Development of cellular immune response after infant pneumococcal conjugate vaccinations - Pneumococcal cellular immune response
- Conditions
- Cellular immune response(long term memory) after following the infant immunisation programme with a pneumococcal conjugate vaccine (Prevenar).
- Registration Number
- EUCTR2008-004489-23-NL
- Lead Sponsor
- etherlands Vaccine Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
•The children have to be of normal health (same health criteria apply as used in well-baby clinics when a child receives a vaccination, e.g. also children with small increases in temperature or cold are seen as children with normal health)
•They have to be willing and able to participate in the trial according to procedure
•Presence of a signed informed consent (the parents/legally representatives have
given written informed consent after receiving oral and written information)
•The children have received or will receive the Prevenar® vaccinations according to the 3+1 schedule of the Dutch NIP
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Previous vaccinations with Prevenar® using a schedule that differs from the Dutch 3+1 schedule
•Previous vaccinations with other pneumoccocal vaccines
•Presence of a serious disease that requires medical care that can interfere with the results of the study
•Known or expected allergy/hypersensitivity against one of the vaccine ingredients
(anamnestic, be alert if the child has had medical complaints after previous Prevenar® vaccinations)
•Known or suspected immunological disorder
•Previously administration of plasma products (including immunoglobulin), within three months of study enrolment
•Bleeding disorders
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the development of the cellular immune response (plasma B cells and memory B-cells), immediately before and after the booster of the 3+1 Prevenar® vaccination schedule at 11 months of age and before and after the challenge vaccination at 24 months of age;Secondary Objective: To determine development of the immune response by looking at antibody concentrations, avidity and opsonophagocytoses immediately before and after the booster of the 3+1 Prevenar® vaccination schedule at 11 months of age and before and after the challenge vaccination at 24 months of age;Primary end point(s): Main study parameter/endpoint<br>Cellular immune respons (Plasma B cells and memory B cells)<br><br>Secondary study parameters/endpoints <br>Antibody titers, avidity and opsonophagocytoses<br>
- Secondary Outcome Measures
Name Time Method