The purpose of this study is to assess the safety, tolerability and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY-2Gen) vaccine intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups, in healthy infants 2 months of age (MoA) at enrolment.
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Percentage of participants with solicited administration site events
Timeframe: 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
Timeframe: 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)
Timeframe: 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
Timeframe: 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
Timeframe: At 1 month after the second vaccination (Day 91)
Percentage of participants with hSBA titers ≥ LLOQ for each serogroup B indicator strain
Timeframe: At pre-third vaccination (Day 301)
Percentage of participants with hSBA titers ≥ LLOQ for each serogroup B indicator strain
Timeframe: At 1 month after the third vaccination (Day 331)
hSBA geometric mean titers (GMTs) for each serogroup B indicator strain
Timeframe: At 1 month after the second vaccination (Day 91)
hSBA GMTs for each serogroup B indicator strain
Timeframe: At pre-third vaccination (Day 301)
hSBA GMTs for each serogroup B indicator strain
Timeframe: At 1 month after the third vaccination (Day 331)
Within group hSBA geometric mean ratios (GMRs) for each serogroup B indicator strain
Timeframe: 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
Timeframe: At 1 month after the second vaccination (Day 91)
Percentage of participants with hSBA titers ≥ LLOQ for each A, C, W and Y serogroup
Timeframe: At pre-third vaccination (Day 301)
Percentage of participants with hSBA titers ≥ LLOQ for each A, C, W and Y serogroup
Timeframe: At 1 month after the third vaccination (Day 331)
hSBA GMTs for each A, C, W and Y serogroup
Timeframe: At 1 month after the second vaccination (Day 91)
hSBA GMTs for each A, C, W and Y serogroup
Timeframe: At pre-third vaccination (Day 301)
hSBA GMTs for each A, C, W and Y serogroup
Timeframe: At 1 month after the third vaccination (Day 331)
Within group hSBA GMRs for each A, C, W and Y serogroup
Timeframe: At 1 month after the third vaccination (Day 331) compared to pre-third vaccination (Day 301)