A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above
- Conditions
- Influenza Immunization
- Interventions
- Biological: Quadrivalent Influenza Standard Dose VaccineBiological: Quadrivalent Influenza High-Dose Vaccine
- Registration Number
- NCT06361875
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of different formulations of Quadrivalent Influenza Vaccine (QIV) messenger ribonucleic acid (mRNA) (MRT5421, MRT5424, and MRT5429) 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.
- Detailed Description
Study duration per participant is approximately 12 months.
* Treatment duration: 1 injection of one of the 7 QIV mRNA or one of the controls
* Dose escalation with sequential enrollment
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 910
- Aged from 18 years on the day of inclusion or aged from 21 years on the days of inclusion, depending on the countries.
-
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.
-
A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours before the 1st dose of study intervention
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)
- Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA vaccine
- Previous history of myocarditis, pericarditis, and / or myopericarditis
- Known history of previous episodes of Gillian-Barre Syndrome (GBS), neuritis (including Bell's palsy), convulsions, encephalitis, transverse myelitis, and vasculitis
- Participants with an ECG that is consistent with possible myocarditis or pericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results
- 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
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
- 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
- Participant who had acute infection symptoms or a positive SARS-CoV-2 RT-PCR or antigen test in the past 10 days prior to the 1st visit (V01)
- Receipt of any vaccine in the 4 weeks preceding study intervention administration or planned receipt of any vaccine in the 4 weeks following study intervention administration
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Previous vaccination against influenza in the previous 6 months with an investigational or marketed vaccine
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Quadrivalent Influenza mRNA Vaccine MRT5424 Dose 2 Quadrivalent Influenza mRNA Vaccine MRT5424 participants will receive a single dose of QIV mRNA vaccine MRT5424 Quadrivalent Influenza SD Vaccine Quadrivalent Influenza Standard Dose Vaccine participants will receive a single dose of QIV-SD vaccine Quadrivalent Influenza HD Vaccine Quadrivalent Influenza High-Dose Vaccine participants will receive a single dose of QIV -HD vaccine (for adults ≥ 65 years of age only) Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 2 Quadrivalent Influenza mRNA Vaccine MRT5429 participants will receive a single dose of QIV mRNA vaccine MRT5429 Quadrivalent Influenza RIV4 Vaccine Quadrivalent Recombinant Influenza Vaccine participants will receive a single dose of RIV4 vaccine Quadrivalent Influenza mRNA Vaccine MRT5421 Dose 1 Quadrivalent Influenza mRNA Vaccine MRT5421 participants will receive a single dose of QIV mRNA vaccine MRT5421 Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 3 Quadrivalent Influenza mRNA Vaccine MRT5429 participants will receive a single dose of QIV mRNA vaccine MRT5429 Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 1 Quadrivalent Influenza mRNA Vaccine MRT5429 participants will receive a single dose of QIV mRNA vaccine MRT5429 Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 4 Quadrivalent Influenza mRNA Vaccine MRT5429 participants will receive a single dose of QIV mRNA vaccine MRT5429 Quadrivalent Influenza mRNA Vaccine MRT5424 Dose 1 Quadrivalent Influenza mRNA Vaccine MRT5424 participants will receive a single dose of QIV mRNA vaccine MRT5424
- Primary Outcome Measures
Name Time Method Number of participants with immediate unsolicited systemic adverse events (AEs) Within 30 minutes after injection Unsolicited systemic AEs that occur within 30 minutes after vaccination
Number of participants with solicited injection site reactions Up to 7 days after injection Adverse reactions pre-listed in the protocol and case report form (CRF) Injection site reactions: Injection site pain, Injection site erythema, and Injection site swelling
Number of participants with solicited systemic reactions Up to 7 days after injection Adverse reactions pre-listed in the protocol and case report form (CRF) Systemic reactions: fever, headache, fatigue, myalgia, arthralgia, chills
Number of participants with unsolicited AEs Up to 28 days after injection AEs that do not fulfill the conditions of solicited reactions
Number of participants with medically attended adverse events (MAAEs) Up to 180 days after injection MAAEs reported up to 180 days after injection
HAI Ab titer ≥ 40 (1/dil) Day 29 HAI Ab titer ≥ 40 (1/dil) at D29
Number of participants with serious adverse events (SAEs) Throughout the study (approximately 12 months) SAEs reported throughout the study
AESIs reported throughout the study AESIs reported throughout the study (approximatley 12 months) AESIs reported throughout the study (approximately 12 months)
Number of participants with adverse events of special interests (AESIs) Throughout the study (approximately 12 months) AESIs reported throughout the study
Number of participants with out-of-range biological test results Up to 8 days after injection Out-of-range biological test results (including shift from baseline values)
Geometric Mean Titer (GMT) At Day 1 and Day 29 Hemagglutinin inhibition (HAI) antibody (Ab) titers at D01 and D29
Geometric Mean of individual Titer Ratio (GMTR) At Day 1 and Day 29 Individual HAI Ab titer ratio D29/D01
Seroconversion At Day 1 and Day 29 Number of participants with HAI Ab 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
- Secondary Outcome Measures
Name Time Method Neutralizing Ab titers at D01 and D29 At Day 1 and Day 29 Neutralizing Ab titers at D01 and D29
Individual neutralizing antibodies titer ratio At Day 1 and Day 29 Individual neutralizing antibodies titer ratio D29/D01
2-fold and 4-fold increase in neutralizing titers Day 1 through Day 29 2-fold and 4-fold increase in neutralizing titers
Trial Locations
- Locations (20)
Coastal Carolina Research Center Site Number : 8400014
🇺🇸North Charleston, South Carolina, United States
Suncoast Research Group, LLC Site Number : 8400015
🇺🇸Miami, Florida, United States
California Research Foundation Site Number : 8400038
🇺🇸San Diego, California, United States
Clinical Trials of Texas, Inc. - PPDS Site Number : 8400029
🇺🇸San Antonio, Texas, United States
Velocity Clinical Research Norfolk Site Number : 8400046
🇺🇸Norfolk, Nebraska, United States
AMR Knoxville Site Number : 8400043
🇺🇸Knoxville, Tennessee, United States
Long Beach Clinical Trials Site Number : 8400013
🇺🇸Long Beach, California, United States
Brengle Family Medicine Site Number : 8400045
🇺🇸Indianapolis, Indiana, United States
AMR Lexington Site Number : 8400042
🇺🇸Lexington, Kentucky, United States
Rochester Clinical Research. Inc. Site Number : 8400005
🇺🇸Rochester, New York, United States
Investigational Site Number : 6300002
🇵🇷Barrio Sabana, Puerto Rico
Accel Clinical Research-Deland Clinical Research Unit Site Number : 8400001
🇺🇸DeLand, Florida, United States
SIMEDHealth, LLC Site Number : 8400011
🇺🇸Gainesville, Florida, United States
Investigational Site Number : 3400001
🇭🇳San Pedro Sula, Honduras
Cenexel Research Centers of America Site Number : 8400037
🇺🇸Hollywood, Florida, United States
Indago Research and Health Center Site Number : 8400032
🇺🇸Hialeah, Florida, United States
Velocity Clinical Research- New Orleans Site Number : 8400053
🇺🇸New Orleans, Louisiana, United States
The Alliance for Multispecialty Research - KCM, LLC Site Number : 8400034
🇺🇸Kansas City, Missouri, United States
Cenexel JBR Site Number : 8400051
🇺🇸Salt Lake City, Utah, United States
Velocity Clinical Research, Omaha Site Number : 8400008
🇺🇸Omaha, Nebraska, United States