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ID
Source
Brief title
Health condition
Infectious diseases, whooping cough, Bordetella pertussis.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
In this study the immunogenicity of the whole cell pertussis vaccine and 3 acellular pertussis vaccines is compared after administration as a booster in children 4 years of age. The occurence of adverse events within 1 week after vaccination and the persistence of antibody levels after 2 years are also investigated.
After vaccination with the ACV’s almost all the titers are high against the different pertussis components and generally reflect the composition of these components present in the vaccines. The titers are comparable with those observed in other trials with these vaccines. After vaccination with the WCV the antibody levels are lower as found for the ACV's and more diverse, varying from good to low for the different pertussis vaccine antigens. A drawback of the WCV is the rate of adverse events which is in general 4 times as much as observed for the ACV's, although the adverse reactions are mostly mild and of limited duration. 2 Years after the booster vaccination almost all pertussis antibody titers have decreased to background level.
Study objective
To compare the immunogenicity of the Dutch whole cell vaccine versus 3 acellular pertussis vaccines administered as a booster at 4 years of age by measuring the antibody levels in serum after 1 month and 2 years.
Study design
Blood samples were taken just before the vaccination, 4-6 weeks and 2 years postvaccination.
Intervention
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 aP from Wyeth-Lederle (N=23)
5 DT-IPV and aP from Pasteur-Merieux (N=24).
Blood samples were taken just before the vaccination, 4-6 weeks and 2 years postvaccination.
Postbus 1
G. Berbers
Bilthoven 3720 BA
The Netherlands
+31 30-2742496
guy.berbers@rivm.nl
Postbus 1
G. Berbers
Bilthoven 3720 BA
The Netherlands
+31 30-2742496
guy.berbers@rivm.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL1346 |
| NTR-old | NTR1406 |
| Other | : LVO66A, LVO121A |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |