Phase 3 Pivotal Trial of NanoFlu™ in Older Adults
Public ClinicalTrials.gov record NCT04120194. 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-blinded, Active-controlled Trial to Evaluate Immunogenicity & Safety of a Recombinant Quadrivalent Nanoparticle Influenza Vaccine (Quad-NIV) With Matrix-M1™ Adjuvant Against Fluzone® Quadrivalent in Clinically Stable Adults ≥ 65 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A Phase 3, randomized, observer-blinded, active-controlled trial to evaluate the immunogenicity and safety of a recombinant quadrivalent nanoparticle influenza vaccine with Matrix-M1 adjuvant (NanoFlu) compared with a licensed quadrivalent inactivated influenza vaccine in adults ≥ 65 years of age. Both vaccines were formulated with the 4 influenza strains recommended for the 2019-20 Northern hemisphere influenza season. 2654 subjects were enrolled and randomized into 1 of 2 treatment groups to receive either NanoFlu or active comparator. Subjects were followed for approximately 1 year following injection; with primary immunogenicity analyses based on Day 28 sera. This trial was conducted in the United States at approximately 19 clinical sites.
Study identification
- NCT ID
- NCT04120194
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,654 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 65 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
- Oct 14, 2019 (Actual)
- Primary completion
- Oct 29, 2020 (Actual)
- Completion
- Dec 13, 2020 (Actual)
- Last update posted
- May 6, 2023
2019 – 2020
United States locations
- U.S. sites
- 19
- U.S. states
- 14
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| US135 | Hollywood | Florida | 33024 | — |
| US045 | Savannah | Georgia | 31406 | — |
| US013 | Stockbridge | Georgia | 30281 | — |
| US012 | Meridian | Idaho | 83642 | — |
| US032 | Nampa | Idaho | 83687 | — |
| US003 | Lenexa | Kansas | 66219 | — |
| US138 | Rockville | Maryland | 20854 | — |
| US025 | Norfolk | Nebraska | 68701 | — |
| US018 | Omaha | Nebraska | 68134 | — |
| US056 | Binghamton | New York | 13901 | — |
| US017 | Endwell | New York | 13760 | — |
| US030 | Cleveland | Ohio | 44122 | — |
| US053 | Oklahoma City | Oklahoma | 73112 | — |
| US044 | Warwick | Rhode Island | 02886 | — |
| US079 | Mt. Pleasant | South Carolina | 29464 | — |
| US050 | Dakota Dunes | South Dakota | 57049 | — |
| US029 | Nashville | Tennessee | 37203 | — |
| US004 | San Antonio | Texas | 78229 | — |
| US073 | Tomball | Texas | 77375 | — |
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 NCT04120194, 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 6, 2023 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04120194 live on ClinicalTrials.gov.