C vaccination against meningococcal A W and Y disease
Conditions
Interventions
None listed
Sponsors
RIVM
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: Participants are former participants of the JIM-study (2014) and all received a primary vaccination with a single dose of MenC_PS conjugated (MenC-TT vaccine) either during the mass catch-up campaign in 2002 or at the age of 14 months (regular vaccination time point since 2002 according to the Dutch NIP) and also received a booster vaccination with a MenACWY-TT vaccine at the age of 10, 12, or 15 respectively 5 years ago in the context of the JIM-study. Furthermore, participants will have to fulfil all of the following criteria: - Provision of written informed consent by the participant itself and both parents and if the child is under 16 years old. - 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 potential subject from participation in this study: - Previous administration of plasma products (including immunoglobulins) within the last 6 months; - Pregnancy; - Previous confirmed or suspected meningococcal disease; - Received any vaccination in the past month; - Former received tetravalent MenACWY vaccination administered not as part of the JIM-study - Known or suspected immune deficiency; - History of any neurologic disorder, including epilepsy; - Present evidence of serious disease(s) demanding (immunosuppressive) medical treatment that might interfere with the results of the study within the last 3 months (like corticosteroids, chronic infection, bleeding disorder, immune dysfunction, or genetic anomaly).;In the JIM-study, in addition, any of the following criteria excluded a potential subject from participation in the study: - Severe acute (infectious) illness or fever (>38.5°C) within 14 days before vaccination; - Antibiotic use within 14 days of enrollment; - 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) - Former received doses of MenC vaccines in addition to the primary vaccination; - Former received any tetravalent MenACWY vaccination;;The participants included in the JIM-study did not meet these exclusion criteria at time of the JIM-study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to explore the duration of SBA levels for protection (>=8 = persistence of vaccine induced protective antibody levels) 5 years after a MenACWY-TT vaccine was administered at the age of 10, 12 or 15 respectively. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To compare SBA levels against MenA, MenC, MenW and MenY of >=8 between the three age groups at 5 years (T1) after a MenACWY-TT vaccine was administered. - To compare serum MenA-PS, MenY-PS and MenW-PS specific IgG levels between the three age groups at 5 years (T1) after a MenACWY-TT vaccine was administered. - To compare serum IgG antibody levels against tetanus, the carrier protein for the vaccine, between the three age groups at 5 years (T1) after a MenACWY-TT vaccine was adminis-tered. - To compare serum IgA levels against MenA, MenC, MenW and MenY between the three age groups at 5 years (T1) after a MenACWY-TT vaccine was administered. - To compare MenA-PS specific, MenC-PS specific, MenW-PS specific and MenY-PS specific IgG subclasses (IgG1/IgG2 ratio) and avidity within the three age groups at 5 years (T1) after a MenACWY-TT vaccine was administered. | — |
Countries
Netherlands
Outcome results
None listed