 | — |
| SECONDARY HAI Geometric Mean Fold Rise (GMFR) From Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years |
4.9; 4.1; 6.0; 5.6; 1.7; 2.4 | — |
| SECONDARY HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years |
4.2; 2.6; 3.7; 2.2; 1.4; 1.4 | — |
| SECONDARY Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years |
65.0; 63.1; 99.2; 96.5; 68.0; 63.5 | — |
| SECONDARY Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years |
84.5; 85.6; 99.6; 97.3; 70.5; 73.2 | — |
| SECONDARY HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years |
18.2; 17.6; 22.7; 23.1; 22.7; 22.7 | — |
| SECONDARY HAI GMTs at Baseline for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years |
19.7; 19.0; 25.2; 24.5; 18.1; 17.2 | — |
| SECONDARY HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: 18-64 Years |
5.4; 2.9; 7.5; 4.4; 2.2; 2.4 | — |
| SECONDARY HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years |
4.2; 1.9; 4.5; 2.0; 1.9; 1.5 | — |
| SECONDARY Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years |
36.8; 35.2; 91.1; 75.8; 41.6; 44.9 | — |
| SECONDARY Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: >=65 Years |
40.4; 37.6; 88.3; 64.6; 46.4; 44.4 | — |
| SECONDARY HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: 18-64 Years |
— | — |
| SECONDARY HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years |
84.1; 82.9; 460.9; 272.2; 10.9; 12.2 | — |
| SECONDARY HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern- Based on HAI Assay 2: 18-64 Years |
— | — |
| SECONDARY HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years |
5.5; 3.3; 4.8; 5.4; 1.8; 2.0 | — |
| SECONDARY Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 2: 18-64 Years |
— | — |
| SECONDARY Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years |
68.9; 41.6; 58.5; 58.7; 16.3; 21.6 | — |
| SECONDARY Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: 18-64 Years |
— | — |
| SECONDARY Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years |
93.8; 94.0; 100.0; 99.0; 19.8; 23.6 | — |
| SECONDARY HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: 18-64 Years |
— | — |
| SECONDARY HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years |
32.9; 30.4; 224.0; 96.8; 14.8; 15.0 | — |
| SECONDARY HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 1: 18-64 Years |
— | — |
| SECONDARY HAI GMFR Before Vaccination to 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years |
6.4; 3.0; 6.8; 4.5; 2.2; 2.1 | — |
| SECONDARY Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: 18-64 Years |
— | — |
| SECONDARY Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years |
81.7; 44.9; 77.2; 57.9; 29.8; 28.8 | — |
| SECONDARY Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: 18-64 Years |
— | — |
| SECONDARY Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years |
61.3; 58.3; 98.2; 89.8; 27.9; 28.5 | — |
Summary
This is a Phase 3, randomized, observer-blinded study to evaluate the efficacy, safety, tolerability, and immunogenicity of a single dose of a quadrivalent influenza modRNA vaccine compared to licensed inactivated influenza vaccine in healthy adults 18 years of age and older.
Eligibility Criteria
Inclusion Criteria
- Male or female participants ≥18 years of age at Visit 1 (Day 1).
- Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
- Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
- Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Exclusion Criteria
- Medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
- Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Allergy to egg proteins (egg or egg products) or chicken proteins.
- Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), eg, for cancer or an autoimmune disease, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
- Receipt of blood/plasma products or immunoglobulin from 60 days before study intervention administration, or planned receipt throughout the study.
- Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration, or ongoing receipt of chronic antiviral therapy with activity against influenza.
- Any participant who has received or plans to receive a modRNA-platform SARS CoV-2 vaccine within 14 days before or after study vaccination at Visit 1.
- Participation in other studies involving administration of a study intervention within 28 days prior to, and/or during, participation in this study.
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
Data sourced from ClinicalTrials.gov (NCT05540522). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.