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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)

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ClinicalTrials.gov Identifier: NCT03547167
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE May 24, 2018
First Posted Date  ICMJE June 6, 2018
Last Update Posted Date April 15, 2019
Actual Study Start Date  ICMJE July 16, 2018
Estimated Primary Completion Date January 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2018)
  • Percentage of Participants with a Solicited Injection-site Adverse Event [ Time Frame: Up to Day 5 after Vaccination 1 ]
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs will be redness/erythema, swelling, and pain/tenderness.
  • Percentage of Participants with a Solicited Systemic Adverse Event [ Time Frame: Up to Day 14 after Vaccination 1 ]
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs will be muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
  • Percentage of Participants with a Vaccine-related Serious Adverse Event [ Time Frame: Up to Month 6 (before Vaccination 2) ]
    A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine will be determined by the investigator.
  • Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) [ Time Frame: Day 30 ]
    Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03547167 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2018)
  • Percentage of Participants with a Solicited Injection-site Adverse Event [ Time Frame: Up to Day 5 after Vaccination 2 (Month 6) ]
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs will be redness/erythema, swelling, and pain/tenderness.
  • Percentage of Participants with a Solicited Systemic Adverse Event [ Time Frame: Up to Day 14 after Vaccination 2 (Month 6) ]
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs will be muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
  • Percentage of Participants with a Vaccine-related Serious Adverse Event [ Time Frame: From Month 6 (before Vaccination 2) to Month 7 ]
    An SAE is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine will be determined by the investigator.
  • Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) [ Time Frame: Day 30 ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay.
  • Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA [ Time Frame: Day 1 (Baseline) and Day 30 ]
    Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay. GMFR is GMT at Day 30 / GMT at Day 1.
  • GMFR in Serotype-specific IgG [ Time Frame: Day 1 (Baseline) and Day 30 ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay. GMFR is GMC at Day 30 / GMC at Day 1.
  • Percentage of Participants with GMFR ≥4 in Serotype-specific OPA [ Time Frame: Day 1 (Baseline) and Day 30 ]
    Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay.
  • Percentage of Participants with GMFR ≥4 in Serotype-specific IgG [ Time Frame: Day 1 (Baseline) and Day 30 ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay.
  • Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity [ Time Frame: Month 7 ]
    Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay.
  • Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) [ Time Frame: Month 7 ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay.
  • GMFR in Serotype-specific OPA [ Time Frame: Day 1 (Baseline) and Month 7 ]
    Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay. GMFR is GMT at Month 7 / GMT at Day 1.
  • GMFR in Serotype-specific IgG [ Time Frame: Day 1 (Baseline) and Month 7 ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay. GMFR is GMC at Month 7 / GMC at Day 1.
  • Percentage of Participants with GMFR ≥4 in Serotype-specific OPA [ Time Frame: Day 1 (Baseline) and Month 7 ]
    Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay.
  • Percentage of Participants with GMFR ≥4 in Serotype-specific IgG [ Time Frame: Day 1 (Baseline) and Month 7 ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay.
  • GMFR in Serotype-specific OPA [ Time Frame: Month 6 (Baseline before Vaccination 2) and Month 7 ]
    Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay. GMFR is GMT at Month 7 / GMT at Month 6.
  • GMFR in Serotype-specific IgG [ Time Frame: Month 6 (Baseline before Vaccination 2) and Month 7 ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay. GMFR is GMC at Month 7 / GMC at Month 6.
  • Percentage of Participants with GMFR ≥4 in Serotype-specific OPA [ Time Frame: Month 6 (Baseline before Vaccination 2) and Month 7 ]
    Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay.
  • Percentage of Participants with GMFR ≥4 in Serotype-specific IgG [ Time Frame: Month 6 (Baseline before Vaccination 2) and Month 7 ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 Six Months Later in Immunocompetent Adults Between 18 and 49 Years of Age at Increased Risk for Pneumococcal Disease (PNEU - DAY)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Infections
Intervention  ICMJE
  • 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: 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
Study Arms  ICMJE
  • 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)
    Interventions:
    • Biological: V114
    • Biological: PNEUMOVAX™23
  • 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)
    Interventions:
    • Biological: Prevnar 13™
    • Biological: PNEUMOVAX™23
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 24, 2018)
1500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 17, 2020
Estimated Primary Completion Date January 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com
Listed Location Countries  ICMJE Australia,   Canada,   Chile,   New Zealand,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03547167
Other Study ID Numbers  ICMJE V114-017
2017-004915-38 ( EudraCT Number )
V114-017 ( Other Identifier: Merck Protocol Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP