Full name
A Phase 1/2, First-Time-in Human (FTiH), Randomized, Observer-blind, Placebo-controlled, Dose Escalation Study to Assess Safety, Reactogenicity and Immunogenicity of a Candidate Cytomegalovirus (CMV) Vaccine Comprising Recombinant Protein and Adjuvant When Administered Intramuscularly in Healthy Adults
NCT Number
NCT05089630
Geography
US
Locations
United States
Primary Endpoints
- Number of participants reporting solicited administration site events. Within 7 days (the day of dose and 6 subsequent days) after each dose (vaccines administered on Day 1, Day 61 and Day 181)
- Number of participants reporting solicited systemic events. Within 7 days (the day of dose and 6 subsequent days) after each dose (vaccines administered on Day 1, Day 61 and Day 181)
- Number of participants reporting unsolicited adverse events (AEs) within 7 days after each dose. Within 7 days (the day of dose and 6 subsequent days) after each dose (vaccines administered on Day 1, Day 61 and Day 181)
- Number of participants reporting serious adverse events (SAEs) within 7 days after each dose. Within 7 days (the day of dose and 6 subsequent days) after each dose (vaccines administered on Day 1, Day 61 and Day 181)
- Number of participants reporting unsolicited AEs up to 30 days after each dose. Up to 30 days after each dose (vaccines administered on Day 1, Day 61 and Day 181)
- Number of participants reporting SAEs up to 30 days after each dose. Up to 30 days after each dose (vaccines administered on Day 1, Day 61 and Day 181)
- Number of participants reporting medically attended AEs (MAEs) up to 30 days after each dose. Up to 30 days after each dose (vaccines administered on Day 1, Day 61 and Day 181)
- Number of participants reporting hematological and biochemical laboratory abnormalities on Day 1. At Day 1
- Number of participants reporting hematological and biochemical laboratory abnormalities on Day 8. At Day 8
- Number of participants reporting hematological and biochemical laboratory abnormalities on Day 61. At Day 61
- Number of participants reporting hematological and biochemical laboratory abnormalities on Day 68. At Day 68
- Number of participants reporting hematological and biochemical laboratory abnormalities on Day 181. At Day 181
- Number of participants reporting hematological and biochemical laboratory abnormalities on Day 188. At Day 188
External Link
https://clinicaltrials.gov/study/NCT05089630
Order
0
Disease
Version
Phase
1/2