The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1403, and to demonstrate the efficacy of mRNA-1403 to prevent protocol-defined moderate or severe norovirus acute gastroenteritis (AGE) associated with vaccine matched genotypes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
28,000
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Day 1 up to Day 7 (7 days after study intervention)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Day 1 up to Day 28 (28 days after study intervention)
Number of Participants with Medically Attended Adverse Events (MAAEs)
Time frame: Day 1 through Day 181
Number of Participants with Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Study Withdrawal
Time frame: Day 1 up to Day 546 (Cohort 1) and Day 365 (Cohorts 2 and 3)
Vaccine Efficacy (VE) of mRNA-1403 to Prevent First Occurrence of Protocol-defined Moderate or Severe AGE Associated with Vaccine Matched Genotypes
Time frame: Day 15 up to 6 months after the last participant dosed in each cohort
VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined Severe AGE Associated with Vaccine Matched Genotypes
Time frame: Day 15 up to 6 months after the last participant dosed in each cohort
VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined Severe Norovirus (NoV) AGE Associated with Any Genogroup I or II Norovirus (NoV) Genotype
Time frame: Day 15 up to 6 months after the last participant dosed in each cohort
VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined Moderate or Severe AGE Associated with Any Genogroup I or II NoV Genotype
Time frame: Day 15 up to 6 months after the last participant dosed in each cohort
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Accel Research Sites - Achieve Clinical Research
Birmingham, Alabama, United States
ACTIVE_NOT_RECRUITINGCullman Clinical Trials
Cullman, Alabama, United States
ACTIVE_NOT_RECRUITINGAlliance for Multispecialty Research, LLC
Daphne, Alabama, United States
ACTIVE_NOT_RECRUITINGClinMed, LLC
Phoenix, Arizona, United States
ACTIVE_NOT_RECRUITINGDM Clinical - Phoenix
Phoenix, Arizona, United States
ACTIVE_NOT_RECRUITINGHOPE Research Institute
Phoenix, Arizona, United States
ACTIVE_NOT_RECRUITINGHOPE Research Institute
Phoenix, Arizona, United States
RECRUITINGAbby's Research Institute
Phoenix, Arizona, United States
ACTIVE_NOT_RECRUITINGHeadlands Research Scottsdale
Scottsdale, Arizona, United States
ACTIVE_NOT_RECRUITINGScottsdale Clinical Trials
Scottsdale, Arizona, United States
ACTIVE_NOT_RECRUITING...and 273 more locations
VE of mRNA-1403 to Prevent First Occurrence of Protocol-defined AGE of Any Severity Associated with Vaccine Matched NoV Genotypes
Time frame: Day 15 up to 6 months after the last participant dosed in each cohort
VE of mRNA-1403 to Prevent Any Occurrence of Medically Attended AGE Associated with Vaccine Matched NoV Genotypes, as well as any Genogroup I or II NoV Genotype
Time frame: Day 15 up to Day 546 (Cohort 1) and Day 365 (Cohorts 2 and 3)
VE of mRNA-1403 to Prevent Any Occurrence of AGE Hospitalizations Associated With Vaccine Matched NoV Genotypes, as well as any Genogroup I or II NoV Genotype
Time frame: Day 15 up to Day 546 (Cohort 1) and Day 365 (Cohorts 2 and 3)
VE of mRNA-1403 to Prevent Any Occurrence of Protocol-defined Moderate or Severe AGE Associated with Vaccine Matched Genotypes
Time frame: Day 15 up to Day 546 (Cohort 1) and Day 365 (Cohorts 2 and 3)
VE of mRNA-1403 to Prevent Any Occurrence of Protocol-defined AGE of Any Severity Associated with Any Genogroup I or II NoV Genotype
Time frame: Day 15 up to Day 546 (Cohort 1) and Day 365 (Cohorts 2 and 3)
Geometric Mean Titer (GMT) of Histo-blood Group Antigen (HBGA)-blocking Antibodies Titers Against Vaccine Matched Genotypes
Time frame: Day 1 and Day 29
Geometric Mean Fold Rise (GMFR) of HBGA-blocking Antibodies Titers Against Vaccine Matched Genotypes
Time frame: Day 1 and Day 29
Percentage of Participants with Seroresponse Based on HBGA-blocking Antibody Titer
Time frame: Day 29
GMT of Binding Antibody (bAb) Against Vaccine-matched NoV Genotypes
Time frame: Day 1 and Day 29
GMFR of bAb Titers
Time frame: Day 1 and Day 29
Percentage of Participants with Seroresponse Based on bAb Titer
Time frame: Day 29