Cross-sectional surveillance study on pneumococcal serotypes and other pathogens in nasopharyngeal samples from infants and parents performed 6.5 years after introduction of pneumococcal vaccination in The Netherlands

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 1320

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.
Adults with limited contact with children < 6 years:
The adults are aged 20-49 years (both inclusive).
The adults have no contact with children < 6 years for more than 8 hours per week.
The adults have to be willing and able to participate in the trial according to procedure.
Presence of a signed informed consent.

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 and adults with limited contact with children < 6 years:
Chromosomal abnormalities or craniofacial abnormalities, known or suspected immunodeficiency disease or other medical conditions that will severely affect immunological responses
Coagulation disorder/anticoagulant medication

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The percentage of total vaccine- and non-vaccine pneumococcal serotypes found<br /><br>in the nasopharyngeal swabs from infants at 11 and 24 months of age by<br /><br>conventional culture. Serotyping is performed at single colony level by<br /><br>Quellung reaction as in previous surveillance studies.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The percentage of total vaccine- and non-vaccine pneumococcal serotypes found<br /><br>in the nasopharyngeal swabs from parents of the 24-month-old infants as<br /><br>determined by culture and Quellung.<br /><br>The percentage of infants and parents with nasopharyngeal swabs positive for S.<br /><br>aureus, H. influenzae and M. catarrhalis as determined by culture.<br /><br>The percentage of individual pneumococcal serotypes found in the nasopharyngeal<br /><br>swabs from infants at 11 and 24 months of age and parents of the 24-month-old<br /><br>infants as determined by culture and Quellung.</p><br>