mRNA-1010
BiologicalSterile liquid for injection
NCT Number: NCT05585632
The primary goal of this study is to evaluate the safety and reactogenicity of multi-component vaccines mRNA-1045 (Influenza and RSV) and mRNA-1230 (influenza, RSV, and SARS-CoV-2) compared with mRNA-1010 (influenza), mRNA-1345 (RSV), and mRNA-1273.214 (SARS-CoV-2) vaccines in healthy older participants.
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Notify Me50 year–75 year
All sexes
Interventional
Phase 1
Paratus Clinical Research Western Sydney, Blacktown, New South Wales, Australia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Note: Other inclusion and exclusion criteria may apply.
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Formulation for injection
Formulation for injection
Time frame: Up to Day 8 (7 days post vaccination)
Time frame: Up to Day 29 (28 days post vaccination)
Time frame: Day 1 through Day 361
Time frame: Day 1 through Day 361
Time frame: Day 1 through Day 361
Time frame: Day 1 through Day 361
Time frame: Baseline (Day 1), Day 29
Time frame: Baseline (Day 1), Day 29
Time frame: Baseline (Day 1), Day 29
Time frame: Baseline (Day 1), Day 29
Time frame: Baseline (Day 1), Day 29
Time frame: Baseline (Day 1), Day 29
Time frame: Baseline (Day 1) to Day 29
Seroconversion is defined as a Day 29 titer ≥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: Baseline (Day 1) to Day 29
Seroresponse is defined as a Day 29 titer ≥4-fold if baseline is ≥lower limit of quantification (LLOQ) or ≥4*LLOQ if baseline titer is <LLOQ in nAb titers measured by PsVNA (or binding antibody assay).
Time frame: Baseline (Day 1) to Day 29
Seroresponse is defined as a Day 29 titer ≥4-fold if baseline is ≥LLOQ or ≥4*LLOQ if baseline titer is <LLOQ in nAb titers measured by RSV neutralization assay.
ModernaTX, Inc.
Industry
Phase 1, Randomized, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Multi-component Vaccines mRNA-1045 (Influenza and RSV) or mRNA-1230 (Influenza, RSV, and SARS-CoV-2) Compared With mRNA-1010 (Influenza), mRNA-1345 (RSV), and mRNA-1273.214 (SARS-CoV-2) Vaccines in Healthy Adults 50-75 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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