NCT04961541

Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine

A Phase 1/2, Randomized, Observer-Blinded Study to Evaluate the Safety and Immunogenicity of a Quadrivalent Hemagglutinin Nanoparticle Influenza and SARS-CoV-2 rS Nanoparticle Combination Vaccine With Matrix M1™ Adjuvant in Healthy Participants ≥ 50 to ≤ 70 Years of Age

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 637 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, observer-blinded, Phase 1/2 study evaluating the safety and immunogenicity of a quadrivalent HA nanoparticle influenza and SARS-CoV-2 rS nanoparticle combination vaccine with Matrix-M1 adjuvant; this combination is referred to as ICC vaccine.

Detailed description

This is a randomized, observer-blinded, Phase 1/2 study evaluating the safety and immunogenicity of a quadrivalent hemagglutinin (HA) nanoparticle influenza vaccine (qNIV) and severe acute respiratory syndrome coronavirus 2 (SARSCoV2) recombinant spike (rS) nanoparticle combination vaccine with Matrix-M1™ adjuvant; this combination vaccine is referred to as Influenza COVID-19 Combination (ICC) vaccine. The study will enroll approximately 640 healthy (based on history and physical examination) adult male and female participants 50 to 70 years of age, inclusive, targeting participants who are baseline seropositive (either previously infected with SARS-CoV-2 ≥ 8 weeks prior to enrollment, or have been previously immunized against SARS-CoV-2 with a completed regimen of an authorized vaccine at ≥ 8 weeks prior to enrollment). Randomization will be stratified on age ≥ 50 to ≤60 or ≥ 60 to ≤ 70 years to distribute the proportions of each age stratum evenly across vaccine groups.

Conditions

• SARS-CoV Infection
• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	ICC Vaccine	Intramuscular (deltoid) injections of in-clinic mix of various doses of quadrivalent hemagglutinin nanoparticle influenza vaccine(qNIV2), SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
BIOLOGICAL	qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant	Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
BIOLOGICAL	SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant	Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.

Timeline

• Start date: 2021-09-08
• Primary completion: 2021-12-22
• Completion: 2022-04-22
• First posted: 2021-07-14
• Last updated: 2025-04-10
• Results posted: 2025-04-10

Locations

10 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study