> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/safety-and-immunogenicity-of-quadrivalent-influenza-mrna-c559d9fd-d492-429f-aed1-6fef73c7211a
> Record changed: 2026-10-13

# Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adult Participants18 Years of Age and Older

NCT05553301

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

Phase

Phase 1/Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

Recruitment status

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

Participants

560

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

Start date

2022-10-03

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

Number of sites

25

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

## Title and summary

**Summary**

The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of up to 2 dose levels of Quadrivalent Influenza messenger ribonucleic acid (mRNA) Vaccine MRT5407 compared to an active control (QIV standard-dose (SD), QIV high-dose (HD) \\\[adults ≥ 65 years of age only\\\], or quadrivalent recombinant influenza vaccine (RIV4)) in adults 18 years of age and older.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

**Short title**

Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adult Participants18 Years of Age and Older

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

**Official title**

Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adults Aged 18 Years and Older

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

## Status and phase

**Control arm**

Active comparator

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

**Recruitment status**

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

**Phase**

Phase 1/Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

## Dates

**Completion date**

2024-01-19

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

**First posted**

2022-09-23

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

**Registry last updated**

2025-01-24

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

**Primary completion date**

2024-01-19

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

**Start date**

2022-10-03

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

## Size and sites

**Actual participants**

560

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

**Participants**

560

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

**Protocol amendments**

3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

**Number of sites**

25

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

**Lead sponsor**

Sanofi Pasteur, a Sanofi Company

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

## Identifiers

**Registry ID**

NCT05553301

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

**ClinicalTrials.gov ID**

NCT05553301

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Prevention

**Masking**

Triple masking

**Masking description**

This is a parallel-group prevention study with up to 5 arms that will be blinded to participants, investigators / sub-investigators, outcomes assessors, and laboratory personnel (with the exception of the sentinel safety portion of the study, which will be open-label). The Sponsor study staff will be unblinded (except laboratory testing personnel).

**Masked roles**

Participants, Investigators, Outcome assessors

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

## Outcomes

### Primary outcomes

1. Number of participants with immediate adverse events (AEs)  
Timeframe: Within 30 minutes after injection  
Unsolicited systemic AEs that occur within 30 minutes after vaccination
2. Number of participants with solicited injection site and systemic reactions  
Timeframe: Up to 7 days after injection  
Adverse reactions pre-listed in the protocol and case report form (CRF) Injection site reactions: pain, redness, swelling, hardening, bruising Systemic reactions: fever, headache, malaise, myalgia, arthralgia, chills
3. Number of participants with unsolicited AEs  
Timeframe: Up to 28 days after injection  
AEs that do not fulfill the conditions of solicited reactions
4. Number of participants with medically attended adverse events (MAAE)s  
Timeframe: Up to 28 days after injection  
AEs with a new onset or a worsening of a condition that prompts the participant or participant to seek unplanned medical advice at a physician's office or Emergency Department
5. Number of participants with serious adverse events (SAEs)  
Timeframe: From Day one to Day 366  
SAEs reported throughout the study
6. Number of participants with out-of-range biological test results  
Timeframe: Up to 8 days after injection  
Out-of-range biological test results (including shift from baseline values)
7. Individual Hemagglutination inhibition (HAI) titer  
Timeframe: At Day 1 and Day 29  
Antibody titers are expressed as GMTs at baseline and post-baseline
8. Percentage of participants with detectable antibody HAI titers greater than or equal to (≥) 10 \[1/dil\]  
Timeframe: At Day 1 and Day 29
9. Individual HAI titer ratio  
Timeframe: At Day 1 and Day 29  
Ratios of antibody titers measured by HAI in each group before and after vaccination
10. Number of participants archiving HAI seroconversion against Antigens  
Timeframe: At Day 1 and Day 29  
Number of participants with titer \\< 10 \\\[1/dil\\\] at Day 1 and post-vaccination titer ≥ 40 \\\[1/dil\\\] at Day 29, or titer ≥ 10 \\\[1/dil\\\] at Day 1 and a ≥ 4-fold-rise in titer \\\[1/dil\\\] at Day 29
11. Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 \[1/dil\]  
Timeframe: At Day 29
12. Percentage of participants with 2-fold and 4-fold rise in HAI titers  
Timeframe: At Day 1 and Day 29

### Secondary outcomes

1. Neutralizing Ab titers  
Timeframe: At Day 1 and Day 29  
Neutralizing Ab titers expressed as GMTs
2. Individual neutralizing antibodies titer ratio  
Timeframe: At Day 1 and Day 29
3. Percentage of participants with 2-fold and 4-fold increase in neutralizing titers  
Timeframe: At Day 1 and Day 29
4. Individual HAI Ab titer ratio  
Timeframe: Day 1, Day 91, Day 181 and Day 366
5. Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 \[1/dil\]  
Timeframe: At Day 91, Day 181 and Day 366
6. Individual neutralizing Ab titer ratio  
Timeframe: Day 1, Day 91, Day 181 and Day 366

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Healthy volunteers**

Yes

### Inclusion criteria

- Aged 18 years on the day of inclusion
- A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:

  - Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile OR
  - Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.

### Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Previous history of myocarditis, pericarditis, and / or myopericarditis
- Self-reported thrombocytopenia, contraindicating Intramuscular vaccination based on Investigator's judgment
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating Intramuscular vaccination based on Investigator's judgment
- Moderate or severe acute illness / infection (according to Investigator's judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
- Self-reported or documented seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
- Receipt of any mRNA vaccine/product in the 2 months preceding study intervention administration

NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

## Sites

- Peninsula Research Associates Site Number : 8400025Rolling Hills Estates, United States
- Optimal Research Site Number : 8400059San Diego, United States
- California Research Foundation Site Number : 8400008San Diego, United States
- Accel Clinical Research-Deland Clinical Research Unit Site Number : 8400052DeLand, United States
- SIMEDHealth, LLC Site Number : 8400024Gainesville, United States
- Indago Research and Health Center Site Number : 8400014Hialeah, United States
- Cenexel Research Centers of America Site Number : 8400048Hollywood, United States
- Dade Research Center Site Number : 8400011Miami, United States
- Suncoast Research Group, LLC Site Number : 8400038Miami, United States
- Florida International Research Center Site Number : 8400051Miami, United States
- Palm Beach Research Center Site Number : 8400020West Palm Beach, United States
- DM Clinical Research Site Number : 8400032Melrose Park, United States
- DM Clinical Research - Chicago Site Number : 8400028River Forest, United States
- Brengle Family Medicine Site Number : 8400005Indianapolis, United States
- AMR Lexington Site Number : 8400054Lexington, United States
- AMR Kansas City Site Number : 8400006Kansas City, United States
- Velocity Clinical Research Site Number : 8400003Omaha, United States
- Coastal Carolina Research Center - N Charleston Site Number : 8400010North Charleston, United States
- AMR Knoxville Site Number : 8400046Knoxville, United States
- Elligo Health Research Site Number : 8400056Austin, United States
- Sun Research Institute Site Number : 8400030San Antonio, United States
- Clinical Trials of Texas, Inc. Site Number : 8400026San Antonio, United States
- DM Clinical Research - Sugar Land Site Number : 8400031Sugar Land, United States
- Investigational Site Number : 6300003Barrio Sabana, Puerto Rico
- Investigational Site Number : 6300002San Juan, Puerto Rico

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

## References

### Other registry identifiers

- U1111-1271-1302

Sources for references

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05553301)

## Related records

### Drugs (3)

- [Anakinra](https://trialight.com/data/asset/anakinra-2c0352ee-cb20-46c5-bd87-6350d9024e75.md)
- [Interferon alfa-2A](https://trialight.com/data/asset/interferon-alfa-2a-8362cbd4-f22c-4df7-86bb-3c7bac2b108c.md)
- [Nepafenac](https://trialight.com/data/asset/nepafenac-96b6dc32-9431-4662-97dd-bbaf8ea3d7a7.md)

### Lead sponsors (1)

- [Sanofi Pasteur, a Sanofi Company](https://trialight.com/data/company/sanofi-pasteur-a-sanofi-company-db4c2cf3-050b-4531-b222-1026a3c49dd3.md)

### Conditions (1)

- [Influenza](https://trialight.com/data/condition/influenza-ea12369b-7ed6-5f6b-94fe-eb0e56c24def.md)

### Targets (5)

- [IFNAR1](https://trialight.com/data/target/ifnar1-b87a0a08-6346-52f4-927e-c5d552c5babd.md)
- [IFNAR2](https://trialight.com/data/target/ifnar2-810ce9c4-ab9c-5d25-aff1-f53086c07427.md)
- [IL1R1](https://trialight.com/data/target/il1r1-fd2f6b61-a37d-5c74-a0ab-8e599b34b339.md)
- [PTGS1](https://trialight.com/data/target/ptgs1-5707ce48-8ccd-5bd5-8c18-9c64cacc2fef.md)
- [PTGS2](https://trialight.com/data/target/ptgs2-85dbd9a5-4609-5423-b863-90d0a825b213.md)

---

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