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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.

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)
Actual Enrollment : 652 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
Actual Primary Completion Date : December 23, 2019
Actual Study Completion Date : December 23, 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Show Show 22 study locations
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    
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: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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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