Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
Public ClinicalTrials.gov record NCT04074928. 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, Observer-Blind, Multicenter, Noninferiority Study to Evaluate Safety and Immunogenicity of a Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) and a United States Licensed Quadrivalent Influenza Virus Vaccine (QIV) in Healthy Subjects 6 Months Through 47 Months
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase 3 clinical study is a randomized, observer-blind, comparator-controlled, multicenter study of QIVc versus a US-licensed comparator QIV in children 6 months through 47 months of age. The purpose of this study is to demonstrate that vaccination with QIVc elicits an immune response that is noninferior to that of a US-licensed comparator QIV containing the same virus strains, in children 6 months through 47 months of age.
Study identification
- NCT ID
- NCT04074928
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,414 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Months to 47 Months
- 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 6, 2019 (Actual)
- Primary completion
- Sep 3, 2020 (Actual)
- Completion
- Sep 3, 2020 (Actual)
- Last update posted
- Jan 12, 2022
2019 – 2020
United States locations
- U.S. sites
- 47
- U.S. states
- 19
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 84035 CCR Research | Mobile | Alabama | 36608 | — |
| 84040 Southland Clnical Research Center | Anaheim | California | 92804 | — |
| 84044 Premier Health Research Center | Downey | California | 90240 | — |
| 84028 Orange County Research Institute | Ontario | California | 91763 | — |
| 84029 Center for Clinical Trials | Paramount | California | 90723 | — |
| 84012 Benchmark Research | Sacramento | California | 95864 | — |
| 84006 California Research Foundation | San Diego | California | 92123-1881 | — |
| 84001 Acevedo Clincal Research Associates | Miami | Florida | 33142 | — |
| 84005 Sunshine Research Center | Opa-locka | Florida | 33054 | — |
| 84052 Tekton Research | Chamblee | Georgia | 30341 | — |
| 84036 Advanced Clinical Research | Meridian | Idaho | 83642 | — |
| 84027 Heartland Research Associates | El Dorado | Kansas | 67042 | — |
| 84020 Heartland Research Associates | Newton | Kansas | 67114 | — |
| 84014 Heartland Research Associates | Wichita | Kansas | 67205 | — |
| 84026 Heartland Research Associates | Wichita | Kansas | 67207 | — |
| 84041 Kentucky Pediatric/ Adult Research | Bardstown | Kentucky | 40004 | — |
| 84009 Bluegrass Clinical Research Inc. | Louisville | Kentucky | 40291 | — |
| 84008 Meridian Clinical Research | Baton Rouge | Louisiana | 70806 | — |
| 84046 ACC Pediatric Research | Haughton | Louisiana | 71037 | — |
| 84004 Benchmark Research | Metairie | Louisiana | 70006 | — |
| 84022 Med Pharmics | Metairie | Louisiana | 70006 | — |
| 84053 MedPharmics | Gulfport | Mississippi | 39503 | — |
| 84051 Office of Craig A. Spiegel | Bridgeton | Missouri | 63044 | — |
| 84016 Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | — |
| 84037 Meridian Clinical Research | Norfolk | Nebraska | 68701 | — |
| 84017 Meridian Clinical Research | Omaha | Nebraska | 68116 | — |
| 84033 Med Pharmics | Albuquerque | New Mexico | 87102 | — |
| 84013 Regional Clinical Research | Binghamton | New York | 13901 | — |
| 84045 Dayton Clinical | Dayton | Ohio | 45406 | — |
| 84003 PriMed Clinical Research | Dayton | Ohio | 45419 | — |
| 84015 Meridian Clinical Research | Dakota Dunes | South Dakota | 57049 | — |
| 84032 Clinical Research Associates | Nashville | Tennessee | 37203 | — |
| 84007 Benchmark Research | Austin | Texas | 78705 | — |
| 84023 Ventavia Research Group | Fort Worth | Texas | 76104 | — |
| 84042 Universtiy of North Texas Health Science Center | Fort Worth | Texas | 76107 | — |
| 84043 Benchmark Research | Fort Worth | Texas | 76135 | — |
| 84047 Ventavia Research Group | Houston | Texas | 77008 | — |
| 84011 West Houston Clinical Research | Houston | Texas | 77055 | — |
| 84019 Ventavia Research Group | Keller | Texas | 76248 | — |
| 84021 Benchmark Research | San Angelo | Texas | 76904 | — |
| 84002 Tekton Research | San Antonio | Texas | 78240 | — |
| 84025 Pediatric Healthcare of NW Houston | Tomball | Texas | 77375 | — |
| 84018 Tanner Clinic | Layton | Utah | 84041 | — |
| 84050 JBR Clinical Research Group | Salt Lake City | Utah | 84107 | — |
| 84048 J. Lewis Research/Foothill Family Clinic South | Salt Lake City | Utah | 84121 | — |
| 84031 Advanced Clinical Research | West Jordan | Utah | 84088 | — |
| 84039 Pediatric Research of Charlottesville | Charlottesville | Virginia | 22902 | — |
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 NCT04074928, 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 Jan 12, 2022 · 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 NCT04074928 live on ClinicalTrials.gov.