NCT06482359

Lot Consistency Study of COVID-19 and Influenza Combination Vaccine

A Phase 3, Randomized, Observer-Blinded, Study to Compare the Safety and Immunogenicity of 3 Lots of SARS-CoV-2 rS Nanoparticle and Trivalent Hemagglutinin Nanoparticle Influenza Combination Vaccine With Matrix M™ Adjuvant in Participants ≥ 65 Years of Age

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The goal of Phase 3 Study is Comparing the Safety and Immune Response of Three Batches of a COVID-19 and Flu Combination Vaccine in Seniors Aged 65+

Detailed description

This is a randomized, Phase 3 study comparing the safety and immunogenicity of 3 different lots of Novavax coronavirus disease 2019 (COVID-19) and influenza combination (CIC) vaccine in terms of wild-type influenza hemagglutinin inhibition (HAI) antibody responses to 3 vaccine-homologous influenza strains (i.e., 2 influenza A strains and an influenza B-Victoria lineage strain) and 1 IM dose of Fluzone HD in terms of the neutralizing antibody (NAb) responses to the homologous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strain.

Conditions

• COVID-19
• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	coformulated CIC Vaccine	SARS-CoV-2 rS (35 µg) + trivalent hemagglutinin nanoparticle influenza (tNIV) antigen (180 µg; 60 µg per strain) + Matrix-M adjuvant (75 µg)
BIOLOGICAL	Fluzone HD trivalent	60 µg per strain of 3 strains (sodium phosphate buffered isotonic sodium chloride solution + formaldehyde and octyl phenol ethoxylate)

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-11-16
• Completion: 2026-05-17
• First posted: 2024-07-01
• Last updated: 2025-03-11

Regulatory

• FDA-regulated drug study