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Trial record 1 of 1 for:    NCT03480763
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A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Healthy Adults 50 Years of Age or Older (V114-016/PNEU-PATH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03480763
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE March 22, 2018
First Posted Date  ICMJE March 29, 2018
Last Update Posted Date January 14, 2020
Actual Study Start Date  ICMJE June 22, 2018
Actual Primary Completion Date December 23, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2018)
  • Percentage of Participants with a Solicited Injection-site Adverse Event [ Time Frame: Up to Day 5 after Vaccination 1 and Vaccination 2 ]
    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, swelling, and pain/tenderness.
  • Percentage of Participants with a Solicited Systemic Adverse Event [ Time Frame: Up to Day 14 after Vaccination 1 and Vaccination 2 ]
    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, joint pain, headache, and tiredness.
  • Percentage of Participants with a Vaccine-related Serious Adverse Event [ Time Frame: Up to Month 13 ]
    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 of Serotype-specific Opsonophagocytic Activity (OPA) [ Time Frame: Month 13 ]
    OPA for the serotypes contained in V114 will be determined using a Multiplex Opsonophagocytic Assay.
Original Primary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
  • Percentage of Participants with a Solicited Injection-site Adverse Event [ Time Frame: Up to Day 5 after Vaccination 1 and Vaccination 2 ]
    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, swelling, and pain/tenderness.
  • Percentage of Participants with a Solicited Systemic Adverse Event [ Time Frame: Up to Day 14 after Vaccination 1 and Vaccination 2 ]
    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, joint pain, headache, and tiredness.
  • Percentage of Participants with a Vaccine-related Serious Adverse Event [ Time Frame: Up to Month 13 ]
    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 of Serotype-specific Opsonophagocytic Activity (OPA) [ Time Frame: Month 13 ]
    Serotype-specific OPA will be determined using a Multiplex Opsonophagocytic Assay.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2018)
  • Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) [ Time Frame: Day 30, Month 12 (before Vaccination 2), and Month 13 ]
    IgG for the serotypes contained in V114 will be determined using an electrochemiluminescence assay.
  • Geometric Mean Titer of Serotype-specific OPA [ Time Frame: Day 30 and Month 12 (before Vaccination 2) ]
    OPA for the serotypes contained in V114 will be determined using a Multiplex Opsonophagocytic Assay.
  • Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA [ Time Frame: Day 1 (Baseline) and Day 30 ]
    OPA for the serotypes contained in V114 will be determined using a Multiplex Opsonophagocytic Assay.
  • GMFR in Serotype-specific IgG [ Time Frame: Day 1 (Baseline) and Day 30 ]
    IgG for the serotypes contained in V114 will be determined using an electrochemiluminescence assay.
  • Percentage of Participants with GMFR ≥4 in Serotype-specific OPA [ Time Frame: Day 1 (Baseline) and Day 30 ]
    OPA for the serotypes contained in V114 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 ]
    IgG for the serotypes contained in V114 will be determined using an electrochemiluminescence assay.
  • GMFR in Serotype-specific OPA [ Time Frame: Day 1 (Baseline) and Month 12 (before Vaccination 2) ]
    OPA for the serotypes contained in V114 will be determined using a Multiplex Opsonophagocytic Assay.
  • GMFR in Serotype-specific IgG [ Time Frame: Day 1 (Baseline) and Month 12 (before Vaccination 2) ]
    IgG for the serotypes contained in V114 will be determined using an electrochemiluminescence assay.
  • Percentage of Participants with GMFR ≥4 in Serotype-specific OPA [ Time Frame: Day 1 (Baseline) and Month 12 (before Vaccination 2) ]
    OPA for the serotypes contained in V114 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 12 (before Vaccination 2) ]
    IgG for the serotypes contained in V114 will be determined using an electrochemiluminescence assay.
  • GMFR in Serotype-specific OPA [ Time Frame: Day 1 (Baseline) and Month 13 ]
    OPA for the serotypes contained in V114 will be determined using a Multiplex Opsonophagocytic Assay.
  • GMFR in Serotype-specific IgG [ Time Frame: Day 1 (Baseline) and Month 13 ]
    IgG for the serotypes contained in V114 will be determined using an electrochemiluminescence assay.
  • Percentage of Participants with GMFR ≥4 in Serotype-specific OPA [ Time Frame: Day 1 (Baseline) and Month 13 ]
    OPA for the serotypes contained in V114 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 13 ]
    IgG for the serotypes contained in V114 will be determined using an electrochemiluminescence assay.
  • GMFR in Serotype-specific OPA [ Time Frame: Month 12 (Baseline) and Month 13 ]
    OPA for the serotypes contained in V114 will be determined using a Multiplex Opsonophagocytic Assay.
  • GMFR in Serotype-specific IgG [ Time Frame: Month 12 (Baseline) and Month 13 ]
    IgG for the serotypes contained in V114 will be determined using an electrochemiluminescence assay.
  • Percentage of Participants with GMFR ≥4 in Serotype-specific OPA [ Time Frame: Month 12 (Baseline) and Month 13 ]
    OPA for the serotypes contained in V114 will be determined using a Multiplex Opsonophagocytic Assay.
  • Percentage of Participants with GMFR ≥4 in Serotype-specific IgG [ Time Frame: Month 12 (Baseline) and Month 13 ]
    IgG for the serotypes contained in V114 will be determined using an electrochemiluminescence assay.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
  • Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) [ Time Frame: Day 30, Month 12 (before Vaccination 2), and Month 13 ]
    Serotype-specific IgG will be determined using an electrochemiluminescence assay.
  • Geometric Mean Titer of Serotype-specific OPA [ Time Frame: Day 30 and Month 12 (before Vaccination 2) ]
    Serotype-specific OPA will be determined using a Multiplex Opsonophagocytic Assay.
  • Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA [ Time Frame: Day 1 (Baseline) and Day 30 ]
    Serotype-specific OPA will be determined using a Multiplex Opsonophagocytic Assay.
  • GMFR in Serotype-specific IgG [ Time Frame: Day 1 (Baseline) and Day 30 ]
    Serotype-specific IgG will be determined using an electrochemiluminescence assay.
  • Percentage of Participants with GMFR ≥4 in Serotype-specific OPA [ Time Frame: Day 1 (Baseline) and Day 30 ]
    Serotype-specific OPA 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 ]
    Serotype-specific IgG will be determined using an electrochemiluminescence assay.
  • GMFR in Serotype-specific OPA [ Time Frame: Day 1 (Baseline) and Month 12 (before Vaccination 2) ]
    Serotype-specific OPA will be determined using a Multiplex Opsonophagocytic Assay.
  • GMFR in Serotype-specific IgG [ Time Frame: Day 1 (Baseline) and Month 12 (before Vaccination 2) ]
    Serotype-specific IgG will be determined using an electrochemiluminescence assay.
  • Percentage of Participants with GMFR ≥4 in Serotype-specific OPA [ Time Frame: Day 1 (Baseline) and Month 12 (before Vaccination 2) ]
    Serotype-specific OPA 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 12 (before Vaccination 2) ]
    Serotype-specific IgG will be determined using an electrochemiluminescence assay.
  • GMFR in Serotype-specific OPA [ Time Frame: Day 1 (Baseline) and Month 13 ]
    Serotype-specific OPA will be determined using a Multiplex Opsonophagocytic Assay.
  • GMFR in Serotype-specific IgG [ Time Frame: Day 1 (Baseline) and Month 13 ]
    Serotype-specific IgG will be determined using an electrochemiluminescence assay.
  • Percentage of Participants with GMFR ≥4 in Serotype-specific OPA [ Time Frame: Day 1 (Baseline) and Month 13 ]
    Serotype-specific OPA 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 13 ]
    Serotype-specific IgG will be determined using an electrochemiluminescence assay.
  • GMFR in Serotype-specific OPA [ Time Frame: Month 12 (Baseline) and Month 13 ]
    Serotype-specific OPA will be determined using a Multiplex Opsonophagocytic Assay.
  • GMFR in Serotype-specific IgG [ Time Frame: Month 12 (Baseline) and Month 13 ]
    Serotype-specific IgG will be determined using an electrochemiluminescence assay.
  • Percentage of Participants with GMFR ≥4 in Serotype-specific OPA [ Time Frame: Month 12 (Baseline) and Month 13 ]
    Serotype-specific OPA will be determined using a Multiplex Opsonophagocytic Assay.
  • Percentage of Participants with GMFR ≥4 in Serotype-specific IgG [ Time Frame: Month 12 (Baseline) and Month 13 ]
    Serotype-specific IgG will be determined using an electrochemiluminescence assay.
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 Healthy Adults 50 Years of Age or Older (V114-016/PNEU-PATH)
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 One Year Later in Healthy Adults 50 Years of Age or Older (PNEU-PATH)
Brief Summary This study is designed 1) to evaluate the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in healthy adults 50 years of age or older, 2) to describe the safety of sequential administration of V114 or Prevnar 13™ followed by PNEUMOVAX™23, and 3) to evaluate the immune responses to the 15 serotypes contained in V114 when PNEUMOVAX™23 is given approximately 12 months after receipt of either V114 or Prevnar 13™.
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, 19F, 19A, 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 serotypes1, 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) 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, 19F, 19A, 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 12 (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 12 (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 Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2020)
652
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2018)
600
Actual Study Completion Date  ICMJE December 23, 2019
Actual Primary Completion Date December 23, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female in good health
  • 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 administration of study vaccine.

Exclusion Criteria:

  • History of invasive pneumococcal disease
  • Known hypersensitivity to any vaccine component
  • Known or suspected impairment of immune function
  • Coagulation disorder contraindicating intramuscular vaccination
  • History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
  • Female participant: positive urine or serum pregnancy test
  • Prior administration of any pneumococcal vaccine
  • Received systemic corticosteroids for ≥14 consecutive days and have not completed within 30 days of enrollment
  • Received immunosuppressive therapy
  • Received a blood transfusion or blood products within 6 months of enrollment
  • Participated in another clinical study of an investigational product within 2 months of enrollment
  • Current user of recreational or illicit drugs or history of drug or alcohol abuse or dependence.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of,   Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03480763
Other Study ID Numbers  ICMJE V114-016
V114-016 ( Other Identifier: Merck Protocol Number )
2017-004024-30 ( EudraCT 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 January 2020

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