C Second vaccination against meningococcal A W and Y disease
Conditions
Interventions
Participants will receive the vaccination with either the registered
tetravalent vaccine (Nimenrix
0,5mL) or the registered monovalent (NeisVac-C*
0,5 mL) at the first visit. Blood and saliva samples will be drawn prior to the
vaccination (T0), 1 month (T1) and 1 year (T2) after the vaccination.
Sponsors
RIVM
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: Participants are 10-, 12, and 15-year old children who have received a primary vaccination with a single dose of MenC-PS conjugated (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
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°C) within 14 days before vaccination; - Antibiotic use within 14 days of enrollment; - Present evidence of serious disease(s) demanding (immunosuppressive) medical treatment that might interfere the results of the study within the last 3 months (like corticosteroids, 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 a tetravalent MenACWY vaccine - Received vaccination in the past month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| - 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. - 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. | — |
Countries
Netherlands
Outcome results
None listed