Juveniele Immunisatie Meningokokken ACWY studie

INTERVENTION: ‐ Vaccination with Nimenrix or NeisVacC ‐ Venapunction ‐ Salivary CONDITION: Children, Meningococcal serogroup C conjugate vaccination ; ; PRIMARY OUTCOME: 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.; 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 ¡Ý8 (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 ¡Ý8 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. INCLUSION CRITERIA: 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.