|- candidate number||16381|
|- NTR Number||NTR4430|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-feb-2014|
|- Secondary IDs||NL44863.100.13 |
|- Public Title||Juveniele Immunisatie Meningokokken ACWY studie|
|- Scientific Title||Second meningococcal vaccination in Dutch children: Study to compare the tetravalent MenACWY-TT conjugate vaccine with the monovalent MenC-TT conjugate vaccine.
|- hypothesis||The 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) studied||Children, Meningococcal serogroup C conjugate vaccination|
|- 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.|
|- Exclusion criteria||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;
- 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 received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||10-mrt-2014|
|- planned closingdate||1-mei-2015|
|- Target number of participants||410|
|- Interventions||- Vaccination with Nimenrix or NeisVacC
|- 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.
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.|
|- Timepoints||T0 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|
|- CONTACT FOR PUBLIC QUERIES||PhD G. Berbers|
|- CONTACT for SCIENTIFIC QUERIES||PhD G. Berbers|
|- Sponsor/Initiator ||National Institute for Public Health and the Environment (RIVM)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Neisseria 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)|
|- RECORD||7-feb-2014 - 7-apr-2014|