NCT06485752

Phase 3 Lot Consistency Study of Trivalent Hemagglutinin Nanoparticle Influenza Vaccine

A Phase 3, Randomized, Observer-Blinded, Study to Compare the Safety and Immunogenicity of 3 Lots of Trivalent Hemagglutinin Nanoparticle Influenza Vaccine With Matrix M™ Adjuvant in Participants ≥ 60 Years of Age

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Phase 3 Study Comparing Safety and Immune Response of Three Batches of Novavax Flu Vaccine in older adult participants

Detailed description

This is a randomized, Phase 3 study comparing the safety and immunogenicity of 3 different lots of Novavax trivalent hemagglutinin (HA) nanoparticle influenza vaccine (NIV) with Matrix-M (tNIV) in terms of wild-type influenza hemagglutinin inhibition (HAI) antibody responses to 3 vaccine-homologous influenza strains (ie, 2 influenza A strains and an influenza B-Victoria lineage strain).

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	tNIV 1 and Matrix-M Adjuvant	tNIV will be administered as a single 0.5 mL IM injection Day 0

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-02-04
• Completion: 2025-02-04
• First posted: 2024-07-03
• Last updated: 2025-03-11

Regulatory

• FDA-regulated drug study