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NCT03950622 · ClinicalTrials.gov registry record · Phase 3
Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE)
A Phase 3 study of Pneumococcal Infections, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,205
- Enrollment target
- 20
- Study locations
NCT03950622 is a Phase 3 study of Pneumococcal Infections that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,205 participants, above the 784-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (54% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT03950622, a Phase 3 study of Pneumococcal Infections, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,205 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to 1) evaluate the safety and tolerability of V114 and 2) to compare the immune responses of the 15 serotypes contained in V114 with V114 versus Prevnar 13™. The primary hypotheses are that 1) V114 is noninferior to Prevnar 13™ as measured by the serotype specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for 13 shared serotypes at 30 days postvaccination and that 2) V114 is superior to Prevnar 13™ as measured by serotype-specific OPA GMTs for 2 unique serotypes in V114 at 30 days postvaccination.
Conditions Studied
Interventions
- BIOLOGICAL V114
- BIOLOGICAL Prevnar 13®
Study Locations (20)
Florida
- Indago Research & Health Center, Inc ( Site 1002) - Hialeah
- Research Centers of America, LLC ( Site 1014) - Hollywood
- Advanced Medical Research Institute ( Site 0117) - Miami
- Lakes Research LLC ( Site 1005) - Miami Lakes
Ontario
- Milestone Research ( Site 2003) - London
- Bluewater Clinical Research Group Inc ( Site 2004) - Sarnia
- Manna Research Inc.. ( Site 2007) - Toronto
Texas
- Diagnostics Research Group ( Site 1000) - San Antonio
- Synexus ( Site 1009) - San Antonio
Virginia
- Charlottesville Medical Research Center, LLC ( Site 1003) - Charlottesville
- Health Research of Hampton Roads, Inc. ( Site 1007) - Newport News
Quebec
- Dynamik Research ( Site 2000) - Pointe-Claire
- Q & T Research Sherbrooke Inc. ( Site 2001) - Sherbrooke
Arizona
- Synexus ( Site 1001) - Mesa
California
- Artemis Institute for Clinical Research ( Site 1012) - San Diego
Kansas
- Alliance for Multispecialty Research, LLC ( Site 1008) - Newton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,205 participants |
| Start Date | 2019-06-13 |
| Est. Completion | 2020-03-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03950622
The ClinicalTrials.gov registry entry for NCT03950622 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,205 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 784-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (54% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pneumococcal Infections appearing as the primary indexed condition, and to 2 interventions - of which V114 is the first listed.
NCT03950622 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, Ontario, Texas.
Frequently Asked Questions
What is clinical trial NCT03950622 about?
NCT03950622 is a clinical study titled "Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE)". The purpose of this study is to 1) evaluate the safety and tolerability of V114 and 2) to compare the immune responses of the 15 serotypes contained in V114 with V114 versus Prevnar 13™. The primary hypotheses are that 1) V114 is noninferior to Prevnar 13™ as measured by the serotype specific opsono...
What is the current status of trial NCT03950622?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,205 participants. The study started on 2019-06-13. Estimated completion is 2020-03-30.
What conditions does trial NCT03950622 study?
This clinical trial studies the following conditions: Pneumococcal Infections.
What interventions are being tested in trial NCT03950622?
The interventions under investigation include: V114 (BIOLOGICAL), Prevnar 13® (BIOLOGICAL).
Who is sponsoring clinical trial NCT03950622?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03950622 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Kansas, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
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