Development of humoral and cellular immune response in infants after pneumococcal conjugate vaccinations withSynflorix® or Prevenar-13® - Pneumococcal immune response to PCV10 and PCV13 in infants

RIVM0 个研究点开始时间: 2013年8月13日最近更新: 2013年8月19日

试验速览

暂无简介。

•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 (=38.5 °C) or cold are seen as children with normal health)
•The parents/legally representatives have to be willing and able to allow their child to participate in the trial according to the described procedures
•Presence of a signed informed consent (the parents/legally representatives have given written informed consent after receiving oral and written information)
•Group 1: The children are 2 months old (± 2 weeks), have not received any vaccinations and will receive all vaccinations (DTaP-IPV-Hib-HepB and PCV13) by the study team
•Group 2: The children are 4-6 months old and have received three DTaP-IPV-Hib-HepB and PCV10 vaccinations according to the 3+1 schedule of the Dutch NIP*.
•*The Dutch NIP 3+1 schedule: All children born as of August 1st 2011 will receive Synflorix (PCV10) and DTaP-IPV-Hib-HepB vaccinations, at the age of 2, 3 4 and 11 months of age.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 132
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Exclusion criteria
•Group 1: Previous vaccinations with PCV7 or PCV10
•Group 2: Previous vaccinations with PCV7 of PCV13
•Vaccinations using a schedule that differs from the Dutch 3+1 schedule
•Presence of a serious disease that requires medical care that can interfere with the results of the study
•Known or expected allergy/hypersensitivity against one of the vaccine ingredients
•(anamnestic, be alert if the child has had medical complaints after previous pneumococcal vaccinations)
•Known or suspected immunological disorder
•Previously administration of plasma products (including immunoglobulin), within three months of study enrolment
•Presence of bleeding disorders
•Communication problems that interfere with the trial
•Prematurity (<37 weeks after gestation)

发起方

RIVM