Cross-sectional surveillance study on pneumococcal serotypes and other pathogens in nasopharyngeal samples from children and parents performed in the tenth year after introduction of pneumococcal vaccination in The Netherlands
- Conditions
- virale infectieziektenasymptomatic pneumococcal nasopharyngeal colonisationpneumococcal carriage10004018
- Registration Number
- NL-OMON42659
- Lead Sponsor
- RIVM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 990
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, fever >38.5°C in the last two days is not considered as normal health).
The parents have to be willing and able to participate in the trial according to procedure.
The child is 24-months-old (± 4 weeks) or 46-months-old (43-48-months)
The child has been vaccinated according to the Dutch NIP
Presence of a signed informed consent (the parents/legally representatives have
given written informed consent after receiving oral and written information).
Parents of 24-month-old children are included when their child fulfils the inclusion criteria.
For children:
Previous vaccinations with PCV using a vaccine and schedule that differs from the Dutch NIP of that age group.
Medical conditions that will severely affect immunological responses to vaccinations or NP carriage rates (certain chromosomal abnormalities or craniofacial abnormalities (like Trisomy 21 or schisis), known or suspected immunodeficiency disease or other medical conditions).
Coagulation disorder/anticoagulant medication.;For parents:
Medical conditions that will severely affect immunological responses to vaccinations or NP carriage rates (certain chromosomal abnormalities or craniofacial abnormalities (like Trisomy 21 or schisis), known or suspected immunodeficiency disease or other medical conditions).
Coagulation disorder/anticoagulant medication.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Total pneumococcal vaccine and non-vaccine serotypes</p><br>
- Secondary Outcome Measures
Name Time Method <p>Frequencies of individual pneumococcal serotypes, respiratory viral and<br /><br>non-pneumococcal bacterial carriage, (functional) antibody titers, B and T cell<br /><br>immunity, age related immune markers, microbiome, antibiotic non-susceptibility<br /><br>of pathogens.</p><br>