Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)
Public ClinicalTrials.gov record NCT05425732. 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine (\[Prevnar 20™ / APEXXNAR™\]) in pneumococcal vaccine-naïve adults. It is hypothesized that V116 is noninferior to PCV20 for the common serotypes and superior to PCV20 for the unique serotypes as assessed by serotype specific opsonophagocytic activity (OPA) 30 days postvaccination. It is also hypothesized that V116 in participants 18 to 49 years of age immunobridges to V116 in participants 50 to 64 years of age as assessed by serotype specific OPA geometric mean titers (GMTs) 30 days postvaccination for all 21 serotypes in V116. Participants ≥50 years of age will be enrolled in Cohort 1, and participants 18 to 49 years of age will be enrolled in Cohort 2.
Study identification
- NCT ID
- NCT05425732
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,663 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
- Jul 13, 2022 (Actual)
- Primary completion
- May 18, 2023 (Actual)
- Completion
- May 18, 2023 (Actual)
- Last update posted
- Oct 26, 2024
2022 – 2023
United States locations
- U.S. sites
- 60
- U.S. states
- 21
- U.S. cities
- 55
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Central Research Associates ( Site 0067) | Birmingham | Alabama | 35205 | — |
| Lenzmeier Family Medicine/CCT Research ( Site 0006) | Glendale | Arizona | 85308 | — |
| Desert Clinical Research/ CCT Research ( Site 0040) | Mesa | Arizona | 85213 | — |
| Foothills Research Center/ CCT Research ( Site 0021) | Phoenix | Arizona | 85044 | — |
| Fiel Family and Sports Medicine, PC/CCT Research ( Site 0003) | Tempe | Arizona | 85283 | — |
| Baptist Health Center For Clinical Research ( Site 0019) | Little Rock | Arkansas | 72205 | — |
| Southland Clinical Research Center-Research ( Site 0054) | Fountain Valley | California | 92708 | — |
| Sunwise Clinical Research ( Site 0024) | Lafayette | California | 94549 | — |
| Chemidox Clinical Trials ( Site 0048) | Lancaster | California | 93534 | — |
| Paradigm Clinical Research Centers, Inc ( Site 0018) | Redding | California | 96001 | — |
| Peninsula Research Associates ( Site 0079) | Rolling Hills Estates | California | 90274 | — |
| Acclaim Clinical Research ( Site 0083) | San Diego | California | 92120 | — |
| Millennium Clinical Trials ( Site 0013) | Simi Valley | California | 93065 | — |
| Lynn Institute of Denver ( Site 0012) | Aurora | Colorado | 80012 | — |
| Paradigm Clinical Research Centers, Inc ( Site 0027) | Wheat Ridge | Colorado | 80033 | — |
| JEM Research Institute ( Site 0072) | Atlantis | Florida | 33462 | — |
| Alliance for Multispecialty Research, LLC ( Site 0015) | Coral Gables | Florida | 33134 | — |
| Hillcrest Medical Research ( Site 0049) | DeLand | Florida | 32720 | — |
| East Coast Institute for Research, LLC ( Site 0070) | Jacksonville | Florida | 32204 | — |
| East Coast Institute for Research ( Site 0071) | Lake City | Florida | 32055 | — |
| L&C Professional Medical Research Institute ( Site 0025) | Miami | Florida | 33144 | — |
| Advanced Medical Research Institute ( Site 0014) | Miami | Florida | 33174 | — |
| Headlands Research Orlando ( Site 0031) | Orlando | Florida | 32819 | — |
| Genesis Clinical Research, LLC ( Site 0016) | Tampa | Florida | 33603 | — |
| Clinical Research Trials of Florida ( Site 0007) | Tampa | Florida | 33607 | — |
| Palm Beach Research Center ( Site 0060) | West Palm Beach | Florida | 33409 | — |
| Clinical Research Prime ( Site 0010) | Idaho Falls | Idaho | 83404 | — |
| Solaris Clinical Research ( Site 0008) | Meridian | Idaho | 83646 | — |
| Versailles Family Medicine / CCT Research ( Site 0063) | Versailles | Kentucky | 40383 | — |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0038) | Troy | Michigan | 48098 | — |
| Alliance for Multispecialty Research, LLC ( Site 0026) | Kansas City | Missouri | 64114 | — |
| Skyline Medical Center/CCT Research ( Site 0028) | Elkhorn | Nebraska | 68022 | — |
| Methodist Physicians Clinic/CCT Research ( Site 0058) | Fremont | Nebraska | 68025 | — |
| Meridian Clinical Research, LLC ( Site 0045) | Norfolk | Nebraska | 68701 | — |
| Healor Primary Care / CCT Research ( Site 0056) | Las Vegas | Nevada | 89102 | — |
| Excel Clinical Research, LLC ( Site 0077) | Las Vegas | Nevada | 89109 | — |
| Santa Rosa Medical Centers of Nevada / CCT Research ( Site 0029) | Las Vegas | Nevada | 89119 | — |
| Smith Allergy & Asthma Specialists-Corning Center for Clinical Research ( Site 0032) | Horseheads | New York | 14845 | — |
| Aventiv Research Inc ( Site 0044) | Columbus | Ohio | 43213 | — |
| Advanced Medical Research ( Site 0002) | Maumee | Ohio | 43537 | — |
| Lynn Institute of Norman ( Site 0001) | Norman | Oklahoma | 73072 | — |
| Lynn Health Science Institute ( Site 0005) | Oklahoma City | Oklahoma | 73112 | — |
| Lynn Institute of Tulsa ( Site 0084) | Tulsa | Oklahoma | 74135 | — |
| Summit Headlands ( Site 0047) | Portland | Oregon | 97210 | — |
| Velocity Clinical Research, Greenville ( Site 0043) | Greenville | South Carolina | 29615 | — |
| Trial Management Associates ( Site 0089) | Myrtle Beach | South Carolina | 29572 | — |
| Tekton Research, Inc. ( Site 0053) | Austin | Texas | 78745 | — |
| WR-Global Medical Research, LLC ( Site 0065) | Dallas | Texas | 75224 | — |
| Elixir Research Group - W Houston ( Site 0068) | Houston | Texas | 77077 | — |
| Epic Clinical Research ( Site 0082) | Lewisville | Texas | 75067 | — |
| DCOL Center for Clinical Research ( Site 0051) | Longview | Texas | 75605 | — |
| Research Your Health ( Site 0042) | Plano | Texas | 75093 | — |
| IMA Clinical Research San Antonio ( Site 0009) | San Antonio | Texas | 78229 | — |
| VIP Trials ( Site 0086) | San Antonio | Texas | 78230 | — |
| Dynamed Clinical Research, LP d/b/a DM Clinical Research-DM Clinical Research ( Site 0036) | Tomball | Texas | 77375 | — |
| Olympus Family Medicine/CCT Research ( Site 0074) | Holladay | Utah | 84117 | — |
| South Ogden Family Medicine/ CCT Research ( Site 0022) | Ogden | Utah | 84405 | — |
| Charlottesville Medical Research ( Site 0034) | Charlottesville | Virginia | 22911 | — |
| Health Research of Hampton Roads, Inc. ( Site 0004) | Newport News | Virginia | 23606 | — |
| MultiCare Rockwood Cheney Clinic ( Site 0037) | Spokane | Washington | 99204 | — |
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 52 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05425732, 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 Oct 26, 2024 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05425732 live on ClinicalTrials.gov.