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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/NCT03565900
Registration number
NCT03565900
Ethics application status
Date submitted
12/06/2018
Date registered
21/06/2018
Date last updated
28/07/2023
Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM)
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Scientific title
A Phase 3, Randomized, Double-blind, Active Comparator-controlled, Multicenter Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Recipients of Allogeneic Hematopoietic Stem Cell Transplant (PNEU-STEM)
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Secondary ID [1]
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0
V114-022
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Secondary ID [2]
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V114-022
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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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Condition category
Condition code
Infection
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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, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who develop chronic graft-versus-host-disease (GVHD) during the first year after HSCT will receive V114 instead of PNEUMOVAX™23 as their fourth dose.
Active Comparator: Prevnar 13™ - Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who develop chronic GVHD during the first year after HSCT will receive Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
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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Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With 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 treatment, whether or not considered related to the study treatment. Following any of the first 3 doses of V114 or Prevnar 13™, the percentage of adult participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, pain, and swelling.
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Timepoint [1]
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Up to 5 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13™)
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Primary outcome [2]
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Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™
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Assessment method [2]
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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. Following any of the first 3 doses of V114 or Prevnar 13™, the percentage of pediatric participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, induration, pain, and swelling.
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Timepoint [2]
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Up to 14 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13™)
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Primary outcome [3]
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Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™
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Assessment method [3]
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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. Following any of the first 3 doses of V114 or Prevnar 13™, the percentage of adult participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were arthralgia, fatigue, headache, and myalgia.
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Timepoint [3]
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Up to 14 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13™)
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Primary outcome [4]
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Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™
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Assessment method [4]
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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. Following any of the first 3 doses of V114 or Prevnar 13™, the percentage of pediatric participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were arthralgia, fatigue, headache, myalgia, and hives or welts.
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Timepoint [4]
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Up to 14 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13™)
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Primary outcome [5]
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Percentage of Participants With a Vaccine-related Serious Adverse Event Up to Month 12 After Allogeneic HSCT
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Assessment method [5]
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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. The percentage of participants with a vaccine-related SAE following dose 1 (with either V114 or Prevnar 13™) was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 up to 12 months post-HSCT, which could be up to 9 months post-vaccine dose 1.
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Timepoint [5]
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Up to 9 months
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Primary outcome [6]
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Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
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Assessment method [6]
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The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.
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Timepoint [6]
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Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13™)
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Secondary outcome [1]
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Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23
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Assessment method [1]
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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. Following a single dose vaccination with PNEUMOVAX™23, the percentage of adult participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, pain, and swelling.
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Timepoint [1]
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Up to 5 days after the PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
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Secondary outcome [2]
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Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23
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Assessment method [2]
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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. Following single dose vaccination with PNEUMOVAX™23, the percentage of pediatric participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were induration, pain, swelling, and erythema.
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Timepoint [2]
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Up to 14 days after the PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
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Secondary outcome [3]
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Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23
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Assessment method [3]
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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. Following a single dose vaccination with PNEUMOVAX™23, the percentage of adult participants with solicited systemic AEs was assessed. The solicited systemic AEs were arthralgia, fatigue, headache, and myalgia.
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Timepoint [3]
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Up to 14 days after the PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
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Secondary outcome [4]
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Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23
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Assessment method [4]
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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. Following a single dose vaccination with PNEUMOVAX™23, the percentage of pediatric participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, headache, myalgia, hives or welts, and arthralgia.
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Timepoint [4]
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Up to 14 days after the PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
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Secondary outcome [5]
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Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With PNEUMOVAX™23
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Assessment method [5]
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A 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. The percentage of participants with a vaccine-related SAE following a single dose vaccination with PNEUMOVAX™23 was reported.
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Timepoint [5]
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Up to 1 month after PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 10 months after Day 1)
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Secondary outcome [6]
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Adult Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™
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Assessment method [6]
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This end point applies to adult participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as the fourth vaccination. 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. Following dose 4 with V114 or Prevnar 13™, the percentage of adult participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, pain, and swelling.
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Timepoint [6]
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Up to 5 days after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
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Secondary outcome [7]
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Pediatric Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™
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Assessment method [7]
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This end point applies to pediatric participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as the fourth vaccination dose. 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. Following dose 4 with V114 or Prevnar 13™, the percentage of pediatric participants with solicited injection-site AEs was assessed. The solicited injection-site AE assessed were pain, erythema, swelling, and induration.
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Timepoint [7]
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Up to 14 days after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
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Secondary outcome [8]
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Adult Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™
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Assessment method [8]
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This end point applies to adult participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as the fourth vaccination dose. 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. Following dose 4 with V114 or Prevnar 13™, the percentage of adult participants with solicited systemic AEs was assessed. The solicited systemic AEs were arthralgia, fatigue, headache, and myalgia.
