Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03486834 | V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002) | PHASE2 | COMPLETED | 2,200 | — | — | Apr 30, 2018 | Jun 30, 2021 | Jan 23, 2024 | 95 | United States, Australia +5 |
Cytomegalovirus infection (CMVi) was defined as the detection of wild-type cytomegalovirus (CMV) (non vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. CMVi cases in the 3-dose regimen and placebo groups were reported and incidence rate (per 100 person-years) calculated based on follow-up time starting at 4 weeks post last dose (Month 7) through approximately Month 24 (or time point to reach required cases for assessment). The percent reduction in CMVi incidence rate in the 3-dose regimen group compared to the placebo group was assessed.
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Following vaccination with V160 or placebo, the number of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and pain.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Following vaccination with V160 or placebo, the number of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, joint pain/arthralgia, muscle pain/myalgia, and headache.
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following vaccination with V160 or placebo, the number of participants with vaccine-related serious adverse events was assessed.
| Arm | Type | Description |
|---|---|---|
| V160 3-Dose Regimen | EXPERIMENTAL | Participants received 3 doses of vaccine V160 (100 Units/0.5 mL dose with Merck aluminum phosphate adjuvant \[MAPA\], 4°C stable formulation) administered by intramuscular (IM) injection on Day 1, Month 2, and Month 6. |
| V160 2-Dose Regimen | EXPERIMENTAL | Participants received 2 doses of vaccine V160 (100 Units/0.5 mL dose with MAPA, 4°C stable formulation) administered IM on Day 1 and Month 6 and a placebo-saline solution at Month 2. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo (saline solution) by IM injection on Day 1, Month 2, and Month 6. |
| Name | Type | Description |
|---|---|---|
| V160 | BIOLOGICAL | V160 was administered as a 0.5 mL (100 Units/0.5 mL dose with Merck aluminum phosphate adjuvant \[MAPA\], 4°C stable formulation) IM injection. |
| Placebo | DRUG | Saline solution administered as a 0.5 mL IM injection |
Inclusion Criteria: * Healthy based on medical history and physical examination. * Serologically confirmed to be CMV seronegative prior to receiving the first dose of V160/placebo * Have direct exposure to young children (≤5 years of age) at home or occupationally * Of childbearing potential * Agre...