The study investigates the presence of nasopharyngeal vaccine- and non-vaccine pneumococcal serotypes in 11- and 24-month-old infants and parents, 6.5 years after implementation of a pneumococcal vaccine in the National Immunization Program. We also determine nasopharyngeal colonising of respiratory non-pneumococcal bacteria and of virusses.
Conditions
Interventions
Trade Name: Prevenar-7
Pharmaceutical Form: Suspension for injection
Trade Name: Synflorix
Pharmaceutical Form: Suspension for injection
Sponsors
RIVM
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Infants: The infants have to be of normal health (same health criteria apply as used in well-baby clinics when an infant receives a vaccination, e.g. also infants with small increases in temperature or cold are seen as infants with normal health) The parents have to be willing and able to participate in the trial according to procedure The infant is 11 or 24 months old (± 4 weeks) dependent on the group The infant has been vaccinated according to the Dutch 3+1 schedule and received 3 pneumococcal vaccinations before the age of 6 months (11-month-old infant) and the 11 month booster (24-month-old infant). Presence of a signed informed consent signed by both parents/legal representatives. Parents: Parents are included when their 24 month-old infant fulfils the inclusion criteria. Are the trial subjects under 18? yes Number of subjects for this age range: 660 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 330 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Infants: Previous vaccinations with pneumococcal vaccine using a schedule that differs from the Dutch 3+1 schedule Previous vaccinations with other pneumoccocal vaccines than Synflorix (11-month-old infant) or Prevenar-7 (24-month-old infant) Chromosomal abnormalities or craniofacial abnormalities (like Trisomy 21 or schisis), known or suspected immunodeficiency disease or other medical conditions that will severely affect immunological responses to vaccinations or nasopharyngeal carriage rates. Coagulation disorder/anticoagulant medication Parents: Chromosomal abnormalities or craniofacial abnormalities, known or suspected immunodeficiency disease or other medical conditions that will severely affect immunological responses Coagulation disorder/anticoagulant medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine trends in nasopharyngeal colonization with total vaccine- and non-vaccine serotypes of S. pneumoniae in healthy 11-month-old and 24-month-old infants who have been immunized according to the Dutch National Immunization Program 6.5 years after implementation of PCV7 and 1.5 years after implementation of PCV10.;Secondary Objective: To determine trends in nasopharyngeal pneumococcal colonization with total vaccine- and non-vaccine serotypes in the parents of 24-month-old infants. To determine trends in colonization of other respiratory pathogens like S. aureus, H. influenzae, M. catarrhalis in infants and parents of 24-month-old infants. To determine trends in individual serotype colonization in healthy 11-month-old and 24-month-old infants who have been immunized according to the Dutch NIP as well as in parents of 24-month-old infants. ;Primary end point(s): The percentage of total vaccine- and non-vaccine pneumococcal serotypes found in the nasopharyngeal swabs from infants at 11 and 24 months of age by conventional culture. Serotyping is performed at single colony level by Quellung reaction as in previous surveillance studies.;Timepoint(s) of evaluation of this end point: 11 month timepoint before the 11 month booster (11-month-old infant) 24 month timepoint (24-month-old infant and parent) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The percentage of total vaccine- and non-vaccine pneumococcal serotypes found in the nasopharyngeal swabs from parents of the 24-month-old infants as determined by culture and Quellung. The percentage of infants and parents with nasopharyngeal swabs positive for S. aureus, H. influenzae and M. catarrhalis as determined by culture. The percentage of individual pneumococcal serotypes found in the nasopharyngeal swabs from infants at 11 and 24 months of age and parents of the 24-month-old infants as determined by culture and Quellung. ;Timepoint(s) of evaluation of this end point: 11 month timepoint before the 11 month booster (11-month-old infant) 24 month timepoint (24-month-old infant and parent) | — |
Countries
Netherlands
Contacts
Public ContactClinical and Regulatory Research
RIVM
Outcome results
None listed