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About
This is a Phase I, first-in-human, randomized, modified double-blind, active-controlled, dose-escalation study to assess the safety and immunogenicity of up to 3 dose levels of mRNA NA vaccines, administered as a single IM injection in healthy adults aged 18 years and older. Two age groups, 18 to 64 years and ≥65 years, will be included in this study.
Full description
This study will include a screening visit, 6 study visits occurring on Days 1, 3, 9, 29, 91, and 181, and a safety follow-up telephone call on Day 366.
Enrollment
Sex
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Volunteers
Inclusion criteria
Aged 18 years or older on the day of inclusion.
A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours before administration of study intervention.
Informed consent form has been signed and dated.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
233 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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