Infectious diseases, whooping cough, Bordetella pertussis.
Conditions
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
Sponsors
National Institute of Public Health and the Environment
Eligibility
Inclusion criteria
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
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 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactG. Berbers
RIVM, afd. LIS Postbus 1
Outcome results
None listed