Second serosurveillance study in The Netherlands for the evaluation of the Dutch National Immunisation Programme: the PIENTER 2 study

ISRCTN	ISRCTN20164309
DOI	https://doi.org/10.1186/ISRCTN20164309
Secondary identifying numbers	N/A

Submission date: 27/06/2007
Registration date: 27/06/2007
Last edited: 18/03/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr F.R.M. van der Klis
Scientific

National Institute of Public Health and Environmental Protection (RIVM)
afdeling LIS
P.O. Box 1
Bilthoven
3720 BA
Netherlands

Phone	+31 (0)30 274 2272
Email	fiona.van.der.klis@rivm.nl

Study information

Study design	Observational, cross-section survey
Primary study design	Observational
Secondary study design	Cross-section survey
Study setting(s)	Not specified
Study type	Screening
Scientific title
Study acronym	PIENTER 2
Study objectives	The age-specific seroprevalence of a cross-section of the Dutch population for the vaccinations used in the Dutch National Immunisation Programme.
Ethics approval(s)	Approval received from the local ethics committee (Stichting Therapeutische Evaluatie Geneesmiddelen [STEG]) on the 11th October 2005 (ref: R05-044).
Health condition(s) or problem(s) studied	Vaccination and the National Immunisation Program, infectious diseases
Intervention	A blood sample and a questionnaire regarding health perception, diseases (including sexually transmitted), vaccination data.
Intervention type	Other
Primary outcome measure	The age-specific seroprevalence (immunity) for diseases included in the National Immunisation Program of the Dutch general population. As each participant is sampled only once, there will be only one timepoint measurement per person. The timepoint for the complete study population varies from February 2006 to June 2007. Because the participants represent a cross section of the Dutch population aged 0 to 80, we will be able to estimate the seroprevalence in the Dutch population in 2006-2007.
Secondary outcome measures	1. The 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 2. The age-specific seroprevalence amongst the allochtonous populations (additional sample) 3. The age-specific seroprevalence amongst non-vaccinated orthodox reformed individuals (additional sample) As each participant is sampled only once, there will be only one timepoint measurement per person. The timepoint for the complete study population varies from February 2006 to June 2007. Because the participants represent a cross section of the Dutch population aged 0 to 80, we will be able to estimate the seroprevalence in the Dutch population in 2006-2007.
Overall study start date	06/02/2006
Completion date	19/06/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	7700
Key inclusion criteria	1. Subject is part of the study sample 2. Aged 0 - 79 years old 3. Has received a personal invitation for the study 4. Subject has given written informed consent before start of the study
Key exclusion criteria	Subject is an employee of the National Institute of Public Health and Environmental Protection (RIVM).
Date of first enrolment	06/02/2006
Date of final enrolment	19/06/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

National Institute of Public Health and Environmental Protection (RIVM)

Bilthoven
3720 BA
Netherlands

Sponsor information

National Institute of Public Health and Environmental Protection (RIVM) (The Netherlands)
Government

P.O. Box 1
Bilthoven
3720 BA
Netherlands

Phone	+31 (0)30 274 9111
Email	info@rivm.nl
Website	http://www.rivm.nl/en/
"ROR"	https://ror.org/01cesdt21

Funders

Funder type

Government

The Netherlands Ministry of Health, Welfare and Sport (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	19/10/2012		Yes	No
Results article	results	01/04/2014		Yes	No