Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE)
Public ClinicalTrials.gov record NCT03950622. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults 50 Years of Age or Older (PNEU-AGE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03950622
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,205 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 50 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 13, 2019 (Actual)
- Primary completion
- Mar 30, 2020 (Actual)
- Completion
- Mar 30, 2020 (Actual)
- Last update posted
- Apr 26, 2021
2019 – 2020
United States locations
- U.S. sites
- 14
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Synexus ( Site 1001) | Mesa | Arizona | 85206 | — |
| Artemis Institute for Clinical Research ( Site 1012) | San Diego | California | 92103 | — |
| Indago Research & Health Center, Inc ( Site 1002) | Hialeah | Florida | 33012 | — |
| Research Centers of America, LLC ( Site 1014) | Hollywood | Florida | 33024 | — |
| Advanced Medical Research Institute ( Site 0117) | Miami | Florida | 33174 | — |
| Lakes Research LLC ( Site 1005) | Miami Lakes | Florida | 33014 | — |
| Alliance for Multispecialty Research, LLC ( Site 1008) | Newton | Kansas | 67114 | — |
| Wake Research Clinical Research Center of Nevada, LLC ( Site 1010) | Las Vegas | Nevada | 89104 | — |
| Rapid Medical Research, Inc. ( Site 1011) | Cleveland | Ohio | 44122 | — |
| Diagnostics Research Group ( Site 1000) | San Antonio | Texas | 78229 | — |
| Synexus ( Site 1009) | San Antonio | Texas | 78229 | — |
| J Lewis Research Inc / Foothill Family Clinic ( Site 1013) | Salt Lake City | Utah | 84109 | — |
| Charlottesville Medical Research Center, LLC ( Site 1003) | Charlottesville | Virginia | 22911 | — |
| Health Research of Hampton Roads, Inc. ( Site 1007) | Newport News | Virginia | 23606 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03950622, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 26, 2021 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03950622 live on ClinicalTrials.gov.