Pneumococcal carriership in children having previously received Prevenar vaccination (7-valent pneumococcal conjugate vaccine) according to the 3+1 vaccination schedule used in the Dutch National Immunization Program (NIP). Comparison will be done to the 2+1 schedule group of the MINOES trial (ISRCNTN25571720).
Conditions
Sponsors
Nederlands Vaccin Instituut
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: These criteria are derived from the related MINOES study, in order to increase comparability • 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 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
Exclusion criteria
Exclusion criteria: These criteria are derived from the related MINOES study, in order to increase comparability • Previous vaccinations with Prevenar® using a schedule that differs from the Dutch 3+1 schedule • Previous vaccinations with other pneumoccocal vaccines • Previous vaccinations of older brother(s) and/or sister(s) and/or parents with a pneumococcal conjugate vaccine (e.g. brother(s) and/or sister(s) that participated in the MINOES trial)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the NP vaccine type (VT) pneumococcal colonisation (seven vaccine serotypes together) of infants aged 12 months, who previously received 4 (3+1) pneumococcal conjugate vaccinations Prevenar® in the Dutch NIP and to compare this data to NP colonisation data of infants from the MINOES study that received 3 (2+1) Prevenar® vaccinations.;Secondary Objective: To compare pneumococcal replacement by non-vaccine type (NVT) pneumococcal serotypes after a 3+1 and 2+1 doses scheme To compare the influence on other NP colonising bacteria like S. aureus, H. influenzae, M. catarrhalis and P. aeruginosa after a 3+1 and 2+1 doses scheme ;Primary end point(s): The overall percentage of the seven VT pneumococcal serotypes found in the NP swabs at 12 months of age The percentage of NVT pneumococcal serotypes found in the NP swabs at 12 months The percentage of children positive for S.aureus, H. influenzae, M. catarrhalis and P. aeruginosa | — |
Countries
Netherlands
Outcome results
None listed