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)

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 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
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 - 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 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.