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Timepoint [8]
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Up to 14 days after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
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Secondary outcome [9]
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Pediatric Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™
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Assessment method [9]
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This end point applies to pediatric participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as the fourth vaccination. 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. Following dose 4 with V114 or Prevnar 13™, the percentage of pediatric participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed myalgia, arthralgia, headache, fatigue, and hives or welts.
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Timepoint [9]
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Up to 14 days after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
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Secondary outcome [10]
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Participants With GVHD: Percentage of Participants With a Vaccine-related Serious Adverse Event Following Dose 4 With V114 or Prevnar 13™
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Assessment method [10]
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This end point applies to participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as vaccine dose 4. 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. The percentage of participants with a vaccine-related SAE following dose 4 with V114 or Prevnar 13™ through completion of study was reported.
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Timepoint [10]
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Up to 6 months after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 15 months after Day 1)
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Secondary outcome [11]
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Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
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Assessment method [11]
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The GMT of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay.
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Timepoint [11]
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Up to Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13™)
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Secondary outcome [12]
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Percentage of Participants With Geometric Mean Fold Rises (GMFR) =4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
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Assessment method [12]
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The GMFR of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.
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Timepoint [12]
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Day 1 (Baseline) and Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13™)
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Secondary outcome [13]
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Percentage of Participants With GMFR =4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
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Assessment method [13]
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Activity for the 15 serotypes contained in V114 vaccine were determined using a Multiplex Opsonophagocytic Assay. The GMFR of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using multiplexed opsonophagocytic assay.
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Timepoint [13]
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Time Frame: Day 1 (Baseline) and Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13™)
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Eligibility
Key inclusion criteria
- Received a human leukocyte antigen (HLA) compatible donor including haploidentical and
mismatched (related or unrelated) first allogeneic HSCT (i.e., bone marrow or
peripheral blood stem cell) 90 to 180 days prior to randomization.
- Received the allogeneic HSCT for acute lymphoblastic leukemia (ALL) in first or second
remission, acute myeloid leukemia (AML) in first or second remission, chronic myeloid
leukemia (CML) in first chronic or accelerated phase, Hodgkin's lymphoma,
non-Hodgkin's lymphoma, myelodysplastic syndrome (MDS), myelofibrosis and
myeloproliferative diseases, and non-malignant disease such as aplastic anemia or
sickle cell disease in participants =18 years of age and any non-malignant disease for
participants 3 to <18 years of age.
- Life expectancy >12 months after allogeneic HSCT, according to investigator judgement.
- Clinically stable engraftment according to investigator judgment.
- A female participant is eligible to participate if she is not pregnant or
breastfeeding, and at least 1 of the following conditions applies: a) not a woman of
childbearing potential (WOCBP) OR b) a WOCBP who agrees to use acceptable
contraceptive methods during the treatment period and for at least 6 weeks after the
last dose of study intervention.
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Minimum age
3
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Receipt of a previous allogeneic HSCT.
- Received allogeneic HSCT with ex-vivo graft manipulation, in vivo T cell depletion
with alemtuzumab, or haploidentical allogeneic HSCT with high dose anti-thymocyte
globulin.
- Received allogeneic HSCT for multiple myeloma or, for participants =18 years of age
only, for any nonmalignant diseases except sickle cell disease and aplastic anemia.
- Persistent or relapsed primary disease after allogeneic HSCT.
- History of severe GVHD (Grade 3 or 4 GVHD) after allogeneic HSCT.
- Planned organ transplantation after allogeneic HSCT.
- History of culture-positive pneumococcal disease occurring after allogeneic HSCT.
- Known hypersensitivity to any component of pneumococcal polysaccharide vaccine,
pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine.
- History of acquired immunodeficiency such as documented HIV infection, or anatomic
asplenia.
- Coagulation disorder contraindicating intramuscular vaccinations.
- Severe hepatic impairment (defined as Child-Pugh Class C) at Screening.
- Serum aspartate transaminase (AST) or alanine transaminase (ALT) >6 × upper limit of
normal (ULN) or serum total bilirubin >2.5 × ULN at Screening.
- A WOCBP who has a positive urine or serum pregnancy test before the 1st vaccination.
- Received chimeric antigen receptor T-cell (CAR-T) therapy or checkpoint inhibitor
directed therapy (i.e., anti-Programmed Cell Death (PD)-1) after allogeneic HSCT.
- Received or planned to receive anti-Cluster of Differentiation (CD) 20 B-cell targeted
therapy (e.g., rituximab) after allogeneic HSCT.
