This study includes 3 parts: Parts A, B, and C. The purpose of this study is to evaluate the immunogenicity and safety of mRNA-1010 seasonal influenza vaccine in adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
8,411
Sterile liquid for injection
Sterile suspension for injection
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibody Levels as Measured by Hemagglutination Inhibition (HAI)
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria and Yamagata strains. Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5\*LLOQ. Values greater than the upper limit of quantification (ULOQ) were converted to the ULOQ.
Time frame: Day 29
Percentage of Participants Reaching Seroconversion, as Measured by HAI
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria and Yamagata strains. Seroconversion rate was defined as the percentage of participants with either a Baseline HAI titer \<1:10 and a postbaseline titer ≥1:40 or a Baseline HAI titer ≥1:10 and a minimum 4-fold rise in postbaseline HAI antibody titer. Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were converted to the ULOQ.
Time frame: Day 29
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Solicited ARs, representative of vaccine reactogenicity, were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Per prespecified analysis, only solicited ARs that were assessed and confirmed by the Investigator as both serious and related to IP were recorded as an adverse event. These adverse events were recorded as a serious AE (SAE) and are included in the summary of SAEs in the "Reported Adverse Events" section.
Time frame: Up to 7 days after study injection
Number of Participants With Unsolicited Adverse Events (AEs)
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Unsolicited AEs included any AE not collected as a solicited AR, and also included solicited ARs assessed and confirmed as both serious and related by the Investigator. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
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Pinnacle Research Group
Anniston, Alabama, United States
North Alabama Research Center LLC
Athens, Alabama, United States
Cullman Research Center
Cullman, Alabama, United States
Medical Affiliated Research Center Inc
Huntsville, Alabama, United States
Desert Clinical Research - CCT
Mesa, Arizona, United States
Foothills Research Center - CCT
Phoenix, Arizona, United States
Fiel Family & Sports Medicine - PC - CCT
Tempe, Arizona, United States
Noble Clinical Research
Tucson, Arizona, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
Velocity Clinical Research, Banning
Banning, California, United States
...and 93 more locations
Time frame: Up to 28 days after study injection
Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), SAEs, and AEs Leading to Discontinuation
An MAAE was an AE that led to an unscheduled visit to a healthcare practitioner. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Time frame: Day 1 through Day 181
Percentage of Participants With HAI Titer ≥1:40
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria and Yamagata strains.
Time frame: Day 29
Geometric Mean Fold-Rise (GMFR) of Postinjection Anti-HA Antibodies for Influenza, as Measured by HAI Assay
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria and Yamagata strains. The GMFR measured the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% confidence interval (CI) for GMFR was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
Time frame: Baseline (Day 1) to Day 29