Effects of Routine Infant Vaccination With the 7-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization with Streptococcus pneumoniae in Children and Parents in the Netherlands - Impact of PCV-7 on pneumococcal carriage in infants and parents

etherlands Vaccine Institute0 个研究点目标入组 660 人开始时间: 2008年7月23日最近更新: 2022年4月4日

适应症

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•The children have to be of normal health (same health criteria apply as used in well-baby clinics when a child receives a vaccination, e.g. also children with small increases in temperature or cold are seen as children with normal health)
•They have to be willing and able to participate in the trial according to procedure
•Presence of a signed informed consent (the parents/legally representatives have
•given written informed consent after receiving oral and written information)
•The children have received the Prevenar® vaccinations according to the 3+1 schedule of the Dutch NIP
•Parents are included when their children fulfil inclusion criteria
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•Previous vaccinations with Prevenar® using a schedule that differs from the Dutch 3+1 schedule
•Previous vaccinations with other pneumoccocal vaccines
•Previous vaccinations of older brother(s) and/or sister(s) and/or parents with a pneumococcal conjugate vaccine (e.g. brother(s) and/or sister(s) that participated in the MINOES trial)
•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 are excluded
•when they have a bleeding disorder/ anticoagulant medication (because of the transnasal swab)

发起方

etherlands Vaccine Institute