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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
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Scientific title
Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adults Aged 18 Years and Older
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Secondary ID [1]
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U1111-1279-3180
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Secondary ID [2]
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VAV00029
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Influenza Immunization
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with immediate adverse events (AEs)
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Assessment method [1]
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Unsolicited systemic AEs that occur within 30 minutes after vaccination
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Timepoint [1]
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Within 30 minutes after injection
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Primary outcome [2]
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Number of participants with solicited injection site or systemic reactions
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Assessment method [2]
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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
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Timepoint [2]
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Up to 7 days after injection
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Primary outcome [3]
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Number of participants with unsolicited AEs
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Assessment method [3]
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AEs that do not fulfill the conditions of solicited reactions
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Timepoint [3]
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Up to 28 days after injection
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Primary outcome [4]
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Number of participants with medically attended adverse events (MAAE)s
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Assessment method [4]
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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
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Timepoint [4]
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Up to 180 days after injection
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Primary outcome [5]
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Number of participants with serious adverse events (SAEs)
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Assessment method [5]
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SAEs reported throughout the study
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Timepoint [5]
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From Day one to Day 366
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Primary outcome [6]
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Number of participants with out-of-range biological test results
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Assessment method [6]
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Out-of-range biological test results (including shift from baseline values)
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Timepoint [6]
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Up to 8 days after injection
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Primary outcome [7]
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Individual Hemagglutination inhibition (HAI) titer
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Assessment method [7]
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Antibody titers are expressed as GMTs at baseline and post-baseline
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Timepoint [7]
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At Day 1 and Day 29
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Primary outcome [8]
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Percentage of participants with detectable antibody HAI titers greater than or equal to (=) 10 [1/dil]
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Assessment method [8]
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Timepoint [8]
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At Day 1 and Day 29
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Primary outcome [9]
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Individual HAI titer ratio
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Assessment method [9]
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Ratios of antibody titers measured by HAI in each group before and after vaccination
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Timepoint [9]
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At Day 1 and Day 29
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Primary outcome [10]
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Number of participants archiving HAI seroconversion against Antigens
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Assessment method [10]
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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
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Timepoint [10]
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At Day 1 and Day 29
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Primary outcome [11]
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Percentage of participants with antibody HAI titers greater than or equal to (=) 40 [1/dil]
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Assessment method [11]
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Timepoint [11]
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At Day 29
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Primary outcome [12]
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Percentage of participants with 2-fold and 4-fold rise in HAI titers
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Assessment method [12]
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Timepoint [12]
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At Day 1 and Day 29
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Secondary outcome [1]
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Neutralizing Ab titers
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Assessment method [1]
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Neutralizing Ab titers expressed as GMTs
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Timepoint [1]
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At Day 1 and Day 29
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Secondary outcome [2]
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Individual neutralizing antibodies titer ratio
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Assessment method [2]
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Timepoint [2]
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At Day 1 and Day 29
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Secondary outcome [3]
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Percentage of participants with 2-fold and 4-fold increase in neutralizing titers
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Assessment method [3]
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Timepoint [3]
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At Day 1 and Day 29
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Secondary outcome [4]
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Individual HAI Ab titer ratio
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Assessment method [4]
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Timepoint [4]
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Day 1, Day 91, Day 181 and Day 366
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Secondary outcome [5]
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Percentage of participants with antibody HAI titers greater than or equal to (=) 40 [1/dil]
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Assessment method [5]
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Timepoint [5]
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At Day 91, Day 181 and Day 366
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Secondary outcome [6]
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Individual antibodies HAI titer ratio
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Assessment method [6]
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Timepoint [6]
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Day 1, Day 91, Day 181 and Day 366
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/12/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/04/2024
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Sample size
Target
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Accrual to date
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Final
682
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Investigational Site Number : 0360004 - Darlinghurst
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Recruitment hospital [2]
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Investigational Site Number : 0360005 - Kanwal
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Recruitment hospital [3]
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Investigational Site Number : 0360003 - Maroubra
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Recruitment hospital [4]
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Investigational Site Number : 0360001 - Morayfield
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Recruitment hospital [5]
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Investigational Site Number : 0360002 - North Melbourne
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2259 - Kanwal
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Recruitment postcode(s) [3]
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2035 - Maroubra
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Recruitment postcode(s) [4]
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4506 - Morayfield
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Recruitment postcode(s) [5]
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3051 - North Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Georgia
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Country [4]
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United States of America
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State/province [4]
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Idaho
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Country [5]
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United States of America
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State/province [5]
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Illinois
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Country [6]
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United States of America
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State/province [6]
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Indiana
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Country [7]
0
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United States of America
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State/province [7]
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Nebraska
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Country [8]
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United States of America
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State/province [8]
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New York
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Country [9]
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United States of America
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State/province [9]
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Ohio
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Country [10]
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United States of America
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State/province [10]
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Rhode Island
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Country [11]
0
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United States of America
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State/province [11]
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South Carolina
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Country [12]
0
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United States of America
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State/province [12]
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Tennessee
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Country [13]
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United States of America
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State/province [13]
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Texas
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Country [14]
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Puerto Rico
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State/province [14]
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Barrio Sabana
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Country [15]
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Puerto Rico
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State/province [15]
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San Juan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi Pasteur, a Sanofi Company
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05650554
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Sciences & Operations
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Address
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Sanofi
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05650554
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