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

Phase 4

Completed

• Conditions: C; 10004018; Second vaccination against meningococcal A; W and Y disease

• Registration Number: NL-OMON38656
• Lead Sponsor: RIVM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-05-12
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 410

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to demonstrate non-inferiority of SBA levels against<br /><br>MenC at 1 year (T2) after vaccination in the group vaccinated with tetravalent<br /><br>MenACWY-TT vaccine as compared with the group vaccinated with monovalent<br /><br>MenC-TT conjugate vaccine in 10-, 12-, and 15-years old children.<br /><br>If non-inferiority is demonstrated, the objective is to compare SBA<br /><br>levels against MenA, MenW and MenY at 1 year (T2) after vaccination between<br /><br>the three age groups that are vaccinated with tetravalent MenACWY-TT vaccine.</p><br>