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 - Nasopharyngeal colonization in infants and parents/OKIDOKI-3

RIVM0 个研究点目标入组 1,320 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•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 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.

•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

发起方

RIVM