TABLE 3

Strategies for demonstration of effectiveness of a CMV vaccine in clinical trials prelicensure

Prelicensure demonstration of CMV vaccine efficacy
Protection against experimental challenge (e.g., Toledo challenge studies)
Protection of toddlers against acquisition of CMV infection in group day care
Protection of mothers (parents?) against acquisition of CMV infection from their children attending group day care
Protection of SOT/HSCT patients against acquisition of CMV/reactivation/CMV DNAemia/antiviral therapy/complications of transplantation
Protection of adolescents/young adults against acquisition of CMV infection
Cohort study in women prior to establishment of pregnancy for protection against:
    Congenital CMV infections
    Congenital CMV-associated disease in infants
Combination of human clinical trial data with animal studies of vaccine protection against congenital CMV transmission (FDA Animal Rule)