Phase 2
Completed N=572
A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults
Source: ClinicalTrials.gov NCT05333289 ↗Enrolled (actual)
572
Serious AEs
2.1%
Results posted
Feb 2024
Primary outcomePrimary: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) — 37; 63; 59; 60 Participants
Summary
The primary objective of this study is to evaluate the safety, reactogenicity, and humoral immunogenicity of mRNA-1020, mRNA-1030, and mRNA-1010 vaccines against vaccine-matched influenza A and B strains.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) |
37; 63; 59; 60; 57; 58 | — |
| PRIMARY Number of Participants With Unsolicited Adverse Events (AEs) |
10; 17; 6; 15; 11; 15 | — |
| PRIMARY Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs) |
23; 20; 16; 24; 18; 19 | — |
| PRIMARY Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains |
724.69; 498.43; 328.44; 472.81; 387.92; 378.34 | — |
| PRIMARY GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains |
103.61; 97.52; 163.35; 219.26; 195.34; 198.70 | — |
| PRIMARY Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains |
9.93; 9.12; 5.29; 8.56; 6.83; 8.39 | — |
| PRIMARY GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains |
1.01; 1.00; 1.42; 2.18; 1.82; 2.35 | — |
| PRIMARY Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B |
66.2; 75.4; 56.7; 74.6; 71.4; 71.7 | — |
| PRIMARY Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay |
84.6; 93.4; 80.6; 84.1; 92.1; 93.3 | — |
| SECONDARY GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains |
348.67; 242.49; 167.43; 207.90; 195.65; 186.93 | — |
| SECONDARY GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains |
4.37; 4.32; 2.78; 3.97; 3.18; 4.16 | — |
Eligibility Criteria
Inclusion Criteria
- Body mass index of 18 kilograms (kg)/square meter (m^2) to 35 kg/m^2 (inclusive) at the Screening Visit.
- For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 90 days following vaccine administration, and not currently breastfeeding.
Exclusion Criteria
- Participant has had close contact to someone with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) or has had a positive SARS-CoV-2 test in the past 10 days prior to the Screening Visit.
- Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1.
- Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
- Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 180 days prior to screening (for corticosteroids ≥10 milligrams [mg]/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
- Participant has received or plans to receive any licensed or authorized vaccine, including COVID-19 vaccines, ≤28 days prior to the study injection (Day 1) or plans to receive a licensed or authorized vaccine within 28 days after the study injection.
- Participant has received a Northern Hemisphere (NH) 2021-2022 seasonal influenza vaccine or any other influenza vaccine within 180 days prior to Day 1.
- Participant tested positive for influenza by CDC-recommended testing methods within 180 days prior to Day 1.
- Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.
Note: Other inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT05333289). 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. Informational only — not medical advice.