search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


nasopharyngeal colonization in children and parents


- candidate number22789
- NTR NumberNTR5405
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-aug-2015
- Secondary IDsNL53027.094.15 M015-015
- Public Titlenasopharyngeal colonization in children and parents
- Scientific TitleCross-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
- ACRONYMOKIDOKI-4
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedPneumococcal carriage
- 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 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
- Exclusion criteria•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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 18-aug-2015
- planned closingdate28-feb-2016
- Target number of participants990
- Interventionsnot applicable
- Primary outcomeTotal pneumococcal vaccine and non-vaccine serotypes
- Secondary outcomeFrequencies 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
- Timepointschildren of 24 months of age (and one parent of each child).
children of 46 months of age.
One home visit per child.
- Trial web sitena
- statusstopped
- CONTACT FOR PUBLIC QUERIESDr. A.J. Wijmenga-Monsuur
- CONTACT for SCIENTIFIC QUERIESDr. A.J. Wijmenga-Monsuur
- Sponsor/Initiator National Institute for Public Health and the Environment (RIVM)
- Funding
(Source(s) of Monetary or Material Support)
Ministery of Health and Social Affairs
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD24-aug-2015 - 22-mei-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl