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 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT02654704
Eligibility Criteria:
Inclusion Criteria:
* Participants ages 18 to 25 years old, or 55 and older, who have been diagnosed with asthma, other immune-compromising condition (e.g. Leukemia treated, Pulmonary disorders) or are healthy.
Exclusion Criteria:
* Subjects may not participate in this study if any of the following applies:
The potential subjects have already been vaccinated with PPSV23. Subjects have special risks attendant to venipuncture. Existence of any medical conditions that study investigators believe will interfere with the study participation or evaluation of results. This includes subjects on immunosuppressive medications and/or glucocorticoids.
Mental incapacity and/or cognitive impairment that would preclude adequate understanding of, or cooperation with, the study protocol.
For female participants: subjects will be excluded if pregnant. There are no known risks to pregnant women from the PPSV23 vaccine (also indicated in the Vaccine Information Statement (VIS) attachment provided to participants), and there is no additional risk associated with becoming pregnant during the study. However, as pregnancy affects immune system responses, this may affect the molecular readout in this study and introduce confounding factors in the analysis by the investigators. If a participant is already enrolled and becomes pregnant during this study, the investigators will temporarily withdraw them from the study from the day the participants become pregnant. If the participants would like to stay in the study, the investigators may continue their participation after their delivery.
If a participant has any severe allergies (life-threatening) or a participant has ever had a life-threatening allergic reaction after a dose of pneumococcal vaccine, or have a known severe allergy to any part of this vaccine, the participants will be advised not participate.
If a participant is not feeling well on the scheduled day of vaccination, the study coordinators will suggest waiting until the participants feel better. If the participant agrees, the vaccination will be rescheduled for a later date.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02654704
Study Brief:
Protocol Section:
NCT02654704