Purpose

This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults at increased risk for pneumococcal disease and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 6 months after receipt of either V114 or Prevnar 13™. Increased risk for pneumococcal disease is defined as 1) an underlying medical condition, 2) behavioral habits such as smoking, or 3) living in a community/environment with increased risk of disease transmission.

Condition

Eligibility

Eligible Ages
Between 18 Years and 49 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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:
  • diabetes mellitus Type 1 or Type 2 and with hemoglobin A1c (HgA1c) <10%
  • chronic liver disease with documented history of compensated cirrhosis (Child-Pugh Score A)
  • confirmed diagnosis of chronic obstructive pulmonary disease with spirometric Global Initiative for Chronic Obstructive Lung Disease Stage 1 to 3
  • confirmed diagnosis of mild or moderate persistent asthma receiving guideline directed therapy
  • 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.
  • 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
V114
Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2)
  • Biological: V114
    15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
  • Biological: PNEUMOVAX™23
    23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose
Active Comparator
Prevnar 13™
Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2)
  • Biological: Prevnar 13™
    13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg), and aluminum phosphate adjuvant (125 mcg aluminum) in each 0.5 ml dose
  • Biological: PNEUMOVAX™23
    23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose

Recruiting Locations

University of Texas Medical Branch at Galveston ( Site 0034)
Galveston, Texas 77555-1115
Contact:
Study Coordinator
409-772-5278

More Details

NCT ID
NCT03547167
Status
Recruiting
Sponsor
Merck Sharp & Dohme Corp.

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@merck.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.