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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

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 - Nasopharyngeal colonization in children and parents (acronym: OKIDOKI-4)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42659
Enrollment
990
Registered
2015-08-18
Start date
2015-09-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

virale infectieziekten asymptomatic pneumococcal nasopharyngeal colonisation pneumococcal carriage

Interventions

None listed

Sponsors

RIVM
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

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, 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Total pneumococcal vaccine and non-vaccine serotypes

Secondary

MeasureTime frame
Frequencies of individual pneumococcal serotypes, respiratory viral and non-pneumococcal bacterial carriage, (functional) antibody titers, B and T cell immunity, age related immune markers, microbiome, antibiotic non-susceptibility of pathogens.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)