The monovalent MenC-TT vaccin administered in this study is used to prevent invasive disease caused by Meningococcal group C. The tetravelent MenACWY-TT vaccin administered in this study is used to prevent invasive disease caused by Meningococcal serogroup A, C, W and Y.
Conditions
Interventions
Trade Name: NeisVac-C
Product Name: NeisVac-C
Product Code: NeisVac-C
Pharmaceutical Form: Suspension for injection
Trade Name: Nimenrix
Product Name: Nimenrix
Product Code: Nimenrix
Pharmaceutical F
Sponsors
National Institute of Public Health and Environment (RIVM, the Netherlands)
Eligibility
Sex/Gender
All
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-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. Are the trial subjects under 18? yes Number of subjects for this age range: 410 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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 any tetravalent MenACWY vaccination; - Received any vaccination in the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 Objective: See E.5.2 Secondary end points;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: T0: First visit (Informed consent, blood sample, saliva sample and vaccination) T1: Second visit 1 month after T0 (blood sample, saliva sample) T2: Final visit 1 year after T0 (blood sample, saliva sample) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - 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. - Explorative: To measure saliva IgG and IgA levels at T0 1 month (T1) and 1 year (T2 | — |
Countries
Netherlands
Contacts
Public ContactGuy Berbers
National Institute of Public Health and Environment (RIVM, the Netherlands)
Outcome results
None listed