A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
Age
18–49
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY)
