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 个研究点开始时间: 2012年7月10日最近更新: 2013年7月15日

试验速览

暂无简介。

•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.
•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

•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
•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