Meningococcal vaccination in Dutch teenagers and adolescents: Study to investigate the long-term immune response after a tetravalent MenACWY-TT conjugate vaccine.
- Conditions
- Cvaccination against meningococcal AW and Y disease10004018
- Registration Number
- NL-OMON48391
- Lead Sponsor
- RIVM
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 55
Participants are former participants of the JIM-study (2014) and all received a primary vaccination with a single dose of MenC_PS conjugated (MenC-TT vaccine) either during the mass catch-up campaign in 2002 or at the age of 14 months (regular vaccination time point since 2002 according to the Dutch NIP) and also received a booster vaccination with a MenACWY-TT vaccine at the age of 10, 12, or 15 respectively 5 years ago in the context of the JIM-study.
Furthermore, participants will have to fulfil all of the following criteria:
- Provision of written informed consent by the participant itself and both parents and if the child is under 16 years old.
- 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 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;;The participants included in the JIM-study did not meet these exclusion criteria at time of the JIM-study.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to explore the duration of SBA levels for protection<br /><br>(>=8 = persistence of vaccine induced protective antibody levels) 5 years after<br /><br>a MenACWY-TT vaccine was administered at the age of 10, 12 or 15 respectively.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To compare SBA levels against MenA, MenC, MenW and MenY of >=8 between the<br /><br>three age groups at 5 years (T1) after a MenACWY-TT vaccine was administered.<br /><br>- To compare serum MenA-PS, MenY-PS and MenW-PS specific IgG levels between the<br /><br>three age groups at 5 years (T1) after a MenACWY-TT vaccine was administered.<br /><br>- To compare serum IgG antibody levels against tetanus, the carrier protein for<br /><br>the vaccine, between the three age groups at 5 years (T1) after a MenACWY-TT<br /><br>vaccine was adminis-tered.<br /><br>- To compare serum IgA levels against MenA, MenC, MenW and MenY between the<br /><br>three age groups at 5 years (T1) after a MenACWY-TT vaccine was administered.<br /><br>- To compare MenA-PS specific, MenC-PS specific, MenW-PS specific and MenY-PS<br /><br>specific IgG subclasses (IgG1/IgG2 ratio) and avidity within the three age<br /><br>groups at 5 years (T1) after a MenACWY-TT vaccine was administered.</p><br>