About this trial
The main objective of this trial is to evaluate the safety and immunogenicity of mRNA-1189 after intradermal and intramuscular delivery.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy as determined by medical evaluation including medical history and physical examination.
Participants who are assigned female at birth or could become pregnant are eligible to participate if the participant is not pregnant or breast/chest feeding.
Disqualifiers
Have undergone surgical procedures within 7 days prior to Day 1 or Day 57 or are scheduled to undergo a surgical procedure within 28 days after study intervention administration.
Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infectious disease.
Received corticosteroids at ≥10 milligrams per day (mg/day) of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study.
Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses, within 180 days prior to Day 1 or plans to do so during the study.
Trial design
Parallel
Treatments tested in this trial
mRNA-1189
Biological/VaccineSterile liquid for injection
Treatment groups
Trial outcomes
Primary outcomes
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Number of Participants with Unsolicited Adverse Events (AEs)
Number of Participants with Medically Attended Adverse Events (MAAEs)
Number of Participants With Serious Adverse Events (SAEs), Any AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine and AEs of Special Interest (AESIs)
Secondary outcomes
Geometric Mean Titer of Antigen-Specific Binding Antibody (bAb)
Geometric Mean Fold Rise (GMFR) of Antigen-Specific bAb
Number of Participants With Seroconversion of Antigen-Specific bAbs
Sponsors and contacts
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