Pertussis, whooping cough Infections and Infestations Infectious diseases
Conditions
Interventions
Four 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 (Infa
Sponsors
National Institute of Public Health and Environmental Protection (RIVM) (The Netherlands)
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 (greater than 38.5°C) 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 titres at 11 months before the fourth vaccination and at 12 months. The antibody titres are determined by a twofold serial dilution Enzyme Linked Immunosorbent Assay (ELISA). | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody titres for all vaccine components are measured at 11 months before vaccination and at four to eight weeks after the fourth 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) | — |
Countries
Netherlands
Outcome results
None listed