NCT06291857

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

A Randomized, Observer-Blinded, Active-Controlled Study to Evaluate the Safety and Immunogenicity of a COVID-19 Influenza Combination Nanoparticle Vaccine and a Standalone Trivalent Nanoparticle Influenza Hemagglutinin Vaccine in Participants ≥ 65 Years of Age.

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9,320 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 65 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study will enroll up to approximately 7,022,000 medically stable (based on history and physical examination) adult male and female participants ≥ 65 65 years of age in Part 1 and up to approximately 2,300 medically stable (based on history and physical examination) adult male and female participants ≥ 65 years of age in Part 2. In Part 1, pParticipants will be randomly assigned to receive either CIC, Novavax COVID-19 Vaccine, tNIV, or Fluzone High-Dose in a 3:2:1:3 ratio, respectively. All participants will receive a single intramuscular (IM) injection on Day 0, will remain on study for immunogenicity data collection through Day 182 and safety data collection through Day 364 (End of Study \[EoS\]).

Conditions

• COVID-19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-12-09
• Primary completion: 2026-07-26
• Completion: 2026-09-30
• First posted: 2024-03-04
• Last updated: 2025-07-18

Locations

58 sites across 2 countries: Australia, New Zealand

Regulatory

• FDA-regulated drug study