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A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults

Primary Purpose

Influenza

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
mRNA-1010
Egg-based Quadrivalent Influenza Vaccine
Adjuvanted Quadrivalent Influenza Vaccine
Inactivated Influenza Vaccine
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 - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Part A only: Body mass index (BMI) of 18 kilograms (kg)/meter (m)^2 to < 40 kg/m^2 at the screening visit. There will be no BMI requirement for inclusion in Part B. Female participants of childbearing potential: has a negative pregnancy test on the day of vaccination (D1); practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days before D1; has agreed to continue adequate contraception through 3 months after vaccine administration; and is not currently breastfeeding. Exclusion Criteria: Acutely ill or febrile (temperature ≥ 38.0°Celsius (C)/100.4° Fahrenheit (F) hours before or at the D1 vaccination visit. Participants meeting this criterion may be rescheduled within the 28-day screening window. 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. Reported history of congenital or acquired immunodeficiency, immunocompromising or immunosuppressive condition, asplenia, or history of recurrent severe infections. Certain immune-mediated conditions that are stable and well-controlled (for example, Hashimoto's thyroid disease) or that do not require systemic immunosuppressive therapy may be permitted at the discretion of the Investigator. Dermatologic conditions that could affect local solicited AR assessments (tattoos, psoriatic patches or vitiligo affecting skin over the deltoid injection site area). Has received systemic immunosuppressants (for glucocorticoids ≥ 10 mg/day of prednisone or equivalent) for > 14 days in total within 180 days before vaccination visit (D1) 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. Has received systemic immunoglobulins or long-acting biological therapies that may suppress or alter immune responses (for example, Infliximab®) or blood products within 90 days before the vaccination visit or plans to receive them during the study. Has a history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA or influenza vaccines or any components of the mRNA or influenza vaccines, including egg protein. Other protocol-defined inclusion/exclusion criteria apply.

Sites / Locations

  • Washington University in St. Louis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Experimental

Arm Label

mRNA-1010 (Age Group 18-50 years)

Egg-based Quadrivalent Influenza Vaccine (Age Group 18-50 years)

Adjuvanted Quadrivalent Influenza Vaccine (Age Group 65-80 years)

Inactivated Influenza Vaccine (Age Group 65-80 years)

mRNA-1010 (Age Group 65-80 years)

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 egg-based quadrivalent influenza vaccine by IM injection on Day 1.

Participants will receive a single dose of adjuvanted quadrivalent influenza vaccine by IM injection on Day 1.

Participants will receive a single dose of inactivated influenza vaccine by IM injection on Day 1.

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

Outcomes

Primary Outcome Measures

Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Number of Unsolicited Adverse Events (AEs)
Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation
Change from Baseline in Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutinin 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 Seroresponse, as Measured by HAI Assay
Seroresponse is defined as a Day 29 titer > 1:40 if baseline is < 1:10 or a minimum 4-fold rise if baseline is >1:10 in anti-HA antibodies measured by HAI assay.

Secondary Outcome Measures

Change from Baseline in GMT of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or Microneutralization (MN) Assay
Change from Baseline in GMFR of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or MN Assay

Full Information

First Posted
October 31, 2022
Last Updated
September 14, 2023
Sponsor
ModernaTX, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05606965
Brief Title
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults
Official Title
Phase 2, Open-Label Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 and Comparator Seasonal Influenza Vaccines in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
July 10, 2024 (Anticipated)
Study Completion Date
July 10, 2024 (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 humoral immunogenicity of mRNA-1010 and comparator influenza vaccines against homologous influenza A and B strains at Day 29.
Detailed Description
The study consists of two parts. Part A of the study was conducted for the 2022-23 influenza season. Part B of the study will be conducted in 2023-24 influenza season.

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
Model Description
The study design for Part A is randomized and Part B is non-randomized.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mRNA-1010 (Age Group 18-50 years)
Arm Type
Experimental
Arm Description
Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
Arm Title
Egg-based Quadrivalent Influenza Vaccine (Age Group 18-50 years)
Arm Type
Active Comparator
Arm Description
Participants will receive a single dose of egg-based quadrivalent influenza vaccine by IM injection on Day 1.
Arm Title
Adjuvanted Quadrivalent Influenza Vaccine (Age Group 65-80 years)
Arm Type
Active Comparator
Arm Description
Participants will receive a single dose of adjuvanted quadrivalent influenza vaccine by IM injection on Day 1.
Arm Title
Inactivated Influenza Vaccine (Age Group 65-80 years)
Arm Type
Active Comparator
Arm Description
Participants will receive a single dose of inactivated influenza vaccine by IM injection on Day 1.
Arm Title
mRNA-1010 (Age Group 65-80 years)
Arm Type
Experimental
Arm Description
Participants will receive a single dose of mRNA-1010 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)
Egg-based Quadrivalent Influenza Vaccine
Other Intervention Name(s)
Fluarix®
Intervention Description
Sterile suspension for injection
Intervention Type
Biological
Intervention Name(s)
Adjuvanted Quadrivalent Influenza Vaccine
Other Intervention Name(s)
Fluad®
Intervention Description
Sterile injectable emulsion
Intervention Type
Biological
Intervention Name(s)
Inactivated Influenza Vaccine
Other Intervention Name(s)
Fluzone®
Intervention Description
Sterile suspension for injection
Primary Outcome Measure Information:
Title
Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Time Frame
Up to Day 7 (7 days after vaccination)
Title
Number of Unsolicited Adverse Events (AEs)
Time Frame
Up to Day 28 (28 days after vaccination)
Title
Number of 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
Title
Change from Baseline in Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutinin Inhibition (HAI) Assay
Time Frame
Baseline, 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 29
Title
Percentage of Participants with Seroresponse, as Measured by HAI Assay
Description
Seroresponse is defined as a Day 29 titer > 1:40 if baseline is < 1:10 or a minimum 4-fold rise if baseline is >1:10 in anti-HA antibodies measured by HAI assay.
Time Frame
Day 29
Secondary Outcome Measure Information:
Title
Change from Baseline in GMT of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or Microneutralization (MN) Assay
Time Frame
Baseline, Days 121 and 181
Title
Change from Baseline in GMFR of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or MN Assay
Time Frame
Baseline, Days 121 and 181

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Part A only: Body mass index (BMI) of 18 kilograms (kg)/meter (m)^2 to < 40 kg/m^2 at the screening visit. There will be no BMI requirement for inclusion in Part B. Female participants of childbearing potential: has a negative pregnancy test on the day of vaccination (D1); practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days before D1; has agreed to continue adequate contraception through 3 months after vaccine administration; and is not currently breastfeeding. Exclusion Criteria: Acutely ill or febrile (temperature ≥ 38.0°Celsius (C)/100.4° Fahrenheit (F) hours before or at the D1 vaccination visit. Participants meeting this criterion may be rescheduled within the 28-day screening window. 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. Reported history of congenital or acquired immunodeficiency, immunocompromising or immunosuppressive condition, asplenia, or history of recurrent severe infections. Certain immune-mediated conditions that are stable and well-controlled (for example, Hashimoto's thyroid disease) or that do not require systemic immunosuppressive therapy may be permitted at the discretion of the Investigator. Dermatologic conditions that could affect local solicited AR assessments (tattoos, psoriatic patches or vitiligo affecting skin over the deltoid injection site area). Has received systemic immunosuppressants (for glucocorticoids ≥ 10 mg/day of prednisone or equivalent) for > 14 days in total within 180 days before vaccination visit (D1) 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. Has received systemic immunoglobulins or long-acting biological therapies that may suppress or alter immune responses (for example, Infliximab®) or blood products within 90 days before the vaccination visit or plans to receive them during the study. Has a history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA or influenza vaccines or any components of the mRNA or influenza vaccines, including egg protein. Other protocol-defined inclusion/exclusion criteria apply.
Facility Information:
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults

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