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COMPLETED Phase 3

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)

NCT03547167 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

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

Study Locations (20)

Arizona

  • Chinle Comprehensive Health Care Facility ( Site 0001) — Chinle
  • Fort Defiance Center for American Indian Health ( Site 0002) — Fort Defiance
  • Pulmonary Associates, PA ( Site 0043) — Glendale
  • Central Phoenix Medical Clinic, LLC ( Site 0031) — Phoenix
  • Whiteriver Center for American Indian Health ( Site 0005) — Whiteriver

Florida

  • Top Medical Research, Inc ( Site 0033) — Cutler Bay
  • Indago Research & Health Center, Inc ( Site 0054) — Hialeah
  • Renstar Medical Research ( Site 0008) — Ocala
  • Triple O Research Institute, P.A. ( Site 0026) — West Palm Beach

Illinois

  • Evanston Premier Healthcare & Research, LLC. ( Site 0012) — Evanston
  • Pharmakon Inc ( Site 0049) — Evergreen Park

New Mexico

  • Gallup Center for American Indian Health ( Site 0003) — Gallup
  • Shiprock Center for American Indian Health ( Site 0004) — Shiprock

California

  • Inland Empire Clinical Trials, LLC ( Site 0052) — Rialto

Georgia

  • Emory University School of Medicine at Grady Hospital ( Site 0027) — Atlanta

Idaho

  • Kootenai Health ( Site 0042) — Coeur d'Alene

Indiana

  • Reid Physician Associates ( Site 0055) — Richmond

Trial Details

FieldValue
Enrollment Target 1,515 participants
Start Date 2018-07-16
Est. Completion 2020-01-20
Phase Phase 3

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03547167

The ClinicalTrials.gov registry entry for NCT03547167 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,515 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03547167 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Arizona, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03547167 about?

NCT03547167 is a clinical study titled "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)". 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 ...

What is the current status of trial NCT03547167?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,515 participants. The study started on 2018-07-16. Estimated completion is 2020-01-20.

What conditions does trial NCT03547167 study?

This clinical trial studies the following conditions: Pneumococcal Infections. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03547167?

The interventions under investigation include: V114 (BIOLOGICAL), Prevnar 13™ (BIOLOGICAL), PNEUMOVAX™23 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03547167?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03547167 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial