Washington University in St. Louis
St Louis, Missouri, 63110, United States
NCT Number: NCT05606965
The main purpose of the study is to evaluate the safety, reactogenicity, and the humoral immunogenicity of mRNA-1010 and comparator influenza vaccines against homologous influenza A and B strains at Day 29.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 2
St Louis, Missouri, 63110, United States
The study consists of 3 parts. Part A of the study was conducted for the 2022-23 influenza season. Part B of the study was conducted in 2023-24 influenza season. Part C of the study will be conducted in 2024-25 influenza season.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria apply.
Sterile liquid for injection
Sterile suspension for injection
Other names: Fluarix®
Sterile injectable emulsion
Other names: Fluad®
Sterile suspension for injection
Other names: Fluzone®
Sterile liquid for injection
Sterile liquid for injection
Time frame: Up to Day 7 (7 days after vaccination)
Time frame: Up to Day 28 (28 days after vaccination)
Time frame: Day 1 through Day 181
Time frame: Day 29
Time frame: Day 29
Time frame: Baseline, Day 29
Time frame: Baseline, Day 29
Time frame: Day 29
Seroresponse is defined as a Day 29 titer > 1:40 if baseline is < 1:10 or a minimum 4-fold rise if baseline is >1:10 in anti-HA antibodies measured by HAI assay.
Time frame: Day 29
Seroresponse is defined as post-baseline titer ≥4-fold if baseline is ≥LLOQ or ≥4×LLOQ if baseline titer is <LLOQ in neutralizing antibody titers measured by RSV neutralization assay, at Day 29.
Time frame: Days 121 and 181
Time frame: Days 57, 121, and 181
Time frame: Baseline, Days 121 and 181
Time frame: Baseline, Days 57, 121, and 181
Time frame: Days 57, 121, and 181
Seroresponse is defined as a Day 57, 121, or 181 titer > 1:40 if baseline is < 1:10 or a minimum 4-fold rise if baseline is >1:10 in anti-HA antibodies measured by HAI assay.
Time frame: Days 57, 121, and 181
Seroresponse is defined as post-baseline titer ≥4-fold if baseline is ≥LLOQ or ≥4×LLOQ if baseline titer is <LLOQ in neutralizing antibody titers measured by RSV neutralization assay, at Days 57, 121, or 181.
ModernaTX, Inc.
Industry
Phase 2, Open-Label Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 and Comparator Seasonal Influenza Vaccines in Healthy Adults
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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