The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular injection of different formulations of a hexavalent influenza messenger ribonucleic acid (mRNA) vaccine composed of differing dose levels of trivalent (TIV) mRNA hemagglutinin (HA) in combination with TIV mRNA-neuraminidase (NA) compared to an active control ((Fluzone standard-dose quadrivalent influenza vaccine (QIV-SD) or Fluzone high-dose quadrivalent influenza vaccine (QIV-HD) in adults 50 years of age and older.
Study details include the following: * Study Duration: approximately 12 months for each participant * Treatment: 1 injection of hexavalent vaccine, trivalent vaccine, or active control * Visit frequency: Day (D) 01, D03, D09, D29, and D181; D366 (telephone call) * Dose escalation with sequential enrollment of sentinel cohorts followed by parallel enrollment of the main cohort
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,162
* Pharmaceutical form: solution for injection in a vial * Route of administration: Intramuscular injection
* Pharmaceutical form: solution for injection in a vial * Route of administration: Intramuscular injection
* Pharmaceutical form: solution for injection in a vial * Route of administration: Intramuscular injection
* Pharmaceutical form: Liquid suspension for injection in pre-filled syringe * Route of administration: Intramuscular injection
* Pharmaceutical form: Liquid suspension for injection in pre-filled syringe * Route of administration: Intramuscular injection
Accel Research Sites Network - Birmingham- Site Number : 8400008
Birmingham, Alabama, United States
AMR Mobile- Site Number : 8400022
Mobile, Alabama, United States
Alliance for Multispeciality Research - Clinical Research Consortium- Site Number : 8400015
Tempe, Arizona, United States
AMR Miami- Site Number : 8400021
Coral Gables, Florida, United States
Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400003
DeLand, Florida, United States
Number of participants with immediate unsolicited systemic adverse events (AEs)
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Time frame: Within 30 minutes after injection
Number of participants with solicited injection site reactions
Solicited injection site reactions pre-listed in the participant diary and in the case report form CRF
Time frame: Up to 7 days after injection
Number of participants with solicited systemic reactions
Solicited systemic reactions pre-listed in the participant diary and in the CRF
Time frame: Up to 7 days after injection
Number of participants with unsolicited AEs
AEs that do not fulfill the conditions of solicited reactions
Time frame: Up to 28 days after injection
Number of participants with medically attended adverse events (MAAEs)
MAAEs reported up to 180 days after injection
Time frame: Up to 180 days after injection
Number of participants with serious adverse events (SAEs)
Throughout the study
Time frame: SAEs throughout the study (Up to approximately 12 months)
Number of participants with adverse events of special interest (AESIs)
Throughout the study
Time frame: AESIs throughout the study (Up to approximately 12 months)
Number of participants with out-of-range biological test results
Out-of-range biological test results (including shift from baseline values)
Time frame: Up to 8 days after injection
Hemagglutinin inhibition (HAI) titers
HAI titers at D01 and D29
Time frame: At Day 1 and Day 29
Individual HAI antibody (Ab) titer ratio D29/D01
Individual HAI Ab titer ratio D29/D01
Time frame: At Day 1 and Day 29
Seroconversion (HAI Ab titer)
Number of participants with HAI Ab titer \< 10 \[1/dil\] at Day 1 and post-injection titer ≥ 40 \[1/dil\] at Day 29, or titer ≥ 10 \[1/dil\] at Day 1 and a ≥ 4-fold increase in titer \[1/dil\] at Day 29
Time frame: At Day 1 and Day 29
HAI Ab titer ≥ 40 (1/dil)
HAI Ab titer ≥ 40 (1/dil) at D29
Time frame: At Day 29
Neuraminidase inhibition (NAI) titers
NAI titers at D01 and D29
Time frame: At Day 1 and Day 29
Individual NAI Ab titer ratio D29/D01
Individual NAI Ab titer ratio D29/D01
Time frame: At Day 1 and Day 29
Seroconversion (NAI Ab titer)
Number of participants with NAI Ab titer \< 10 \[1/dil\] at D01 and post-injection titer ≥ 40 \[1/dil\] at D29, or titer ≥ 10 \[1/dil\] at D01 and a ≥ 4-fold increase in titer \[1/dil\] at D29)
Time frame: At Day 1 and Day 29
NAI Ab titer ≥ 40 (1/dil)
NAI Ab titer ≥ 40 (1/dil) at D29
Time frame: At Day 29
2-fold and 4-fold rise in NAI titers
2-fold and 4-fold rise in NAI titers from D01 to D29
Time frame: Day 1 to Day 29
Neutralizing antibodies titers
Neutralizing antibodies titers at D01 and D29
Time frame: At Day 1 and Day 29
Individual neutralizing antibodies titer ratio
Individual neutralizing antibodies titer ratio D29/D01
Time frame: At Day 1 and Day 29
2-fold and 4-fold increase in neutralizing titers
2-fold and 4-fold increase in neutralizing titers D01 through D29
Time frame: Day 1 to Day 29
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Alliance for Multispeciality Research - Fort Myers- Site Number : 8400013
Fort Myers, Florida, United States
Accel Research Sites - Maitland- Site Number : 8400007
Maitland, Florida, United States
Innovation Medical Research Center - Palmetto Bay- Site Number : 8400011
Palmetto Bay, Florida, United States
Accel Research Site - NeuroStudies.net, LLC - ERN - PPDS- Site Number : 8400001
Decatur, Georgia, United States
AMR - Chicago- Site Number : 8400012
Oak Brook, Illinois, United States
...and 14 more locations