Early protection against meningococcal disease B in infants

Phase 4

• Conditions: Meningococcal disease B; Infections and Infestations; Meningococcal infection, unspecified

• Registration Number: ISRCTN52318758
• Lead Sponsor: St George's, University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-16
• Last Update Posted: 9 September 2024
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 221

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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):<br>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). <br>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)