Plain English Summary
Not provided at time of registration
Trial website
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 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 trial start date
06/02/2006
Overall trial end date
19/06/2007
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list
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
-
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.