Quadrivalent Influenza mRNA Vaccine MRT5421
BiologicalPharmaceutical form:solution in a vial-Route of administration:Intramuscular injection
NCT Number: NCT06361875
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Investigational Site Number : 3400001, San Pedro Sula, Honduras
Study duration per participant is approximately 12 months.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Aged from 18 years on the day of inclusion or aged from 21 years on the days of inclusion, depending on the countries.
Pharmaceutical form:solution in a vial-Route of administration:Intramuscular injection
Pharmaceutical form:solution in a vial-Route of administration:Intramuscular injection
Pharmaceutical form:solution in a vial-Route of administration:Intramuscular Injection
Pharmaceutical form: suspension for injection in prefilled syringe -Route of administration:Intramuscular injection
Other names: Fluzone Qudrivalent®
Pharmaceutical form:suspension for injection in pre filled syringe -Route of administration:Intramuscular injection
Other names: Fluzone High-Dose Quadrivalent®
Pharmaceutical form:suspension for injection in pre filled syringe-Route of administration:Intramuscular injection
Other names: Flublok Quadrivalent®
Time frame: Within 30 minutes after injection
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Time frame: 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
Time frame: 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
Time frame: Up to 28 days after injection
AEs that do not fulfill the conditions of solicited reactions
Time frame: Up to 180 days after injection
MAAEs reported up to 180 days after injection
Time frame: Throughout the study (approximately 12 months)
SAEs reported throughout the study
Time frame: AESIs reported throughout the study (approximatley 12 months)
AESIs reported throughout the study (approximately 12 months)
Time frame: Throughout the study (approximately 12 months)
AESIs reported throughout the study
Time frame: Up to 8 days after injection
Out-of-range biological test results (including shift from baseline values)
Time frame: At Day 1 and Day 29
Hemagglutinin inhibition (HAI) antibody (Ab) titers at D01 and D29
Time frame: At Day 1 and Day 29
Individual HAI Ab titer ratio D29/D01
Time frame: 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
Time frame: Day 29
HAI Ab titer ≥ 40 (1/dil) at D29
Time frame: At Day 1 and Day 29
Neutralizing Ab titers at D01 and D29
Time frame: At Day 1 and Day 29
Individual neutralizing antibodies titer ratio D29/D01
Time frame: Day 1 through Day 29
2-fold and 4-fold increase in neutralizing titers
Sanofi Pasteur, a Sanofi Company
Industry
A Phase I/II Study to Investigate the Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccines MRT5421, MRT5424, and MRT5429 in Healthy Participants Aged 18 Years and Above
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.
Published trials that share one or more normalized conditions with this study.
NCT06695130
COVID-19 Immunization, Infections
Phoenix, Arizona, United States
View Trial DetailsNCT06695117
COVID-19 Immunization, Infections
Birmingham, Alabama, United States
View Trial DetailsNCT06727058
Infections, Influenza Immunization
La Mesa, California, United States
View Trial DetailsNCT06765187
Health Volunteers, Infections
Swiftwater, Pennsylvania, United States
View Trial Details