NCT04120194

Phase 3 Pivotal Trial of NanoFlu™ in Older Adults

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,654 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	NanoFlu	Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
BIOLOGICAL	Fluzone Quadrivalent	Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.

Timeline

• Start date: 2019-10-14
• Primary completion: 2020-10-29
• Completion: 2020-12-13
• First posted: 2019-10-09
• Last updated: 2023-05-06
• Results posted: 2023-05-06

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study