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PIENTER-onderzoek


- candidate number23560
- NTR NumberNTR5611
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-jan-2016
- Secondary IDsIIV-284 NL54228.094.15
- Public TitlePIENTER-onderzoek
- Scientific TitleThird population-based immune surveillance study for the evaluation of the National Immunisation Programme in the Netherlands: the PIENTER3 study
- ACRONYMPIENTER3
- hypothesisRationale: Measuring the serological effects of the different vaccinations (immune surveillance) is an important tool for the evaluation of the National Immunisation Programme (NIP) by providing insight in the immune status of the population, by identifying possible gaps in the immunity and subpopulations at risk and by assessing (re) emergence of disease.
- Healt Condition(s) or Problem(s) studiedPrevalence
- Inclusion criteria• Subject is part of the national study sample drawn from the population register, aged 0 to 89 year old and has received a personal invitation for the PIENTER study.
• Subject has given written Informed Consent (IC) before the start of the study visit.
- Exclusion criteriaNone
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-feb-2016
- planned closingdate31-dec-2017
- Target number of participants8400
- InterventionsNone
- Primary outcomeThe age-specific seroprevalence (immunity) for diseases included in the NIP of the Dutch general population.
- Secondary outcomeThe age-specific seroprevalence against other infectious diseases, in particular those that might be vaccine-preventable in the near future and against those diseases with a frequent subclinical course.
By collecting additional samples, the relationship between immune status and carriage of potential pathogens, lifestyle factors and environmental factors can be studied.
- TimepointsA single time point for the collection of samples.
- Trial web sitewww.rivm.nl/pienteronderzoek
- statusplanned
- CONTACT FOR PUBLIC QUERIES R.A.J. Boxtel, van
- CONTACT for SCIENTIFIC QUERIESPhD F.R.M Klis, van der
- Sponsor/Initiator National Institute for Public Health and the Environment (RIVM)
- Funding
(Source(s) of Monetary or Material Support)
Ministry of Health, Welfare and Sports
- PublicationsVan der Klis FR, Mollema L, Berbers GA, de Melker HE, Coutinho RA. Second national serum bank for population-based seroprevalence studies in the Netherlands. Neth J Med. 2009 Jul-Aug;67(7):301-8.
Mollema L, de Melker HE, Hahné SJM, van Weert JWM, Berbers GAM, van der Klis FRM. PIENTER 2 project: second research project on the protection against infectious diseases offered by the national immunization programme in the Netherlands. RIVM report 230421001/2009.
PIENTER2 study 2006-2007: A summary of the main findings. Van der Klis FRM, Mollema L, van Weert JWM. RIVM report, April 2012.
- Brief summaryMeasuring the serological effects of the different vaccinations (immune surveillance) is an important tool for the evaluation of the National Immunisation Programme (NIP) by providing insight in the immune status of the population, by identifying possible gaps in the immunity and subpopulations at risk and by assessing (re) emergence of disease. To obtain insight into the age-specific seroprevalence (immunity) for diseases included in the NIP of the Dutch general population, this observational study with a single invasive measurement (drawing of blood) and non-invasive measurement (saliva) is performed. For a subgroup, optional, a nose and throat swab will be collected as well as a faecal sample. A representative part sample of the Dutch population (age 0-89 years) is invited to participate. The age-specific seroprevalence (immunity) for diseases included in the NIP of the Dutch general population and against other infectious diseases, in particular those that might be vaccine-preventable in the near future and against those diseases with a frequent subclinical course, will be asessed.
- Main changes (audit trail)
- RECORD5-jan-2016 - 14-feb-2016


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