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A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine

NCT06291857 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9320

Last updated 2026-05-05

No results posted yet for this study

Summary

This is a medical study where participants will be randomly assigned to receive either a new combination vaccine that protects against both COVID-19 and the flu, or a standard flu vaccine. The researchers conducting the study won't know which vaccine each participant receives, ensuring their observations are unbiased. This study compares the new combination vaccine to an already available flu vaccine to see how well it works. It's a large-scale, final-stage study designed to thoroughly check how well the vaccines trigger an immune response (immunogenicity) and how safe they are.

Conditions

Interventions

BIOLOGICAL

CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant

CIC will contain SARs-CoV-2 antigen (35 μg), tNIV antigens (2 influenza A \[H1N1 and H3N2\] and 1 influenza B-Victoria lineage strains; 60 μg/strain

BIOLOGICAL

Novavax COVID-19 Vaccine

Each 0.5 mL dose comprises 5 µg SARS-CoV-2 S protein and 50 µg Matrix-M adjuvant

BIOLOGICAL

tNIV Vaccine

2 influenza A \[H1N1 and H3N2\] and 1 influenza B-Victoria lineage strains (60 μg/strain), and Matrix-M adjuvant (75 μg)

BIOLOGICAL

Fluzone High Dose

Fluzone High-Dose is supplied as a suspension for IM injection 0.5 mL with 60 µg per strain

Sponsors & Collaborators

  • Novavax

    lead INDUSTRY

Principal Investigators

  • Clinical Development · Novavax, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-09
Primary Completion
2026-07-26
Completion
2026-09-30
FDA Drug
Yes

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06291857 on ClinicalTrials.gov