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

  • STATUS
    Not Recruiting
  • participants needed
    2100
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 20 June 2021
Investigator
Toll Free Number
Primary Contact
Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0187) (1.5 mi away) Contact
+95 other location

Summary

This study will evaluate the safety, tolerability, and efficacy of Human Cytomegalovirus (CMV) vaccine V160 administered in a 2-dose or 3-dose regimen in healthy seronegative women 16 to 35 years of age. Participants will receive 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 will be followed to approximately Month 36. The primary hypothesis of the study is that administration of a 3-dose regimen of V160 will reduce the incidence of primary CMV infection compared to placebo.

Details
Condition Cytomegalic Inclusion Disease
Treatment Placebo, V160
Clinical Study IdentifierNCT03486834
SponsorMerck Sharp & Dohme Corp.
Last Modified on20 June 2021

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