*Primary and booster meningococcal vaccination in Dutch elderly: study to investigate the immune response and determine functional antibodies after the tetravalent MenACWY-TT conjugate vaccine in the elderly population*

Phase 4

Recruiting

• Conditions: invasive meningococcal disease; meningitis; sepsis; 10004018

• Registration Number: NL-OMON54103
• Lead Sponsor: RIVM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 280

Inclusion Criteria

Participants eligible for this study are Dutch older persons 65-85 years of
age, of moderate to good general health with regard to age, who did not receive
a MenACWY-TT vaccine before.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
* Antibiotic use within 14 days of enrolment
* Severe acute infectious illness or fever above 38.0 °C within 14 days before
vaccination;
* Present evidence of serious diseases either demanding regular use of oral
immunosuppressive medical treatment, like corticosteroids, that might interfere
with the results of the study within the last 3 months or demanding acute use
of high dose oral immunosuppressive that might interfere with the results of
the study within the last 2 weeks;
* Known or suspected allergy to any of the vaccine components (by medical
history);
* Occurrence of a serious adverse event after other vaccination by medical
history;
* Known or suspected immune deficiency;
* Known or suspected coagulation disorder;
* Oral hormone use, such as postmenopausal hormones, within the last 3 months;
* History of one of the following neurological disorders: multiple sclerosis,
Parkinson*s disease, or epilepsy;
* Previous administration of plasma-serum products including immunoglobulins
within 6 months before vaccination and blood sampling;
* Serious surgery within the last 3 months;
* Previous vaccination with the MenC, MenC-TT or MenACWY-TT vaccine;
* Previous confirmed or suspected meningococcal disease;
* Any vaccination within a month before enrolment.
Presence of in-and exclusion criteria will be checked by interviewing the
participant during the first phone call. In addition, presence of in-and
exclusion criteria will be checked at the first study visit again, prior to
signing the informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Functional antibody levels against MenA, MenC, MenW and MenY are measured using<br /><br>the serum bactericidal antibody (SBA) assay. </p><br>