Determine the appropriate age for a second immunization against MenC, an intervention study among Ducth adolescents.
Completed
- Conditions
- To determine the appropriate age during adolescence (10, 12 or 15 years) for a second Meningococcal serogroup C conjugate vaccination, the quality and quantity of the MenC-PS specific antibody response after the MenCC vaccination are studied.
- Registration Number
- NL-OMON26279
- Lead Sponsor
- ational Institute for Public Health and Environment (RIVM, Bilthoven, The Netherlands)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 268
Inclusion Criteria
Healthy children aged 10, 12 or 15 years Vaccinated according to the Dutch National Immunization Programme (NIP) Vaccinated (primed) with Meningococcal C conjugated vaccine one time at a young age.
Exclusion Criteria
1. Severe acute (infectious) illness or fever (>38.5 degrees C) within 14 days before vaccination;
2. Antibiotic use within 14 days of enrollment;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess serum bactericidal antibody assay (SBA) levels at T0 and at 1 month (T1) and 1 year (T2) after the second MenCC vaccination and determine whether there is a difference between the different age groups in the levels and the proportion of participants that have an SBA level of ¡Ý8 (persistence of vaccine induced protective antibody levels). <br>To asses SBA levels 3 years after vaccination and to estimate long-term protection.
- Secondary Outcome Measures
Name Time Method