Second meningococcal vaccination in Dutch children: Study to compare the tetravalent MenACWY-TT conjugate vaccine with the monovalent MenC-TT conjugate vaccine. - JIM study

ational Institute of Public Health and Environment (RIVM, the Netherlands)0 个研究点开始时间: 2013年8月5日最近更新: 2013年8月19日

试验速览

暂无简介。

•Participants are 10-, 12, and 15-year old children who have received a primary vaccination with a single dose of MenC-TT vaccine (NeisVac-C™) either during the mass catch-up campaign in 2002 (group 4 and 5) or at the age of 14 months (regular vaccination time point since 2002 according to the Dutch NIP; group 1,2 and 3).
•Furthermore, participants have to fulfil all of the following criteria:
•- Provision of written informed consent by both parents and (if child is 12 or 15 years old; see Annex 3) child;
•- Good general health;
•- Received all regular vaccines according to Dutch NIP;
•- Adherent to protocol, and available during the study period.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 410
•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

•Any of the following criteria at the start of the study will exclude a volunteering child from participation:
•- Severe acute (infectious) illness or fever (>38.5°C) within 14 days before vaccination;
•- Antibiotic use within 14 days of enrollment;
•- Present evidence of serious disease(s) demanding (immunosuppressive) medical treatment that might interfere the results of the study within the last 3 months (like, corticosteroids, chronic infection, bleeding disorder, immune dysfunction, genetic anomaly);
•- Known or suspected allergy to any of the vaccine components (by medical history);
•- Occurrence of serious adverse event after primary MenC-TT vaccination or other vaccination (by medical history)
•- Known or suspected immune deficiency;
•- History of any neurologic disorder, including epilepsy;
•- Previous administration of plasma products (including immunoglobulins) within the last 6 months;
•- Pregnancy;
•- Previous confirmed or suspected meningococcal disease;
•- Former received doses of MenC vaccines in addition to the primary vaccination;
•- Former received any tetravalent MenACWY vaccination;
•- Received any vaccination in the past month.

发起方

ational Institute of Public Health and Environment (RIVM, the Netherlands)