Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults

NCT05868382 | Completed Phase 2 Results FDA Drug

• 1 other identifier: mRNA-CRID-004
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Influenza

Keywords

mRNA-1010; Influenza Vaccine; Moderna

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)

  Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  7 days post-vaccination

• Number of Participants With Unsolicited Adverse Events (AEs)

  An unsolicited AE was an AE that was not solicited using a participant diary and that was communicated by a participant who has signed the informed consent. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Number of participants with unsolicited AEs (SAEs and non-serious AEs) up to 28 days post-vaccination are reported in this outcome measure.

  Up to 28 days post-vaccination

• Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study or Treatment Discontinuation

  An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or coronavirus disease 2019 \[COVID-19\] and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). Number of participants with SAEs, AESIs, MAAEs, and AEs leading to discontinuation up to the end of study (Day 181) are reported in this outcome measure.

  Day 1 to Day 181 (end of study [EOS])

Secondary Outcomes (3)

• Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains

  Days 1 (Baseline), 8, 29, 91, and 181

• Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains

  Baseline, Days 8, 29, 91, and 181

• Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains

  Days 8, 29, 91, and 181

Study Arms (6)

mRNA-1010 Dose C

EXPERIMENTAL

Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.

Biological: mRNA-1010

mRNA-1010.4 Dose B

EXPERIMENTAL

Participants will receive a single dose of mRNA-1010.4 by IM injection on Day 1.

Biological: mRNA-1010.4

mRNA-1010.4 Dose C

EXPERIMENTAL

Participants will receive a single dose of mRNA-1010.4 by IM injection on Day 1.

Biological: mRNA-1010.4

mRNA-1010.6 Dose A

EXPERIMENTAL

Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1.

Biological: mRNA-1010.6

mRNA-1010.6 Dose B

EXPERIMENTAL

Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1.

Biological: mRNA-1010.6

mRNA-1010.6 Dose C

EXPERIMENTAL

Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1.

Biological: mRNA-1010.6

Interventions

mRNA-1010 BIOLOGICAL

Sterile liquid for injection

mRNA-1010 Dose C

mRNA-1010.4 BIOLOGICAL

Sterile liquid for injection

mRNA-1010.4 Dose B; mRNA-1010.4 Dose C

mRNA-1010.6 BIOLOGICAL

Sterile liquid for injection

mRNA-1010.6 Dose A; mRNA-1010.6 Dose B; mRNA-1010.6 Dose C

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (10)

CenExel RCA

Hollywood, Florida, 33024, United States

Location

Suncoast Research Group

Miami, Florida, 33135, United States

Location

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Location

Rockville Internal Medicine

Rockville, Maryland, 20854, United States

Location

DM Clinical Research

Southfield, Michigan, 48076, United States

Location

Meridian Clinical Research

Hastings, Nebraska, 68901, United States

Location

Meridian Clinical Research

Lincoln, Nebraska, 68510, United States

Location

United Medical Associates

Binghamton, New York, 13905, United States

Location

DM Clinical Research

Sugar Land, Texas, 77478, United States

Location

Texas Center for Drug Development

Tomball, Texas, 77375, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

mRNA-1010 influenza vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Moderna Clinical Trials Support Center
• Organization: ModernaTX, Inc.

clinicaltrials@modernatx.com

1-877-777-7187

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 22, 2023
• Study Start: May 15, 2023
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: December 20, 2024
• Results First Posted: December 20, 2024

Record last verified: 2024-11

Locations

US (10)