Study to investigate the immune response and determine functional antibodies after a MenACWY-vaccinatio
- Conditions
- 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
- EUCTR2019-001301-24-NL
- Lead Sponsor
- ational Institute for Public Health and the Environment (RIVM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 140
Participants eligible for this study are healthy Dutch elderly 65-85 years of age, who did not receive a MenACWY-TT vaccine before.
Are the trial subjects under 18? no
Number of subjects for this age range:
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) yes
F.1.3.1 Number of subjects for this age range 140
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method