V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002)
Status:
Completed
Trial end date:
2021-06-30
Target enrollment:
Participant gender:
Summary
This study evaluated the safety, tolerability, and efficacy of the cytomegalovirus (CMV)
vaccine (V160) administered in a 2-dose or 3-dose regimen to healthy seronegative women 16 to
35 years of age. Participants received blinded V160 on Day 1, Month 2, and Month 6 (3-dose
regimen), V160 on Day 1 and Month 6 and placebo at Month 2 (2-dose regimen), or placebo on
Day 1, Month 2, and Month 6, and were followed to approximately Month 24. The primary
hypothesis of the study was that administration of a 3-dose regimen of V160 will reduce the
incidence of primary CMV infection compared to placebo.