The vaccine administered in this study is used to prevent pertussis caused by the bacterium Bordetella pertussis
Conditions
Interventions
Trade Name: Boostrix IPV
Product Name: Boostrix Polio
Product Code: Boostrix Polio
Pharmaceutical Form: Suspension for injection
Sponsors
National Institute for Public Health and the Environment (RIVM, the Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Good general health; • 8-9 years of age; • Vaccinated with Infanrix-IPV + Hib (GSK) at 2, 3, 4, and 11 months of age and with Infanrix-IPV (GSK) at 4 years of age; • Received all other regular vaccines according to the Dutch NIP; • Provision of written informed consent by both parents or legal representatives; • Adherent to protocol and available during the study period Are the trial subjects under 18? yes Number of subjects for this age range: 80 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Present evidence of serious disease(s) demanding immunosuppressive medical treatment, like corticosteroids, that might interfere with the results of the study within the last 3 months; • Antibiotic use within 14 days of enrollment; • Any known primary or secondary immunodeficiency; • Previous administration of plasma products (including immunoglobulins) within the last 6 months; • Vaccination with any other pertussis vaccine than those described in the inclusion criteria (i.e. vaccinated with Pediacel or Triaxis (both from Sanofi Pasteur MSD)); • Vaccination other than those used in the NIP within a month before vaccination/ blood sampling; • Boostrix Polio® must not be given to people with a known hypersensitivity after a previous injection of diphtheria-, tetanus-, pertussis- or poliomyelitis-vaccines or one of the substances of the vaccines; • Boostrix Polio® is contraindicated to people who suffered from an encephalopathy without a known cause within 7 days after a former pertussis vaccination; • Boostrix Polio® must not be administered to people who suffered from a temporary trombocytopathia or people who had neurologic complications (convulsions or hypotonehyporesponsive episodes) after a former administration with a diphtheria or tetanus vaccine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess pertussis specific IgG antibody levels in serum to determine the effects of a second aP booster vaccination and determine whether there is a difference in IgG levels between wP and aP primed children at 8-9 years of age; • To assess memory B- and T-cell responses against the various B. pertussis proteins and determine whether there is a difference between wP and aP primed children at 9 years of age.;Secondary Objective: • To assess pertussis specific IgG-subclasses and -avidity; • To measure serum specific IgG-antibodies, -subclasses and -avidity and memory B- and T-cell responses against the other vaccine components (Diphtheria, Tetanus, Polio, Mumps, Measles and Rubella); • To measure serum specific IgG-antibodies, -subclasses and -avidity against other vaccine components from the NIP; • To measure IgA- and IgE- antibodies in serum against the proteins of B. pertussis and other vaccine components from the NIP.;Primary end point(s): Overview of current pertussis specific IgG -levels and -avidity and numbers of B- and T-cells before and after vaccination to determine vaccine responses ;Timepoint(s) of evaluation of this end point: After second blood sample and after third and optional fourth blood sample | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overview of current IgG -levels and -avidity and numbers of B- and T-cells before and after vaccination to determine vaccine responses of the other vaccine components;Timepoint(s) of evaluation of this end point: After second blood sample and after third and optional fourth blood sample | — |
Countries
Netherlands
Contacts
Public ContactAnnemarie Buisman
RIVM
Outcome results
None listed