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NCT03547167 · ClinicalTrials.gov registry record · 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)
A Phase 3 study of Pneumococcal Infections, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,515
- Enrollment target
- 20
- Study locations
NCT03547167: Completed Phase 3 study of Pneumococcal Infections, sponsored by Merck Sharp & Dohme.
NCT03547167 is a Phase 3 study of Pneumococcal Infections that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,515 participants, above the 753-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (101% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03547167, a Phase 3 study of Pneumococcal Infections, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,515 participants
- Enrollment target
- 20
- Study locations
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.
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 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 calcula
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
| Field | Value |
|---|---|
| Enrollment Target | 1,515 participants |
| Start Date | 2018-07-16 |
| Est. Completion | 2020-01-20 |
| Phase | Phase 3 |
What the finished NCT03547167 record still lists
NCT03547167 is an interventional study that assigns participants to a tested intervention. Its 1,515 participants enrollment target places it among the larger protocols in the corpus, above the 753-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (101% higher).
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.
NCT03547167 names 20 study sites across 11 states, led by Arizona, Florida, Illinois.
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.
What interventions are being tested in trial NCT03547167?
The interventions under investigation include: V114 (BIOLOGICAL), Prevnar 13™ (BIOLOGICAL), PNEUMOVAX™23 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03547167?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
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 NCT03547167's enrollment target sits among peer trials
1,515 1st of 10 higher than 10 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
-
Study of the Safety and Immunogenicity of Catch-up Vaccination With a 21-valent Pneumococcal Conjugate Vaccine (PCV21) in Healthy Infants, Toddlers, Children, and Adolescents
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 When Administered Concomitantly With Influenza Vaccine in Healthy Adults 50 Years of Age or Older (V114-021/PNEU-FLU)
COMPLETED · Phase 3
-
Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
COMPLETED · Phase 3
-
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM)
COMPLETED · Phase 3
-
A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)
COMPLETED · Phase 3
-
Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE)
COMPLETED · Phase 3
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