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 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT06077656
Eligibility Criteria:
Inclusion Criteria:
* Healthy adults who are 18 through 49 years old on the day of randomization (Day 1).
* Participant must provide voluntary written informed consent to participate in the study.
* Participant must be able to comprehend and comply with study requirements and procedures and be willing and able to return for all scheduled follow-up visits.
* Adult female participants who are not surgically sterile must have a negative pregnancy test at screening and negative pregnancy test prior to vaccination and must agree to employ a highly effective method to avoid pregnancy through Day 57 of the study.
Exclusion Criteria:
* Use of any investigational medicinal product within 90 days prior to randomization or planned use of such a product during the period of study participation.
* Adults who have previously been vaccinated against S. pneumoniae.
* History of microbiologically confirmed invasive disease caused by S. pneumoniae.
* History of allergic disease (including angioedema) or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines, including PEG.
* Any abnormal vital sign deemed clinically relevant by the PI.
* Acute illness at time of randomization (moderate or severe) and/or fever (body temperature of ≥ 38.0°C)
* History of any non-study vaccine administration within 14 days of study vaccine administration.
* No planned vaccines until after Day 29 (Visit 3).
* Chronic administration (defined as more than 14 consecutive days) of immunosuppressant or other immune modifying drugs prior to the administration of the study vaccine (and within the 6 months prior to administration of the study vaccine), including the use of glucocorticoids. The use of topical and inhaled glucocorticoids will be permitted.
* Administration of immunoglobulins and/or any blood products within the 6 months prior to administration of the study vaccine or anticipation of such administration during the study period.
* Any medical or social condition that in the opinion of the PI , may interfere with the study objectives, pose a risk to the participant, or prevent the participant from completing the study follow-up.
* Any screening laboratory test result outside the normal range and with toxicity score ≥ 2, unless allowed by study team.
* A positive serologic test for human immunodeficiency virus (HIV)-1 or HIV-2 (HIV 1/2 Ab), hepatitis B (HBsAg) or hepatitis C (HCV Ab).
* History of malignancy, excluding non-melanoma skin and cervical carcinoma in situ.
* Recent history (within the past year) or signs of alcohol or substance abuse.
* History of major psychiatric disorder.
* Female adult participants who are pregnant or breastfeeding.
* Participant is an employee of, or direct descendant (child or grandchild) of any person employed by the Sponsor, PATH, the Contract Research Organization (CRO), the PI.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT06077656
Study Brief:
Protocol Section:
NCT06077656