mRNA-1018 for H5N8
BiologicalSterile liquid for injection
NCT Number: NCT05972174
The purpose of this Phase 1/2 study is to generate sufficient safety and immunogenicity data of mRNA-1018 pandemic influenza candidate vaccines in healthy adults ≥18 years of age to enable the initiation of a large Phase 3 trial with one selected vaccine candidate. The study will be conducted in 2 Parts (Part A and Part B) that will enroll and run concurrently. Part A of the study will evaluate 4 vaccine candidates (H5N8, H7N9, H5 only, and H7 only). Part B of the study will evaluate a single vaccine candidate (H5 only-CG).
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Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Royal Victoria Infirmary, Newcastle upon Tyne, England, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other inclusion/exclusion criteria may apply.
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Time frame: Up to Day 29 (7 days after each injection)
Time frame: Up to Day 43 (21 days after each injection)
Time frame: Day 1 to Day 205 (end of study [EoS])
Time frame: Day 1 to Day 205 (EoS)
Time frame: Day 1 to Day 205 (EoS)
Time frame: Day 1 to Day 205 (EoS)
Time frame: Days 22, 29, and 43
Time frame: Baseline (Day 1), Days 22, 29, and 43
Time frame: Baseline (Day 1) to Days 22, 29, and 43
Seroconversion is defined as a Day 22, 29, or 43 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: Days 22, 29, and 43
Time frame: Days 22, 29, and 43
Time frame: Baseline (Day 1), Days 22, 29, and 43
Time frame: Baseline (Day 1) to Days 22, 29, and 43
Number of participants with a change in the Days 22, 29, or 43 NAI titer of at least 2-/3-/4-fold rise, defined as ≥2-/3-/4-fold of the lower level of quantitation (LLOQ) if the Day 1 titer is <LLOQ; or ≥2-/3-/4-fold of the Day 1 titer if the Day 1 titer is ≥LLOQ.
ModernaTX, Inc.
Industry
Phase 1/2, Randomized, Observer-Blind, Parallel, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults ≥18 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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