Influenza Immunization
Conditions
Brief 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.
Detailed description
Study duration is approximately 12 months.
Interventions
BIOLOGICALQuadrivalent Influenza mRNA Vaccine MRT5407
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular Injection
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular Injection
Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe Route of Administration: Intramuscular Injection
BIOLOGICALQuadrivalent Influenza High-Dose Vaccine
Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe Route of Administration: Intramuscular Injection
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
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).
Intervention model description
Sentinel Cohort: Open label Main Cohort: * Open label (Sponsor, except laboratory testing personnel) * Blinded (Sites, except for those preparing/administering study intervention)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with 2-fold and 4-fold rise in HAI titers | At Day 1 and Day 29 | — |
| 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) |
| Individual Hemagglutination inhibition (HAI) titer | At Day 1 and Day 29 | Antibody titers are expressed as GMTs at baseline and post-baseline |
| Percentage of participants with detectable antibody HAI titers greater than or equal to (≥) 10 [1/dil] | At Day 1 and Day 29 | — |
| Individual HAI titer ratio | At Day 1 and Day 29 | Ratios of antibody titers measured by HAI in each group before and after vaccination |
| Number of participants archiving HAI seroconversion against Antigens | 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 |
| Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil] | At Day 29 | — |
| Number of participants with immediate 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 and systemic reactions | 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 |
| 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 (MAAE)s | 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 |
| Number of participants with serious adverse events (SAEs) | From Day one to Day 366 | SAEs reported throughout the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Individual neutralizing antibodies titer ratio | At Day 1 and Day 29 | — |
| Percentage of participants with 2-fold and 4-fold increase in neutralizing titers | At Day 1 and Day 29 | — |
| Individual HAI Ab titer ratio | Day 1, Day 91, Day 181 and Day 366 | — |
| Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil] | At Day 91, Day 181 and Day 366 | — |
| Individual neutralizing Ab titer ratio | Day 1, Day 91, Day 181 and Day 366 | — |
| Neutralizing Ab titers | At Day 1 and Day 29 | Neutralizing Ab titers expressed as GMTs |
Countries
Puerto Rico, United States
Outcome results
None listed