- Non-study pneumococcal vaccine administered after allogeneic HSCT, or is expected to
receive non-study pneumococcal vaccine during participation in the study.
- Is currently participating or has participated in an interventional clinical study
with an investigational compound/agent or device within 2 weeks of participating in
this current study, or plans to receive any investigational compound/agent or device
(in addition to existing therapy) within 2 weeks of any vaccination, that in the
opinion of the investigator would interfere with the evaluation of the study
objectives.
- Is, at the time of signing informed consent, a user of recreational or illicit drugs
or has had a recent history (within the last year) of drug or alcohol abuse or
dependence as assessed by the study investigator.
- Has history or current evidence of any condition, therapy, laboratory test result
abnormality, or other circumstance that might expose the participant to risk by
participating in the study, confound the results of the study, or interfere with the
participant's participation for the full duration of the study.
- Is or has an immediate family member who is investigational site or Sponsor staff
directly involved with this study.
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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 administering 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
12/09/2018
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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
4/11/2021
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Sample size
Target
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Accrual to date
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Final
277
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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St. Vincent's Hospital ( Site 0041) - Sydney
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Recruitment hospital [2]
0
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The Children s Hospital at Westmead ( Site 0191) - Westmead
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Recruitment hospital [3]
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Royal Adelaide Hospital ( Site 0040) - Adelaide
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Recruitment hospital [4]
0
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Austin Health-Austin Hospital ( Site 0038) - Heidelberg
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Recruitment hospital [5]
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The Alfred Hospital ( Site 0037) - Melbourne
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Recruitment hospital [6]
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Royal Melbourne Hospital ( Site 0039) - Parkville
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Recruitment postcode(s) [1]
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0
2010 - Sydney
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
0
0
5000 - Adelaide
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment postcode(s) [6]
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3050 - Parkville
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
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Colorado
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Illinois
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Indiana
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Kansas
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Maryland
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Missouri
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Country [9]
0
0
United States of America
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State/province [9]
0
0
New York
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Ohio
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Oregon
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Texas
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Country [13]
0
0
Belgium
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State/province [13]
0
0
Bruxelles-Capitale, Region De
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Country [14]
0
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Belgium
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State/province [14]
0
0
Vlaams-Brabant
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Country [15]
0
0
Belgium
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State/province [15]
0
0
West-Vlaanderen
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Country [16]
0
0
Belgium
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State/province [16]
0
0
Liège
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Country [17]
0
0
Brazil
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State/province [17]
0
0
Bahia
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Country [18]
0
0
Brazil
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State/province [18]
0
0
Minas Gerais
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Country [19]
0
0
Brazil
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State/province [19]
0
0
Paraná
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Country [20]
0
0
Canada
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State/province [20]
0
0
Nova Scotia
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Country [21]
0
0
Canada
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State/province [21]
0
0
Ontario
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Country [22]
0
0
Canada
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State/province [22]
0
0
Quebec
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Country [23]
0
0
Colombia
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State/province [23]
0
0
Antioquia
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Country [24]
0
0
Colombia
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State/province [24]
0
0
Valle Del Cauca
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Country [25]
0
0
France
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State/province [25]
0
0
Alpes-Maritimes
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Country [26]
0
0
France
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State/province [26]
0
0
Doubs
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Country [27]
0
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France
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State/province [27]
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Isere
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Country [28]
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France
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Nord
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Country [29]
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0
France
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0
Val-de-Marne
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Country [30]
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0
France
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Paris
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Country [31]
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0
Germany
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State/province [31]
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Nordrhein-Westfalen
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Country [32]
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Germany
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State/province [32]
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Rheinland-Pfalz
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Country [33]
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Mexico
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State/province [33]
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Nuevo Leon
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Country [34]
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Mexico
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State/province [34]
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Ciudad de Mexico
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Country [35]
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Mexico
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State/province [35]
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Mexico City
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Country [36]
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Mexico
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State/province [36]
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Mexico
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Country [37]
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Sweden
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State/province [37]
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0
Stockholms Lan [se-01]
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Country [38]
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Sweden
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State/province [38]
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Uppsala Lan [se-03]
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Country [39]
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Sweden
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State/province [39]
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Vastra Gotalands Lan [se-14]
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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
The purpose of this study is to 1) evaluate the safety and tolerability, and immunogenicity
of blinded V114 and Prevnar 13™ within each vaccination group, and 2) evaluate the safety and
tolerability, and immunogenicity of PNEUMOVAX™23 (administered as open label, 12 months after
allogeneic hematopoietic stem cell transplant [allo-HSCT] in participants who do not develop
chronic graft-versus-host disease [GVHD]).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03565900
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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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Fax
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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/NCT03565900
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