A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults

Seasonal Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05333289
• Other study ID #: mRNA-1020-P101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 6, 2022
• Est. completion date: November 22, 2022

Study information

• Verified date: January 2024
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 572
• Est. completion date: November 22, 2022
• Est. primary completion date: November 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza, Human
• Seasonal Influenza

Intervention

Biological:
• mRNA-1030
Sterile liquid for injection
• mRNA-1020
Sterile liquid for injection
• mRNA-1010
Sterile liquid for injection
• Active Comparator
Sterile liquid for injection

Locations

Country	Name	City	State
United States	Meridian Clinical Research	Cincinnati	Ohio
United States	IACT Health	Columbus	Georgia
United States	Alliance for MultiSpecialty Research	Coral Gables	Florida
United States	Meridian Clinical Research	Endwell	New York
United States	Health Awareness, Inc.	Jupiter	Florida
United States	Lucas Research	Morehead City	North Carolina
United States	Lynn Institute of Norman	Norman	Oklahoma
United States	LinQ Research, LLC	Pearland	Texas
United States	Foothills Research Center	Phoenix	Arizona
United States	Sundance Clinical Research, LLC	Saint Louis	Missouri
United States	Olympus Family Medicine	Salt Lake City	Utah
United States	Meridian Clinical Research	Sioux City	Iowa
United States	South Ogden Family Medicine	South Ogden	Utah
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	Trial Management Associates, LLC	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)	Solicited ARs (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. 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 and presented by each dose group separately.	Up to Day 7 (7 days after vaccination)
Primary	Number of Participants With Unsolicited Adverse Events (AEs)	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. 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 worsens from baseline and is considered clinically significant in the medical and scientific judgment of the Investigator. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study, regardless of causality, is located in the "Reported Adverse Events" section and presented by each dose group separately.	Up to Day 28 (28 days after vaccination)
Primary	Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs)	An SAE was defined as any AE that resulted in death, is 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 leads to an unscheduled visit to an healthcare practitioner. This would include visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or COVID-19 and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section and presented by each dose group separately.	Day 1 through Day 181
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	Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.	Day 29
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	Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.	Day 29
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	The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% CI for GMFR was calculated based on the t distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.	Day 29
Primary	GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains	The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation.	Day 29
Primary	Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B	Seroconversion at a participant level is defined as corresponding visit titer = 4*LLOQ (lower limit of quantification) if baseline is < LLOQ or a 4-fold or greater rise if baseline is = LLOQ in anti-HA antibodies. When LLOQ is 1:10, seroconversion is defined as a corresponding visit titer = 1:40 if baseline is < 1:10 or a 4-fold or greater rise if baseline is = 1:10 in anti- HA antibodies measured by HAI assay. 95% CI was calculated using the Clopper-Pearson method.	Day 29
Primary	Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay	= z-fold rise from baseline at participant level is defined as a = z x LLOQ for participants with baseline antibody level < LLOQ, or a z-times or higher antibody level ratio in participants with baseline antibody level = LLOQ. 95% CI was calculated using the Clopper-Pearson method.	Baseline (Day 1), Day 29
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	Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.	Days 8 and 181
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	The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation.	Days 8 and 181