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

Primary Purpose

Seasonal Influenza

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
mRNA-1011.1
mRNA-1011.2
mRNA-1012.1
mRNA-1010
mRNA-1010.2
mRNA-1010.3
Sponsored by
ModernaTX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Seasonal Influenza focused on measuring Influenza vaccine, mRNA-1010, mRNA-1011.1, mRNA-1011.2, mRNA-1012.1, Moderna

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Long Beach Research Institute
  • Long Beach Clinical Trials
  • Tekton Research
  • Critical Care, Pulmonary and Sleep Associates / CCT Research
  • CenExel RCA
  • Suncoast Research Associates, LLC
  • CenExel FCR
  • Georgia Clinic / CCT Research
  • CenExel CBH
  • DelRicht Research
  • Sundance Clinical Research, LLC
  • DelRicht Research
  • DelRicht Research
  • Meridian Clinical Research, LLC
  • Healor Primary Care
  • Meridian Clinical Research, LLC
  • Tekton Research
  • Tekton Research
  • The Corvallis Clinic, PC
  • Hatboro Medical Associates / CCT Research
  • Trial Management Associates, LLC
  • Springville Dermatology / CCT Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

mRNA-1011.1

mRNA-1011.2

mRNA-1012.1 Dose Level A

mRNA-1012.1 Dose Level B

mRNA-1010

mRNA-1010.2

mRNA-1010.3

Arm Description

Participants will receive mRNA-1011.1 by intramuscular (IM) injection on Day 1.

Participants will receive mRNA-1011.2 by IM injection on Day 1.

Participants will receive mRNA-1012.1 at dose level A by IM injection on Day 1.

Participants will receive mRNA-1012.1 at dose level B by IM injection on Day 1.

Participants will receive mRNA-1010 by IM injection on Day 1.

Participants will receive mRNA-1010.2 by IM injection on Day 1.

Participants will receive mRNA-1010.3 by IM injection on Day 1.

Outcomes

Primary Outcome Measures

Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Number of Participants With Unsolicited Adverse Events (AEs)
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

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
Change From Baseline in Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay
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.

Full Information

First Posted
April 12, 2023
Last Updated
May 17, 2023
Sponsor
ModernaTX, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05827068
Brief Title
A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
December 7, 2023 (Anticipated)
Study Completion Date
December 7, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Influenza
Keywords
Influenza vaccine, mRNA-1010, mRNA-1011.1, mRNA-1011.2, mRNA-1012.1, Moderna

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mRNA-1011.1
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1011.1 by intramuscular (IM) injection on Day 1.
Arm Title
mRNA-1011.2
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1011.2 by IM injection on Day 1.
Arm Title
mRNA-1012.1 Dose Level A
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1012.1 at dose level A by IM injection on Day 1.
Arm Title
mRNA-1012.1 Dose Level B
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1012.1 at dose level B by IM injection on Day 1.
Arm Title
mRNA-1010
Arm Type
Active Comparator
Arm Description
Participants will receive mRNA-1010 by IM injection on Day 1.
Arm Title
mRNA-1010.2
Arm Type
Active Comparator
Arm Description
Participants will receive mRNA-1010.2 by IM injection on Day 1.
Arm Title
mRNA-1010.3
Arm Type
Active Comparator
Arm Description
Participants will receive mRNA-1010.3 by IM injection on Day 1.
Intervention Type
Biological
Intervention Name(s)
mRNA-1011.1
Other Intervention Name(s)
Seasonal influenza vaccine
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1011.2
Other Intervention Name(s)
Seasonal influenza vaccine
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1012.1
Other Intervention Name(s)
Seasonal influenza vaccine
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1010
Other Intervention Name(s)
Seasonal influenza vaccine
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1010.2
Other Intervention Name(s)
Seasonal influenza vaccine
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1010.3
Other Intervention Name(s)
Seasonal influenza vaccine
Intervention Description
Sterile liquid for injection
Primary Outcome Measure Information:
Title
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Time Frame
Up to Day 7 (7 days after vaccination)
Title
Number of Participants With Unsolicited Adverse Events (AEs)
Time Frame
Up to Day 28 (28 days after vaccination)
Title
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
Time Frame
Day 1 through Day 181
Secondary Outcome Measure Information:
Title
Change From Baseline in Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay
Time Frame
Baseline (Day 1), Day 29
Title
Change From Baseline in Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay
Time Frame
Baseline (Day 1), Day 29
Title
Percentage of Participants With Seroconversion, as Measured by HAI Assay
Description
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.
Time Frame
Baseline (Day 1) to Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Long Beach Research Institute
City
Lakewood
State/Province
California
ZIP/Postal Code
90805
Country
United States
Facility Name
Long Beach Clinical Trials
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Tekton Research
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Critical Care, Pulmonary and Sleep Associates / CCT Research
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
CenExel RCA
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Suncoast Research Associates, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
CenExel FCR
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Georgia Clinic / CCT Research
City
Norcross
State/Province
Georgia
ZIP/Postal Code
30092
Country
United States
Facility Name
CenExel CBH
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Facility Name
DelRicht Research
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Sundance Clinical Research, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
DelRicht Research
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
DelRicht Research
City
Town And Country
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Healor Primary Care
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Facility Name
Tekton Research
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
Tekton Research
City
Moore
State/Province
Oklahoma
ZIP/Postal Code
73160
Country
United States
Facility Name
The Corvallis Clinic, PC
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Hatboro Medical Associates / CCT Research
City
Hatboro
State/Province
Pennsylvania
ZIP/Postal Code
19040
Country
United States
Facility Name
Trial Management Associates, LLC
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Springville Dermatology / CCT Research
City
Springville
State/Province
Utah
ZIP/Postal Code
84663
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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