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    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

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    Authors
    Berbers GAM
    Lafeber AB
    Labadie J
    Vermeer-de Bondt PE
    Bolscher DJA
    Plantinga AD
    Type
    Report
    Language
    en
    
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    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
    Translated Title
    Een gerandomiseerde, gecontroleerde veldproef met "whole cell" en acellulaire kinkhoest vaccins in combinatie met het reguliere DTP vaccin en een nieuwe polio (IPV vero) component bij 4-jarige kinderen in Nederland
    Publiekssamenvatting
    In deze veldproef is de immunogeniteit en de reactogeniteit van 3 verschillende ACVAs en WCV van het RIVM onderzocht, gecombineerd met DTP toegediend als booster bij 4-jarige kinderen. Bij deze kinderen is tevens de immuunrespons op IPVvero (geproduceerd op Vero cellen) vergeleken met het reguliere IPV-MK (geproduceerd op MK cellen). De kinderen in deze studie zijn eerder gevaccineerd met 4 doses DKTP van het RIVM op de leeftijd van 3, 4, 5 en 11 maanden. De ACVAs bevatten PT en FHA (ACV-PM), met PRN als derde component (ACV-SB) en FIM als vierde component (AVC-WL). Het was een open, gerandomiseerde, gecontroleerde studie met geblindeerde serologische bepalingen. Samenvattend geeft deze studie aan dat een toevoeging van een pertussis vaccinatie op 4-jarige leeftijd zinvol kan zijn bij een epidemische verheffing, waarbij de voorkeur uitgaat naar een combinatievaccin met een ACV- of een WCV-component vanwege de enkelvoudige toediening. Het IPVvero blijkt een zeer immunogeen vaccin te zijn en op zijn minst gelijkwaardig aan het huidige IPV-MK.<br>
    In this trial we studied the immunogenicity and reactogenicity of three different ACVAs and the RIVM-WCV combined with DT-IPV, administered as a booster in children four years of age. In these children, the immune response of IPV vero (produced on Vero cells) was also evaluated, together with the regular IPV-MK (produced on MK cells). The children in this study were immunized three years earlier with four doses of the RIVM DTP-IPV at the ages of 3, 4, 5 and 11 months. The ACVAs were composed of PT and FHA (2 components of ACV-PM), PT, FHA and PRN (3 components of ACV-SB) and PT, FHA, PRN and FIM (4 components of ACV-WL). The study was an open, randomized, controlled study with a blinded serological evaluation. All the responses to the different vaccine components clearly demonstrate that the children were well primed with the DTP-IPV. In conclusion, this study demonstrates that an addition of a pertussis vaccination in four year-old children could be useful in an epidemical situation, in which a combination vaccine with an ACV- or a WCV-component requiring a single administration is preferred. IPV vero is shown to be a very immunogenic vaccine and at least similar to the regular IPV-MK.<br>
    Publisher
    Rijksinstituut voor Volksgezondheid en Milieu RIVM
    Sponsors
    Hoofdinspecteur Volksgezondheid
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