The current OKIDOKI-4 study is part of an ongoing surveillance program intended to monitor the carriage of Streptococcus pneumoniae (pneumococcus) serotypes through collection of nasopharyngeal swabs in children and their parents. S. pneumoniae is…
ID
Bron
Verkorte titel
Aandoening
Pneumococcal carriage
Prevenar
Synflorix
PCV7
PCV10
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Total pneumococcal vaccine and non-vaccine serotypes
Achtergrond van het onderzoek
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 in 330 24-month-old children, 330 46-month-old-children and 330 parents of 24-month-old-children
Doel van het onderzoek
The current OKIDOKI-4 study is part of an ongoing surveillance program intended to monitor the carriage of Streptococcus pneumoniae (pneumococcus) serotypes through collection of nasopharyngeal swabs in children and their parents. S. pneumoniae is the leading cause of invasive pneumococcal disease (IPD) like meningitis, sepsis and bacteremic pneumonia as well as of respiratory infections like community acquired pneumonia and otitis media. The highest disease incidence is observed in children below two years of age and in elderly >65 years of age. Diseases caused by S. pneumoniae are preceded by asymptomatic nasopharyngeal acquisition and colonization. Vaccination with a 7-valent pneumococcal vaccine (Prevenar-7, PCV-7) was introduced in the Dutch National Immunization Program (NIP) for children in 2006 and replaced in 2011, by a 10-valent vaccine (PCV-10). PCV vaccination reduced acquisition and density of colonization of vaccine-serotype pneumococci in the nasopharynx of vaccinated children and subsequent transmission to others leading to an indirect protection of the community (herd effect). The vacant niche in the nasopharynx of vaccinated children is however immediately filled by non-vaccine pneumococci and possibly other potential pathogens that may be involved in respiratory or invasive disease.
Surveillance of nasopharyngeal carriage of pneumococci is important to evaluate shifts in circulation of specific serotypes after pneumococcal conjugate vaccine introduction as a measure for vaccine effectiveness and impact. This surveillance information is used to determine whether adjustments in the vaccination program/strategy are needed.
Onderzoeksopzet
children of 24 months of age (and one parent of each child).
children of 46 months of age.
One home visit per child.
Onderzoeksproduct en/of interventie
not applicable
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
•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 or 46-months-old (± 4 weeks)
•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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
•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
A parent who meets any of the following criteria will be excluded from participation in this study:
•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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5296 |
| NTR-old | NTR5405 |
| CCMO | NL53027.094.15 |
| OMON | NL-OMON42659 |