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’
- Conditions
- meningococcal disease
- Registration Number
- NL-OMON20287
- Lead Sponsor
- ational Institute for Public Health and the Environment
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 140
? Moderate to good general health with regard to age;
? 65-85 years of age;
? Provision of written informed consent;
? Adherent to the protocol and available during the study period.
? 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to determine the level of protection in the elderly (divided into two age groups: 65-75 and 75-85 years of age) to the MenACWY-TT conjugate vaccine. The primary parameter to determine the level of protection will be by measuring meningococcal specific serum bactericidal antibody (SBA) levels pre-vaccination (T0) and 1 month (T1) and 1 year (T2) after vaccination. Also, in the booster-subcohort SBA levels will be determined 1 month (T3) and 1 year (T4) after the booster vaccination. At T4, blood samples will also be drawn and SBA levels determined from participants who did not receive a booster vaccination.
- Secondary Outcome Measures
Name Time Method