Summary:
Click image to enlargeThis is a Phase 3 study, randomized, observer-blinded, placebo-controlled study in healthy participants 16 to 40 years of age. The primary efficacy objective is to demonstrate vaccine effect of mRNA-1647 against primary cytomegalovirus (CMV) infection in female participants who are CMV-seronegative at enrollment. Primary CMV infection is defined as seroconversion from a negative result to a positive result for serum immunoglobin G (IgG) against CMV as measured by a platform-based automated immunoassay based on at least 1 of the 4 recombinant CMV antigens not encoded by mRNA-1647 also defines as Cytomegalovirus (CMV) is a common virus. Once infected, your body retains the virus for life. Most people don't know they have CMV because it rarely causes problems in healthy people. If you're pregnant or if your immune system is weakened, CMV is cause for concern.This is why this study is very important for women and their health to prevent this happing in your body and future of your children.
Criteria:
- Is a female and 16 to 40 years of age, at the time of consent.
- For female participants aged ≥ 20 years, has or anticipates having direct exposure within 7 months after the planned first dose (in the home, socially, or occupationally) to at least 1 child ≤ 5 years of age. Direct exposure is defined as either a) participant is the parent, or b) participant has close contact (feeding, diaper changes, childcare/supervision) for at least 8 hours per week.