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

Sponsor

ModernaTX, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05827068

Collaborator

(none)

700

Enrollment

Locations

Arms

8.4

Anticipated Duration (Months)

31.8

Patients Per Site

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Seasonal Influenza	Biological: mRNA-1011.1 Biological: mRNA-1011.2 Biological: mRNA-1012.1 Biological: mRNA-1010 Biological: mRNA-1010.2 Biological: mRNA-1010.3	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

700 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Mar 27, 2023

Anticipated Primary Completion Date :

Dec 7, 2023

Anticipated Study Completion Date :

Dec 7, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mRNA-1011.1 Participants will receive mRNA-1011.1 by intramuscular (IM) injection on Day 1.	Biological: mRNA-1011.1 Sterile liquid for injection Other Names: Seasonal influenza vaccine
Experimental: mRNA-1011.2 Participants will receive mRNA-1011.2 by IM injection on Day 1.	Biological: mRNA-1011.2 Sterile liquid for injection Other Names: Seasonal influenza vaccine
Experimental: mRNA-1012.1 Dose Level A Participants will receive mRNA-1012.1 at dose level A by IM injection on Day 1.	Biological: mRNA-1012.1 Sterile liquid for injection Other Names: Seasonal influenza vaccine
Experimental: mRNA-1012.1 Dose Level B Participants will receive mRNA-1012.1 at dose level B by IM injection on Day 1.	Biological: mRNA-1012.1 Sterile liquid for injection Other Names: Seasonal influenza vaccine
Active Comparator: mRNA-1010 Participants will receive mRNA-1010 by IM injection on Day 1.	Biological: mRNA-1010 Sterile liquid for injection Other Names: Seasonal influenza vaccine
Active Comparator: mRNA-1010.2 Participants will receive mRNA-1010.2 by IM injection on Day 1.	Biological: mRNA-1010.2 Sterile liquid for injection Other Names: Seasonal influenza vaccine
Active Comparator: mRNA-1010.3 Participants will receive mRNA-1010.3 by IM injection on Day 1.	Biological: mRNA-1010.3 Sterile liquid for injection Other Names: Seasonal influenza vaccine

Outcome Measures

Primary Outcome Measures

Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) [Up to Day 7 (7 days after vaccination)]
Number of Participants With Unsolicited Adverse Events (AEs) [Up to Day 28 (28 days after vaccination)]
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 Outcome Measures

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]
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]
Percentage of Participants With Seroconversion, as Measured by HAI Assay [Baseline (Day 1) to Day 29]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Long Beach Research Institute	Lakewood	California	United States	90805
2	Long Beach Clinical Trials	Long Beach	California	United States	90806
3	Tekton Research	Fort Collins	Colorado	United States	80528
4	Critical Care, Pulmonary and Sleep Associates / CCT Research	Lakewood	Colorado	United States	80228
5	CenExel RCA	Hollywood	Florida	United States	33024
6	Suncoast Research Associates, LLC	Miami	Florida	United States	33173
7	CenExel FCR	Tampa	Florida	United States	33613
8	Georgia Clinic / CCT Research	Norcross	Georgia	United States	30092
9	CenExel CBH	Gaithersburg	Maryland	United States	20877
10	DelRicht Research	Rockville	Maryland	United States	20852
11	Sundance Clinical Research, LLC	Saint Louis	Missouri	United States	63141
12	DelRicht Research	Springfield	Missouri	United States	65807
13	DelRicht Research	Town And Country	Missouri	United States	63017
14	Meridian Clinical Research, LLC	Omaha	Nebraska	United States	68134
15	Healor Primary Care	Las Vegas	Nevada	United States	89102
16	Meridian Clinical Research, LLC	Vestal	New York	United States	13850
17	Tekton Research	Edmond	Oklahoma	United States	73013
18	Tekton Research	Moore	Oklahoma	United States	73160
19	The Corvallis Clinic, PC	Corvallis	Oregon	United States	97330
20	Hatboro Medical Associates / CCT Research	Hatboro	Pennsylvania	United States	19040
21	Trial Management Associates, LLC	Myrtle Beach	South Carolina	United States	29572
22	Springville Dermatology / CCT Research	Springville	Utah	United States	84663