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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03547167
Registration number
NCT03547167
Ethics application status
Date submitted
24/05/2018
Date registered
6/06/2018
Date last updated
15/01/2021
Titles & IDs
Public title
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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Scientific 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 Six Months Later in Immunocompetent Adults Between 18 and 49 Years of Age at Increased Risk for Pneumococcal Disease (PNEU - DAY)
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Secondary ID [1]
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0
2017-004915-38
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Secondary ID [2]
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0
V114-017
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pneumococcal Infections
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0
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Condition category
Condition code
Infection
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0
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - V114
Other interventions - Prevnar 13™
Other interventions - PNEUMOVAX™23
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)
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)
Other interventions: 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
Other interventions: 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
Other interventions: 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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™
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Assessment method [1]
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An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Estimated confidence intervals (CIs) are calculated based on the exact binomial method proposed by Clopper and Pearson.
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Timepoint [1]
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Up to 5 days after Vaccination 1
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Primary outcome [2]
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Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™
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Assessment method [2]
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An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.
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Timepoint [2]
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Up to 14 days after Vaccination 1
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Primary outcome [3]
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Percentage of Participants With a Vaccine-related Serious Adverse Event Following V114 or Prevnar 13™
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Assessment method [3]
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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 was determined by the investigator. Following vaccination with V114 or Prevnar 13™, the percentage of serious adverse events of V114 compared with Prevnar 13™ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.
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Timepoint [3]
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Up to Month 6 (before Vaccination 2)
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Primary outcome [4]
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Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™
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Assessment method [4]
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The geometric mean titer (GMT) of serotype-specific opsonophagocytic activity (OPA) for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplex opsonophagocytic assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
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Timepoint [4]
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Day 30
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Secondary outcome [1]
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Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23
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Assessment method [1]
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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. Following Vaccination 2 with PNEUMOVAX™23, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.
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Timepoint [1]
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Up to 5 days after Vaccination 2 (Month 6)
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Secondary outcome [2]
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Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23
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Assessment method [2]
0
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An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.
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Timepoint [2]
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Up to 14 days after Vaccination 2 (Month 6)
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Secondary outcome [3]
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Percentage of Participants With a Vaccine-related Serious Adverse Event Following PNEUMOVAX™23
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Assessment method [3]
0
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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 was determined by the investigator. Following vaccination with PNEUMOVAX™23, the percentage of serious adverse events of V114 compared with Prevnar 13™ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.
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Timepoint [3]
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From Month 6 (before Vaccination 2) to Month 7
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Secondary outcome [4]
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Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30
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Assessment method [4]
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The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
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Timepoint [4]
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Day 30
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Secondary outcome [5]
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Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
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Assessment method [5]
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Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplex Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
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Timepoint [5]
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Day 1 (Baseline) and Day 30
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Secondary outcome [6]
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GMFR in Serotype-specific IgG Day 1 to Day 30
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Assessment method [6]
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IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
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Timepoint [6]
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Day 1 (Baseline) and Day 30
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Secondary outcome [7]
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Percentage of Participants With =4-Fold Rise in Serotype-specific OPA Day 1 to Day 30
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Assessment method [7]
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Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had =4-fold rise in OPA titers were calculated from baseline to postvaccination.
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Timepoint [7]
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Day 1 (Baseline) and Day 30
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Secondary outcome [8]
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Percentage of Participants With =4-Fold Rise in Serotype-specific IgG Day 1 to Day 30
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Assessment method [8]
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IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had = 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
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Timepoint [8]
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Day 1 (Baseline) and Day 30
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Secondary outcome [9]
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Geometric Mean Titer of Serotype-specific OPA at Month 7
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Assessment method [9]
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The geometric mean titer (GMT) of serotype-specific OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplex opsonophagocytic assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
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Timepoint [9]
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Month 7
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Secondary outcome [10]
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Geometric Mean Concentration of Serotype-specific IgG at Month 7
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Assessment method [10]
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The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.
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Timepoint [10]
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Month 7
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Secondary outcome [11]
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GMFR in Serotype-specific OPA Day 1 to Month 7
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Assessment method [11]
0
0
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
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Timepoint [11]
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Day 1 (Baseline) and Month 7
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Secondary outcome [12]
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GMFR in Serotype-specific IgG Day 1 to Month 7
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Assessment method [12]
0
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IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
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Timepoint [12]
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0
Day 1 (Baseline) and Month 7
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Secondary outcome [13]
0
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Percentage of Participants With =4-Fold Rise in Serotype-specific OPA Day 1 to Month 7
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Assessment method [13]
0
0
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had =4-fold rise in OPA titers were calculated from baseline to postvaccination.
