Whooping cough is a respiratory disease caused by Bordetella pertussis. Young infants are mostly at risk, but older children are the main source of infection. Since the incidence of whooping cough (pertussis) is increasing in the Netherlands, the effect of the booster vaccination on the long term immunity against Bordetella pertussis needs to be addressed.
Conditions
Interventions
Trade Name: Boostrix polio
Product Name: Boostrix-polio
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: pertussis toxoid
Concentration unit: µg microgram(s)
Concentration type: equal
Sponsors
National Institute of Health and the Environment (RIVM)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A population of healthy, Dutch 8-9 years old children who received four vaccinations at 2,3,4 and 11 months with DTPwcv-IPV-(Hib) and a booster vaccination at 4 years old with a three component ACV will be recruited. Are the trial subjects under 18? yes Number of subjects for this age range: 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: Any of the following criteria will exclude a volunteer from participation, at start of the study: • Present evidence of serious disease(s) demanding immunosuppressive medical treatment, like corticosteroids that might interfere with the results of the study within 3 months. • Any known primary or secondary immunodeficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The assessment of the duration of the cellular (B- and T-cel) immunity to Bordetella pertussis after an extra ACV booster and the relationship between the memory B- cells and antibody responses. ;Secondary Objective: The assesement of memory B- and T-cel immunity to the other vaccine-components (polio, diphteria, tetanus, measles, rubella etc.);Primary end point(s): The main study parameters will be the longitudinal kinetics of B- and T- cell memory immune responses and antibody responses against the vaccine proteins of B. pertussis. | — |
Countries
Netherlands
Outcome results
None listed