To evaluate immune responses of an Investigational mRNA-1273.815 vaccine against the Omicron subvariant strain (XBB.1.5) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
217
Sterile solution for injection
Commercially available formulation
Paratus Canberra
Canberra, Australian Capital Territory, Australia
Holdsworth House
Darlinghurst, New South Wales, Australia
Paratus Brisbane
Brisbane, Queensland, Australia
USC Morayfield
Morayfield, Queensland, Australia
Geometric Mean (GM) Value of Neutralizing Antibodies (nAbs) Against SARS-CoV-2-specific Strain at Day 15
Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5 \* LLOQ. Values reported greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ if actual values were not available. LLOQ was 38 arbitrary unit (AU)/milliliter (mL) and ULOQ was 6960 AU/mL. 95% confidence interval (CI) of GM value was calculated based on the t-distribution of the log-transformed values for antibodies, then back transformed to the original scale for presentation.
Time frame: Day 15
Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) of Special Interest (AESIs), and AEs Leading to Withdrawal From the Study
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/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. Number of participants with SAEs, AESIs, and AEs leading to discontinuation up to Day 15 are reported in this outcome measure. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Time frame: Day 1 through Day 15
Seroresponse Rate of nAb Against the SARS-CoV-2-specific Strain: Percentage of Participants With Seroresponse
Seroresponse at a participant level was defined as a change from baseline below the LLOQ to equal or above 4 \* LLOQ, or at least a 4-fold rise if baseline was equal to or above the LLOQ. LLOQ was 38 AU/mL.
Time frame: Day 15
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University of the Sunshine Coast, South Bank
South Brisbane, Queensland, Australia
Emeritus Melbourne
Camberwell, Victoria, Australia
AusTrials Sunshine Hospital
Melbourne, Victoria, Australia