Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-24 @ 7:17 PM
NCT ID:
NCT06202703
Eligibility Criteria:
Inclusion Criteria:
* Participants between the ages of 20 and 40 years old
* Participants should be generally healthy and without substantial co-morbidities, including all auto-immune diseases that are being actively treated with immunosuppressive therapy. Patients with chronic diseases that do not require immunosuppressive therapy and are stable, defined as not requiring change of therapy or hospitalization in the six weeks preceding study enrollment, might be eligible for this study.
Exclusion Criteria:
* BMI \> 30 kg/m2
* Pregnancy at time of inclusion
* Breastfeeding during the course of the study
* Documented pneumococcal vaccination and/or infection
* Pneumococcal infection is defined as any infection that is microbiologically confirmed to be caused by S. pneumoniae (e.g. positive blood or sputum cultures for S. pneumoniae, positive urine S. pneumoniae antigen test)
* Documented HIV infection
* Documented primary immune disorder or primary coagulopathy
* Use of immunosuppressive medication or anticoagulants
* Known hypersensitivity to any of the vaccine components
* Recent (i.e. \<4 weeks before inclusion) surgery in axillar area or major surgery elsewhere
* Vaccination with any vaccine \< 1 month before inclusion
* Subjects vaccinated 1 - 6 months before enrolment can be included into the study. Study vaccine will be injected in the contralateral arm.
* Fever at time of inclusion
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT06202703
Study Brief:
Protocol Section:
NCT06202703