Meningococcal disease B Infections and Infestations Meningococcal infection, unspecified
Conditions
Interventions
This study is an open-label, phase IV study which will recruit 220 infants from suitable participating sites.
Recruitment: A variety of recruitment strategies will be used by the different participa
Sponsors
St George's, University of London
Eligibility
Sex/Gender
All
Age
56 Days to 70 Days
Inclusion criteria
Inclusion criteria: 1. Term infants born at =37 weeks gestation 2. Aged =56 days to =70 days on the day of the first visit 3. No contraindications to vaccination according to the ‘Green Book’ 4. Willing and able to comply with study procedures 5. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Contraindication to vaccination according to the Green Book 2. Life-limiting congenital abnormality or condition 3. Prior diagnosis of an immunodeficiency syndrome 4. Previous vaccination against meningococcal disease 5. History of Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically 6. Considered unlikely to complete the expected follow up until the end of the study 7. Child in care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The immunological responses of UK infants between two different primary immunisation schedules of 4CMenB (2 and 3 versus 2 and 4 months of age): 1.1. Antibody geometric mean titers (GMTs) against relevant 4CMenB antigens (fHbp, NadA and PorA) measured by serum bactericidal assay using human complement (hSBA) 4 weeks after 2nd dose of 4CMenB (at 4 months of age for Group 1 versus 5 months of age for Group 2). 1.2. The proportion of infants with antibody titers = 1:4 against relevant 4CMenB antigens (fHbp, NadA and PorA) measured by hSBA assessed at 4 weeks after 2nd dose of 4CMenB (at 4 months of age for Group 1 versus 5 months of age for Group 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the persistence of immunological responses to 4CMenB at 12 months chronological age after two different primary immunisation schedules of 4CMenB (2 and 3 versus 2 and 4 months of age). 1.1. GMTs against relevant 4CMenB antigens (fHbp, NadA and PorA) measured by hSBA at 12 months of chronological age (pre-booster). 1.2. The proportion of infants with antibody titers = 1:4 against relevant 4CMenB antigens (fHbp, NadA and PorA) measured by hSBA at 12 months of chronological age (pre booster). 2. To compare the immunological responses one month after the 12-month 4CMenB booster in infants who received two different primary immunisation schedules of 4CMenB (2 and 3 versus 2 and 4 months of age). 2.1. GMTs against relevant 4CMenB antigens (fHbp, NadA and PorA) measured by hSBA at 13 months of chronological age (4 weeks post-booster). 2.2. The proportion of infants with antibody titers = 1:4 against relevant 4CMenB antigens (fHbp, NadA and PorA) measured by hSBA at 13 months of chronological age (4 weeks post booster). 3. To compare the persistence of immunological responses to PCV13 at 12 months chronological age after two different primary immunisation schedules of PCV13 (3 versus 4 months of age). 3.1. Serotype specific GMCs against PCV13 serotypes at 12 months of age (pre PCV13 booster). 3.2. The proportion of infants with serotype-specific GMCs = 0.35 µg/ml against PCV13 serotypes at 12 months of age (pre PCV13 booster). 4. To compare the immunological responses to the booster dose of PCV13 given at 12 months in infants who received two different primary immunisation schedules of PCV13 (3 versus 4 months of age). 5.1 Serotype specific GMCs against PCV13 serotypes at 13 months of age (4 weeks post PCV13 booster). 5.2. The proportion of infants with serotype-specific GMCs = 0.35 µg/ml against PCV13 serotypes at 13 months of age (4 weeks post PCV13 booster). | — |
Countries
England, United Kingdom
Contacts
Public ContactStudy Team
Outcome results
None listed