A Phase 1/Phase 2 Study of Polyvalent Pneumococcal Conjugate Vaccine (V116) in Adults (V116-001)
Public ClinicalTrials.gov record NCT04168190. 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 1/Phase 2, Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine in Adults.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase 1 and Phase 2 study will evaluate the safety, tolerability and immunogenicity of V116 when administered to adults. Phase 1 has no formal hypothesis. The primary hypotheses for Phase 2 are: V116 is noninferior to Pneumovax™23 as measured by the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for the common serotypes at 30 days postvaccination and that the serotype-specific OPA GMTs for the unique serotypes in V116 at 30 days postvaccination are statistically significantly greater following vaccination with V116 than those following vaccination with Pneumovax™23.
Study identification
- NCT ID
- NCT04168190
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 600 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 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
- Dec 6, 2019 (Actual)
- Primary completion
- Jul 12, 2021 (Actual)
- Completion
- Jul 12, 2021 (Actual)
- Last update posted
- Sep 16, 2022
2019 – 2021
United States locations
- U.S. sites
- 20
- U.S. states
- 13
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Simon Williamson Clinic ( Site 0004) | Birmingham | Alabama | 35211 | — |
| Central Arizona Medical Associates ( Site 0003) | Mesa | Arizona | 85206 | — |
| Clinical Research of South Florida ( Site 0008) | Coral Gables | Florida | 33134 | — |
| Indago Research & Health Center, Inc ( Site 0011) | Hialeah | Florida | 33012 | — |
| Research Centers of America, LLC ( Site 0001) | Hollywood | Florida | 33024 | — |
| QPS Miami Research Associates ( Site 0016) | Miami | Florida | 33143 | — |
| L&C Professional Medical Research Institute ( Site 0009) | Miami | Florida | 33144 | — |
| Advanced Medical Research Institute ( Site 0010) | Miami | Florida | 33174 | — |
| Optimal Research ( Site 0006) | Peoria | Illinois | 61614 | — |
| Benchmark Research ( Site 0012) | Metairie | Louisiana | 70006 | — |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0018) | Troy | Michigan | 48098 | — |
| Meridian Clinical Research, LLC ( Site 0024) | Norfolk | Nebraska | 68701 | — |
| Wake Research Clinical Research Center of Nevada, LLC ( Site 0014) | Las Vegas | Nevada | 89104 | — |
| Meridian Clinical Research, LLC ( Site 0025) | Endwell | New York | 13760 | — |
| Rochester Clinical Research, Inc. ( Site 0002) | Rochester | New York | 14609 | — |
| PriMED Clinical Research ( Site 0021) | Dayton | Ohio | 45419 | — |
| Advanced Medical Research ( Site 0017) | Maumee | Ohio | 43537 | — |
| Kaiser Permanente Center for Health Research ( Site 0015) | Portland | Oregon | 97227 | — |
| Diagnostics Research Group ( Site 0013) | San Antonio | Texas | 78229 | — |
| Advanced Clinical Research ( Site 0022) | West Jordan | Utah | 84088 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04168190, 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 Sep 16, 2022 · 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 NCT04168190 live on ClinicalTrials.gov.