| - candidate number | 2587 |
| - NTR Number | NTR977 |
| - ISRCTN | ISRCTN20164309 |
| - Date ISRCTN created | 27-jun-2007 |
| - date ISRCTN requested | 11-jun-2007 |
| - Date Registered NTR | 16-mei-2007 |
| - Secondary IDs | N/A |
| - Public Title | Second serosurveillance study in the Netherlands for the evaluation of the Dutch National Immunisation Programme: the PIENTER 2 study. |
| - Scientific Title | Second serosurveillance study in the Netherlands for the evaluation of the Dutch National Immunisation Programme: the PIENTER 2 study. |
| - ACRONYM | PIENTER 2 |
| - hypothesis | The age-specific seroprevalence of a cross-section of the Dutch population for the vaccinations used in the Dutch National Immunisation Programme. |
| - Healt Condition(s) or Problem(s) studied | Infectious diseases, Vaccines, National immunisation program |
| - 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. |
| - Exclusion criteria | 1 Subject is an employee of the RIVM. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | no |
| - group | [default] |
| - Type | Single arm |
| - Studytype | intervention |
| - planned startdate | 6-feb-2006 |
| - planned closingdate | 19-jun-2007 |
| - Target number of participants | 7700 |
| - Interventions | A blood sample and a questionnaire regarding health perception, diseases (including sexually transmitted), vaccination data. |
| - Primary outcome | The age-specific seroprevalence (immunity) for diseases included in the National Immunisation Program of the Dutch general population. |
| - Secondary outcome | 1. The age-specific seroprevalence against other infectious diseases, in particular those that might be vaccin 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). |
| - Timepoints | N/A |
| - Trial web site | http://www.pienterproject.nl |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | PhD F.R.M Klis, van der |
| - CONTACT for SCIENTIFIC QUERIES | PhD 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) | Dutch Ministry of Health, Welfare and Sport |
| - Publications | N/A |
| - Brief summary | This study measures the serological effects of the different vaccinations within the National Immunisation Programme in the Netherlands. A cross-section of the Dutch population (n=21000) will be invited to partake in the study. The study consists of a single blood collection. In addition, the participant is asked to fill in data on past vaccinations and diseases in a questionnaire. The results will provide insight into the immune status of the Dutch population and identify potential gaps in the immunity and subpopulations at risk. |
| - Main changes (audit trail) | |
| - RECORD | 16-mei-2007 - 1-dec-2009 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl