Quadrivalent Influenza mRNA Vaccine MRT5410
BiologicalPharmaceutical form: Liquid frozen solution for injection in a vial Route of administration: Intramuscular
NCT Number: NCT05624606
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Investigational Site Number : 6300002, Barrio Sabana, Puerto Rico
Approximately 12 months
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Pharmaceutical form: Liquid frozen solution for injection in a vial Route of administration: Intramuscular
Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular
Other names: Flublok Quadrivalent®
Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular
Other names: Fluzone Quadrivalent®
Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular
Other names: Fluzone High-Dose Quadrivalent®
Time frame: Within 30 minutes after injection
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Time frame: 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
Time frame: Within 28 days after injection
AEs that do not fulfill the conditions of solicited reactions
Time frame: 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
Time frame: From Day 1 until Day 366
SAEs reported throughout the study
Time frame: Within 8 days after injection
Out-of-range biological test results (including shift from baseline values)
Time frame: Day 1 and Day 29
Antibody titers are expressed as GMTs at baseline and post-baseline
Time frame: Day 1 and Day 29
Time frame: Day 1 and Day 29
Ratios of antibody titers measured by HAI in each group before and after vaccination
Time frame: 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
Time frame: Day 29
Time frame: Day 1 and Day 29
Time frame: Day 1 and Day 29
Neutralizing Ab titers expressed as GMTs
Time frame: Day 1 and Day 29
Time frame: Day 1 and Day 29
Time frame: Day 1, Day 91, Day 181 and Day 366
Time frame: Day 91, Day 181 and Day 366
Time frame: Day 1, Day 91, Day 181 and Day 366
Sanofi Pasteur, a Sanofi Company
Industry
Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adults Aged 18 Years and Older
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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