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Juveniele Immunisatie Meningokokken ACWY studie


- candidate number16381
- NTR NumberNTR4430
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-feb-2014
- Secondary IDsNL44863.100.13 
- Public TitleJuveniele Immunisatie Meningokokken ACWY studie
- Scientific TitleSecond meningococcal vaccination in Dutch children: Study to compare the tetravalent MenACWY-TT conjugate vaccine with the monovalent MenC-TT conjugate vaccine.
- ACRONYMJIM-studie
- hypothesisThe aim of this study is to investigate the immune response to the tetravalent MenACWY-TT vaccine administered as a second meningococcal vaccination and compare the booster response to MenC with the booster response to the monovalent MenC-TT conjugate vaccine.
- Healt Condition(s) or Problem(s) studiedChildren, Meningococcal serogroup C conjugate vaccination
- Inclusion criteriaParticipants 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.
- Exclusion criteriaAny of the following criteria at the start of the study will exclude a volunteering child from participation: - Severe acute (infectious) illness or fever (>38.5C) 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 10-mrt-2014
- planned closingdate1-mei-2015
- Target number of participants410
- Interventions- Vaccination with Nimenrix or NeisVacC - Venapunction - Salivary
- Primary outcomeThe 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. 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- To compare SBA levels against MenC at 1 month (T1) between the vaccine groups within the three age groups. - To compare SBA levels against MenC of 8 (persistence of vaccine induced protective antibody levels) at 1 month (T1) and 1 year (T2) between the vaccine groups within the three age groups. - To compare serum MenC-PS specific IgG levels at 1 month (T1) and 1 year (T2) between the vaccine groups within the three age groups. - To compare the decay rate of SBA levels and MenC-PS specific IgG levels after secondary vaccination (i.e. the difference between T2 and T1) between the vaccine groups within the three age groups. - To compare SBA levels against MenA, MenW and MenY at 1 month (T1) between the three age groups within the MenACWY-TT vaccine group. - To compare SBA levels against MenA, MenW and MenY of 8 at 1 month (T1) and 1 year (T2) between the three age groups within the MenACWY-TT vaccine group. - To compare serum MenA-PS, MenY-PS and MenW-PS specific IgG levels at 1 month (T1) and 1 year (T2) between the three age groups within the MenACWY-TT vaccine group. - To compare serum IgG antibody levels against tetanus, the carrier protein for both vaccines, at 1 month (T1) and 1 year (T2)? between the vaccine groups within the three age groups. JIM-Study Research protocol C Version 1.9 C May 24, 2013, Pagina 17 - To compare serum IgA levels against MenA, MenC, MenW and MenY at 1 month (T1) and at 1 year (T2) between the vaccine groups within the three age groups. - To compare MenC-PS specific IgG subclasses (IgG1/IgG2 ratio) and avidity at 1 month (T1) and 1 year (T2)? between the vaccine groups within the three age groups. - To compare SBA and IgG levels against MenC at 1 month and 1 year between the MenC-TT group of the current study and the TIM-study for the the 12- and 15- year olds, to establish the effect of the age at priming on antibody responses to a second MenC-TT vaccination during adolescence. - Explorative: To measure saliva IgG and IgA levels at T0 1 month (T1) and 1 year (T2) in all groups. - Explorative: To measure B- and T-cell memory immune responses at T0, 1 month (T1) and 1 year (T2) in all groups.
- TimepointsT0 first visit: - Sign informed consent form - Draw first blood sample - Draw first saliva sample - Administer MenACWY-TT vaccination or second MenC-TT vaccination T1 (1 month after T0) - Draw second blood sample - Draw second saliva sample T2 (1 year after T0) - Draw third blood sample - Draw third saliva sample
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESPhD G. Berbers
- CONTACT for SCIENTIFIC QUERIESPhD G. Berbers
- Sponsor/Initiator National Institute for Public Health and the Environment (RIVM)
- Funding
(Source(s) of Monetary or Material Support)
GlaxoSmithKline
- Publications
- Brief summaryNeisseria meningitides is a gram-negative diplococcal bacterium that causes septicemia and meningitis. The incidence of meningococcal serogroup Y (MenY) appears to increase throughout countries in Europe, including the Netherlands. Nowadays, many young adults go travelling world-wide. Even though the increase of MenC in 1999/2000 was much more notable, the MenACWY-TT vaccine may be beneficial for a second vaccination at older age in the future. This second vaccination will protect the adolescents and maintain the herd immunity that persists up until today. Currently, a MenACWY-TT vaccination in adolescence is considered in many countries. However, longitudinal effectiveness studies with the MenACWY-TT vaccine for a second meningococcal vaccination are lacking. Therefore, the evaluation of persistence of antibodies, after a booster vaccination with MenACWY-TT is critical to monitor the duration of protection of a MenACWY-TT conjugate vaccine in adolescence after priming with MenC-TT at age of 14 months.
- Main changes (audit trail)
- RECORD7-feb-2014 - 7-apr-2014


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