Second meningococcal vaccination in Dutch children: Study to compare the tetravalent MenACWY-TT conjugate vaccine with the monovalent MenC-TT conjugate vaccine.

• Conditions: 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.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-001823-38-NL
• Lead Sponsor: ational Institute of Public Health and Environment (RIVM, the Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-05
• Last Update Posted: 19 August 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified