Condition category
Infections and Infestations
Date applied
27/06/2007
Date assigned
27/06/2007
Last edited
18/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.pienterproject.nl

Contact information

Type

Scientific

Primary contact

Dr F.R.M. van der Klis

ORCID ID

Contact details

National Institute of Public Health and Environmental Protection (RIVM)
afdeling LIS
P.O. Box 1
Bilthoven
3720 BA
Netherlands
+31 (0)30 274 2272
fiona.van.der.klis@rivm.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PIENTER 2

Study hypothesis

The age-specific seroprevalence of a cross-section of the Dutch population for the vaccinations used in the Dutch National Immunisation Programme.

Ethics approval

Approval received from the local ethics committee (Stichting Therapeutische Evaluatie
Geneesmiddelen [STEG]) on the 11th October 2005 (ref: R05-044).

Study design

Observational, cross-section survey

Primary study design

Observational

Secondary study design

Cross-section survey

Trial setting

Not specified

Trial type

Screening

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

06/02/2006

Overall trial end date

19/06/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

7700

Participant exclusion criteria

Subject is an employee of the National Institute of Public Health and Environmental Protection (RIVM).

Recruitment start date

06/02/2006

Recruitment end date

19/06/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

National Institute of Public Health and Environmental Protection (RIVM)
Bilthoven
3720 BA
Netherlands

Sponsor information

Organisation

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

Sponsor details

P.O. Box 1
Bilthoven
3720 BA
Netherlands
+31 (0)30 274 9111
info@rivm.nl

Sponsor type

Government

Website

http://www.rivm.nl/en/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22959981
2. 2012 results in http://ard.bmj.com/content/early/2013/03/14/annrheumdis-2012-202561.full

Publication citations

  1. Results

    Scherpenisse M, Mollers M, Schepp RM, Boot HJ, de Melker HE, Meijer CJ, Berbers GA, van der Klis FR, Seroprevalence of seven high-risk HPV types in The Netherlands., Vaccine, 2012, 30, 47, 6686-6693, doi: 10.1016/j.vaccine.2012.08.068.

Additional files

Editorial Notes