Pneumococcal carriage in children and their parents Infections and Infestations
Conditions
Interventions
The study is an observational, cross-sectional surveillance study, in 24-month-old children that have been vaccinated according to the National Immunization Program, and one of the parents/legal guard
Sponsors
National Institute for Public Health and the Environment
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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) 2. The parents/legal guardians have to be willing and able to participate in the trial according to procedure 3. The child is 24-months-old (± 4 weeks) 4. The child has been vaccinated according to the Dutch NIP 5. Presence of a signed informed consent (the parents/legal guardians have given written informed consent after receiving oral and written information) 6. Parents/legal guardians of 24-month-old children are included when the child fulfils the inclusion criteria and sign their own informed consent
Exclusion criteria
Exclusion criteria: A potential participating child who meets any of the following criteria will be excluded from participation in this study: 1. Previous vaccinations with PCV using a vaccine and schedule that differs from the Dutch NIP of that age group 2. Medical conditions that will severely affect immunological responses to vaccinations or nasopharyngeal carriage rates (certain chromosomal abnormalities or craniofacial abnormalities (like Trisomy 21 or schisis), known or suspected immunodeficiency disease or other medical conditions) A parent/legal guardian who meets any of the following criteria will be excluded from participation in this study: 3. Medical conditions that will severely affect immunological responses to vaccinations or nasopharyngeal carriage rates (certain chromosomal abnormalities or craniofacial abnormalities (like Trisomy 21 or schisis), known or suspected immunodeficiency disease or other medical conditions)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pneumococcal (multi-) serotype carriage is measured in naso- (oro) pharyngeal swabs at a single time point. | — |
Secondary
| Measure | Time frame |
|---|---|
| At a single time point: 1. Respiratory viral and non-pneumococcal bacterial carriage is measured in naso- (oro) pharyngeal swabs 2. Antibiotic (non-) susceptibility of pathogens is measured in naso- (oro) pharyngeal swabs 3. (Functional) antibody levels against respiratory bacterial and viral pathogens is measured in saliva 4. Demographic, lifestyle and medical data influencing bacterial colonization are collected by verbal questions | — |
Countries
Netherlands
Outcome results
None listed