Safety, Tolerability, and Efficacy of the Human Cytomegalovirus Vaccine (V160) in Healthy Women 16 to 35 Years of Age (V160-002)

Inclusion Criteria:

- Healthy based on medical history and physical examination

- Serologically confirmed to be CMV seronegative

- Have direct exposure to young children (≤5 years of age) at home or occupationally

- Of child bearing potential

- Agrees to avoid becoming pregnant during the 6-month treatment period and for at least
4 weeks after the last dose of study drug by either 1) practicing abstinence from
heterosexual activity, or 2) use a highly-effective method of birth control (as
specified in the protocol) during heterosexual activity.

Exclusion Criteria:

- Has history of allergic reaction or anaphylactic reaction to any vaccine component
that required medical intervention

- Is currently immunocompromised or has been diagnosed as having a congenital or
acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma,
leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid
arthritis, inflammatory bowel disease, or other autoimmune condition that requires
immunosuppressive medication.

- Has a condition in which repeated venipuncture or injections pose more than minimal
risk for the participant

- A woman of childbearing potential (WOCBP) who has a positive pregnancy test at
screening or within 24 hours before the first dose of study treatment

- Has previously received a CMV vaccine

- Had any live virus vaccine administered or scheduled to be administered in the period
from 4 weeks prior to, and 4 weeks following receipt of any dose of trial vaccine

- Had any inactivated vaccine administered or scheduled within the period from 14 days
prior to, through 14 days following, any dose of trial vaccine

- Had administration of any immune globulin or blood product within 90 days prior to
injection with V160/placebo or scheduled within 30 days thereafter

- Received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of
prednisone or ≥20 mg/d for persons weighing >10 kg) for ≥14 consecutive days and has
not completed treatment at least 30 days prior to trial entry

- Received systemic corticosteroids exceeding physiologic replacement doses (≈5 mg/d
prednisone equivalent) within 14 days prior to the first vaccination (participants
using inhaled, nasal, or topical steroids are considered eligible for the trial)

- Received any anti-viral agent with proven or potential activity against CMV two weeks
prior to vaccination or is likely to receive such an agent within 2 weeks after
vaccination

- Receiving or has received in the year prior to enrollment immunosuppressive therapies
or other therapies used for solid organ/cell transplant, radiation therapy,
immunosuppressive/cytotoxic immunotherapy, chemotherapy and other immunosuppressive
therapies known to interfere with the immune response. Topical tacrolimus is allowed
provided that it is not used within 2 weeks prior to, or 2 weeks following a V160 dose

- Participated in another clinical trial in the past 4 weeks, or plans to participate in
a treatment-based trial or a trial in which an invasive procedure is to be performed
while enrolled in this trial

- Plans donation of eggs at any time from signing the informed consent through 1 month
after receiving the last dose of the trial V160/placebo.