NCT03658629

Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,375 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This randomized, observer-blind, active-controlled, Phase 2 trial was conducted at multiple sites. The composition of the Quad-NIV Influenza Vaccines used in this trial included recombinant H1, H3, and two B hemagglutinin proteins for the 2018-2019 Northern Hemisphere influenza virus strains. Approximately 1375 healthy male and female subjects ≥ 65 years were randomized into 7 treatment groups (group A to group G), receiving various formulations of Quad-NIV, with or without Matrix-M1 adjuvant or one of two active comparator influenza vaccines. Within each site, randomization was stratified by history of receipt of 2017-2018 influenza vaccine. Subjects received two injections 28 days apart. On Day 0, subjects received one of the five Quad-NIV formulations or one of the two comparator influenza vaccines. On Day 28, subjects received either placebo or a licensed influenza vaccine rescue dose, depending on his or her initial randomization. Subjects were followed for safety for approximately 6 months, with primary immunogenicity results at Day 28.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	NanoFlu (Quad-NIV)	2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
OTHER	Matrix-M Adjuvant	Adjuvant
OTHER	Placebo	Placebo
BIOLOGICAL	Fluzone HD	2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
BIOLOGICAL	Flublok Quadrivalent	2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
BIOLOGICAL	Influenza Vaccine	2018-19 Licensed Seasonal Influenza Vaccine

Timeline

• Start date: 2018-09-24
• Primary completion: 2019-04-26
• Completion: 2019-04-26
• First posted: 2018-09-05
• Last updated: 2022-11-04
• Results posted: 2022-11-04

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study