|- candidate number||3830|
|- NTR Number||NTR1406|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-aug-2008|
|- Secondary IDs||LVO66A, LVO121A |
|- Public Title||A randomised controlled study with whole-cell or acellular pertussis vaccines in combination with regular DT-IPV vaccine and a new poliomyelitis (IPV-Vero) component in children 4 years of age in the Netherlands.
|- Scientific Title||A randomised controlled study with whole-cell or acellular pertussis vaccines in combination with regular DT-IPV vaccine and a new poliomyelitis (IPV-Vero) component in children 4 years of age in the Netherlands.
|- ACRONYM||Apeldoorn studie|
|- hypothesis||To compare the immunogenicity of the Dutch whole cell vaccine versus 3 acellular pertussis vaccines administered as a booster at 4 years of age by measuring the antibody levels in serum after 1 month and 2 years.|
|- Healt Condition(s) or Problem(s) studied||Infectious diseases, Whooping cough, Bordetella pertussis|
|- Inclusion criteria||1. Children in good general health eligible for the DT-IPV vaccination at 4 years of age |
2. Written informed consent (IC) from parents
|- Exclusion criteria||1. Severe acute illness or fever (>38.5) within two days before vaccination |
2. Present evidence of serious disease(s) demanding medical treatment that might interfere with the results of the study
3. Known or suspected allergy to any of the vaccine components
4. Known or suspected immune disorder
5. History of any neurological disorder, including epilepsy
6. Previous administration of plasma products (including immunoglobulins)
7. Previous vaccination with any other vaccine than those used in the National Immunisation Programme.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-1998|
|- planned closingdate||1-sep-2000|
|- Target number of participants||180|
|- Interventions||A total of 180 children 4 years of age were divided over 5 groups. |
1. DT-IPV vaccine administration as controlgroup (N=45)
2. DTwP-IPV (N=44)
3. DT-IPV and aP from SKB (N=44)
4. DT-IPV and aP from Wyeth-Lederle (N=23)
5 DT-IPV and aP from Pasteur-Merieux (N=24).
Blood samples were taken just before the vaccination, 4-6 weeks and 2 years postvaccination.
|- Primary outcome||To compare the immunogenicity of the whole cell versus the acellular pertussis vaccine components as measured by the antibody titers at the 3 time points. The antibody levels are determined by a twofold serial dilution ELISA. |
|- Secondary outcome||The occurrence of adverse events after the administration of the different pertussis vaccines as recorded by the parents (non-blinded). Antibody titers directed against all other vaccine components are measured.|
|- Timepoints||Blood samples were taken just before the vaccination, 4-6 weeks and 2 years postvaccination.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||PhD G. Berbers|
|- CONTACT for SCIENTIFIC QUERIES||PhD G. Berbers|
|- Sponsor/Initiator ||National Institute for Public Health and the Environment (RIVM)|
(Source(s) of Monetary or Material Support)
|The Netherlands Healthcare Inspectorate |
|- Publications||GAM Berbers et al. RIVM report 105000 001, Jan. 1999|
|- Brief summary||In this study the immunogenicity of the whole cell pertussis vaccine and 3 acellular pertussis vaccines is compared after administration as a booster in children 4 years of age. The occurence of adverse events within 1 week after vaccination and the persistence of antibody levels after 2 years are also investigated. |
After vaccination with the ACV’s almost all the titers are high against the different pertussis components and generally reflect the composition of these components present in the vaccines. The titers are comparable with those observed in other trials with these vaccines. After vaccination with the WCV the antibody levels are lower as found for the ACV's and more diverse, varying from good to low for the different pertussis vaccine antigens. A drawback of the WCV is the rate of adverse events which is in general 4 times as much as observed for the ACV's, although the adverse reactions are mostly mild and of limited duration. 2 Years after the booster vaccination almost all pertussis antibody titers have decreased to background level.
|- Main changes (audit trail)|
|- RECORD||14-aug-2008 - 22-aug-2008|