Table 2.

Issues to Consider: Vaccination of Women of Childbearing Age

Screen for CMV IgG antibodies

Recruit seronegatives in contact with children, contemplating pregnancy, including postpartum

Randomize to receive vaccine or placebo

Primary endpoint for phase 2: seroconversion

If phase 2 results encouraging:

Adaptive design to phase 3

Primary endpoint for phase 3: congenital infection

The trial patient information sheet may empower women to avoid exposures to CMV

Increased sample size needed for phase 2

The effect of vaccination on intrauterine transmission may be more potent than expected

Decreased sample size needed for phase 3

Plan large sample size for phase 2 + 3 and deploy DSMB with clear rules for stopping and switching phases

Recruit the seropositives and randomize them to vaccine/placebo also

Abbreviations: CMV, cytomegalovirus; DSMB, Data Safety Monitoring Board; IgG, immunoglobulin G.