Vaccination against Pertussis
Conditions
Interventions
Participants will receive one injection of DTaP-IPV (Boostrix Polio® (GSK))
combination vaccine intramuscularly in the upper arm as a replacement of the
normal DT-IPV vaccine. Venapunctures will be
Sponsors
RIVM
Eligibility
Age
2 Years to 11 Years
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
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. Treatment within the 3 months before the study (chronic infection, clotting disorder, genetic disorder); • Serious infection disease or fever (>38.5°C) within 14 days before the vaccination; • Antibiotic use within 14 days before vaccination; • 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/ venapuncture; • (suspected) Presence of allergy against (one of the) components of het vaccine; • In the past an allergic reactions after vaccination; • Neurologic condition (like epilepsy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • 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 to determine the effects of a second aP booster vaccination and determine whether there is a difference between wP and aP primed children at 9 years of age. | — |
Secondary
| Measure | Time frame |
|---|---|
| • 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; • To measure serum specific IgG-antibodies and cellulair immune responses against other infectious diseases occurring in Dutch children. | — |
Countries
Netherlands
Outcome results
None listed