A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 When Administered Concomitantly With Influenza Vaccine in Healthy Adults 50 Years of Age or Older (V114-021/PNEU-FLU)
Public ClinicalTrials.gov record NCT03615482. 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, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 When Administered Concomitantly With Influenza Vaccine in Healthy Adults 50 Years of Age or Older (PNEU-FLU)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study was designed to evaluate the safety and tolerability of a single dose of V114 when administered concomitantly and non-concomitantly (i.e., 30 days after) with influenza vaccine. It also evaluated whether V114 can be administered concomitantly with influenza vaccine without impairing the antibody response to the 15 serotypes contained in V114 and to the 4 influenza viruses contained in the seasonal inactivated quadrivalent influenza vaccine (QIV). The primary hypotheses state that immune responses to V114 and to QIV are non-inferior when administered concomitantly as compared with non-concomitant administration as measured by serotype-specific opsonophagocytic activity (OPA) and hemagglutination inhibition (HAI) geometric mean titers (GMTs) at 30 days postvaccination. This study will also contribute to the overall safety database and immunogenicity data for V114 to support initial licensure in adults.
Study identification
- NCT ID
- NCT03615482
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,200 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 14, 2018 (Actual)
- Primary completion
- Jun 24, 2019 (Actual)
- Completion
- Jun 24, 2019 (Actual)
- Last update posted
- May 22, 2024
2018 – 2019
United States locations
- U.S. sites
- 45
- U.S. states
- 22
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Achieve Clinical Research, LLC ( Site 0046) | Birmingham | Alabama | 35216 | — |
| Synexus Clinical Research US, Inc. ( Site 0039) | Chandler | Arizona | 85224 | — |
| Synexus Clinical Research, US,Inc/Central Arizona Medical Associates, PC ( Site 0004) | Mesa | Arizona | 85206 | — |
| Synexus Clinical Research US, Inc. ( Site 0042) | Scottsdale | Arizona | 85251 | — |
| Southland Clinical Research Center ( Site 0033) | Fountain Valley | California | 92708 | — |
| Valley Clinical Trials Inc. ( Site 0001) | Northridge | California | 91325 | — |
| Center for Clinical Trials, LLC ( Site 0025) | Paramount | California | 90723 | — |
| Artemis Institute for Clinical Research ( Site 0026) | San Diego | California | 92103 | — |
| California Research Foundation ( Site 0002) | San Diego | California | 92123 | — |
| Bayview Research Group, LLC ( Site 0010) | Valley Village | California | 91607 | — |
| Synexus Clinical Research US, Inc./Colorado Springs Family Practice ( Site 0021) | Colorado Springs | Colorado | 80909 | — |
| Indago Research & Health Center, Inc ( Site 0007) | Hialeah | Florida | 33012 | — |
| Research Centers of America, LLC ( Site 0036) | Hollywood | Florida | 33024 | — |
| Suncoast Research Group, LLC ( Site 0020) | Miami | Florida | 33135 | — |
| L&C Professional Medical Research Institute ( Site 0015) | Miami | Florida | 33144 | — |
| Alpha Science Research ( Site 0018) | Miami | Florida | 33186 | — |
| Lakes Research LLC ( Site 0034) | Miami Lakes | Florida | 33014 | — |
| Evanston Premier Healthcare & Research, LLC. ( Site 0012) | Evanston | Illinois | 60201 | — |
| Healthcare Research Network LLC ( Site 0006) | Flossmoor | Illinois | 60422 | — |
| Springfield Clinic ( Site 0045) | Springfield | Illinois | 62703 | — |
| Heartland Research Associates, LLC ( Site 0031) | Augusta | Kansas | 67010 | — |
| Heartland Research Associates, LLC ( Site 0016) | Newton | Kansas | 67114 | — |
| Kentucky Pediatric/Adult Research Inc ( Site 0011) | Bardstown | Kentucky | 40004 | — |
| Community Clinical Research Network (Marlboro, MA) ( Site 0030) | Marlborough | Massachusetts | 01752 | — |
| Healthcare Research Network LLC ( Site 0032) | Hazelwood | Missouri | 63042 | — |
| Clinical Research Center of Neveda, LLC. ( Site 0022) | Las Vegas | Nevada | 89104 | — |
| Southwest CARE Center ( Site 0013) | Santa Fe | New Mexico | 87505 | — |
| Regional Clinical Research, Inc. ( Site 0029) | Endwell | New York | 13760 | — |
| Mid Hudson Medical Research ( Site 0024) | New Windsor | New York | 12553 | — |
| Rochester Clinical Research, Inc. ( Site 0009) | Rochester | New York | 14609 | — |
| PMG Research Of Cary LLC ( Site 0035) | Cary | North Carolina | 27518 | — |
| Unity Clinical Research ( Site 0044) | Lindsay | Oklahoma | 73052 | — |
| Clinical Research Center Of Reading LLP ( Site 0014) | Wyomissing | Pennsylvania | 19610 | — |
| Omega Medical Research ( Site 0049) | Warwick | Rhode Island | 02886 | — |
| PMG Research Inc ( Site 0027) | Mt. Pleasant | South Carolina | 29464 | — |
| Holston Medical Group ( Site 0003) | Bristol | Tennessee | 37620 | — |
| Holston Medical Group ( Site 0028) | Kingsport | Tennessee | 37660 | — |
| Clinical Research Associates Inc. ( Site 0040) | Nashville | Tennessee | 37203 | — |
| Wellness Clinical Research Associates ( Site 0048) | Allen | Texas | 75013 | — |
| Benchmark Research ( Site 0037) | Fort Worth | Texas | 76135 | — |
| San Gabriel Clinical Research ( Site 0047) | Georgetown | Texas | 78626 | — |
| Synexus Clinical Research US, Inc. ( Site 0019) | San Antonio | Texas | 78229 | — |
| Charlottesville Medical Research Center, LLC ( Site 0008) | Charlottesville | Virginia | 22911 | — |
| Clinical Research Partners, LLC. ( Site 0005) | Richmond | Virginia | 23220 | — |
| Allegiance Research Specialists ( Site 0017) | Wauwatosa | Wisconsin | 53226 | — |
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 NCT03615482, 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 May 22, 2024 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03615482 live on ClinicalTrials.gov.