asopharyngeal colonization in children and parents
- Conditions
- Pneumococcal carriagePrevenarSynflorixPCV7PCV10
- Registration Number
- NL-OMON25799
- Lead Sponsor
- ational Institute for Public Health and the Environment
- 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
•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)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total pneumococcal vaccine and non-vaccine serotypes
- Secondary Outcome Measures
Name Time Method Frequencies of individual pneumococcal serotypes, respiratory viral and non-pneumococcal bacterial carriage, (functional)<br>antibody titers, B and T cell immunity, age related immune markers, microbiome, antibiotic non-susceptibility of<br>pathogens