A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)
Public ClinicalTrials.gov record NCT05526716. 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, Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This a study of V116 in adults ≥50 years of age who concomitantly received Influenza vaccine. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116 when administered concomitantly with Quadrivalent Influenza Vaccine (QIV) compared with V116 administered sequentially with QIV. The primary hypotheses state that immune responses to V116 and to QIV are non-inferior when administered concomitantly as compared with sequential administration as measured by serotype-specific opsonophagocytic activity (OPA) for V116 and hemagglutination inhibition (HAI) geometric mean titers (GMTs) for QIV, at 30 days postvaccination.
Study identification
- NCT ID
- NCT05526716
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,080 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
- Sep 23, 2022 (Actual)
- Primary completion
- Jun 21, 2023 (Actual)
- Completion
- Jun 21, 2023 (Actual)
- Last update posted
- Oct 29, 2025
2022 – 2023
United States locations
- U.S. sites
- 56
- U.S. states
- 21
- U.S. cities
- 49
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Central Phoenix Medical Clinic-Synexus Clinical Research US ( Site 0012) | Phoenix | Arizona | 85020 | — |
| Hope Clinical Research, Inc. ( Site 0070) | Canoga Park | California | 91303 | — |
| Paradigm Clinical Research Centers, Inc ( Site 0024) | La Mesa | California | 91942 | — |
| Catalina Research Institute, LLC ( Site 0067) | Montclair | California | 91763 | — |
| WR- PRI, LLC ( Site 0044) | Newport Beach | California | 92620 | — |
| Carbon Health - North Hollywood - NoHo West ( Site 0016) | North Hollywood | California | 91606 | — |
| Valley Clinical Trials, Inc. ( Site 0002) | Northridge | California | 91325 | — |
| Artemis Institute for Clinical Research ( Site 0023) | San Diego | California | 92103 | — |
| WR-MCCR, LLC ( Site 0033) | San Diego | California | 92120 | — |
| California Research Foundation ( Site 0005) | San Diego | California | 92123 | — |
| Diablo Clinical Research, Inc. ( Site 0020) | Walnut Creek | California | 94598 | — |
| Velocity Clinical Research, Hallandale Beach ( Site 0064) | Hallandale | Florida | 33009 | — |
| Indago Research & Health Center, Inc ( Site 0029) | Hialeah | Florida | 33012 | — |
| East Coast Institute for Research, LLC ( Site 0013) | Jacksonville | Florida | 32216 | — |
| Health Awareness ( Site 0034) | Jupiter | Florida | 33458 | — |
| Optimal Research ( Site 0008) | Melbourne | Florida | 32934 | — |
| Suncoast Research Group-Clinical Department ( Site 0062) | Miami | Florida | 33135 | — |
| Suncoast Research Associates ( Site 0041) | Miami | Florida | 33173 | — |
| Alpha Science Research ( Site 0042) | Miami | Florida | 33186 | — |
| Lakes Research ( Site 0063) | Miami Lakes | Florida | 33014 | — |
| Triple O Research Institute, P.A ( Site 0054) | West Palm Beach | Florida | 33407 | — |
| East Coast Institute for Research - Canton ( Site 0004) | Canton | Georgia | 30114 | — |
| Clinical Research Atlanta ( Site 0068) | Stockbridge | Georgia | 30281 | — |
| Synexus Clinical Research US, Inc. ( Site 0072) | Chicago | Illinois | 60602 | — |
| Healthcare Research Network - Chicago ( Site 0014) | Flossmoor | Illinois | 60422 | — |
| Centennial Medical Group ( Site 0035) | Elkridge | Maryland | 21075 | — |
| Healthcare Research Network - St. Louis ( Site 0011) | St Louis | Missouri | 63042 | — |
| Radiant Research ( Site 0073) | St Louis | Missouri | 63141 | — |
| Alivation Research-Primary Care ( Site 0066) | Lincoln | Nebraska | 68526 | — |
| WR-CRCN, LLC ( Site 0018) | Las Vegas | Nevada | 89106 | — |
| Axces Research ( Site 0037) | Santa Fe | New Mexico | 87505 | — |
| Smith Allergy and Asthma Specialists-Certified Research Associates ( Site 0019) | Cortland | New York | 13045 | — |
| Synexus Clinical Research US, Inc - New York ( Site 0053) | New York | New York | 10017 | — |
| Rochester Clinical Research, Inc. ( Site 0055) | Rochester | New York | 14609 | — |
| Meridian Clinical Research, LLC ( Site 0032) | Vestal | New York | 13850 | — |
| Carolina Institute for Clinical Research ( Site 0047) | Fayetteville | North Carolina | 28303 | — |
| M3 Wake Research Associates ( Site 0040) | Raleigh | North Carolina | 27612 | — |
| CTI Clinical Research Center ( Site 0071) | Cincinnati | Ohio | 45212 | — |
| Velocity Clinical Research, Medford ( Site 0060) | Medford | Oregon | 97504 | — |
| Hatboro Medical Associates / CCT Research ( Site 0065) | Hatboro | Pennsylvania | 19040 | — |
| Velocity Clinical Research, Providence ( Site 0021) | East Greenwich | Rhode Island | 02818 | — |
| Velocity Clinical Research, Anderson ( Site 0077) | Anderson | South Carolina | 29621 | — |
| Velocity Clinical Research, Columbia ( Site 0058) | Columbia | South Carolina | 29204 | — |
| Holston Medical Group-Clinical Research ( Site 0028) | Bristol | Tennessee | 37620 | — |
| Holston Medical Group-Clinical Research ( Site 0009) | Kingsport | Tennessee | 37660 | — |
| Clinical Research Associates Inc ( Site 0026) | Nashville | Tennessee | 37203 | — |
| Optimal Research ( Site 0015) | Austin | Texas | 78705 | — |
| Headlands Research - Brownsville ( Site 0069) | Brownsville | Texas | 78526 | — |
| Benchmark Research ( Site 0025) | Fort Worth | Texas | 76135 | — |
| New Horizon Medical Group ( Site 0078) | Houston | Texas | 77042 | — |
| Innovative Medical Research of Texas ( Site 0079) | Houston | Texas | 77065 | — |
| LinQ Research ( Site 0074) | Pearland | Texas | 77584 | — |
| Synexus Clinical Research US, Inc. ( Site 0001) | Murray | Utah | 84123 | — |
| Alliance for Multispecialty Research, LLC ( Site 0051) | South Jordan | Utah | 84095 | — |
| Arthritis Northwest, PLLC ( Site 0059) | Spokane | Washington | 99204 | — |
| Velocity Clinical Research, Spokane ( Site 0050) | 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.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05526716, 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 29, 2025 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05526716 live on ClinicalTrials.gov.