Juveniele Immunisatie Meningokokken ACWY 2 studie
- Conditions
- MenACWY conjugate vaccination, meningitis, infectious diseases
- Registration Number
- NL-OMON26652
- Lead Sponsor
- ational Institute for Public Health and Environment (RIVM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 221
In order to be eligible to participate in this study, a subject must meet all of the following criteria: participants from the JIM-study were 10, 12 or 15 years old at time of vaccination with a MenACWY-TT vaccine after they received a primary vaccination with a single dose of MenC-TT vaccine (NeisVac-CTM) either during the mass catch-up campaign in 2002 (group 3) or at the age of 14 months according to the Dutch NIP (group 1, 2 or 3). Furthermore, in order to be eligible to participate in this study, a participant must meet all of the following criteria:
- Provision of written informed consent by the participant and, if the participant is under 16, also by its parent(s) or caregiver(s)
- Good general health
- Received all regular vaccines according to the 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 potential subject from participation in this study:
- Previous administration of plasma products (including immunoglobulins) within the last 6 months;
- Pregnancy;
- Previous confirmed or suspected meningococcal disease;
- Received any vaccination in the past month;
- Former received tetravalent MenACWY vaccination administered not as part of the JIM-study
- Known or suspected immune deficiency;
- History of any neurologic disorder, including epilepsy;
- Present evidence of serious disease(s) demanding (immunosuppressive) medical treatment that might interfere with the results of the study within the last 3 months (like corticosteroids, chronic infection, bleeding disorder, immune dysfunction, or genetic anomaly).
In the JIM-study, in addition, any of the following criteria excluded a potential subject from participation in the study:
- Severe acute (infectious) illness or fever (>38.5°C) within 14 days before vaccination;
- Antibiotic use within 14 days of enrollment;
- 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)
- Former received doses of MenC vaccines in addition to the primary vaccination;
- Former received any tetravalent MenACWY vaccination;
NL68774.100.19 / IIV-401 JIM2-study
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The participants included in the JIM-study did not meet these exclusion criteria at time of the JIM-study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to explore the duration of SBA levels for protection (=8 = persistence of vaccine induced protective antibody levels) and determine the decay rate of SBA levels 5 years after a MenACWY-TT vaccine was administered at the age of 10, 12 or 15 respectively.
- Secondary Outcome Measures
Name Time Method - To compare SBA levels against MenA, MenC, MenW and MenY of =8 between the three age groups at 5 years (T1) after a MenACWY-TT vaccine was administered.<br>- To compare serum MenA-PS, MenY-PS and MenW-PS specific IgG levels between the three age groups at 5 years (T1) after a MenACWY-TT vaccine was administered.<br>- To compare serum IgG antibody levels against tetanus, the carrier protein for the vaccine, between the three age groups at 5 years (T1) after a MenACWY-TT vaccine was adminis-tered.<br>- To compare serum IgA levels against MenA, MenC, MenW and MenY between the three age groups at 5 years (T1) after a MenACWY-TT vaccine was administered.<br>- To compare MenA-PS specific, MenC-PS specific, MenW-PS specific and MenY-PS specific IgG subclasses (IgG1/IgG2 ratio) and avidity within the three age groups at 5 years (T1) after a MenACWY-TT vaccine was administered.