Development of cellular immune response after infant pneumococcal conjugate vaccinations
Phase 4
Completed
- Conditions
- Immunogenicitymemory10004018
- Registration Number
- NL-OMON32887
- Lead Sponsor
- ederlands Vaccin Instituut
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Healthy children 11 or 24 months of age. The parents are willing and able to let their child participate in the trial according to the described procedures, with a a signed informed consent
The children have received (24 months old children) or will receive the Prevenar® vaccinations according to the 3+1 schedule as part of the Dutch NIP
Exclusion Criteria
Previous vaccinations with Prevenar using a schedule that differs from the National Immunisation Program (3+1 schedule) or with other pneumoccocal vaccines.
Presence of a serious disease that can interfere with the results of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Cellular immunogenicity (plasmacells and memory B-cells frequencies)</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Geometric mean titres (GMT)<br /><br>• Avidity<br /><br>• Opsonophagocytoses</p><br>