Infectious diseases, vaccine preventable diseases, national immunisation programme, immunogenicity, Streptococcus pneumoniae. Infectieziekten, Rijksvaccinatieprogramma, pneumokokken-vaccinatieschema.
Conditions
Interventions
4 Groups of 100 children:
1. To administer PCV13 at 2-3-4-11 months
2. To administer PCV13 at 2-4-6-11 months
3. To administer PCV13 at 2-4-11 months
4. To administer PCV13 at 3-5-11 months.
All children will receive the DTaP-IPV-Hib vaccination according to the NIP at 2-3-4 and 11 months.
Blood samples will be taken at 1 month after the primary
Sponsors
National Institute for Public Health and the
Environment (RIVM), Centre for Infectious Disease Control (CIb).
Eligibility
Inclusion criteria
Inclusion criteria: 1. Infants in good general health, eligible to be vaccinated according to the Dutch national vaccination program. The 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. The parents 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 in which the parent(s)/legally representative(s) have given written informed consent after receiving oral and written information (signature from one parent in case of alegal representative of an orphan, or single-parent family).
Exclusion criteria
Exclusion criteria: 1. Children elegible for the Hepatitis B vaccination; 2. Previous Prevenar and DTaP-IPV-Hib vaccination; 3. Present evidence of serious disease(s) demanding immunosuppressive medical treatment, like cytostatics and prednisolons, that might interfere with the results of the study within 3 months; 4. Any known primary or secondary immunodeficiency; 5. Bleeding disorders; 6. Premature birth (<37 weeks).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primairy endpoint of this study will be the antibody concentrations against the 13 serotypes of S. pneumoniae included in the vaccine measured at 12 months, 1 month post-booster vaccination. Serum samples will be analysed for specific IgG by a fluorescent-bead-based multiplex immunoassay (MIA). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are the antibody concentrations at 1 month post-primary, at 8 months and 11 months against the 13 serotypes of S. pneumoniae, and the antibody concentrations against the concomittant vaccines (DTaP-IPV-Hib) to exclude possible interference. | — |
Contacts
Public ContactJudith Spijkerman
Postbus 770
Outcome results
None listed