Clinical trial NCT05827068: A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults
Official title: A Phase 1/2, Randomized, Open-Label Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults 50 to 75 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Seasonal Influenza
Keywords: Influenza vaccine
mRNA-1010
mRNA-1011.1
mRNA-1011.2
mRNA-1012.1
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-24
Enrollment: 698
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to measure the safety and the immune response to 3 next-generation influenza vaccine candidates (mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1) compared with influenza vaccine candidate mRNA-1010 controls in healthy adult participants.


Eligibility criteria: Key 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 3 months following vaccine administration, and not currently breastfeeding.

Key Exclusion Criteria:

* 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 for \>14 days in total within 180 days prior to the Randomization Visit (for glucocorticosteroids ≥10 milligrams \[mg\]/day of prednisone equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed.
* 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 seasonal influenza vaccine or any other influenza vaccine within 180 days prior to the Randomization Visit.
* Participant tested positive for influenza by local health authority-approved testing methods within 180 days prior to the Randomization Visit.
* Participant has had close contact to someone with or been diagnosed themselves with respiratory syncytial virus or SARS-CoV-2 infection as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 days prior to the Randomization Visit.
* Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Randomization 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: 7 days post-vaccination
measure: Number of Participants With Unsolicited AEs
timeFrame: Up to 28 days post-vaccination
measure: Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation
timeFrame: Day 1 to Day 181 (end of study [EOS])
Secondary outcomes:
measure: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched 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 for Vaccine-matched Influenza A and B Strains
timeFrame: Baseline, Day 29
measure: Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
timeFrame: Day 29
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: Long Beach Research Institute
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials
state: California
city: Fort Collins
country: United States
facility: Tekton Research
state: Colorado
city: Lakewood
country: United States
facility: Critical Care, Pulmonary and Sleep Associates / CCT Research
state: Colorado
city: Hollywood
country: United States
facility: CenExel RCA
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates, LLC
state: Florida
city: Tampa
country: United States
facility: CenExel FCR
state: Florida
city: Norcross
country: United States
facility: Georgia Clinic / CCT Research
state: Georgia
city: Gaithersburg
country: United States
facility: CenExel CBH
state: Maryland
city: Rockville
country: United States
facility: DelRicht Research
state: Maryland
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Springfield
country: United States
facility: DelRicht Research
state: Missouri
city: Town And Country
country: United States
facility: DelRicht Research
state: Missouri
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Healor Primary Care
state: Nevada
city: Vestal
country: United States
facility: Meridian Clinical Research, LLC
state: New York
city: Edmond
country: United States
facility: Tekton Research
state: Oklahoma
city: Moore
country: United States
facility: Tekton Research
state: Oklahoma
city: Corvallis
country: United States
facility: The Corvallis Clinic, PC
state: Oregon
city: Hatboro
country: United States
facility: Hatboro Medical Associates / CCT Research
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Trial Management Associates, LLC
state: South Carolina
city: Springville
country: United States
facility: Springville Dermatology / CCT Research
state: Utah
Study officials:
References: