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NCT03565900 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM)

A Phase 3 study of Pneumococcal Infections, sponsored by Merck Sharp & Dohme.

Completed
Registry status
Phase 3
Development phase
277
Enrollment target
20
Study locations

NCT03565900: Completed Phase 3 study of Pneumococcal Infections, sponsored by Merck Sharp & Dohme.

NCT03565900 is a Phase 3 study of Pneumococcal Infections that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 277 participants, below the 877-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03565900, a Phase 3 study of Pneumococcal Infections, has completed, sponsored by Merck Sharp & Dohme.

COMPLETED
Registry status
Phase 3
Development phase
277 participants
Enrollment target
20
Study locations

Study 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 \[GVHD\]).

Primary Outcome

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.

Conditions Studied

Pneumococcal Infections

Interventions

  • BIOLOGICAL V114
  • BIOLOGICAL Prevnar 13™
  • BIOLOGICAL PNEUMOVAX™23

Study Locations (20)

Victoria

  • Austin Health-Austin Hospital ( Site 0038) - Heidelberg
  • The Alfred Hospital ( Site 0037) - Melbourne
  • Royal Melbourne Hospital ( Site 0039) - Parkville

Ohio

  • Cincinnati Children's Hospital Medical Center ( Site 0010) - Cincinnati
  • Cleveland Clinic Foundation ( Site 0168) - Cleveland

New South Wales

  • St. Vincent's Hospital ( Site 0041) - Sydney
  • The Children s Hospital at Westmead ( Site 0191) - Westmead

California

  • Stanford Health Care ( Site 0005) - Palo Alto

Colorado

  • Children's Hospital Colorado ( Site 0166) - Aurora

Florida

  • University of Florida ( Site 0011) - Gainesville

Illinois

  • University of Chicago ( Site 0016) - Chicago

Indiana

  • Indiana Blood and Marrow Transplantation ( Site 0001) - Indianapolis

Trial Details

FieldValue
Enrollment Target 277 participants
Start Date 2018-09-12
Est. Completion 2021-11-04
Phase Phase 3
Merck Sharp & Dohme

558 total trials

What the finished NCT03565900 record still lists

NCT03565900 is an interventional study that assigns participants to a tested intervention. The registered 277 participants enrollment target is mid-sized for trials with a published cap, below the 877-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (68% lower).

The record links to 1 condition, with Pneumococcal Infections appearing as the primary indexed condition, and to 3 interventions - of which V114 is the first listed.

NCT03565900 names 20 study sites across 16 states, led by Victoria, Ohio, New South Wales.

Frequently Asked Questions

What is clinical trial NCT03565900 about?

NCT03565900 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM)". 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 hematopoi...

What is the current status of trial NCT03565900?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 277 participants. The study started on 2018-09-12. Estimated completion is 2021-11-04.

What conditions does trial NCT03565900 study?

This clinical trial studies the following conditions: Pneumococcal Infections.

What interventions are being tested in trial NCT03565900?

The interventions under investigation include: V114 (BIOLOGICAL), Prevnar 13™ (BIOLOGICAL), PNEUMOVAX™23 (BIOLOGICAL).

Who is sponsoring clinical trial NCT03565900?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03565900 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Pneumococcal Infections

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03565900's enrollment target sits among peer trials

277 10th of 10 higher than 1 of 10 other Pneumococcal Infections trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pneumococcal Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03565900, the US trial registry maintained by the National Library of Medicine. NCT03565900 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.