The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of different dose levels of messenger ribonucleic acid (mRNA) vaccine encoding influenza hemagglutinin compared to an active control quadrivalent recombinant influenza vaccine (RIV4) in adults 18 years of age and older. Study details include: Study Duration: approximately 6 months Treatment Duration: 1 injection of mRNA vaccine encoding influenza hemagglutinin encoding influenza hemagglutinin or control. Visit Frequency: Screening visit, Day 01, Day 02, Day 03, Day 09, Day 29, Day 91, Day 181
Approximately 6 months
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
388
Pharmaceutical form:Solution for injection-Route of administration:IM injection
Pharmaceutical form:Solution for injection-Route of administration:IM injection
Peninsula Research Associates Site Number : 8400013
Rolling Hills Estates, California, United States
Optimal Research Site Number : 8400026
San Diego, California, United States
AMR Coral Gables/Miami, Formerly Clinical Research of South Florida, an AMR company (Clinic) Site Number : 8400004
Coral Gables, Florida, United States
Research Centers of America Site Number : 8400003
Hollywood, Florida, United States
Meridian Clinical Research, LLC Site Number : 8400016
Savannah, Georgia, United States
AES Peoria Site Number : 8400017
Peoria, Illinois, United States
AMR El Dorado Site Number : 8400009
El Dorado, Kansas, United States
AMR - Newton Site Number : 8400005
Newton, Kansas, United States
AMR Wichita West Site Number : 8400030
Wichita, Kansas, United States
AMR Lexington Site Number : 8400014
Lexington, Kentucky, United States
...and 10 more locations
Presence of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after injection
Number of participants with unsolicited systemic immediate adverse events (AEs)
Time frame: Within 30 minutes after injection
Presence of solicited injection site reactions (ie, pre listed in the participant's diary card [DC] and in the electronic case report form [eCRF]) occurring up to 7 days after injection
Number of participants with solicited injection site reactions
Time frame: Up to 7 days after injection
Presence of solicited systemic reactions (ie, pre-listed in the participant's DC and in the eCRF) occurring up to 7 days after injection
Number of participants with solicited systemic reactions
Time frame: Up to 7 days after injection
Presence of unsolicited AEs reported up to 28 days after injection
Number of participants with unsolicited AEs
Time frame: Up to 28 days after injection
Presence of medically attended AEs (MAAEs) reported up to 28 days after injection
Number of participants with medically attended adverse events (MAAE)s
Time frame: Up to 28 days after injection
Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study
Number of participants with serious adverse events (SAEs)
Time frame: From baseline up to 6 months
Presence of out-of-range biological test results (including shift from baseline values) up to 28 days after injection
Number of participants with out-of-range biological test results
Time frame: Up to 28 days after injection
Hemagglutination inhibition (HAI) antibody (Ab) titers to homologous H3 strain at D29, D91, and D181
Antibody titers are expressed as Geometric Mean Titers (GMTs)
Time frame: At Day 29, Day 91, and Day 181
Individual HAI Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29
Ratios of antibody titers measured by HAI in each group before and after vaccination
Time frame: From baseline up to 6 months
HAI Ab titer ≥ 40 [1/dil] at D29, D91, and D181
Time frame: At Day 29, Day 91 and Day 181
2-fold and 4-fold rise in HAI titers from D01 to D91 and D01 to D181
Time frame: From Day 01 through Day 91 and Day 01 through Day 181
Neutralizing Ab titers to homologous H3 strain at D29, D91, and D181
Time frame: At Day 29, Day 91, and Day 181
Individual neutralizing Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29
Time frame: From baseline up to 6 months
2-fold and 4-fold rise in neutralizing titers from D01 to D91 and D01 to D181
Time frame: From Day 01 through Day 29 and Day 01 through Day 181
HAI Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181
Time frame: At Day 01, Day 29, D91 and D181
Neutralizing Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181
Time frame: At Day 01, Day 29, Day 91, and Day 181
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