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

RIVM0 个研究点目标入组 410 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

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•Participants are 10-, 12, and 15-year old children who have received a primary vaccination with a single dose of MenC-PS conjugated (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.

•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 a tetravalent MenACWY vaccine
•- Received vaccination in the past month

发起方

RIVM