Juveniele Immunisatie Meningokokken ACWY studie
- Conditions
- Second Meningococcal VaccinationMenC-TT conjugate vaccineMenACWY-TT conjugate vaccineDutch children
- Registration Number
- NL-OMON19891
- Lead Sponsor
- ational Institute for Public Health and Environment (RIVM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 410
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.
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¡ãC) within 14 days before vaccination;
- Antibiotic use within 14 days of enrollment;
- Present evidence of serious disease(s) demanding medical treatment that might interfere the results of the study (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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to demonstrate non-inferiority of SBA levels against MenC at 1 year (T2) after vaccination in the group vaccinated with tetravalent MenACWY-TT vaccine as compared with the group vaccinated with monovalent MenC-TT conjugate vaccine in 10-, 12-, and 15-years old children.<br>If non-inferiority is demonstrated, the objective is to compare SBA levels against MenA, MenW and MenY at 1 year (T2) after vaccination between the three age groups that are vaccinated with tetravalent MenACWY-TT vaccine.
- Secondary Outcome Measures
Name Time Method