Clinical trial NCT05868382: Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults
Official title: A Phase 2, Randomized, Active-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults 18 to 49 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: mRNA-1010
Influenza Vaccine
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-22
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main purpose of the study is to evaluate the safety, reactogenicity, and the immunogenicity of mRNA-1010 vaccine candidate variations.


Eligibility criteria: Inclusion Criteria:

* Investigator has assessed that the participant understands and is willing and physically able to comply with protocol mandated follow up, including all procedures.
* For assigned females at birth and 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, and agreement to continue adequate contraception through 90 days following vaccine administration.

Exclusion Criteria:

* Participant has had close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®) within the past 5 days prior to Day 1.
* Participant is acutely ill or febrile (temperature ≥38.0℃elcius \[100.4°Fahrenheit\]) 72 hours prior to or at the Screening visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window.
* Participant has a history of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
* Reported history of congenital or acquired immunodeficiency, immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections.
* Participant has tested positive for influenza by local health authority-approved testing methods within 150 days prior to Day 1.
* Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of mRNA vaccines or any components of the mRNA-1010 or influenza vaccines, including egg protein.
* Participant has received systemic immunosuppressants for \>14 days in total within 180 days prior to Day 1 (for corticosteroids, ≥10 mg/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled, nasal and topical steroids are allowed. Intra-articular and epidural steroid injections are not allowed within 28 days before and/or after study intervention dosing.
* Participant has received any vaccine authorized or approved by local health agency ≤28 days prior to study intervention dosing (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after study intervention dosing.
* Participant has received a licensed seasonal influenza vaccine within 5 months (150 days) prior to Day 1.
* Participant has participated in any investigational seasonal influenza vaccine study within12 months prior to Day 1.
* Participant is not aware whether they have received an influenza vaccine in the prior 12 months.
* Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to Day 1 or plans to donate blood products during the study.

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 Adverse Events (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 Study or Treatment Discontinuation
timeFrame: Day 1 to Day 181 (end of study [EOS])
Secondary outcomes:
measure: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
timeFrame: Days 1 (Baseline), 8, 29, 91, and 181
measure: Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
timeFrame: Baseline, Days 8, 29, 91, and 181
measure: Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
timeFrame: Days 8, 29, 91, and 181
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: CenExel RCA
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group
state: Florida
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
city: Rockville
country: United States
facility: Rockville Internal Medicine
state: Maryland
city: Southfield
country: United States
facility: DM Clinical Research
state: Michigan
city: Hastings
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Lincoln
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Binghamton
country: United States
facility: United Medical Associates
state: New York
city: Sugar Land
country: United States
facility: DM Clinical Research
state: Texas
city: Tomball
country: United States
facility: Texas Center for Drug Development
state: Texas
Study officials:
References: