A Study to Investigate the Safety, Efficacy, and Immunogenicity of mRNA-1010 Candidate Influenza Vaccine Compared with a Licensed Influenza Vaccine in Adults ≥50 Years of Age

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Moderna Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

11 Oct 2024 → 21 Aug 2025

Decision date (initial)

2024-10-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

ModernaTX

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Efficacy

To evaluate the safety and reactogenicity of mRNA-1010 and to evaluate rVE of mRNA-1010 versus an active comparator against RT-PCR-confirmed protocol-defined ILI caused by any influenza A or B strains.

Secondary objectives 4

1. To evaluate rVE of mRNA-1010 versus an active comparator against RT-PCR-confirmed modified CDC-defined ILI caused by any influenza A or B strains
2. To evaluate rVE of mRNA-1010 versus an active comparator against RT-PCR-confirmed protocol-defined ILI or RT-PCR-confirmed modified CDC-defined ILI caused by influenza A or B strains with antigenic match to the vaccine strains.
3. To evaluate the humoral immunogenicity of mRNA-1010 relative to that of an active comparator against vaccine-matched influenza A and B strains in a subset of approximately 2400 participants.
4. To evaluate HAI titers as a surrogate of risk and protection against RT-PCR-confirmed protocol-defined ILI (CoR and CoP) for mRNA-1010 and an active comparator.

Conditions and MedDRA coding

Influenza

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
2. Participants who are assigned female at birth or can become pregnant are eligible to participate if: • The participant is a person of nonchildbearing potential (PONCBP) or • The participant is a person of childbearing potential (POCBP) who: - Is not breast/chest feeding. - Is using an acceptable contraceptive method at least 28 days prior to Day 1 (Baseline) to at least 90 days after Day 1 (Baseline). - Has a negative highly sensitive pregnancy test (urine or serum as required by local regulation or institutional review board [IRB]/independent ethics committee [IEC]) at the Screening Visit and before study intervention (if the Day 1 [Baseline] Visit is not on the same day as the Screening Visit).

Exclusion criteria 15

1. Acutely ill or febrile (temperature ≥38.0 degrees Celsius (℃) [100.4° Fahrenheit [F]]) within 72 hours prior to Day 1 (Baseline).
2. Close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®/oseltamivir) within 5 days prior to Day 1 (Baseline).
3. History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.
4. Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections disease.
5. Tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1 (Baseline).
6. History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any of the following: mRNA vaccine or therapeutic; components of an mRNA vaccine or therapeutic; influenza vaccine; or components of an influenza vaccine, including egg protein.
7. Malignancy within 2 years prior to Day 1 (Baseline) (adequately treated basal cell carcinoma and squamous cell carcinoma are allowed).
8. Received corticosteroids at ≥10 milligram (mg)/day of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 (Baseline) or is anticipating the need for corticosteroids at any time during the study.
9. Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (for example, infliximab), within 180 days prior to Day 1 (Baseline) or plans to do so during the study.
10. Treated with antiviral therapies for influenza (for example, Tamiflu) within 180 days prior to Day 1 (Baseline).
11. Received any vaccine authorized or approved by local health agency within 28 days prior to Day 1 (Baseline) or plans to do so within 14 days after Day 1 (Baseline).
12. Received a licensed seasonal influenza vaccine within 180 days prior to Day 1 (Baseline) or plans to do so (outside of this study) at any time during the study.
13. Received an investigational seasonal influenza vaccine within 1 year prior to Day 1 (Baseline).
14. Participated in a clinical study with investigational treatment within 90 days prior to Day 1 (Baseline) based on the medical history interview or plans to do so while participating in this study.
15. Is working or has worked as study personnel or is an immediate family member or house member of study personnel, study staff, or Sponsor personnel.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) from day 1 to day 7
2. Number of Participants with Unsolicited Adverse Events (AEs) from day 1 to day 28
3. Number of Participants with Medically Attended AEs (MAAEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), or Adverse Events of Special Interest (AESI) from day 1 to day 181
4. Time to First Episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) Confirmed Protocol Defined ILI (ILI caused by any influenza A or B strain from day 14 up to End of Season (up to approximately day 181)

Secondary endpoints 8

1. Number of Participants with First Episode of RT-PCR Confirmed Modified US Centers for Disease Control and Prevention (CDC)-Defined ILI (ILI caused by any influenza A or B strains) from Day 14 up to End of Season (up to approximately Day 181)
2. Number of Participants with First Episode of RT-PCR Confirmed Protocol-Defined ILI or Modified CDC-Defined ILI (ILI caused by influenza A or B strains with antigenic match to the vaccine strains) from Day 14 up to End of Season (up to approximately Day 181)
3. Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) (Humoral immunogenicity) at day 29
4. Number of Participants Reaching Seroconversion as Measured by HAI at Day 29
5. Number of Participants with an HAI Titer ≥1:40 at Day 29
6. Geometric Mean Fold Rise (GMFR) of HAI Titers at Day 1 and Day 29
7. HAI Titer (As measured by the HAI Assay) at Day 29
8. Number of Participants with First Episode of RT-PCR-Confirmed Protocol-Defined ILI (Correlates of Risk (CoR) and Correlates of Protection (CoP)) from Day 14 up to End of Season (up to approximately Day 181)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Moderna Inc.

Sponsor organisation

Moderna Inc.

Address

325 Binney Street

City

Cambridge

Postcode

02142-1038

Country

United States

Scientific contact point

Organisation

Moderna Inc.

Contact name

Moderna WeCare Team

Public contact point

Organisation

Moderna Inc.

Contact name

Moderna WeCare Team

Third parties 13

Locations

5 EU/EEA countries · 57 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 159 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

13 submissions — initial application plus substantial / non-substantial modifications