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.
Conditions
Interventions
4 groups of children, in all groups the children will have 1 blood collection. The children in group 4 (n=25) receive a challenge vaccination of Prevenar® at 24 months of age.
Sponsors
Netherlands Vaccine Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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) 2. They have to be willing and able to allow their child to participate in the trial according to the described procedures 3. Presence of a signed informed consent (the parents/legally representatives have given written informed consent after receiving oral and written information) 4. The children have received or will receive the Prevenar® vaccinations according to the 3+1 schedule of the Dutch NIP
Exclusion criteria
Exclusion criteria: 1. Previous vaccinations with Prevenar® using a schedule that differs from the Dutch 3+1 schedule 2. Previous vaccinations with other pneumoccocal vaccines 3. Presence of a serious disease that requires medical care that can interfere with the results of the study 4. 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) 5. Known or suspected immunological disorder 6. Previously administration of plasma products (including immunoglobulin), within three months of study enrolment 7. Bleeding disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Cellular immunogenicity (plasmacells and memory B-cells frequencies) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Geometric mean titres (GMT) - Avidity - Opsonophagocytoses | — |
Contacts
Public ContactD.E. Kleijne
Laboratorium voor Vaccin Onderzoek, PB 117 Nederlands Vaccin Instituut (NVI) Antwoordnummer 3205
Outcome results
None listed