Clinical Trial Search

Primary: Number of Participants With the Composite Primary Outcome — 46; 37 Participants — p=0.42

Primary: Number of Subjects With Any Cytomegalovirus (CMV) Congenital Infection — 24; 20; 4; 58 Participants

Primary: Change in Best Ear Hearing Assessments at 6 Months. — 3; 5; 37; 36 participants

Primary: Number of Ears That Had (1) Improved Hearing or no Change in Hearing (2) Worsened Hearing. — 27; 20; 1; 6 Ears — p=0.0859

Primary: Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum. — 5; 2 Participants

Primary: Number of Patients With Late CMV Disease — 0; 0 Participants

Primary: The Prevalence of CMV Shedding in Saliva, Urine and Vaginal Secretions of CMV Seropositive Women in Pregnancy — 27; 4; 16; 20 Participants

Primary: Number of Participants With Clinically Significant CMV Reactivation or CMV Disease — 62; 89; 78; 32 Participants

Primary: Time to Engraftment (Days) Stratified by CMV DNaemia Occurring Before or After Neutrophil's Engraftment — 17; 19 days

Primary: Number of Participants From Each Arm Who Received Influenza Vaccine — 33; 37; 8 Participants

Primary: Plasma Pharmacokinetics Parameters for Ganciclovir Area Under the Curve at 12 Hours (AUC12mgxh/L) — 47.2; 76.8 mgxh/L

Primary: Participants With Neurologic Impairment at 12 Months as Measured by a Bayley's Neuro-developmental Assessment (Motor Scores). — 10; 5; 0; 1 participants

Primary: Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period — 11; 14; 13; 5 Participants

Primary: Virological Response on Treatment Week 6 — 5 Participants

Primary: Number of Participants With Clinically Significant CMV Infection Through Week 24 Post-Transplant — 155; 78 Participants

Primary: Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs — 56; 41; 6 Participants

Primary: Number of Participants With a Complete Response — 8; 50 Participants

Primary: Concentrations of Antibodies Against Anti-Glycoprotein B (gB) Immunoglobulin G (IgG) — 5091.4; 5495.1; 2587.2 EL.U/mL

Primary: Number of Participants With Adverse Events — 1; 31; 1; 22 Participants

Primary: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) — 33; 59; 40; 12 Participants

Primary: a) CMV Viral Load — 100; 97.6; 86.36; NA percentage of agreement

Primary: Number of Participants With Non-Relapse Mortality — 0 Participants

Primary: Area Under the Curve (AUC) — 21.0 mcg∙h/mL

Primary: Percentage of Patients for Whom 3 or More Vaccines Can be Made — 90.9 percentage of participants

Primary: Complete Response — 20; 57 Participants

Primary: Number of Participants With Clinically Significant CMV Infection — 13; 4; 6; 4 Participants

Primary: Clinically Significant CMV Viremia for Hematopoietic Cell Transplantation/HCT Participants in the Interventional Cohort Only — 5; 0; 31; 0 Participants

Primary: Number of Participants Who Became Infected With Wild-Type Cytomegalovirus Infection Starting at 4 Weeks Post Last Dose (V160 3-dose Regimen Group and Placebo Group)…

Primary: Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant — 43.6; 23.9 Percentage of patients — p=<=0.0002

Primary: Percentage of Participants With an Adverse Event (AE) — 75.0; 92.9; 84.6; 100.0 Percentage of participants