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> Record changed: 2026-10-13

# Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 Vaccine (SARS-CoV-2 \[COVID-19\] and Influenza) in Adults ≥50 Years of Age

NCT06694389

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

Phase

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

Recruitment status

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

Participants

2,457

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

Lead sponsor

ModernaTX, Inc.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

Start date

2024-11-18

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

Number of sites

44

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

## Title and summary

**Summary**

The purpose of the study is to evaluate the immunogenicity, reactogenicity, and safety of mRNA-1083 in adults 50 years of age and older in participating countries (Japan, Taiwan, and South Korea).

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

**Short title**

Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 Vaccine (SARS-CoV-2 \[COVID-19\] and Influenza) in Adults ≥50 Years of Age

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

**Official title**

A Phase 3, Randomized, Observer-Blind, Active-Control Study to Evaluate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adults ≥50 Years of Age

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

## Status and phase

**Control arm**

Active comparator

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

**Recruitment status**

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

**Phase**

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

## Dates

**Completion date**

2025-11-17

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

**First posted**

2024-11-19

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

**Registry last updated**

2025-12-02

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

**Primary completion date**

2025-11-17

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

**Start date**

2024-11-18

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

## Size and sites

**Actual participants**

2,457

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

**Participants**

2,457

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

**Protocol amendments**

3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

**Number of sites**

44

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

**Lead sponsor**

ModernaTX, Inc.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

## Identifiers

**Registry ID**

NCT06694389

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

**ClinicalTrials.gov ID**

NCT06694389

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Prevention

**Masking**

Double masking

**Masked roles**

Participants, Investigators

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

## Outcomes

### Primary outcomes

1. Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay  
Timeframe: Day 29
2. GM Level of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA)  
Timeframe: Day 29
3. Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)  
Timeframe: Day 1 through 7 days after study injection
4. Number of Participants With Unsolicited Adverse Events (AEs)  
Timeframe: Day 1 through 28 days after study injection
5. Number of Participants With Medically Attended Adverse Events (MAAEs)  
Timeframe: Day 1 though Day 181
6. Number of Participants With Adverse Events of Special Interest (AESIs)  
Timeframe: Day 1 though Day 181
7. Number of Participants With Serious Adverse Events (SAEs)  
Timeframe: Day 1 through Day 181
8. Number of Participants With AEs Leading to Discontinuation  
Timeframe: Day 1 through Day 181

### Secondary outcomes

1. Influenza: Percentage of Participants with Seroconversion, as Measured by HAI Assay  
Timeframe: Day 29  
Seroconversion is defined as a Day 29 post-injection level ≥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.
2. SARS-CoV-2: Percentage of Participants with Seroresponse, as Measured by PsVNA  
Timeframe: Day 29  
Seroresponse is defined as a Day 29 post-injection level ≥4-fold if baseline is ≥lower limit of quantification (LLOQ) or ≥4\\\*LLOQ if baseline titer is \\<LLOQ in neutralizing antibody (nAb) values measured by PsVNA.
3. Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay  
Timeframe: Day 1, Day 29
4. GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA  
Timeframe: Day 1, Day 29

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

50 Years

**Healthy volunteers**

Yes

Key Inclusion Criteria:

- Medically stable adults ≥50 years of age at the time of consent (Screening/Day 1 Visit).
- A participant who could become pregnant is eligible to participate if the following is met:

  - Not pregnant or breast/chestfeeding, and is using a contraceptive method that is highly effective for at least 90 days after the study intervention administration and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period.
  - Have a negative highly sensitive pregnancy test (urine) as required by local regulations at Screening/Day 1 Visit, before the study intervention.
- Participants who can produce sperm are eligible to participate if they agree to the following for at least 90 days after the study intervention administration:

  - Refrain from donating sperm.
  - Either be abstinent from reproductive sexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or must agree to use an external condom with a person who could become pregnant partner use of an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse.
- Agree to use an external condom when engaging in any activity that allows for passage of ejaculate to another person.
- Received ≥2 COVID-19 vaccines and the last COVID-19 vaccine was ≥150 days prior to Day 1

Key Exclusion Criteria:

- 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.
- Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol 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.
- Known history of SARS-CoV-2 infection within 150 days prior to Day 1.
- Tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1.
- Received corticosteroids at ≥10 mg/day of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study. Inhaled nasal and topical steroids are allowed.
- Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (for example, infliximab), within 180 days prior to Day 1 or plans to do so during the study.
- Received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study injections or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections.
- Received a seasonal influenza vaccine ≤150 days prior to Day 1.
- Treated with antiviral therapies for influenza (for example, Tamiflu®) ≤150 days prior to Day 1.
- 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 5 days prior to Day 1
- Has had close contact to someone with COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 days prior to Day 1.
- Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit/Day 1 or plans to donate blood products during the study.
- Reported 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.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

## Sites

- Public Health Association.Inc.Nagoya, Japan
- Daido ClinicNagoya, Japan
- Tenjin Sogo ClinicFukuoka, Japan
- PS Clinic - Internal medicineFukuoka, Japan
- Fukuoka Heartnet HospitalFukuoka, Japan
- Medical Coporation of Yamazaki Neurotology, Rhinolaryngology ClinicalSapporo, Japan
- Motomachi Takatsuka Naika Clinic - Internal MedicineYokohama, Japan
- Sakurajyuji Medical Corporation Medimesse Sakurajyuji ClinicKumamoto, Japan
- Nishi-Kumamoto HospitalKumamoto, Japan
- Sato HospitalOsaki-shi, Japan
- Yokoi Medicine ClinicMino, Japan
- Shinwakai Adachi Kyosai Hospital - Internal MedicineAdachi-ku, Japan
- Dojinkinenkai Meiwa HospitalChiyoda-ku, Japan
- Nihonbashi Sakura ClinicChuo-ku, Japan
- Tokyo center clinic - Internal medicineChuo-ku, Japan
- Medical Corporation Asbo Tokyo Asbo ClinicChuo-ku, Japan
- New Medical Research System ClinicHachioji-shi, Japan
- Shimamura Memorial HospitalNerima City, Japan
- Denenchofu Family ClinicŌta-ku, Japan
- Hillside Clinic JingumaeShibuya-ku, Japan
- Clinical Research Tokyo Hospital - Clinical Research CenterShinjuku, Japan
- Higashi-Shinjuku Clinic - Internal MedicineShinjuku, Japan
- Shinei Medical Healthcare ClinicSuginami, Japan
- Souseikai Sumida HospitalSumida-Ku, Japan
- Seishukai ClinicTaito-ku, Japan

And 19 more, listed on the interactive page.

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

## References

- PubMed 42531981  
Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42531981/)
Related publication

Sources for references

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06694389)

## Related records

### Drugs (1)

- [Adintrevimab](https://trialight.com/data/asset/adintrevimab-54fe54a2-887b-412b-94e4-d15b7c142b42.md)

### Lead sponsors (1)

- [ModernaTX, Inc.](https://trialight.com/data/company/modernatx-inc-8ece6782-e44c-4999-be6a-0b94e61dfff5.md)

### Conditions (2)

- [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Primary condition
- [Influenza](https://trialight.com/data/condition/influenza-ea12369b-7ed6-5f6b-94fe-eb0e56c24def.md)

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