The main objective of this trial is to evaluate the safety and immunogenicity of mRNA-1189 after intradermal and intramuscular delivery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
120
Sterile liquid for injection
Nucleus Network
Melbourne, Victoria, Australia
RECRUITINGDoherty Clinical Trials
Melbourne, Victoria, Australia
NOT_YET_RECRUITINGNumber of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to Day 64 (7-day follow-up after vaccination)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to Day 85 (28-day follow-up after vaccination)
Number of Participants with Medically Attended Adverse Events (MAAEs)
Time frame: Day 1 up to Day 225
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)
Time frame: Day 1 to end of study (EOS) (Day 225)
Geometric Mean Titer of Antigen-Specific Binding Antibody (bAb)
Time frame: Days 1 and 85
Geometric Mean Fold Rise (GMFR) of Antigen-Specific bAb
Time frame: Day 85
Number of Participants With Seroconversion of Antigen-Specific bAbs
Time frame: Day 85
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