This study investigates the influence of the Prevenar® vaccination schedule in the NIP on colonisation with vaccine- and non-vaccine serotypes in the third year after implementation of Prevenar® in the NIP. We also determine the impact on other nasopharyngeal colonising bacteria.
Conditions
Sponsors
Netherlands Vaccine Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •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 Parents •Parents are included when their children fulfil inclusion criteria Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •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) •Chromosomal abnormalities or craniofacial abnormalities (like Trisomy 21 or schisis), known or suspected immunodeficiency disease or other medical conditions that will severely affect immunological responses to vaccinations or nasopharyngeal carriage rates. •Coagulation disorder/anticoagulant medication Parents are excluded •when they have a bleeding disorder/ anticoagulant medication (because of the transnasal swab)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine trends in vaccine- and nonvaccine-serotype S. pneumoniae colonisation in 11-month-old and 24-month-old infants who have been immunized according to the Dutch NIP with pneumococcal conjugate vaccinations Prevenar® in the third year after implementation of PCV-7 ( Prevenar®) in the Dutch NIP.;Secondary Objective: • To determine vaccine- and nonvaccine-serotype pneumococcal colonisation in one parent of 24-month-old children • To determine the influence of altered vaccine- and nonvaccine- serotype composition on other colonising bacteria like S.aureus, H. influenzae, M. catarrhalis in children and parents ;Primary end point(s): The percentage of the (the seven) vaccine and non-vaccines pneumococcal serotypes found in the NP swabs from children at 11 and 24 months of age and parents of the 24-month-old children. | — |
Countries
Netherlands
Outcome results
None listed