A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults

Seasonal Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05827068
• Other study ID #: mRNA-1011-P101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 27, 2023
• Est. completion date: November 20, 2023

Study information

• Verified date: November 2023
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: November 20, 2023
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza, Human
• Seasonal Influenza

Intervention

Biological:
• mRNA-1011.1
Sterile liquid for injection
• mRNA-1011.2
Sterile liquid for injection
• mRNA-1012.1
Sterile liquid for injection
• mRNA-1010
Sterile liquid for injection
• mRNA-1010.2
Sterile liquid for injection
• mRNA-1010.3
Sterile liquid for injection

Locations

Country	Name	City	State
United States	The Corvallis Clinic, PC	Corvallis	Oregon
United States	Tekton Research	Edmond	Oklahoma
United States	Tekton Research	Fort Collins	Colorado
United States	CenExel CBH	Gaithersburg	Maryland
United States	Hatboro Medical Associates / CCT Research	Hatboro	Pennsylvania
United States	CenExel RCA	Hollywood	Florida
United States	Critical Care, Pulmonary and Sleep Associates / CCT Research	Lakewood	Colorado
United States	Long Beach Research Institute	Lakewood	California
United States	Healor Primary Care	Las Vegas	Nevada
United States	Long Beach Clinical Trials	Long Beach	California
United States	Suncoast Research Associates, LLC	Miami	Florida
United States	Tekton Research	Moore	Oklahoma
United States	Trial Management Associates, LLC	Myrtle Beach	South Carolina
United States	Georgia Clinic / CCT Research	Norcross	Georgia
United States	Meridian Clinical Research, LLC	Omaha	Nebraska
United States	DelRicht Research	Rockville	Maryland
United States	Sundance Clinical Research, LLC	Saint Louis	Missouri
United States	DelRicht Research	Springfield	Missouri
United States	Springville Dermatology / CCT Research	Springville	Utah
United States	CenExel FCR	Tampa	Florida
United States	DelRicht Research	Town And Country	Missouri
United States	Meridian Clinical Research, LLC	Vestal	New York

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)		Up to Day 7 (7 days after vaccination)
Primary	Number of Participants With Unsolicited Adverse Events (AEs)		Up to Day 28 (28 days after vaccination)
Primary	Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation of Study		Day 1 through Day 181
Secondary	Change From Baseline in Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay		Baseline (Day 1), Day 29
Secondary	Change From Baseline in Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay		Baseline (Day 1), Day 29
Secondary	Percentage of Participants With Seroconversion, as Measured by HAI Assay	Seroconversion is defined as a Day 29 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.	Baseline (Day 1) to Day 29