Clinical trial NCT05333289: A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults
Official title: Phase 1/2, Randomized, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1020 and mRNA-1030 Candidate Seasonal Influenza Vaccines in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Seasonal Influenza
Keywords: Influenza vaccine
mRNA-1020
mRNA-1030
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-18
Enrollment: 572
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


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.

Primary outcomes:
measure: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
timeFrame: Up to Day 7 (7 days after vaccination)
measure: Number of Participants With Unsolicited Adverse Events (AEs)
timeFrame: Up to Day 28 (28 days after vaccination)
measure: Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs)
timeFrame: Day 1 through Day 181
measure: 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
timeFrame: Day 29
measure: 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
timeFrame: Day 29
measure: 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
timeFrame: Day 29
measure: GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
timeFrame: Day 29
measure: Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
timeFrame: Day 29
measure: Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay
timeFrame: Baseline (Day 1), Day 29
Secondary outcomes:
measure: 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
timeFrame: Days 8 and 181
measure: 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
timeFrame: Days 8 and 181
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Foothills Research Center
state: Arizona
city: Coral Gables
country: United States
facility: Alliance for MultiSpecialty Research
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Columbus
country: United States
facility: IACT Health
state: Georgia
city: Sioux City
country: United States
facility: Meridian Clinical Research
state: Iowa
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Endwell
country: United States
facility: Meridian Clinical Research
state: New York
city: Morehead City
country: United States
facility: Lucas Research
state: North Carolina
city: Wilmington
country: United States
facility: Trial Management Associates, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Meridian Clinical Research
state: Ohio
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Pearland
country: United States
facility: LinQ Research, LLC
state: Texas
city: Salt Lake City
country: United States
facility: Olympus Family Medicine
state: Utah
city: South Ogden
country: United States
facility: South Ogden Family Medicine
state: Utah
Study officials:
References: