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Trial record 1 of 1 for:    03480763
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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)

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ClinicalTrials.gov Identifier: NCT03480763
Recruitment Status : Active, not recruiting
First Posted : March 29, 2018
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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™.

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: V114 Biological: Prevnar 13™ Biological: PNEUMOVAX™23 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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)
Actual Study Start Date : June 22, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
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: 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

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)
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480763


Locations
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United States, Arizona
East Valley Family Physicians ( Site 0104)
Chandler, Arizona, United States, 85224
Central Phoenix Medical Clinic, LLC ( Site 0125)
Phoenix, Arizona, United States, 85020
United States, California
Encompass Clinical Research ( Site 0118)
Spring Valley, California, United States, 91978
Diablo Clinical Research, Inc ( Site 0132)
Walnut Creek, California, United States, 94598
United States, Florida
Clinical Research of South Florida ( Site 0126)
Coral Gables, Florida, United States, 33134
QPS Miami Research Associates ( Site 0116)
South Miami, Florida, United States, 33143
United States, Kansas
Heartland Research Associates, Llc ( Site 0115)
Wichita, Kansas, United States, 67207
United States, Maryland
Centennial Medical Group ( Site 0109)
Elkridge, Maryland, United States, 21075
United States, Ohio
Rapid Medical Research, Inc. ( Site 0119)
Cleveland, Ohio, United States, 44122
United States, Texas
University of Texas Medical Branch at Galveston ( Site 0127)
Galveston, Texas, United States, 77555-1115
Texas Center For Drug Development ( Site 0107)
Houston, Texas, United States, 77081
Diagnostics Research Group ( Site 0100)
San Antonio, Texas, United States, 78229
United States, Utah
J Lewis Research Inc / Foothill Family Clinic ( Site 0123)
Salt Lake City, Utah, United States, 84109
J Lewis Research Inc/Jordan River Family Medicine ( Site 0114)
South Jordan, Utah, United States, 84095
United States, Virginia
Health Research of Hampton Roads, Inc. ( Site 0106)
Newport News, Virginia, United States, 23606
Korea, Republic of
Seoul National University Hospital ( Site 0400)
Seoul, Korea, Republic of, 03080
Korea University Guro Hospital ( Site 0401)
Seoul, Korea, Republic of, 08308
Spain
CAP Centelles ( Site 0303)
Centelles, Barcelona, Spain, 08540
Instituto de Ciencias Medicas.ICM ( Site 0301)
Alicante, Spain, 03004
Fundacion Oftalmologica del Mediterraneo ( Site 0300)
Valencia, Spain, 46015
Taiwan
National Taiwan University Hospital ( Site 0500)
Taipei, Taiwan, 100
National Cheng Kung University Hospital ( Site 0502)
Taiwan, Taiwan, 70403
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03480763     History of Changes
Other Study ID Numbers: V114-016
V114-016 ( Other Identifier: Merck Protocol Number )
2017-004024-30 ( EudraCT Number )
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs