The primary goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1073 compared to co-administered mRNA-1010 and mRNA-1273 vaccines and to the individual vaccines alone in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
550
Research Centers of America
Hollywood, Florida, United States
AES - DRS - Optimal Research Illinois - Peoria
Peoria, Illinois, United States
Meridian
Sioux City, Iowa, United States
Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs)
Solicited ARs (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. Note, that not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of all serious AEs (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.
Time frame: Up to Day 8 (7 days post vaccination)
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. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsens from baseline and is considered clinically significant in the medical and scientific judgment of the Investigator. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study, regardless of causality, is located in the Reported "Adverse Events" section.
Time frame: Up to Day 29 (28 days post vaccination)
Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation
An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner. This would include visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or COVID-19 and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
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0.9% sodium chloride (normal saline) injection
Benchmark Research
Metairie, Louisiana, United States
Meridian
Norfolk, Nebraska, United States
Meridian
Binghamton, New York, United States
Rochester Clinical Research Inc
Rochester, New York, United States
Meridian
Cincinnati, Ohio, United States
Meridian
Cincinnati, Ohio, United States
Benchmark Research
Austin, Texas, United States
...and 4 more locations
Time frame: Up to Day 181
Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains
Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included BV and BY.
Time frame: Day 29
Geometric Mean Titer of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Time frame: Day 29
Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains
Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included BV and BY.
Time frame: Day 29
Geometric Mean Fold Rise of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For SARS-CoV-2
The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. 95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation.
Time frame: Day 29
Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains
Seroconversion at a participant level is defined as a pre-vaccination HAI titer \< 1:10 and a post-vaccination HAI titer \>= 1:40 or a pre-vaccination HAI titer \>= 1:10 and a minimum 4-fold rise in post vaccination HAI antibody titer.
Time frame: Day 29
Percentage of Participants With Seroresponse as Measured by PsVNA (or Binding Antibody Assay) For SARS-CoV-2
Seroresponse at a participant level is defined as an increase from below the lower limit of quantification (LLOQ) to \>= 4 x LLOQ if baseline neutralizing antibody (nAb) level is \< LLOQ, or \>= 4 fold rise if baseline nAb level is \>=LLOQ.
Time frame: Day 29