To compare the immunogenicity of the whole cell versus the acellular pertussis component of the DTP IPV-Hib vaccine as measured by the antibody titers at 11 months before the 4th vaccination and at 12 months.
ID
Bron
Verkorte titel
Aandoening
Infectious Diseases, Whooping Cough, Pertussis, Infectieziekten, Kinkhoest
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To compare the immunogenicity of the whole cell versus the acellular pertussis component of the DTP IPV-Hib vaccine as measured by the antibody titers at 11 months before the 4th vaccination and at 12 months. The antibody titers are determined by a twofold serial dilution ELISA.
Achtergrond van het onderzoek
This study is undertaken to monitor the effects of the changes in the pertussis component of the DTP IPV-Hib vaccine as used in the Dutch National Immunisation Programme. There are 4 study groups consisting of 11 month old children who receive the DTp IPV-Hib vaccine with different pertussis components; a whole cell, 3 component acellular, 5 component acellular and a 5 component acellular with concurrent pneumococcal vaccination. The antibody respons is measured before vaccination at 11 months old and 4-8 weeks after vaccination by ELISAs.
Doel van het onderzoek
To compare the immunogenicity of the whole cell versus the acellular pertussis component of the DTP IPV-Hib vaccine as measured by the antibody titers at 11 months before the 4th vaccination and at 12 months.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
4 groups of 75 children aged 11 months:
1. DTwP IPV-Hib primary series and booster (11 months) (n=32);
2. DTwP IPV-Hib primary series and DTaP IPV-Hib booster (Infanrix) (n=79);
3. DTaP IPV-Hib (Infanrix) primary series and booster (n=95);
4. DTaP IPV-Hib (Pediacel) primary series and booster with (n=75) and without (n=75) pneumococcal vaccination (Prevenar).
Publiek
Postbus 1
G. Berbers
Bilthoven 3720 BA
The Netherlands
+31 30-2742496
guy.berbers@rivm.nl
Wetenschappelijk
Postbus 1
G. Berbers
Bilthoven 3720 BA
The Netherlands
+31 30-2742496
guy.berbers@rivm.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Infants in good general health eligible for the fourth DTP IPV-Hib vaccination.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL922 |
NTR-old | NTR946 |
Ander register | : LTR134 |
ISRCTN | ISRCTN97785537 |