The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1010, and to evaluate relative vaccine efficacy (rVE) of mRNA-1010 versus an active comparator against reverse transcription polymerase chain reaction (RT-PCR)-confirmed protocol-defined influenza-like illness (ILI) caused by any influenza A or B strains.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
40,805
Intramuscular (IM) injection
IM injection
IM injection
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Solicited ARs were recorded daily using electronic diaries (eDiaries). 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. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of all Serious Adverse Events (SAEs) and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Time frame: Day 1 up to Day 7
Number of Participants With Unsolicited Adverse Events (AEs)
An unsolicited AE was defined as any AE reported by the participant that was not specified as a solicited AR in the protocol. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Time frame: Day 1 up to Day 28
Number of Participants With Medically Attended AEs (MAAEs), AEs Leading to Study Discontinuation, SAEs, or Adverse Events of Special Interests (AESIs)
MAAEs were AEs that led to an unscheduled visit to a healthcare provider. SAEs were AEs that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was a medically important event. AESIs were AEs (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. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Time frame: Day 1 up to Day 181
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IM injection
IM injection
Pinnacle Research Group, Llc
Anniston, Alabama, United States
North Alabama Research Center, LLC
Athens, Alabama, United States
Flourish Research
Birmingham, Alabama, United States
EmVenio Research Brimingham, AL
Birmingham, Alabama, United States
Cullman Clinical Trials
Cullman, Alabama, United States
Optimal Research
Huntsville, Alabama, United States
Velocity Clinical Research
Mobile, Alabama, United States
Lenzmeier Family Medicine
Glendale, Arizona, United States
DM Clinical Research
Phoenix, Arizona, United States
Helios Clinical Research
Phoenix, Arizona, United States
...and 291 more locations
Number of Participants With First Episode of Reverse Tanscription Polymerase Chain Reaction (RT-PCR) Confirmed Protocol Defined Influenza-like Illness (ILI) Caused by Any Influenza A or B Strains
Protocol-defined ILI: At least 1 systemic symptom (temperature \>37.2 degrees celsius \[°C\] \[\>99.0 degrees Fahrenheit {°F}\], chills, feverish, tiredness, headaches, or myalgia) and at least 1 respiratory symptom (sore throat, cough, sputum production, wheezing, or difficulty breathing).
Time frame: Day 14 up to end of influenza season (up to 7.5 months)
Number of Participants With First Episode of RT-PCR Confirmed Modified United States (US) Centers for Disease Control and Prevention (CDC)-Defined ILI Caused by Any Influenza A or B Strains
Modified CDC-defined ILI: Body temperature ≥37.2°C (≥99.0°F) accompanied by cough and/or sore throat.
Time frame: Day 14 up to end of influenza season (up to 7.5 months)
Number of Participants With First Episode of RT-PCR-confirmed Protocol-defined ILI or Modified CDC-defined ILI Caused by Any Influenza A or B Strains With Antigenic Match to the Vaccine Strains
Protocol-defined ILI: At least 1 systemic symptom (temperature \>37.2°C \[\>99.0°F\], chills, feverish, tiredness, headaches, or myalgia) and at least 1 respiratory symptom (sore throat, cough, sputum production, wheezing, or difficulty breathing). Modified CDC-defined ILI: Body temperature \>37.2°C (\>99.0°F) accompanied by cough and/or sore throat. The confirmed RT-PCR test of influenza A or B strains with antigentic match to the vaccine strains.
Time frame: Day 14 up to end of influenza season (up to 7.5 months)
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI)
Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strain included Victoria. Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5 \* LLOQ. Values greater than upper limit of quantification (ULOQ) were converted to ULOQ. LLOQ = 10, ULOQ = 3620 for H1N1. LLOQ = 10, ULOQ = 2560 for H3N2. LLOQ = 10, ULOQ = 1356. 95% confidence interval (CI) was calculated based on the t-distribution of log-transformed values for geometric mean (GM) titer, then back transformed to original scale for presentation.
Time frame: Day 29
Number of Participants Reaching Seroconversion as Measured by HAI
Seroconversion was defined as either a Baseline HAI titer \<1:10 and a post-baseline titer ≥1:40 or a Baseline HAI titer ≥1:10 and a minimum 4-fold rise in post-baseline HAI antibody titer. Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strain included Victoria.
Time frame: Day 29
Number of Participants With an HAI Titer ≥1:40
Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strain included Victoria.
Time frame: Day 29
Geometric Mean Fold Rise (GMFR) of HAI Titers
Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strain included Victoria. 95% CI was calculated based on the t-distribution of the difference in the log-transformed values for GM fold rise, then back transformed to the original scale for presentation.
Time frame: Baseline, Day 29