Full name
A Phase II, Randomized, Partially Blinded Study to Assess the Safety, Tolerability and Immunogenicity of Meningococcal Combined ABCWY Vaccine When Administered to Healthy Infants
NCT Number
NCT05082285
Geography
Non-US
Locations
Dominican Republic, Finland, Germany, Honduras, Israel, Poland, South Africa, Spain, United Kingdom
Primary Endpoints
- Percentage of participants with solicited administration site events. During the 7 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1 and 61 and Day 301)
- Percentage of participants with solicited systemic events. During the 7 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1 and 61 and Day 301)
- Percentage of participants with any unsolicited adverse events (AEs), including all medically attended adverse events (MAEs), serious adverse events (SAEs), AEs leading to withdrawal, and adverse events of special interest (AESIs). During the 30 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1 and 61 and Day 301)
- Percentages of participants with MAEs, SAEs, AEs leading to withdrawal, and AESIs. During the study period (Day 1 through Day 481)
- Percentage of participants with human serum bactericidal assay (hSBA) titers ≥ lower limit of quantitation (LLOQ) for each serogroup B indicator strain. At 1 month after the second vaccination (Day 91)
- Percentage of participants with hSBA titers ≥ LLOQ for each serogroup B indicator strain. At pre-third vaccination (Day 301)
- Percentage of participants with hSBA titers ≥ LLOQ for each serogroup B indicator strain. At 1 month after the third vaccination (Day 331)
- hSBA geometric mean titers (GMTs) for each serogroup B indicator strain. At 1 month after the second vaccination (Day 91)
- hSBA GMTs for each serogroup B indicator strain. At pre-third vaccination (Day 301)
- hSBA GMTs for each serogroup B indicator strain. At 1 month after the third vaccination (Day 331)
- Within group hSBA geometric mean ratios (GMRs) for each serogroup B indicator strain. At 1 month after the third vaccination (Day 331) compared to pre-third vaccination (Day 301)
- Percentage of participants with hSBA titers ≥ LLOQ for each A, C, W and Y serogroup. At 1 month after the second vaccination (Day 91)
- Percentage of participants with hSBA titers ≥ LLOQ for each A, C, W and Y serogroup. At pre-third vaccination (Day 301)
- Percentage of participants with hSBA titers ≥ LLOQ for each A, C, W and Y serogroup. At 1 month after the third vaccination (Day 331)
- hSBA GMTs for each A, C, W and Y serogroup. At 1 month after the second vaccination (Day 91)
- hSBA GMTs for each A, C, W and Y serogroup. At pre-third vaccination (Day 301)
- hSBA GMTs for each A, C, W and Y serogroup. At 1 month after the third vaccination (Day 331)
- Within group hSBA GMRs for each A, C, W and Y serogroup. At 1 month after the third vaccination (Day 331) compared to pre-third vaccination (Day 301)
External Link
https://clinicaltrials.gov/study/NCT05082285
Order
2
Disease
Version
Phase
2