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:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 12:41 AM
NCT ID:
NCT03547167
Eligibility Criteria:
Inclusion Criteria:
* Native American participant enrolled from any of the clinical sites of the Johns Hopkins Center for American Indian Health (CAIH) without any of the pre-specified risk conditions for pneumococcal disease listed below, OR Native American participant enrolled from any of the CAIH sites or participant from a site other than CAIH with ≥1 of the following risk conditions for pneumococcal disease:
1. Diabetes mellitus Type 1 or Type 2 and with hemoglobin A1c (HgA1c) \<10%
2. Chronic liver disease with documented history of compensated cirrhosis (Child-Pugh Score A)
3. Confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD) with spirometric Global Initiative for Chronic Obstructive Lung Disease Stage 1 to 3
4. Confirmed diagnosis of mild or moderate persistent asthma receiving guideline directed therapy
5. Confirmed diagnosis of chronic heart disease (New York Heart Association \[NYHA\] heart failure Class 1 to 3, receiving guideline-directed oral heart failure treatment) due to reduced or preserved ejection fraction or due to non-cyanotic congenital heart disease.
6. Current smoker
* Female participant: not pregnant, not breastfeeding and 1) not of childbearing potential, or 2) of childbearing potential and agrees to practice contraception through 6 weeks after last administration of study vaccine.
Exclusion Criteria:
* History of active hepatitis within the prior 3 months
* History of diabetic ketoacidosis, or \>1 episodes of severe, symptomatic hypoglycemia within the prior 3 months
* Myocardial infarction, acute coronary syndrome, transient ischemic attack, and ischemic or hemorrhagic stroke within the prior 3 months
* History of severe pulmonary hypertension or history of Eisenmenger syndrome
* History of invasive pneumococcal disease (IPD) or known history of other culture-positive pneumococcal disease within the prior 3 years
* Known hypersensitivity to any vaccine component, pneumococcal conjugate vaccine, or diphtheria toxoid-containing vaccine
* Known or suspected impairment of immunological function (including human immunodeficiency virus (HIV) infection or autoimmune disease)
* History of malignancy within the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
* History of Stage 4 or 5 Chronic Kidney Disease or nephrotic syndrome
* History of alcohol withdrawal or alcohol withdrawal seizure within the prior 12 months
* History of coagulation disorder contraindicating intramuscular vaccination
* History of hospitalization within the prior 3 months
* Planned organ transplantation (heart, liver, lung, kidney, or pancreas) or other planned major surgery during the duration of this study.
* Expected survival for less than 1 year according to the investigator's judgment.
* Female participant: positive urine or serum pregnancy test
* Prior administration of any pneumococcal vaccine
* Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed within the prior 30 days
* Received systemic corticosteroids exceeding physiologic replacement doses within 14 days before study vaccination
* Receiving immunosuppressive or immunomodulatory therapy with a biological agent
* Received any licensed, non-live vaccine within 14 days before receipt of study vaccine or is scheduled to receive any licensed, non-live vaccine within 30 days following receipt of study vaccine
* Received any live vaccine within 30 days before receipt of any study vaccine or is scheduled to receive any live vaccine within 30 days following receipt of any study vaccine
* Received a blood transfusion or blood products within the prior 6 months
* Receiving chronic home oxygen therapy
* Participated in another clinical study of an investigational product within the prior 2 months
* Current user of recreational or illicit drugs or history of drug abuse or dependence
* Diabetes mellitus with HgA1c ≥10%
* Chronic liver disease with Child-Pugh Class B or C cirrhosis
* Chronic lung disease with Chronic Obstructive Pulmonary Disease (COPD) GOLD Stage 4 or severe persistent asthma
* Chronic heart disease with NYHA heart failure Class 4.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT03547167
Study Brief:
Protocol Section:
NCT03547167