Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adult Participants 18 Years of Age and Older
Study Details
Study Description
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 mRNA Vaccine MRT5410 compared to an active control (QIV SD, QIV HD [adults ≥ 65 years of age only], or RIV4) in adults 18 years of age and older.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
Approximately 12 months
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1: Quadrivalent Influenza mRNA Vaccine MRT5410 low dose participants will receive a single dose (low) of QIV mRNA vaccine |
Biological: Quadrivalent Influenza mRNA Vaccine MRT5410
Pharmaceutical form: Liquid frozen solution for injection in a vial Route of administration: Intramuscular
|
| Experimental: Group 2: Quadrivalent Influenza mRNA Vaccine MRT5410 medium dose participants will receive a single dose (medium) of QIV mRNA vaccine |
Biological: Quadrivalent Influenza mRNA Vaccine MRT5410
Pharmaceutical form: Liquid frozen solution for injection in a vial Route of administration: Intramuscular
|
| Experimental: Group 3: Quadrivalent Influenza mRNA Vaccine MRT5410 high dose participants will receive a single dose (high) of QIV mRNA vaccine |
Biological: Quadrivalent Influenza mRNA Vaccine MRT5410
Pharmaceutical form: Liquid frozen solution for injection in a vial Route of administration: Intramuscular
|
| Active Comparator: Group 4: RIV4 participants will receive a single dose of RIV4 vaccine |
Biological: Quadrivalent Recombinant Influenza vaccine RIV4
Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular
Other Names:
|
| Active Comparator: Group 5: QIV-SD participants will receive a single dose of QIV-SD vaccine |
Biological: Quadrivalent Inactivated Influenza Standard Dose QIV-SD
Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular
Other Names:
|
| Active Comparator: Group 6: QIV-HD participants will receive a single dose of QIV -HD vaccine |
Biological: Quadrivalent Inactivated Influenza High Dose QIV-HD
Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 reactions or systemic reactions [Within 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 [Within 28 days after injection]
AEs that do not fulfill the conditions of solicited reactions
- Number of participants with medically attended adverse events (MAAE)s [Within 180 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 1 until Day 366]
SAEs reported throughout the study
- Number of participants with out-of-range biological test results [Within 8 days after injection]
Out-of-range biological test results (including shift from baseline values)
- Individual Hemagglutination inhibition (HAI) titer [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] [Day 1 and Day 29]
- Individual HAI titer ratio [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 [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] [Day 29]
- Percentage of participants with 2-fold and 4-fold rise in HAI titers [Day 1 and Day 29]
Secondary Outcome Measures
- Neutralizing Ab titers [Day 1 and Day 29]
Neutralizing Ab titers expressed as GMTs
- Individual neutralizing antibodies titer ratio [Day 1 and Day 29]
- Percentage of participants with 2-fold and 4-fold increase in neutralizing titers [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] [Day 91, Day 181 and Day 366]
- Individual antibodies HAI titer ratio [Day 1, Day 91, Day 181 and Day 366]
Eligibility Criteria
Criteria
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.
Exclusion Criteria:
-
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 IM vaccination based on Investigator's judgment
-
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brengle Family Medicine-Site Number:8400040 | Indianapolis | Indiana | United States | 46260 |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VAV00020
- U1111-1275-1516