The main purpose of this study is to evaluate the efficacy of mRNA 1647 vaccine in CMV-seronegative female participants and to evaluate the safety and reactogenicity of mRNA-1647 vaccine in all participants. The purpose of the Phase 3 extension substudy is to extend the observation period of the main study and to assess the longer-term immunogenicity, efficacy, and safety of the mRNA-1647 vaccine against primary CMV infection in healthy females who were CMV-seronegative at Baseline of the mRNA-1647-P301 main study (including participants who remain CMV-seronegative upon entry into the extension substudy and participants who seroconverted during the main study). The extension substudy will also evaluate the immune persistence and safety of mRNA-1647 in a subset of female participants who were CMV-seropositive at Baseline of the main study. No interventional vaccine will be administered in the extension substudy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
7,454
Lyophilized product that is reconstituted with 0.9% sodium chloride (normal saline)
0.9% sodium chloride (normal saline) injection
Central Research Associates Inc
Birmingham, Alabama, United States
Accel Research Site - Achieve - Birmingham - ERN - PPDS
Birmingham, Alabama, United States
SEC Clinical Research LLC - Dothan - ClinEdge - PPDS
Dothan, Alabama, United States
Lakeview Clinical Research
Guntersville, Alabama, United States
Chandler Clinical Trials, LLC
Chandler, Arizona, United States
Seroconversion From a Negative to a Positive Result for Serum Immunoglobulin G (IgG) Against Antigens not Encoded by mRNA-1647
Time frame: Day 197 (28 days after the third injection) up to Day 887 (24 months after the third injection)
Number of Participants With Solicited Adverse Reactions (ARs)
Time frame: Up to 176 days (7 days after each injection)
Number of Participants With Unsolicited Adverse Events (AEs)
Time frame: Up to 197 days (28 days after each injection)
Number of Participants With Medically-Attended Adverse Events (MAAEs)
Time frame: Day 1 through 6 months after the last injection (up to 347 days)
Number of Participants With Adverse Event of Special Interests (AESIs) and Serious Adverse Events (SAEs)
Time frame: Day 1 through Month 30
Geometric Mean Titers (GMTs) of Antigen-Specific Neutralizing Antibody (nAb)
Time frame: Month 30 up to Month 54
Geometric Mean Concentration (GMC) of Binding Antibody
Time frame: Month 30 up to Month 54
Seroconversion From a Negative to a Positive Result for Serum IgG Against Antigens not Encoded by mRNA-1647
Time frame: Month 30 up to Month 54
Number of Participants With Systemic Viral Dissemination
Time frame: Month 30 up to Month 54
GMTs of Antigen-Specific nAb
Time frame: Day 1, Months 3, 7, 12, 18, 24, and 30
GMC of Antigen-Specific Binding Antibody
Time frame: Day 1, Months 3, 7, 12, 18, 24, and 30
Number of Participants with AEs leading to Study Discontinuation, SAEs and Deaths
Time frame: Month 30 up to Month 54
Number of Participants With Systemic Viral Dissemination
Time frame: Day 1 through Month 30
Number of Participants With Positive Urine CMV Polymerase Chain Reaction (PCR) Results Post Seroconversion
Time frame: Day 1 through Month 30
Number of Participants With Positive Urine CMV PCR Results Post Seroconversion
Time frame: Month 30 up to Month 54
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Arizona Clinical Trials
Mesa, Arizona, United States
Phoenix Clinical LLC
Phoenix, Arizona, United States
MedPharmics, LLC
Phoenix, Arizona, United States
Hope Research Institute LLC
Phoenix, Arizona, United States
Hope Research Institute LLC
Phoenix, Arizona, United States
...and 286 more locations