Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults
Public ClinicalTrials.gov record NCT03658629. 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
Phase 2 Clinical Trial to Confirm the Dose and Formulation of a Recombinant Quadrivalent Nanoparticle Influenza Vaccine (Quad-NIV) With or Without Matrix-M1™ Adjuvant in Healthy Adults ≥ 65 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A Phase 2 trial to confirm the dose and formulation, demonstrate adjuvant effect, and evaluate the safety and tolerability of a single intramuscular injection of Quad-NIV with or without Matrix-M1 adjuvant in healthy adults ≥ 65 years of age. A total of approximately 1375 subjects were to be randomized to seven treatment groups to receive Quad-NIV or an active comparator.
Study identification
- NCT ID
- NCT03658629
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 1,375 participants
Conditions and interventions
Conditions
Interventions
- NanoFlu (Quad-NIV) Biological
- Matrix-M Adjuvant Other
- Placebo Other
- Fluzone HD Biological
- Flublok Quadrivalent Biological
- Influenza Vaccine Biological
Biological · Other
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
- Sep 24, 2018 (Actual)
- Primary completion
- Apr 26, 2019 (Actual)
- Completion
- Apr 26, 2019 (Actual)
- Last update posted
- Nov 4, 2022
2018 – 2019
United States locations
- U.S. sites
- 14
- U.S. states
- 7
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| US135 | Hollywood | Florida | 33024 | — |
| US045 | Savannah | Georgia | 31406 | — |
| US013 | Stockbridge | Georgia | 30281 | — |
| US138 | Rockville | Maryland | 20854 | — |
| US025 | Norfolk | Nebraska | 68701 | — |
| US018 | Omaha | Nebraska | 68134 | — |
| US078 | Cary | North Carolina | 27518 | — |
| US108 | Raleigh | North Carolina | 27609 | — |
| US137 | Salisbury | North Carolina | 28144 | — |
| US132 | Statesville | North Carolina | 28625 | — |
| US071 | Wilmington | North Carolina | 28401 | — |
| US063 | Winston-Salem | North Carolina | 27103 | — |
| US056 | Moncks Corner | South Carolina | 29461 | — |
| US050 | Dakota Dunes | South Dakota | 57049 | — |
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 NCT03658629, 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 Nov 4, 2022 · 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 NCT03658629 live on ClinicalTrials.gov.