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Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE)
NCT03950622 · View on ClinicalTrials.gov ↗
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 |
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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. 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 1,205 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 2 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: NCT03950622 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, Ontario, Texas. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03950622?
The interventions under investigation include: V114 (BIOLOGICAL), Prevnar 13® (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03950622?
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 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.
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