Table 1.

Subgroup analysis inclusion and exclusion criteria.

Inclusion criteria

Immunocompetent adults 18–49 years of age with ≥1 of the following medical or behavioral risk factors for pneumococcal disease Diabetes mellitus type 1 or 2, receiving anti-diabetic medication; HbA1c <10% at screening Chronic liver disease with compensated cirrhosis (Child-Pugh Class A) due to nonalcoholic fatty liver disease, chronic hepatitis B or C, or alcoholic liver disease, with at least one liver staging assessment COPD with FEV1/FVC <0.7, and FEV1 ≥30% predicted (spirometric GOLD Stage 1–3) in the prior 5 years Mild or moderate persistent asthma with reversible airflow obstruction on spirometry and receipt of guideline-directed therapy for mild-to-moderate asthma Chronic heart disease due to heart failure with reduced or preserved ejection fraction or non-cyanotic congenital heart disease, diagnosed in the prior 5 years and classified as NYHA heart failure Class 1–3 with receipt of guideline-directed oral heart failure treatment Current smoker (≥100 cigarettes during lifetime) and not currently receiving smoking cessation therapy Alcoholism defined as an AUDIT-C score of ≥5

Key exclusion criteria

History (≤3 years) of pneumococcal disease

Known hypersensitivity to any study vaccine component

Prior or planned receipt of any pneumococcal vaccine during study

History of specific medical conditions, including: Immunodeficiency Febrile illness within 72 hours prior to vaccine Autoimmune disease Recent (≤5 years) malignancy Coagulation disorder Pregnancy

Prohibited prior/concomitant therapies, including: Immunosuppressive therapy, including chemotherapeutic agents and interventions associated with organ or bone marrow transplantation or autoimmune disease Systemic corticosteroids for ≥14 consecutive days and not completed at least 30 days before study entry

Further details on eligibility criteria can be found in Supplemental Table S1.

AUDIT-C: Alcohol Use Disorder Identification Test – Consumption; COPD: chronic obstructive pulmonary disease; FEV1: forced expiratory volume in 1 second; FVC: forced vital capacity; GOLD: Global Initiative for Chronic Obstructive Lung Disease; HbA1c: glycated hemoglobin; NYHA: New York Heart Association.