Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008)
Public ClinicalTrials.gov record NCT05696080. 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, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 18 to 64 Years of Age With Increased Risk for Pneumococcal Disease.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objectives of this study are to evaluate the safety and tolerability of the pneumococcal 21 valent conjugate vaccine (V116), and to evaluate the serotype-specific opsonophagocytic activity (OPA) post-vaccination with V116 and PCV15 (a pneumococcal conjugate vaccine that includes 15 serotypes) + PPSV23 (comprised of the polysaccharides from 23 of the serotypes causing disease in adults) post-vaccination within each vaccination group separately.
Study identification
- NCT ID
- NCT05696080
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 518 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 64 Years
- 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
- Feb 13, 2023 (Actual)
- Primary completion
- Feb 16, 2024 (Actual)
- Completion
- Feb 16, 2024 (Actual)
- Last update posted
- Mar 3, 2026
2023 – 2024
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Aventiv Research ( Site 0022) | Mesa | Arizona | 85206 | — |
| Indago Research & Health Center, Inc ( Site 0002) | Hialeah | Florida | 33012 | — |
| Triple O Research Institute, P.A ( Site 0011) | West Palm Beach | Florida | 33407 | — |
| SKY Integrative Medical Center/SKYCRNG ( Site 0012) | Ridgeland | Mississippi | 39157 | — |
| Mid Hudson Medical Research ( Site 0008) | New Windsor | New York | 12553 | — |
| Holston Medical Group ( Site 0010) | Kingsport | Tennessee | 37660 | — |
| EmVenio Research ( Site 0018) | Fort Worth | Texas | 27713 | — |
| Wenatchee Valley Hospital ( Site 0019) | Wenatchee | Washington | 98801 | — |
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 36 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05696080, 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 Mar 3, 2026 · 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 NCT05696080 live on ClinicalTrials.gov.