A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)
Public ClinicalTrials.gov record NCT05464420. 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, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults 18 to 49 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of age. The primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days postvaccination for all serotypes included in V116.
Study identification
- NCT ID
- NCT05464420
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,162 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 49 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
- Aug 11, 2022
- Primary completion
- May 24, 2023
- Completion
- May 24, 2023
- Last update posted
- Sep 23, 2024
2022 – 2023
United States locations
- U.S. sites
- 30
- U.S. states
- 20
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Desert Clinical Research/ CCT Research ( Site 0019) | Mesa | Arizona | 85213 | — |
| Fiel Family and Sports Medicine, PC/CCT Research ( Site 0008) | Tempe | Arizona | 85283 | — |
| Baptist Health Center For Clinical Research ( Site 0015) | Little Rock | Arkansas | 72205 | — |
| Valley Clinical Trials, Inc. ( Site 0023) | Northridge | California | 91325 | — |
| Artemis Institute for Clinical Research ( Site 0027) | San Diego | California | 92103 | — |
| Millennium Clinical Trials ( Site 0004) | Simi Valley | California | 93065 | — |
| Diablo Clinical Research, Inc. ( Site 0022) | Walnut Creek | California | 94598 | — |
| Lynn Institute of Denver ( Site 0003) | Aurora | Colorado | 80012 | — |
| Indago Research & Health Center, Inc ( Site 0011) | Hialeah | Florida | 33012 | — |
| L&C Professional Medical Research Institute ( Site 0012) | Miami | Florida | 33144 | — |
| Headlands Research Orlando ( Site 0017) | Orlando | Florida | 32819 | — |
| Clinical Research Trials of Florida ( Site 0001) | Tampa | Florida | 33607 | — |
| Clinical Research Prime Rexburg ( Site 0040) | Rexburg | Idaho | 83440 | — |
| Healthcare Research Network - Chicago ( Site 0006) | Flossmoor | Illinois | 60422 | — |
| Kentucky Pediatric/ Adult Research ( Site 0036) | Bardstown | Kentucky | 40004 | — |
| Alliance for Multispecialty Research, LLC ( Site 0031) | Kansas City | Missouri | 64114 | — |
| Methodist Physicians Clinic/CCT Research ( Site 0029) | Fremont | Nebraska | 68025 | — |
| Healor Primary Care / CCT Research ( Site 0028) | Las Vegas | Nevada | 89102 | — |
| Axces Research ( Site 0034) | Santa Fe | New Mexico | 87505 | — |
| Rochester Clinical Research, Inc. ( Site 0033) | Rochester | New York | 14609 | — |
| M3 Wake Research Associates ( Site 0035) | Raleigh | North Carolina | 27612 | — |
| Lynn Health Science Institute ( Site 0014) | Oklahoma City | Oklahoma | 73112 | — |
| Velocity Clinical Research, Providence ( Site 0018) | East Greenwich | Rhode Island | 02818 | — |
| Velocity Clinical Research, Greenville ( Site 0021) | Greenville | South Carolina | 29615 | — |
| Clinical Research Associates Inc ( Site 0039) | Nashville | Tennessee | 37203 | — |
| DCOL Center for Clinical Research ( Site 0025) | Longview | Texas | 75605 | — |
| IMA Clinical Research San Antonio ( Site 0020) | San Antonio | Texas | 78229 | — |
| Dynamed Clinical Research, LP d/b/a DM Clinical Research ( Site 0016) | Tomball | Texas | 77375 | — |
| Charlottesville Medical Research ( Site 0013) | Charlottesville | Virginia | 22911 | — |
| Health Research of Hampton Roads, Inc. ( Site 0002) | 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 42 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05464420, 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 23, 2024 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05464420 live on ClinicalTrials.gov.