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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05650554




Registration number
NCT05650554
Ethics application status
Date submitted
6/12/2022
Date registered
14/12/2022
Date last updated
9/05/2024

Titles & IDs
Public title
Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants18 Years of Age and Older
Scientific title
Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adults Aged 18 Years and Older
Secondary ID [1] 0 0
U1111-1279-3180
Secondary ID [2] 0 0
VAV00029
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza Immunization 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Quadrivalent Influenza mRNA Vaccine MRT5413
Other interventions - Quadrivalent Recombinant Influenza Vaccine
Other interventions - Quadrivalent Influenza Standard Dose Vaccine
Other interventions - Quadrivalent Influenza High-Dose Vaccine

Experimental: Group 1: Quadrivalent Influenza mRNA Vaccine MRT5413 low dose - participants will receive a single dose of QIV mRNA vaccine (low dose)

Experimental: Group 2: Quadrivalent Influenza mRNA Vaccine MRT5413 medium dose - participants will receive a single dose of QIV mRNA vaccine (medium dose)

Experimental: Group 3: Quadrivalent Influenza mRNA Vaccine MRT5413 high dose - participants will receive a single dose of QIV mRNA vaccine (high dose)

Active Comparator: Group 4: RIV4 - participants will receive a single dose of RIV4 vaccine

Active Comparator: Group 5: QIV-SD - participants will receive a single dose of QIV-SD vaccine

Active Comparator: Group 6: QIV-HD - participants will receive a single dose of QIV -HD vaccine (for elderly only)


Other interventions: Quadrivalent Influenza mRNA Vaccine MRT5413
Pharmaceutical Form: Liquid frozen solution in a vial
Route of Administration: Intramuscular injection

Other interventions: Quadrivalent Recombinant Influenza Vaccine
Pharmaceutical Form: Liquid frozen solution in a vial
Route of Administration: Intramuscular injection

Other interventions: Quadrivalent Influenza Standard Dose Vaccine
Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe
Route of Administration: Intramuscular injection

Other interventions: Quadrivalent Influenza High-Dose Vaccine
Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe
Route of Administration: Intramuscular injection
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with immediate adverse events (AEs)
Timepoint [1] 0 0
Within 30 minutes after injection
Primary outcome [2] 0 0
Number of participants with solicited injection site or systemic reactions
Timepoint [2] 0 0
Up to 7 days after injection
Primary outcome [3] 0 0
Number of participants with unsolicited AEs
Timepoint [3] 0 0
Up to 28 days after injection
Primary outcome [4] 0 0
Number of participants with medically attended adverse events (MAAE)s
Timepoint [4] 0 0
Up to 180 days after injection
Primary outcome [5] 0 0
Number of participants with serious adverse events (SAEs)
Timepoint [5] 0 0
From Day one to Day 366
Primary outcome [6] 0 0
Number of participants with out-of-range biological test results
Timepoint [6] 0 0
Up to 8 days after injection
Primary outcome [7] 0 0
Individual Hemagglutination inhibition (HAI) titer
Timepoint [7] 0 0
At Day 1 and Day 29
Primary outcome [8] 0 0
Percentage of participants with detectable antibody HAI titers greater than or equal to (=) 10 [1/dil]
Timepoint [8] 0 0
At Day 1 and Day 29
Primary outcome [9] 0 0
Individual HAI titer ratio
Timepoint [9] 0 0
At Day 1 and Day 29
Primary outcome [10] 0 0
Number of participants archiving HAI seroconversion against Antigens
Timepoint [10] 0 0
At Day 1 and Day 29
Primary outcome [11] 0 0
Percentage of participants with antibody HAI titers greater than or equal to (=) 40 [1/dil]
Timepoint [11] 0 0
At Day 29
Primary outcome [12] 0 0
Percentage of participants with 2-fold and 4-fold rise in HAI titers
Timepoint [12] 0 0
At Day 1 and Day 29
Secondary outcome [1] 0 0
Neutralizing Ab titers
Timepoint [1] 0 0
At Day 1 and Day 29
Secondary outcome [2] 0 0
Individual neutralizing antibodies titer ratio
Timepoint [2] 0 0
At Day 1 and Day 29
Secondary outcome [3] 0 0
Percentage of participants with 2-fold and 4-fold increase in neutralizing titers
Timepoint [3] 0 0
At Day 1 and Day 29
Secondary outcome [4] 0 0
Individual HAI Ab titer ratio
Timepoint [4] 0 0
Day 1, Day 91, Day 181 and Day 366
Secondary outcome [5] 0 0
Percentage of participants with antibody HAI titers greater than or equal to (=) 40 [1/dil]
Timepoint [5] 0 0
At Day 91, Day 181 and Day 366
Secondary outcome [6] 0 0
Individual antibodies HAI titer ratio
Timepoint [6] 0 0
Day 1, Day 91, Day 181 and Day 366

Eligibility
Key inclusion criteria
- Aged 18 years on the day of inclusion (US) and aged 21 years on the day of inclusion
(Puerto Rico)

- 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/04/2024
Sample size
Target
Accrual to date
Final
682
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360004 - Darlinghurst
Recruitment hospital [2] 0 0
Investigational Site Number : 0360005 - Kanwal
Recruitment hospital [3] 0 0
Investigational Site Number : 0360003 - Maroubra
Recruitment hospital [4] 0 0
Investigational Site Number : 0360001 - Morayfield
Recruitment hospital [5] 0 0
Investigational Site Number : 0360002 - North Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2259 - Kanwal
Recruitment postcode(s) [3] 0 0
2035 - Maroubra
Recruitment postcode(s) [4] 0 0
4506 - Morayfield
Recruitment postcode(s) [5] 0 0
3051 - North Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Rhode Island
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Puerto Rico
State/province [14] 0 0
Barrio Sabana
Country [15] 0 0
Puerto Rico
State/province [15] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi Pasteur, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and immunogenicity of a single
intramuscular (IM) injection of up to 3 dose levels of Quadrivalent Influenza messenger
ribonucleic acid (mRNA) Vaccine MRT5413 compared to an active control (QIVstandard-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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05650554
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries