mRNA-1083
BiologicalSuspension for injection
NCT Number: NCT06694389
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).
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Notify Me50 year and older
All sexes
Interventional
Phase 3
Daido Clinic, Nagoya, Aichi-ken, Japan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined inclusion/exclusion criteria may apply.
Suspension for injection
0.9% sodium chloride suspension for injection
Aqueous injectable (SC) or suspension for injection (IM)
Other names: Influenza HA, Biken, and, Fluarix tetra
Suspension for injection
Other names: mRNA-1273
Time frame: Day 29
Time frame: Day 29
Time frame: Day 1 through 7 days after study injection
Time frame: Day 1 through 28 days after study injection
Time frame: Day 1 though Day 181
Time frame: Day 1 though Day 181
Time frame: Day 1 through Day 181
Time frame: Day 1 through Day 181
Time frame: Day 29
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
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 1, Day 29
Time frame: Day 1, Day 29
ModernaTX, Inc.
Industry
A Phase 3, Randomized, Observer-Blind, Active-Control Study to Evaluate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adults ≥50 Years of Age
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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