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Timepoint [13]
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Day 1 (Baseline) and Month 7
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Secondary outcome [14]
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Percentage of Participants With =4-Fold Rise in Serotype-specific IgG Day 1 to Month 7
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Assessment method [14]
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IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had = 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
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Timepoint [14]
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Day 1 (Baseline) and Month 7
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Secondary outcome [15]
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GMFR in Serotype-specific OPA Month 6 to Month 7
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Assessment method [15]
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Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using the Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
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Timepoint [15]
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Month 6 (Baseline before Vaccination 2) and Month 7
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Secondary outcome [16]
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GMFR in Serotype-specific IgG Month 6 to Month 7
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Assessment method [16]
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IgG for the serotypes contained in Prevnar 13™ and V114 and (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
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Timepoint [16]
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Month 6 (Baseline before Vaccination 2) and Month 7
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Secondary outcome [17]
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Percentage of Participants With =4-Fold Rise in Serotype-specific OPA Month 6 to Month 7
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Assessment method [17]
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Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had =4-fold rise in OPA titers were calculated from baseline to postvaccination.
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Timepoint [17]
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Month 6 (Baseline before Vaccination 2) and Month 7
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Secondary outcome [18]
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Percentage of Participants With =4-Fold Rise in Serotype-specific IgG Month 6 to Month 7
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Assessment method [18]
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IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had = 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
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Timepoint [18]
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Month 6 (Baseline before Vaccination 2) and Month 7
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Eligibility
Key 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 (COPD) 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.
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Minimum age
18
Years
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Maximum age
49
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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 (IPD) 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
- Planned organ transplantation (heart, liver, lung, kidney, or pancreas) or other
planned major surgery during the duration of this study.
- Expected survival for less than 1 year according to the investigator's judgment.
- 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 doses 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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/07/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/01/2020
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Sample size
Target
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Accrual to date
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Final
1515
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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0
Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 0174) - Blacktown
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Recruitment hospital [2]
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Holdsworth House Medical Practice ( Site 0170) - Sydney
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Recruitment hospital [3]
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Core Research Group Pty limited ( Site 0175) - Brisbane
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Recruitment hospital [4]
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Emeritus Research Pty Ltd ( Site 0173) - Camberwell
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Recruitment hospital [5]
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Paratus Clinical Kanwal ( Site 0172) - Kanwal
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Recruitment hospital [6]
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Nepean Hospital ( Site 0176) - Kingswood
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2010 - Sydney
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Recruitment postcode(s) [3]
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4064 - Brisbane
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Recruitment postcode(s) [4]
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0
3124 - Camberwell
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Recruitment postcode(s) [5]
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0
2259 - Kanwal
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Recruitment postcode(s) [6]
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0
2747 - Kingswood
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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0
0
United States of America
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State/province [3]
0
0
Florida
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0
0
United States of America
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State/province [4]
0
0
Georgia
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0
0
United States of America
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State/province [5]
0
0
Idaho
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Illinois
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Indiana
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0
0
United States of America
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State/province [8]
0
0
Missouri
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0
0
United States of America
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State/province [9]
0
0
Nevada
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0
0
United States of America
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State/province [10]
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New Jersey
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0
0
United States of America
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State/province [11]
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New Mexico
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0
0
United States of America
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State/province [12]
0
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New York
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0
0
United States of America
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State/province [13]
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0
North Carolina
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0
0
United States of America
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0
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Pennsylvania
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Country [15]
0
0
United States of America
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State/province [15]
0
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South Carolina
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Tennessee
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0
0
United States of America
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0
0
Texas
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0
0
United States of America
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Utah
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United States of America
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Vermont
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0
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Washington
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0
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United States of America
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Wisconsin
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0
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Canada
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British Columbia
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0
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Canada
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0
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New Brunswick
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0
0
Canada
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0
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Nova Scotia
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0
0
Canada
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0
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Ontario
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0
0
Canada
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0
0
Quebec
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0
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Chile
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0
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RM
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Chile
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Santiago
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Chile
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State/province [29]
0
0
Temuco
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Country [30]
0
0
New Zealand
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State/province [30]
0
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Auckland
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Country [31]
0
0
New Zealand
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State/province [31]
0
0
Christchurch
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Country [32]
0
0
New Zealand
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State/province [32]
0
0
Rotorua
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Country [33]
0
0
New Zealand
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State/province [33]
0
0
Tauranga
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0
0
New Zealand
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0
0
Wellington
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0
0
Poland
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State/province [35]
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Bydgoszcz
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Country [36]
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Poland
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State/province [36]
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Gdansk
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Country [37]
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Poland
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State/province [37]
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Krakow
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Country [38]
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Poland
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State/province [38]
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Myslowice
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Country [39]
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Poland
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State/province [39]
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Skierniewice
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Country [40]
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Poland
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State/province [40]
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Sopot
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Country [41]
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Poland
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State/province [41]
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Wroclaw
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Country [42]
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Russian Federation
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State/province [42]
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Kazan
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Country [43]
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Russian Federation
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State/province [43]
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Saratov
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Country [44]
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Russian Federation
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State/province [44]
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Smolensk
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Merck Sharp & Dohme LLC
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Address
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Ethics approval
Ethics application status
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Summary
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 alcohol use, or 3) living in a community/environment with increased risk
of disease transmission.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03547167
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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0
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03547167
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