NCT03293498

Evaluation of the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix M-1 Adjuvant (NanoFlu)

A Phase 1/2, Randomized, Observer-Blinded, Active-Controlled Trials to Evaluate the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix-M1 Adjuvant (NanoFlu) in Healthy Older Adults

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

This was a Phase 1/2, randomized, observer-blinded, active-controlled trial to assess the Safety and Tolerability of a Recombinant Trivalent Nanoparticle Influenza Vaccine (Tri-NIV) with Matrix M1™ Adjuvant in Healthy Older Adults ≥ 60 Years of Age

Detailed description

Study tNIV-E-101 a randomized, observer-blinded, active-controlled trial designed to evaluate the safety and immunogenicity of Novavax's insect cell-derived, egg-free, influenza vaccine (Tri-NIV) based on recombinant HA nanoparticle antigens, representing the 3 major influenza types/subtypes recommended for inclusion in the 2017 - 2018 seasonal influenza vaccine by the World Health Organization (WHO) and the Center for Biologics Evaluation and Research (CBER) Approximately 330 eligible subjects were enrolled and randomized into 1 of 3 treatment groups Each group consisted of approximately 110 subjects total, stratified by age, gender, and history of receipt of the 2016 - 17 influenza vaccine. On Day 0, subjects in Groups A and B were administered an IM injection of NanoFlu at one of two dose levels; subjects in Group C received the preconfigured comparator (Fluzone HD) at the manufacturer's recommended dose and volume. On Day 21, all Group A and B subjects were administered a rescue injection with a licensed seasonal influenza vaccine. In contrast, all Group C subjects were administered an injection with a sterile saline placebo to maintain the trial blind. Trial follow-up for each subject spanned approximately 1 year from Day 0.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	NanoFlu	Vaccine
BIOLOGICAL	Fluzone HD - Day 0	Vaccine
BIOLOGICAL	Fluzone HD - Day 21	Vaccine
OTHER	Saline - Day 21	Placebo

Timeline

• Start date: 2017-09-18
• Primary completion: 2018-03-14
• Completion: 2018-10-29
• First posted: 2017-09-26
• Last updated: 2022-12-21
• Results posted: 2022-12-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study