The purpose of the study is to evaluate the immunogenicity, reactogenicity, and safety of mRNA-1083 in adults 50 years of age and older in participating countries (Japan, Taiwan, and South Korea).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
2,457
Suspension for injection
0.9% sodium chloride suspension for injection
Aqueous injectable (SC) or suspension for injection (IM)
Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay
Time frame: Day 29
GM Level of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA)
Time frame: Day 29
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Day 1 through 7 days after study injection
Number of Participants With Unsolicited Adverse Events (AEs)
Time frame: Day 1 through 28 days after study injection
Number of Participants With Medically Attended Adverse Events (MAAEs)
Time frame: Day 1 though Day 181
Number of Participants With Adverse Events of Special Interest (AESIs)
Time frame: Day 1 though Day 181
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Day 1 through Day 181
Number of Participants With AEs Leading to Discontinuation
Time frame: Day 1 through Day 181
Influenza: Percentage of Participants with Seroconversion, as Measured by HAI Assay
Seroconversion is defined as a Day 29 post-injection level ≥1:40 if baseline is \<1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.
Time frame: Day 29
SARS-CoV-2: Percentage of Participants with Seroresponse, as Measured by PsVNA
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Suspension for injection
Public Health Association.Inc.
Nagoya, Aichi-ken, Japan
Daido Clinic
Nagoya, Aichi-ken, Japan
Tenjin Sogo Clinic
Fukuoka, Fukuoka, Japan
PS Clinic - Internal medicine
Fukuoka, Fukuoka, Japan
Fukuoka Heartnet Hospital
Fukuoka, Fukuoka, Japan
Medical Coporation of Yamazaki Neurotology, Rhinolaryngology Clinical
Sapporo, Hokkaido, Japan
Motomachi Takatsuka Naika Clinic - Internal Medicine
Yokohama, Kanagawa, Japan
Sakurajyuji Medical Corporation Medimesse Sakurajyuji Clinic
Kumamoto, Kumamoto, Japan
Nishi-Kumamoto Hospital
Kumamoto, Kumamoto, Japan
Sato Hospital
Osaki-shi, Miyagi, Japan
...and 34 more locations
Seroresponse is defined as a Day 29 post-injection level ≥4-fold if baseline is ≥lower limit of quantification (LLOQ) or ≥4\*LLOQ if baseline titer is \<LLOQ in neutralizing antibody (nAb) values measured by PsVNA.
Time frame: Day 29
Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay
Time frame: Day 1, Day 29
GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA
Time frame: Day 1, Day 29