Infectious Diseases, Whooping Cough, Pertussis, Infectieziekten, Kinkhoest
Conditions
Interventions
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).
Sponsors
National Institute for Public Health and the Environment (RIVM)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Infants in good general health eligible for the fourth DTP IPV-Hib vaccination.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody titers for all vaccine components are measured at 11 months before vaccination and at 4-8 weeks after the 4th DTP IPV-Hib vaccination. This will also allow to investigate: 1. The effect of the changes in the production process of the Pertussis whole cell component compared to the ‘old’ whole cell component (data on file). 2. The adjuvant effect of the whole cell versus two different acellular Pertussis components in the DTP IPV-Hib vaccine as used in The Netherlands. 3. The immunogenicity and the adjuvant effect of the two different acellular Pertussis components in the DTP IPV-Hib vaccines (Infanrix versus Pediacel) with or without pneumococcal vaccination (Prevenar). | — |
Contacts
Public ContactG. Berbers
RIVM, afd. LIS Postbus 1
Outcome results
None listed