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

Primary Purpose

Influenza

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
mRNA-1010
mRNA-1010.4
mRNA-1010.6
Sponsored by
ModernaTX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring mRNA-1010, Influenza Vaccine, Moderna

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • CenExel RCA
  • Suncoast Research Group
  • Johnson County Clin-Trials
  • Rockville Internal Medicine
  • DM Clinical Research
  • Meridian Clinical Research
  • Meridian Clinical Research
  • United Medical Associates
  • DM Clinical Research
  • Texas Center for Drug Development

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

mRNA-1010 Dose C

mRNA-1010.4 Dose B

mRNA-1010.4 Dose C

mRNA-1010.6 Dose A

mRNA-1010.6 Dose B

mRNA-1010.6 Dose C

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Number of Participants with Unsolicited Adverse Events (AEs)
Number of Participants with Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation

Secondary Outcome Measures

Change from Baseline in Geometric Mean Titer (GMT), as Measured by Hemagglutinin Inhibition (HAI) Assay
Change from Baseline in Geometric Mean Fold Rise (GMFR) of Postinjection/Baseline, as Measured by HAI Assay
Percentage of Participants with Seroresponse for mRNA-1010, as Measured by HAI Assay
Seroresponse is defined as an increase of antibody titers and concentrations from predose below the prespecified lower limit of quantification.

Full Information

First Posted
May 11, 2023
Last Updated
September 8, 2023
Sponsor
ModernaTX, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05868382
Brief Title
Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults
Official Title
A Phase 2, Randomized, Active-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults 18 to 49 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
December 26, 2023 (Anticipated)
Study Completion Date
December 26, 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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
mRNA-1010, Influenza Vaccine, Moderna

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mRNA-1010 Dose C
Arm Type
Experimental
Arm Description
Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
Arm Title
mRNA-1010.4 Dose B
Arm Type
Experimental
Arm Description
Participants will receive a single dose of mRNA-1010.4 by IM injection on Day 1.
Arm Title
mRNA-1010.4 Dose C
Arm Type
Experimental
Arm Description
Participants will receive a single dose of mRNA-1010.4 by IM injection on Day 1.
Arm Title
mRNA-1010.6 Dose A
Arm Type
Experimental
Arm Description
Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1.
Arm Title
mRNA-1010.6 Dose B
Arm Type
Experimental
Arm Description
Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1.
Arm Title
mRNA-1010.6 Dose C
Arm Type
Experimental
Arm Description
Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1.
Intervention Type
Biological
Intervention Name(s)
mRNA-1010
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1010.4
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1010.6
Intervention Description
Sterile liquid for injection
Primary Outcome Measure Information:
Title
Number of Participants with Solicited Local and Systemic Reactogenicity 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 29 (28 days after vaccination)
Title
Number of Participants with Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation
Time Frame
Day 1 through Day 181
Secondary Outcome Measure Information:
Title
Change from Baseline in Geometric Mean Titer (GMT), as Measured by Hemagglutinin Inhibition (HAI) Assay
Time Frame
Baseline, Day 181
Title
Change from Baseline in Geometric Mean Fold Rise (GMFR) of Postinjection/Baseline, as Measured by HAI Assay
Time Frame
Baseline, Day 181
Title
Percentage of Participants with Seroresponse for mRNA-1010, as Measured by HAI Assay
Description
Seroresponse is defined as an increase of antibody titers and concentrations from predose below the prespecified lower limit of quantification.
Time Frame
Day 181

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
CenExel RCA
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Suncoast Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Johnson County Clin-Trials
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Rockville Internal Medicine
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20854
Country
United States
Facility Name
DM Clinical Research
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48076
Country
United States
Facility Name
Meridian Clinical Research
City
Hastings
State/Province
Nebraska
ZIP/Postal Code
68901
Country
United States
Facility Name
Meridian Clinical Research
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
United Medical Associates
City
Binghamton
State/Province
New York
ZIP/Postal Code
13905
Country
United States
Facility Name
DM Clinical Research
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Texas Center for Drug Development
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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